Back to resultsAn Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis (FIGARO UC 303)
Primary Purpose
Ulcerative Colitis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ontamalimab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative colitis
Eligibility Criteria
Inclusion Criteria:
- Participants and/or their parent or legally authorized representative must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.
- Participants must be able to voluntarily provide written, signed, and dated (personally or via a legally authorized representative) informed consent and/or assent, as applicable, to participate in the study.
- Participants must have completed the 12-week induction treatment period (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
Participants must have achieved clinical response in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). Clinical response is defined as:
i) A decrease from the induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) baseline in the composite score of patient reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the sub score for rectal bleeding greater than or equal to (>=) 1 point or a sub score for rectal bleeding less than or equal to (<=) 1 OR ii) A decrease from the induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) baseline in total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding sub score of at least 1 point or an absolute rectal bleeding sub score of 0 or 1.
For eligibility assessment, clinical response will be determined based on the centrally read endoscopy performed during screening and at Week 12 of induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
- Participants receiving any treatment(s) for ulcerative colitis (UC) are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.
Exclusion Criteria:
- Participants who had major protocol deviation(s) (as determined by the sponsor) in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
- Participants who permanently discontinued investigational product because of an adverse event (AE), regardless of relatedness to investigational product, in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
- Participants who are likely to require surgery for UC during the study period.
- Participants are females who became pregnant during induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]), females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue using appropriate contraception methods (that is [i.e,] highly effective methods for female and medically appropriate methods for male study participants) through the conclusion of study participation.
- Participants who do not agree to postpone donation of any organ or tissue, including male participants who are planning to bank or donate sperm and female participants who are planning to harvest or donate eggs, for the duration of the study and through 16 weeks after last dose of investigational product.
- Participants who, in the opinion of the investigator or the sponsor, will be uncooperative or unable to comply with study procedures.
- Participants who have a newly diagnosed malignancy or recurrence of malignancy (other than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix that has been treated with no evidence of recurrence).
- Participants who have developed any major illness/condition or evidence of an unstable clinical condition (example [eg], renal, hepatic, hematologic, gastrointestinal (except disease under study), endocrine, cardiovascular, pulmonary, immunologic [eg, Felty's syndrome], or local active infection/infectious illness) that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study.
- Participants with any other severe acute or chronic medical or psychiatric condition or laboratory or electrocardiogram (ECG) abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Participants with known exposure to Mycobacterium tuberculosis (TB) since testing at screening in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) and who are without a generally accepted course of treatment.
- Participants who are investigational site staff members or relatives of those site staff members or participants who are sponsor employees directly involved in the conduct of the study.
- Participants who are participating in or plan to participate in other investigational studies (other than induction study SHP647- 301 [NCT03259334] and SHP647-302 [NCT03259308]) during study SHP647-303 [NCT03290781].
Sites / Locations
- Arizona Digestive Health Mesa - East
- Elite Clinical Studies - Phoenix - Clinedge - PPDS
- Atria Clinical Research - Clinedge - PPDS
- Advanced Research Center
- Kindred Medical Institute for Clinical Trials, LLC
- United Medical Doctors
- University of California San Diego
- OM Research LLC - Lancaster - ClinEdge - PPDS
- VA Long Beach Healthcare System - NAVREF - PPDS
- Facey Medical Foundation
- United Medical Doctors
- Alliance Clinical Research-(Vestavia Hills)
- Inland Empire Liver Foundation
- University of California San Francisco
- Care Access Research, San Pablo
- Peak Gastroenterology Associates
- Asthma and Allergy Associates PC - CRN - PPDS
- Renaissance Research Medical Group, INC
- Gastro Florida
- Advanced Clinical Research Network
- Alliance Medical Research LLC
- ENCORE Borland-Groover Clinical Research - ERN - PPDS
- SIH Research
- Crystal Biomedical Research
- Hi Tech and Global Research, LLc
- Nuren Medical and Research Center
- Sanchez Clinical Research, Inc
- Gastroenterology Group of Naples
- Pharma Research International Inc
- Omega Research Consultants LLC - Clinedge - PPDS
- Accel Research Sites - St. Petersburg - ERN - PPDS
- BRCR Medical Center, Inc
- East Coast Institute for Research, LLC
- DBC Research
- Bayside Clinical Research - New Port Richey
- Atlanta Gastroenterology Specialists, PC
- Infinite Clinical Trials
- Gastrointestinal Diseases, Inc Research - IACT- HyperCore - PPDS
- Atlanta Center For Gastroenterology PC
- Loretto Hospital
- IL Gastroenterology Group
- Edward Hines Jr VA Hospital - NAVREF - PPDS
- Dupage Medical Group
- Medisphere Medical Research Center LLC
- Laporte County Institute For Clinical Research
- Gastroenterology Associates of Hazard
- CroNOLA, LLC.
- Clinical Trials of SWLA, LLC
- Louisiana Research Center LLC
- Chevy Chase Clinical Research
- Commonwealth Clinical Studies LLC
- UMass Memorial Medical Center
- University of Michigan
- Clinical Research Institute of Michigan
- National Clinical, LLC
- Mayo Clinic Health System - PPDS
- Digestive Health Center PA
- Washington University School of Medicine
- St Louis Center For Clinical Research
- Advanced Biomedical Research of America
- Encompass Care
- New York Total Medical Care PC
- NYU Langone Long Island Clinical Research Associates
- Weill Cornell Medical College
- Southtowns Gastroenterology, PLLC
- East Carolina Gastroenterology
- Piedmont Healthcare
- Consultants For Clinical Research Inc
- Consultants For Clinical Research Inc
- Consultants For Clinical Research Inc
- Prestige Clinical Research
- Ohio Clinical Research Partners LLC
- Veteran's Research and Education Foundation - NAVREF - PPDS
- Veterans Research Foundation of Pittsburgh - NAVREF - PPDS
- Digestive Disease Associates
- Gastro One
- Vanderbilt University Medical Center
- Advanced Gastroenterology-Union City
- Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS
- Northside Gastroenterology
- Digestive Health Associates of Texas, P.A.dba DHAT Research Institute
- Precision Research Institute, LLC
- Biopharma Informatic Inc.
- Southwest Clinical Trials
- Aztec Medical Research
- BI Research Center
- Southern Star Research Institute LLC
- DM Clinical Research - ERN - PPDS
- HP Clinical Research
- Mid Atlantic Health Specialists
- Winchester Gastroenterology Associates
- CHI Franciscan Digestive Care Associates
- Exemplar Research, Inc. - Elkins
- West Virginia University Hospital
- Fundación Favaloro
- Hospital Privado Centro Médico de Córdoba
- Sanatorio 9 de Julio SA
- Concord Repatriation General Hospital
- Liverpool Hospital
- Royal Brisbane & Women's Hospital
- Mater Hospital Brisbane
- Royal Adelaide Hospital
- The Alfred Hospital
- St Vincents Hospital Melbourne - PPDS
- A.ö. Krankenhaus der Barmherzigen Brüder
- Universitätsklinikum St. Pölten
- LKH-Universitätsklinikum Klinikum Graz
- Klinikum Klagenfurt Am Woerthersee
- Salzburger Landeskliniken
- Klinikum Wels-Grieskirchen GmbH
- Medizinische Universitat Wien (Medical University of Vienna)
- UZ Gent
- UZ Gasthuisberg
- AZ Groeninge
- CHU Mouscron
- Clinical Center Banja Luka
- University Multiprofile Hospital for Active Treatment Sveta Anna
- Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD
- University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD
- Multiprofile Hospital for Active Treatment Eurohospital
- Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr.D.Gramatikov- Ruse- PPDS
- Medical Center-1-Sevlievo EOOD
- Second Multiprofile Hospital for Active Treatment Sofia
- Medical Center Excelsior OOD - PPDS
- Diagnostic and Consulting Center Aleksandrovska EOOD
- University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
- University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
- Medical Center Convex EOOD
- Diagnostic Consultative Centre Mladost - M OOD
- Percuro Clinical Research LTD
- Toronto Digestive Disease Associates Inc
- Hospital Pablo Tobón Uribe
- Servimed S.A.S
- IPS Centro Médico Julián Coronel S.A.S. - PPDS
- University Hospital Center Zagreb
- Opca Bolnica Karlovac
- Opca bolnica Bjelovar
- Clinical Hospital Centre Osijek
- University Hospital Centre Split
- General Hospital Virovitica
- General County Hospital Vukovar and Croatian Veterans Hospital
- General Hospital Zadar
- Hepato-Gastroenterologie HK, s. r. o.
- PreventaMed s.r.o.
- Institut Klinicke A Experimentalni Mediciny
- ISCARE I.V.F. a.s.
- Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
- Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice
- East Viru Central Hospital
- OÜ LV Venter
- West Tallinn Central Hospital
- Universitätsklinikum Ulm
- Universitätsklinikum der RWTH Aachen
- Uniklinik Köln
- Gastro Campus Research GbR
- Universitatsklinikum Schleswig-Holstein
- Universitatsklinikum Jena
- Gastroenterologische Facharztpraxis am Mexikoplatz
- Charité - Universitätsmedizin Berlin
- Sana Klinikum Biberach
- Universitätsklinikum Frankfurt
- Asklepios Westklinikum Hamburg Ggmbh
- Klinikum rechts der Isa der Technischen Universitaet Muenchen
- Ippokrateio General Hospital of Athens
- University General Hospital of Patras
- Theageneio Anticancer Oncology Hospital of Thessaloniki
- Euromedica - PPDS
- Magyar Honvédség Egészségügyi Központ
- Pannónia Magánorvosi Centrum Kft
- ENDOMEDIX Kft.
- Bekes Megyei Kozponti Korhaz
- Debreceni Egyetem Klinikai Kozpont
- Bekes Megyei Kozponti Korhaz
- Mohacsi Korhaz
- Tolna Megyei Balassa János Kórház
- Csongrad Megyei Dr. Bugyi Istvan Korhaz
- Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
- Csolnoky Ferenc Korhaz
- Jávorszky Ödön Kórház
- St Vincent's University Hospital
- Shaare Zedek Medical Center
- Hadassah Medical Center - PPDS
- Galilee Medical Center
- Nazareth EMMS Hospital
- Tel Aviv Sourasky Medical Center PPDS
- Baruch Padeh Poriya Medical Center
- Azienda Ospedaliera Mater Domini Di Catanzaro
- Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
- Azienda Ospedaliero Universitaria Di Modena Policlinico
- Azienda Ospedaliera San Camillo Forlanini
- Ospedale Casa Sollievo Della Sofferenza IRCCS
- Azienda Ospedaliera Universitaria Careggi
- IRCCS Ospedale Sacro Cuore Don Calabria
- Azienda Ospedale Università Padova - Dipartimento Salute della Donna e del Bambino
- A.O.U. Maggiore della Carità
- Fondazione IRCCS Policlinico San Matteo di Pavia
- La Sapienza-Università di Roma-Policlinico Umberto I
- Fondazione Policlinico Universitario A Gemelli
- Istituto Clinico Humanitas
- Azienda Ospedaliera Città della Salute e della Scienza di Torino
- Azienda Ospedaliera Ordine Mauriziano di Torino
- Sapporo Medical University Hospital
- Medical Corporation Aoyama Clinic
- Hyogo College of Medicine
- Sagamihara Kyodo Hospital
- Dokkyo Medical University Saitama Medical Center
- Nihonbashi Egawa Clinic
- Jikei University Hospital
- Kitasato University Kitasato Institute Hospital
- Ome Municipal General Hospital
- Tokatsu Tsujinaka Hospital
- Kunimoto Hospital
- Fukuoka University Chikushi Hospital
- Hakodate Koseiin Hakodate Goryoukaku Hospital
- Kawabe Clinic
- Yuai Memorial Hospital
- Hidaka Coloproctology Clinic
- Aizawa Hospital
- Aichi Medical University Hospital
- Nishinomiya Municipal Central Hospital
- Ishida Clinic of IBD and Gastroenterology
- Onomichi General Hospital
- Kinshukai Infusion Clinic
- Chiinkai Dojima General & Gastroenterology Clinic
- Shiga University of Medical Science Hospital
- Bellland General Hospital
- Toho University Sakura Medical Center
- Sapporo Tokushukai Hospital
- Sapporo Higashi Tokushukai Hospital
- Tohoku Rosai Hospital
- Dokkyo Medical University Hospital
- Medical Corporation Shoyu-kai Fujita Gastroenterology Hospital
- Koukokukai Ebisu Clinic
- Shinbeppu Hospital
- Yodogawa Christian Hospital
- Kyungpook National University Hospital
- Yonsei University Wonju Severance Christian Hospital
- CHA Bundang Medical Center, CHA University
- The Catholic University of Korea, St. Vincent's Hospital
- Inje University Haeundae Paik Hospital
- Pusan National University Hospital
- Yeungnam University Hospital
- Kyungpook National University Chilgok Hospital
- Gachon University Gil Medical Center
- Kyung Hee University Hospital
- Seoul National University Hospital
- Kangbuk Samsung Hospital
- Severance Hospital Yonsei University Health System - PPDS
- Asan Medical Center - PPDS
- Samsung Medical Center PPDS
- Inje University Seoul Paik Hospital
- Rafik Hariri University Hospital
- Hammoud Hospital University Medical Center
- Hospital of Lithuanian University of Health Sciences Kaunas Clinics
- Vilnius University Hospital Santaros Klinikos
- Vilnius City Clinical Hospital
- Clinica de Higado y Gastroenterologia Integral, S.C.
- JM Research S.C
- Unidad de Atencion Medica e Investigacion en Salud
- Centro de Investigación Médica Aguascalientes
- Phylasis Clinicas Research S. de R.L. de C.V.
- Centro de Investigacion Clinica Acelerada, S.C.
- Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
- Accelerium, S. de R.L. de C.V.
- Clinical Research Institute
- Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
- ETZ-Elisabeth
- NWZ, location Alkmaar
- Leids Universitair Medisch Centrum
- VU Medisch Centrum
- Academisch Medisch Centrum Amsterdam
- Auckland City Hospital
- Dunedin Hospital
- Wellington Hospital
- Waikato Hospital
- Melita Medical
- Lexmedica
- Vitamed Galaj i Cichomski sp.j.
- Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj
- Centrum Diagnostyczno - Lecznicze Barska sp. z o.o.
- Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny
- Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow
- Instytut Centrum Zdrowia Matki Polki
- Krakowskie Centrum Medyczne
- BioVirtus Centrum Medyczne
- Niepubliczny Zakład Opieki Zdrowotnej VIVAMED
- Miedzyleski Szpital Specjalistyczny w Warszawie
- Uniwersytecki Szpital Kliniczny w Bialymstoku
- Endoskopia Sp. z o.o.
- Szpital Zakonu Bonifratrow pw. Aniolow Strozow w Katowicach
- Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii
- Twoja Przychodnia - Szczecińskie Centrum Medyczne
- Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
- Centrum Medyczne Pratia Bydgoszcz
- Centrum Medyczne Czestochowa - PRATIA - PPDS
- Centrum Medyczne Gdynia - PRATIA - PPDS
- NZOZ All Medicus
- Centrum Medyczne A-Z Clinic Mateusz Sidor, Piotr Puc-Lekarze Spolka Partnerska
- Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
- Med Gastr Sp.z.o.o Sp.k
- Twoja Przychodnia - Centrum Medyczne Nowa Sol
- Centrum Innowacyjnych Terapii
- Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością, Medic-R Spółka Komandytowa
- Korczowski Bartosz, Gabinet Lekarski
- Bandurskiego 98/U12
- Sonomed Sp. z o.o.
- H-T. Centrum Medyczne Endoterapia
- Centrum Zdrowia MDM
- Centrum Medyczne Warszawa - PRATIA - PPDS
- Centralny Szpital Kliniczny MSW
- Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
- Hospital da Luz
- Hospital de Braga
- Centro Hospitalar do Algarve - Hospital de Portimao
- Hospital Senhora da Oliveira - Guimaraes, E.P.E
- Hospital de São Bernardo
- Cluj-Napoca Emergency Clinical County Hospital
- Dr.Carol Davila Emergency University Central Military Hospital
- Sana Monitoring SRL
- Colentina Clinical Hospital
- Prof. Dr. Matei Bals Institute of Infectious Diseases
- Fundeni Clinical Institute
- Centrul Medical Hifu Terramed Conformal S.R.L.
- Affidea Romania SRL
- Gastromedica SRL
- Dr. Tirnaveanu Amelita Private Practice
- Dr. Goldis Gastroenterology Center SRL
- Kazan State Medical University
- Moscow Clinical Scientific Center
- Moscow Regional Research Clinical Institute Na Mfvladimirskiy
- Nizhegorodskaya Regional Clinical Hospital n.a. Semashko
- Research Institute of Physiology and Basic Medicine
- Rostov State Medical University
- Rostov State Medical University
- Union Clinic, LLC
- Russian Medical Military Academy n.a. S.M. Kirov
- Medical University Reaviz
- Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city
- Medical Company Hepatolog, LLC
- SHI Regional Clinical Hospital
- Smolensk Regional Clinical Hospital
- St. Elizabeth Municipal Clinical Hospital
- First St. Petersburg State Medical University n.a. I.P Pavlov
- Stavropol State Medical University
- Regional Consulting and Diagnostics Centre
- Clinical Hospital Center Bezanijska Kosa
- University Clinical Center Nis
- General Hospital Vrsac
- University Clinical Center Kragujevac
- Univerzitna nemocnica Bratislava
- KM Management, spol. s r.o.
- Gastro LM, s.r.o.
- CLINRESCO, ARWYP Medical Suites
- Dr. J Breedt
- Dr JP Wright
- C.H. Regional Reina Sofia - PPDS
- Hospital Universitario de Fuenlabrada
- CHUVI - H.U. Alvaro Cunqueiro
- Centro Medico Teknon - Grupo Quironsalud
- Hospital Universitario Juan Ramon Jimenez
- Hospital Universitario de La Princesa
- Hospital Universitario Fundacion Jimenez Diaz
- Hospital Universitario La Paz - PPDS
- Hospital Universitario Virgen del Rocio - PPDS
- Hospital Universitari i Politecnic La Fe de Valencia
- Universität Zürich
- Istanbul Universitesi Cerrahpasa Tip Fakultesi
- Mersin University Medical Faculty
- Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital"
- Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council
- Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital
- Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC
- Municipal Non-profit Enterprise City Emergency Care Hospital of Zaporizhzhia Regional Council
- ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council
- LLC Medical Center Family Medicine Clinic
- State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"
- Clinic of SI National Institute of Therapy n.a. L.T. Mala of NAMS of Ukraine
- Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital
- MNPE of Kharkiv Regional Council Regional Clinical Specialized Dispensary of Radiation Protection
- Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh
- Municipal Enterprise Kryvyi Rih City Clinical Hospital #2 of Kryvyi Rih City Council
- Medical Center of LLC Medical Clinic Blagomed
- Kyiv City Clinical Hospital #18
- Treatment and Diagnostic Center "Healthy and Happy" of LLC "Healthy and Happy"
- Municipal Institution of KRC Kyiv Regional Hospital #2
- Lviv Railway Clinical Hospital of branch Health Center of Joint Stock Co. Ukrainian Railway
- Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital
- Municipal Non-profit Enterprise Odessa Regional Clinical Hospital of Odessa Regional Council
- MNPE Central City Clinical Hospital of Uzhhorod City Council
- Medical Clinical Research Center of Medical Center LLC Health Clinic
- Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC
- Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1
- MNPE City Hospital No. 6 of Zaporizhzhia City Council
- Aberdeen Royal Infirmary - PPDS
- Fairfield General Hospital - PPDS
- Whipps Cross University Hospital
- North Tyneside General Hospital
- Royal Shrewsbury Hospital
- Western General Hospital Edinburgh - PPDS
- Royal Gwent Hospital - PPDS
- New Cross Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Ontamalimab 25 mg
Ontamalimab 75 mg
Placebo
Arm Description
Participants will receive 25 milligram (mg) of ontamalimab or placebo and achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) will receive 25 mg of ontamalimab as maintenance treatment subcutaneously using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52.
Participants will receive 75 mg of ontamalimab or placebo and achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) will receive 75 mg of ontamalimab as maintenance treatment subcutaneously using a prefilled syringe Q4W up to Week 52.
Participants will receive 25 mg or 75 mg ontamalimab or placebo matched to ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) will receive placebo matched to ontamalimab as maintenance treatment subcutaneously using a prefilled syringe Q4W up to Week 52.
Outcomes
Primary Outcome Measures
Number of Participants With Remission Based on Composite Score at Week 52
Remission: a composite score of participant reported symptoms using daily e-diary and centrally read endoscopy as follows: stool frequency sub-score 0 or 1 with at least a 1-point change from induction study baseline; and rectal bleeding sub-score of 0; and endoscopic sub-score 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisted of Mayo score without the Physician global assessment (PGA) sub-score and ranges from 0-9 points. The Mayo score was a measure of UC disease activity ranged from 0-12 points and consisted of 4 sub-scores, each graded from 0-3 with higher scores indicating more severe disease. Sub-scores were rectal bleeding (range: 0-3, where 0= no blood & 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0-3- higher score= severe disease), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease).
Secondary Outcome Measures
Number of Participants With Endoscopic Remission at Week 52
Endoscopic remission was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score of mayo score ranged from 0 to 3, where 0=normal or inactive disease; 3=severe disease (spontaneous bleeding, ulceration).
Number of Participants With Clinical Remission at Week 52
Clinical remission was defined by stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal; 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease.
Number of Participants With Sustained Remission at Week 52
Sustained remission was defined as in remission at Week 52 visit, among participants who were in remission at the time of baseline. Remission was defined as a stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score and rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1 (modified, excludes friability). Sub-scores were rectal bleeding (range: 0-3, where 0= no blood & 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease).
Number of Participants With Clinical Response Based on Composite Score at Week 52
Clinical response was defined as a decrease from induction study baseline in the composite score of subject reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30%, with an accompanying decrease in the sub-score for rectal bleeding >=1 point or a sub-score for rectal bleeding <= 1. Composite score consisted of Mayo score without the PGA sub-score and ranges from 0 to 9 points. Mayo score was a measure of UC disease activity, ranged from 0 -12 points and consisted of 4 sub-scores, each graded from 0 -3, higher scores indicating more severe disease. The rectal bleeding sub-scores ranges from 0-3, where 0= no blood & 3=blood alone passes and centrally read endoscopic sub-score ranges from 0-3, where 0= normal/inactive disease; 3= severe disease.
Number of Participants With Mucosal Healing Based on Endoscopic and Histologic Assessment at Week 52
Mucosal healing was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability) and centrally read Geboes score of <=2. The centrally read endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease.
Number of Participants With Glucocorticoid-free Clinical Remission at Week 52
Glucocorticoid-free clinical remission was defined as clinical remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit among participants using glucocorticoids at the baseline. Clinical remission was defined as stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0, at the Week 52 visit. The stool frequency sub-score ranges from 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal and rectal bleeding sub-score ranges from 0-3, where 0= no blood & 3=blood alone passes).
Number of Participants With Glucocorticoid-free Remission at Week 52
Glucocorticoid-free remission was defined as remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit, among participants using glucocorticoids at the baseline. Remission was defined as a composite score of participant-reported symptoms using daily e-diary and endoscopy, with stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline, and rectal bleeding sub-score of 0, and endoscopic sub-score of 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisting of the Mayo score without the PGA sub-score and ranges from 0 to 9 points. The stool frequency sub-score, rectal bleeding sub-score and endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease.
Number of Participants With Remission Based on Total Mayo Score at Week 52
Remission defined as a total mayo score of less than or equal to (<=) 2 with no individual sub-score (stool frequency, rectal bleeding, endoscopy [modified, excludes friability], and physician's global assessment) exceeding 1. The total mayo score ranges from 0 to 12 points and consisted of the following 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: Sub-scores were rectal bleeding (range: 0 to 3, where 0=no blood seen and 3=blood alone passes), stool frequency (range: 0 to 3, where 0=normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0 to 3-higher score indicating the severe disease), and an endoscopic sub-score (range: 0 to 3, where 0=normal or inactive disease; 3=severe disease [spontaneous bleeding, ulceration].
Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0
Clinical remission was defined as both rectal bleeding and stool frequency sub-scores of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal, 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease.
Number of Participants With Sustained Endoscopic Remission at Week 52
Sustained endoscopic remission was defined as in endoscopic remission at Week 52 visit among participants who were in endoscopic remission at the time of baseline. Endoscopic remission was defined as a centrally read endoscopic sub-score of 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score range from 0 to 3, where 0=normal or inactive disease; 3=severe disease.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with start dates at the time of or following the first exposure to investigational product. Number of participants with TEAEs were reported.
Number of Participants Who Developed Positive Antidrug Antibodies to Ontamalimab
Antibody testing was conducted using an electro chemiluminescent signal method. Serum samples was analyzed for presence of antidrug antibodies to ontamalimab. Number of participants who developed positive results for ontamalimab were reported.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03290781
Brief Title
An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis
Acronym
FIGARO UC 303
Official Title
A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
April 4, 2018 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy treatment of remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
366 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ontamalimab 25 mg
Arm Type
Experimental
Arm Description
Participants will receive 25 milligram (mg) of ontamalimab or placebo and achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) will receive 25 mg of ontamalimab as maintenance treatment subcutaneously using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52.
Arm Title
Ontamalimab 75 mg
Arm Type
Experimental
Arm Description
Participants will receive 75 mg of ontamalimab or placebo and achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) will receive 75 mg of ontamalimab as maintenance treatment subcutaneously using a prefilled syringe Q4W up to Week 52.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive 25 mg or 75 mg ontamalimab or placebo matched to ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) will receive placebo matched to ontamalimab as maintenance treatment subcutaneously using a prefilled syringe Q4W up to Week 52.
Intervention Type
Drug
Intervention Name(s)
Ontamalimab
Other Intervention Name(s)
PF-00547659, SHP647
Intervention Description
Participants will receive 1 milliliter (mL) of ontamalimab sterile aqueous buffered solution at an appropriate oncentration to provide an intended dose of drug (25 or 75 mg).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Participants will receive 1 mL of sterile aqueous buffered solution.
Primary Outcome Measure Information:
Title
Number of Participants With Remission Based on Composite Score at Week 52
Description
Remission: a composite score of participant reported symptoms using daily e-diary and centrally read endoscopy as follows: stool frequency sub-score 0 or 1 with at least a 1-point change from induction study baseline; and rectal bleeding sub-score of 0; and endoscopic sub-score 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisted of Mayo score without the Physician global assessment (PGA) sub-score and ranges from 0-9 points. The Mayo score was a measure of UC disease activity ranged from 0-12 points and consisted of 4 sub-scores, each graded from 0-3 with higher scores indicating more severe disease. Sub-scores were rectal bleeding (range: 0-3, where 0= no blood & 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0-3- higher score= severe disease), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease).
Time Frame
At Week 52
Secondary Outcome Measure Information:
Title
Number of Participants With Endoscopic Remission at Week 52
Description
Endoscopic remission was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score of mayo score ranged from 0 to 3, where 0=normal or inactive disease; 3=severe disease (spontaneous bleeding, ulceration).
Time Frame
At Week 52
Title
Number of Participants With Clinical Remission at Week 52
Description
Clinical remission was defined by stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal; 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease.
Time Frame
At Week 52
Title
Number of Participants With Sustained Remission at Week 52
Description
Sustained remission was defined as in remission at Week 52 visit, among participants who were in remission at the time of baseline. Remission was defined as a stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score and rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1 (modified, excludes friability). Sub-scores were rectal bleeding (range: 0-3, where 0= no blood & 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease).
Time Frame
At Week 52
Title
Number of Participants With Clinical Response Based on Composite Score at Week 52
Description
Clinical response was defined as a decrease from induction study baseline in the composite score of subject reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30%, with an accompanying decrease in the sub-score for rectal bleeding >=1 point or a sub-score for rectal bleeding <= 1. Composite score consisted of Mayo score without the PGA sub-score and ranges from 0 to 9 points. Mayo score was a measure of UC disease activity, ranged from 0 -12 points and consisted of 4 sub-scores, each graded from 0 -3, higher scores indicating more severe disease. The rectal bleeding sub-scores ranges from 0-3, where 0= no blood & 3=blood alone passes and centrally read endoscopic sub-score ranges from 0-3, where 0= normal/inactive disease; 3= severe disease.
Time Frame
At Week 52
Title
Number of Participants With Mucosal Healing Based on Endoscopic and Histologic Assessment at Week 52
Description
Mucosal healing was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability) and centrally read Geboes score of <=2. The centrally read endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease.
Time Frame
At Week 52
Title
Number of Participants With Glucocorticoid-free Clinical Remission at Week 52
Description
Glucocorticoid-free clinical remission was defined as clinical remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit among participants using glucocorticoids at the baseline. Clinical remission was defined as stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0, at the Week 52 visit. The stool frequency sub-score ranges from 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal and rectal bleeding sub-score ranges from 0-3, where 0= no blood & 3=blood alone passes).
Time Frame
At Week 52
Title
Number of Participants With Glucocorticoid-free Remission at Week 52
Description
Glucocorticoid-free remission was defined as remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit, among participants using glucocorticoids at the baseline. Remission was defined as a composite score of participant-reported symptoms using daily e-diary and endoscopy, with stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline, and rectal bleeding sub-score of 0, and endoscopic sub-score of 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisting of the Mayo score without the PGA sub-score and ranges from 0 to 9 points. The stool frequency sub-score, rectal bleeding sub-score and endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease.
Time Frame
At Week 52
Title
Number of Participants With Remission Based on Total Mayo Score at Week 52
Description
Remission defined as a total mayo score of less than or equal to (<=) 2 with no individual sub-score (stool frequency, rectal bleeding, endoscopy [modified, excludes friability], and physician's global assessment) exceeding 1. The total mayo score ranges from 0 to 12 points and consisted of the following 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: Sub-scores were rectal bleeding (range: 0 to 3, where 0=no blood seen and 3=blood alone passes), stool frequency (range: 0 to 3, where 0=normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0 to 3-higher score indicating the severe disease), and an endoscopic sub-score (range: 0 to 3, where 0=normal or inactive disease; 3=severe disease [spontaneous bleeding, ulceration].
Time Frame
At Week 52
Title
Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0
Description
Clinical remission was defined as both rectal bleeding and stool frequency sub-scores of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal, 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease.
Time Frame
At Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Title
Number of Participants With Sustained Endoscopic Remission at Week 52
Description
Sustained endoscopic remission was defined as in endoscopic remission at Week 52 visit among participants who were in endoscopic remission at the time of baseline. Endoscopic remission was defined as a centrally read endoscopic sub-score of 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score range from 0 to 3, where 0=normal or inactive disease; 3=severe disease.
Time Frame
At Week 52
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Description
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with start dates at the time of or following the first exposure to investigational product. Number of participants with TEAEs were reported.
Time Frame
From start of study drug administration up to follow-up (Week 64)
Title
Number of Participants Who Developed Positive Antidrug Antibodies to Ontamalimab
Description
Antibody testing was conducted using an electro chemiluminescent signal method. Serum samples was analyzed for presence of antidrug antibodies to ontamalimab. Number of participants who developed positive results for ontamalimab were reported.
Time Frame
At Week 12, 24, 36 and 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants and/or their parent or legally authorized representative must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.
Participants must be able to voluntarily provide written, signed, and dated (personally or via a legally authorized representative) informed consent and/or assent, as applicable, to participate in the study.
Participants must have completed the 12-week induction treatment period (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
Participants must have achieved clinical response in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). Clinical response is defined as:
i) A decrease from the induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) baseline in the composite score of patient reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the sub score for rectal bleeding greater than or equal to (>=) 1 point or a sub score for rectal bleeding less than or equal to (<=) 1 OR ii) A decrease from the induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) baseline in total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding sub score of at least 1 point or an absolute rectal bleeding sub score of 0 or 1.
For eligibility assessment, clinical response will be determined based on the centrally read endoscopy performed during screening and at Week 12 of induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
- Participants receiving any treatment(s) for ulcerative colitis (UC) are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.
Exclusion Criteria:
Participants who had major protocol deviation(s) (as determined by the sponsor) in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
Participants who permanently discontinued investigational product because of an adverse event (AE), regardless of relatedness to investigational product, in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
Participants who are likely to require surgery for UC during the study period.
Participants are females who became pregnant during induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]), females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue using appropriate contraception methods (that is [i.e,] highly effective methods for female and medically appropriate methods for male study participants) through the conclusion of study participation.
Participants who do not agree to postpone donation of any organ or tissue, including male participants who are planning to bank or donate sperm and female participants who are planning to harvest or donate eggs, for the duration of the study and through 16 weeks after last dose of investigational product.
Participants who, in the opinion of the investigator or the sponsor, will be uncooperative or unable to comply with study procedures.
Participants who have a newly diagnosed malignancy or recurrence of malignancy (other than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix that has been treated with no evidence of recurrence).
Participants who have developed any major illness/condition or evidence of an unstable clinical condition (example [eg], renal, hepatic, hematologic, gastrointestinal (except disease under study), endocrine, cardiovascular, pulmonary, immunologic [eg, Felty's syndrome], or local active infection/infectious illness) that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study.
Participants with any other severe acute or chronic medical or psychiatric condition or laboratory or electrocardiogram (ECG) abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Participants with known exposure to Mycobacterium tuberculosis (TB) since testing at screening in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) and who are without a generally accepted course of treatment.
Participants who are investigational site staff members or relatives of those site staff members or participants who are sponsor employees directly involved in the conduct of the study.
Participants who are participating in or plan to participate in other investigational studies (other than induction study SHP647- 301 [NCT03259334] and SHP647-302 [NCT03259308]) during study SHP647-303 [NCT03290781].
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Shire
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Digestive Health Mesa - East
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Elite Clinical Studies - Phoenix - Clinedge - PPDS
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Atria Clinical Research - Clinedge - PPDS
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72209
Country
United States
Facility Name
Advanced Research Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Kindred Medical Institute for Clinical Trials, LLC
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
United Medical Doctors
City
Encinitas
State/Province
California
ZIP/Postal Code
92024-1350
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
OM Research LLC - Lancaster - ClinEdge - PPDS
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
VA Long Beach Healthcare System - NAVREF - PPDS
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Facey Medical Foundation
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
United Medical Doctors
City
Murrieta
State/Province
California
ZIP/Postal Code
92563
Country
United States
Facility Name
Alliance Clinical Research-(Vestavia Hills)
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Inland Empire Liver Foundation
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Care Access Research, San Pablo
City
San Pablo
State/Province
California
ZIP/Postal Code
94806
Country
United States
Facility Name
Peak Gastroenterology Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80903
Country
United States
Facility Name
Asthma and Allergy Associates PC - CRN - PPDS
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Renaissance Research Medical Group, INC
City
Cape Coral
State/Province
Florida
ZIP/Postal Code
33991
Country
United States
Facility Name
Gastro Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Advanced Clinical Research Network
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Alliance Medical Research LLC
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33071
Country
United States
Facility Name
ENCORE Borland-Groover Clinical Research - ERN - PPDS
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
SIH Research
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Crystal Biomedical Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33065
Country
United States
Facility Name
Hi Tech and Global Research, LLc
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Nuren Medical and Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Sanchez Clinical Research, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Gastroenterology Group of Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Pharma Research International Inc
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Omega Research Consultants LLC - Clinedge - PPDS
City
Orlando
State/Province
Florida
ZIP/Postal Code
32810
Country
United States
Facility Name
Accel Research Sites - St. Petersburg - ERN - PPDS
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
BRCR Medical Center, Inc
City
Plantation
State/Province
Florida
ZIP/Postal Code
33322
Country
United States
Facility Name
East Coast Institute for Research, LLC
City
Saint Augustine
State/Province
Florida
ZIP/Postal Code
32086
Country
United States
Facility Name
DBC Research
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Bayside Clinical Research - New Port Richey
City
Tampa
State/Province
Florida
ZIP/Postal Code
33604
Country
United States
Facility Name
Atlanta Gastroenterology Specialists, PC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Infinite Clinical Trials
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30349
Country
United States
Facility Name
Gastrointestinal Diseases, Inc Research - IACT- HyperCore - PPDS
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Atlanta Center For Gastroenterology PC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Loretto Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60644
Country
United States
Facility Name
IL Gastroenterology Group
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Edward Hines Jr VA Hospital - NAVREF - PPDS
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
Dupage Medical Group
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60181
Country
United States
Facility Name
Medisphere Medical Research Center LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Laporte County Institute For Clinical Research
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
Country
United States
Facility Name
Gastroenterology Associates of Hazard
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
CroNOLA, LLC.
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Clinical Trials of SWLA, LLC
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Louisiana Research Center LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Commonwealth Clinical Studies LLC
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02302
Country
United States
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Clinical Research Institute of Michigan
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
National Clinical, LLC
City
Hamtramck
State/Province
Michigan
ZIP/Postal Code
48212
Country
United States
Facility Name
Mayo Clinic Health System - PPDS
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Digestive Health Center PA
City
Ocean Springs
State/Province
Mississippi
ZIP/Postal Code
39564
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St Louis Center For Clinical Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Advanced Biomedical Research of America
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Encompass Care
City
North Las Vegas
State/Province
Nevada
ZIP/Postal Code
89086
Country
United States
Facility Name
New York Total Medical Care PC
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
NYU Langone Long Island Clinical Research Associates
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Southtowns Gastroenterology, PLLC
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
Facility Name
East Carolina Gastroenterology
City
Jacksonville
State/Province
North Carolina
ZIP/Postal Code
28546
Country
United States
Facility Name
Piedmont Healthcare
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
Country
United States
Facility Name
Consultants For Clinical Research Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Consultants For Clinical Research Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Consultants For Clinical Research Inc
City
Fairfield
State/Province
Ohio
ZIP/Postal Code
45014
Country
United States
Facility Name
Prestige Clinical Research
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Ohio Clinical Research Partners LLC
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Veteran's Research and Education Foundation - NAVREF - PPDS
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Veterans Research Foundation of Pittsburgh - NAVREF - PPDS
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
Digestive Disease Associates
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Advanced Gastroenterology-Union City
City
Union City
State/Province
Tennessee
ZIP/Postal Code
38237
Country
United States
Facility Name
Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
Northside Gastroenterology
City
Cypress
State/Province
Texas
ZIP/Postal Code
77429
Country
United States
Facility Name
Digestive Health Associates of Texas, P.A.dba DHAT Research Institute
City
Garland
State/Province
Texas
ZIP/Postal Code
75044
Country
United States
Facility Name
Precision Research Institute, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77039
Country
United States
Facility Name
Biopharma Informatic Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77043
Country
United States
Facility Name
Southwest Clinical Trials
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Aztec Medical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
BI Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
Southern Star Research Institute LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
DM Clinical Research - ERN - PPDS
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
HP Clinical Research
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
Mid Atlantic Health Specialists
City
Galax
State/Province
Virginia
ZIP/Postal Code
24333
Country
United States
Facility Name
Winchester Gastroenterology Associates
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601-2872
Country
United States
Facility Name
CHI Franciscan Digestive Care Associates
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Exemplar Research, Inc. - Elkins
City
Elkins
State/Province
West Virginia
ZIP/Postal Code
26241
Country
United States
Facility Name
West Virginia University Hospital
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Fundación Favaloro
City
Buenos Aires
ZIP/Postal Code
C1093AAS
Country
Argentina
Facility Name
Hospital Privado Centro Médico de Córdoba
City
Córdoba
Country
Argentina
Facility Name
Sanatorio 9 de Julio SA
City
San Miguel De Tucumán
Country
Argentina
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Royal Brisbane & Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Mater Hospital Brisbane
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
The Alfred Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
St Vincents Hospital Melbourne - PPDS
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
A.ö. Krankenhaus der Barmherzigen Brüder
City
St. Veit an der Glan
State/Province
Kärnten
ZIP/Postal Code
9300
Country
Austria
Facility Name
Universitätsklinikum St. Pölten
City
St. Pölten
State/Province
Saint Pölten
ZIP/Postal Code
3100
Country
Austria
Facility Name
LKH-Universitätsklinikum Klinikum Graz
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
Klinikum Klagenfurt Am Woerthersee
City
Klagenfurt am Wörthersee
ZIP/Postal Code
9020
Country
Austria
Facility Name
Salzburger Landeskliniken
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Klinikum Wels-Grieskirchen GmbH
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Medizinische Universitat Wien (Medical University of Vienna)
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
UZ Gent
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Gasthuisberg
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Groeninge
City
Kortrijk
State/Province
West-Vlaanderen
ZIP/Postal Code
8500
Country
Belgium
Facility Name
CHU Mouscron
City
Mouscron
ZIP/Postal Code
7700
Country
Belgium
Facility Name
Clinical Center Banja Luka
City
Banja Luka
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
University Multiprofile Hospital for Active Treatment Sveta Anna
City
Sofia
State/Province
Sofia-Grad
ZIP/Postal Code
1750
Country
Bulgaria
Facility Name
Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD
City
Sofia
State/Province
Sofia-Grad
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Eurohospital
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr.D.Gramatikov- Ruse- PPDS
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Medical Center-1-Sevlievo EOOD
City
Sevlievo
ZIP/Postal Code
5400
Country
Bulgaria
Facility Name
Second Multiprofile Hospital for Active Treatment Sofia
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Facility Name
Medical Center Excelsior OOD - PPDS
City
Sofia
ZIP/Postal Code
1421
Country
Bulgaria
Facility Name
Diagnostic and Consulting Center Aleksandrovska EOOD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Medical Center Convex EOOD
City
Sofia
ZIP/Postal Code
1680
Country
Bulgaria
Facility Name
Diagnostic Consultative Centre Mladost - M OOD
City
Varna
ZIP/Postal Code
9020
Country
Bulgaria
Facility Name
Percuro Clinical Research LTD
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8P 2P5
Country
Canada
Facility Name
Toronto Digestive Disease Associates Inc
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3N 2V7
Country
Canada
Facility Name
Hospital Pablo Tobón Uribe
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050034
Country
Colombia
Facility Name
Servimed S.A.S
City
Bucaramanga
State/Province
Santander
Country
Colombia
Facility Name
IPS Centro Médico Julián Coronel S.A.S. - PPDS
City
Cali
Country
Colombia
Facility Name
University Hospital Center Zagreb
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Opca Bolnica Karlovac
City
Karlovac
State/Province
Karlovacka Županija
ZIP/Postal Code
47000
Country
Croatia
Facility Name
Opca bolnica Bjelovar
City
Bjelovar
ZIP/Postal Code
43000
Country
Croatia
Facility Name
Clinical Hospital Centre Osijek
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
University Hospital Centre Split
City
Split
ZIP/Postal Code
21000
Country
Croatia
Facility Name
General Hospital Virovitica
City
Virovitica
ZIP/Postal Code
33000
Country
Croatia
Facility Name
General County Hospital Vukovar and Croatian Veterans Hospital
City
Vukovar
ZIP/Postal Code
32000
Country
Croatia
Facility Name
General Hospital Zadar
City
Zadar
ZIP/Postal Code
23 000
Country
Croatia
Facility Name
Hepato-Gastroenterologie HK, s. r. o.
City
Hradec Králové
State/Province
Královéhradecký Kraj
ZIP/Postal Code
500 12
Country
Czechia
Facility Name
PreventaMed s.r.o.
City
Olomouc
State/Province
Olomoucký Kraj
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Institut Klinicke A Experimentalni Mediciny
City
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
ISCARE I.V.F. a.s.
City
Praha 7
ZIP/Postal Code
170 00
Country
Czechia
Facility Name
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice
City
Ústi Nad Orlici
ZIP/Postal Code
562 18
Country
Czechia
Facility Name
East Viru Central Hospital
City
Kohta-Järve
ZIP/Postal Code
31025
Country
Estonia
Facility Name
OÜ LV Venter
City
Parnu
ZIP/Postal Code
80010
Country
Estonia
Facility Name
West Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Universitätsklinikum Ulm
City
Ulm
State/Province
Baden-Württemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Universitätsklinikum der RWTH Aachen
City
Aachen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Uniklinik Köln
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Gastro Campus Research GbR
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48159
Country
Germany
Facility Name
Universitatsklinikum Schleswig-Holstein
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitatsklinikum Jena
City
Jena
State/Province
Thüringen
ZIP/Postal Code
07747
Country
Germany
Facility Name
Gastroenterologische Facharztpraxis am Mexikoplatz
City
Berlin-Zehlendorf
ZIP/Postal Code
14163
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Sana Klinikum Biberach
City
Biberach an der Riss
ZIP/Postal Code
88400
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Asklepios Westklinikum Hamburg Ggmbh
City
Hamburg
ZIP/Postal Code
22559
Country
Germany
Facility Name
Klinikum rechts der Isa der Technischen Universitaet Muenchen
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
Ippokrateio General Hospital of Athens
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Facility Name
University General Hospital of Patras
City
Patras
ZIP/Postal Code
26504
Country
Greece
Facility Name
Theageneio Anticancer Oncology Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
54007
Country
Greece
Facility Name
Euromedica - PPDS
City
Thessaloniki
ZIP/Postal Code
54645
Country
Greece
Facility Name
Magyar Honvédség Egészségügyi Központ
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Pannónia Magánorvosi Centrum Kft
City
Budapest
ZIP/Postal Code
1136
Country
Hungary
Facility Name
ENDOMEDIX Kft.
City
Budapest
ZIP/Postal Code
1139
Country
Hungary
Facility Name
Bekes Megyei Kozponti Korhaz
City
Békéscsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Bekes Megyei Kozponti Korhaz
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Mohacsi Korhaz
City
Mohacs
ZIP/Postal Code
7700
Country
Hungary
Facility Name
Tolna Megyei Balassa János Kórház
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Csongrad Megyei Dr. Bugyi Istvan Korhaz
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Csolnoky Ferenc Korhaz
City
Veszprém
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Jávorszky Ödön Kórház
City
Vác
ZIP/Postal Code
2600
Country
Hungary
Facility Name
St Vincent's University Hospital
City
Dublin
Country
Ireland
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Hadassah Medical Center - PPDS
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Galilee Medical Center
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Nazareth EMMS Hospital
City
Nazareth
ZIP/Postal Code
16100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center PPDS
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Baruch Padeh Poriya Medical Center
City
Tiberias
ZIP/Postal Code
15208
Country
Israel
Facility Name
Azienda Ospedaliera Mater Domini Di Catanzaro
City
Catanzaro
State/Province
Calabria
ZIP/Postal Code
88100
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Di Modena Policlinico
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41124
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Roma
State/Province
Lazio
ZIP/Postal Code
00152
Country
Italy
Facility Name
Ospedale Casa Sollievo Della Sofferenza IRCCS
City
San Giovanni Rotondo
State/Province
Puglia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
IRCCS Ospedale Sacro Cuore Don Calabria
City
Negrar
State/Province
Veneto
ZIP/Postal Code
37024
Country
Italy
Facility Name
Azienda Ospedale Università Padova - Dipartimento Salute della Donna e del Bambino
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
A.O.U. Maggiore della Carità
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo di Pavia
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
La Sapienza-Università di Roma-Policlinico Umberto I
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Fondazione Policlinico Universitario A Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano (MI)
ZIP/Postal Code
20089
Country
Italy
Facility Name
Azienda Ospedaliera Città della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Azienda Ospedaliera Ordine Mauriziano di Torino
City
Torino
ZIP/Postal Code
10128
Country
Italy
Facility Name
Sapporo Medical University Hospital
City
Sapporo
State/Province
Hokkaidô
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Medical Corporation Aoyama Clinic
City
Kobe-shi
State/Province
Hyôgo
ZIP/Postal Code
650-0015
Country
Japan
Facility Name
Hyogo College of Medicine
City
Nishinomiya-shi
State/Province
Hyôgo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Sagamihara Kyodo Hospital
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
252-5188
Country
Japan
Facility Name
Dokkyo Medical University Saitama Medical Center
City
Koshigaya
State/Province
Saitama
ZIP/Postal Code
343-8555
Country
Japan
Facility Name
Nihonbashi Egawa Clinic
City
Chuo-Ku
State/Province
Tokyo
ZIP/Postal Code
103-0028
Country
Japan
Facility Name
Jikei University Hospital
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
Facility Name
Kitasato University Kitasato Institute Hospital
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-8642
Country
Japan
Facility Name
Ome Municipal General Hospital
City
Ome
State/Province
Tokyo
ZIP/Postal Code
198-0042
Country
Japan
Facility Name
Tokatsu Tsujinaka Hospital
City
Abiko
ZIP/Postal Code
270-1166
Country
Japan
Facility Name
Kunimoto Hospital
City
Asahikawa
ZIP/Postal Code
070-0061
Country
Japan
Facility Name
Fukuoka University Chikushi Hospital
City
Chikushino
ZIP/Postal Code
818-8502
Country
Japan
Facility Name
Hakodate Koseiin Hakodate Goryoukaku Hospital
City
Hakodate
ZIP/Postal Code
040-0001
Country
Japan
Facility Name
Kawabe Clinic
City
Koganei
ZIP/Postal Code
184-0003
Country
Japan
Facility Name
Yuai Memorial Hospital
City
Koga
ZIP/Postal Code
306-0232
Country
Japan
Facility Name
Hidaka Coloproctology Clinic
City
Kurume-shi
ZIP/Postal Code
839-0809
Country
Japan
Facility Name
Aizawa Hospital
City
Matsumoto-shi
ZIP/Postal Code
390-0814
Country
Japan
Facility Name
Aichi Medical University Hospital
City
Nagakute
ZIP/Postal Code
480-1195
Country
Japan
Facility Name
Nishinomiya Municipal Central Hospital
City
Nishinomiya
ZIP/Postal Code
663-8014
Country
Japan
Facility Name
Ishida Clinic of IBD and Gastroenterology
City
Oita
ZIP/Postal Code
870-0823
Country
Japan
Facility Name
Onomichi General Hospital
City
Onomichi
Country
Japan
Facility Name
Kinshukai Infusion Clinic
City
Osaka-shi
ZIP/Postal Code
530-0011
Country
Japan
Facility Name
Chiinkai Dojima General & Gastroenterology Clinic
City
Osaka
ZIP/Postal Code
530-0003
Country
Japan
Facility Name
Shiga University of Medical Science Hospital
City
Otsu-Shi
ZIP/Postal Code
520-2192
Country
Japan
Facility Name
Bellland General Hospital
City
Sakai
ZIP/Postal Code
599-8247
Country
Japan
Facility Name
Toho University Sakura Medical Center
City
Sakura
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Sapporo Tokushukai Hospital
City
Sapporo-shi
ZIP/Postal Code
065-0033
Country
Japan
Facility Name
Sapporo Higashi Tokushukai Hospital
City
Sapporo
ZIP/Postal Code
065-0033
Country
Japan
Facility Name
Tohoku Rosai Hospital
City
Sendai
ZIP/Postal Code
981-8563
Country
Japan
Facility Name
Dokkyo Medical University Hospital
City
Shimotsuga-gun
ZIP/Postal Code
321-0293
Country
Japan
Facility Name
Medical Corporation Shoyu-kai Fujita Gastroenterology Hospital
City
Takatsuki
ZIP/Postal Code
569-0086
Country
Japan
Facility Name
Koukokukai Ebisu Clinic
City
Tokyo
ZIP/Postal Code
150-0013
Country
Japan
Facility Name
Shinbeppu Hospital
City
Beppu
State/Province
Ôita
ZIP/Postal Code
874-0833
Country
Japan
Facility Name
Yodogawa Christian Hospital
City
Osaka
State/Province
Ôsaka
ZIP/Postal Code
533-0024
Country
Japan
Facility Name
Kyungpook National University Hospital
City
Daegu
State/Province
Daegu Gwang'yeogsi
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Yonsei University Wonju Severance Christian Hospital
City
Wonju
State/Province
Gang'weondo
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Center, CHA University
City
Seongnam
State/Province
Gyeonggido
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, St. Vincent's Hospital
City
Suwon
State/Province
Gyeonggido
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Yeungnam University Hospital
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
702-210
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
02447
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System - PPDS
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center - PPDS
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center PPDS
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Inje University Seoul Paik Hospital
City
Seoul
ZIP/Postal Code
100-032
Country
Korea, Republic of
Facility Name
Rafik Hariri University Hospital
City
Beirut
Country
Lebanon
Facility Name
Hammoud Hospital University Medical Center
City
Saida
Country
Lebanon
Facility Name
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
Vilnius University Hospital Santaros Klinikos
City
Vilnius
ZIP/Postal Code
LT- 08661
Country
Lithuania
Facility Name
Vilnius City Clinical Hospital
City
Vilnius
ZIP/Postal Code
LT-10207
Country
Lithuania
Facility Name
Clinica de Higado y Gastroenterologia Integral, S.C.
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62170
Country
Mexico
Facility Name
JM Research S.C
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62290
Country
Mexico
Facility Name
Unidad de Atencion Medica e Investigacion en Salud
City
Merida
State/Province
Yucatán
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Centro de Investigación Médica Aguascalientes
City
Aguascalientes
ZIP/Postal Code
20116
Country
Mexico
Facility Name
Phylasis Clinicas Research S. de R.L. de C.V.
City
Cuautitlán Izcalli
ZIP/Postal Code
54769
Country
Mexico
Facility Name
Centro de Investigacion Clinica Acelerada, S.C.
City
Distrito Federal
ZIP/Postal Code
07020
Country
Mexico
Facility Name
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
Accelerium, S. de R.L. de C.V.
City
Monterrey
ZIP/Postal Code
64000
Country
Mexico
Facility Name
Clinical Research Institute
City
Tlalnepantla De Baz
ZIP/Postal Code
54055
Country
Mexico
Facility Name
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
City
Zapopan
ZIP/Postal Code
45030
Country
Mexico
Facility Name
ETZ-Elisabeth
City
Tilburg
State/Province
Noord-Brabant
ZIP/Postal Code
5022 GC
Country
Netherlands
Facility Name
NWZ, location Alkmaar
City
Alkmaar
State/Province
Noord-Holland
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
State/Province
Zuid-Holland
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
VU Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Academisch Medisch Centrum Amsterdam
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Auckland City Hospital
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Dunedin Hospital
City
Dunedin
State/Province
South Island
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
Wellington Hospital
City
Newtown
State/Province
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Melita Medical
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-449
Country
Poland
Facility Name
Lexmedica
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
53-114
Country
Poland
Facility Name
Vitamed Galaj i Cichomski sp.j.
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-079
Country
Poland
Facility Name
Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj
City
Torun
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Centrum Diagnostyczno - Lecznicze Barska sp. z o.o.
City
Wloclawek
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
87-800
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny
City
Lódz
State/Province
Lódzkie
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow
City
Lódz
State/Province
Lódzkie
ZIP/Postal Code
90-647
Country
Poland
Facility Name
Instytut Centrum Zdrowia Matki Polki
City
Lódz
State/Province
Lódzkie
ZIP/Postal Code
93-338
Country
Poland
Facility Name
Krakowskie Centrum Medyczne
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-501
Country
Poland
Facility Name
BioVirtus Centrum Medyczne
City
Jozefow
State/Province
Mazowieckie
ZIP/Postal Code
05-410
Country
Poland
Facility Name
Niepubliczny Zakład Opieki Zdrowotnej VIVAMED
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
03-580
Country
Poland
Facility Name
Miedzyleski Szpital Specjalistyczny w Warszawie
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
04-749
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny w Bialymstoku
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Endoskopia Sp. z o.o.
City
Sopot
State/Province
Pomorskie
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Szpital Zakonu Bonifratrow pw. Aniolow Strozow w Katowicach
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-211
Country
Poland
Facility Name
Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii
City
Konskie
State/Province
Swietokrzyskie
ZIP/Postal Code
26-200
Country
Poland
Facility Name
Twoja Przychodnia - Szczecińskie Centrum Medyczne
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
71-434
Country
Poland
Facility Name
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Centrum Medyczne Pratia Bydgoszcz
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Centrum Medyczne Czestochowa - PRATIA - PPDS
City
Czestochowa
ZIP/Postal Code
42-200
Country
Poland
Facility Name
Centrum Medyczne Gdynia - PRATIA - PPDS
City
Gdynia
ZIP/Postal Code
81-338
Country
Poland
Facility Name
NZOZ All Medicus
City
Katowice
ZIP/Postal Code
40-659
Country
Poland
Facility Name
Centrum Medyczne A-Z Clinic Mateusz Sidor, Piotr Puc-Lekarze Spolka Partnerska
City
Krakow
ZIP/Postal Code
31-315
Country
Poland
Facility Name
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
City
Ksawerow
ZIP/Postal Code
95-054
Country
Poland
Facility Name
Med Gastr Sp.z.o.o Sp.k
City
Lodz
ZIP/Postal Code
91-034
Country
Poland
Facility Name
Twoja Przychodnia - Centrum Medyczne Nowa Sol
City
Nowa Sól
ZIP/Postal Code
67-100
Country
Poland
Facility Name
Centrum Innowacyjnych Terapii
City
Piaseczno
ZIP/Postal Code
05-500
Country
Poland
Facility Name
Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością, Medic-R Spółka Komandytowa
City
Poznan
ZIP/Postal Code
60-856
Country
Poland
Facility Name
Korczowski Bartosz, Gabinet Lekarski
City
Rzeszow
ZIP/Postal Code
35-302
Country
Poland
Facility Name
Bandurskiego 98/U12
City
Szczecin
ZIP/Postal Code
71-685
Country
Poland
Facility Name
Sonomed Sp. z o.o.
City
Szczecin
ZIP/Postal Code
71-685
Country
Poland
Facility Name
H-T. Centrum Medyczne Endoterapia
City
Tychy
ZIP/Postal Code
43-100
Country
Poland
Facility Name
Centrum Zdrowia MDM
City
Warszawa
ZIP/Postal Code
00-635
Country
Poland
Facility Name
Centrum Medyczne Warszawa - PRATIA - PPDS
City
Warszawa
ZIP/Postal Code
01-868
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSW
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
City
Zamosc
ZIP/Postal Code
22-400
Country
Poland
Facility Name
Hospital da Luz
City
Lisbon
State/Province
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Facility Name
Hospital de Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Centro Hospitalar do Algarve - Hospital de Portimao
City
Faro
ZIP/Postal Code
8000-385
Country
Portugal
Facility Name
Hospital Senhora da Oliveira - Guimaraes, E.P.E
City
Guimarães
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Hospital de São Bernardo
City
Setubal
ZIP/Postal Code
2910-446
Country
Portugal
Facility Name
Cluj-Napoca Emergency Clinical County Hospital
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400006
Country
Romania
Facility Name
Dr.Carol Davila Emergency University Central Military Hospital
City
Bucharest
ZIP/Postal Code
010825
Country
Romania
Facility Name
Sana Monitoring SRL
City
Bucharest
ZIP/Postal Code
011025
Country
Romania
Facility Name
Colentina Clinical Hospital
City
Bucharest
ZIP/Postal Code
020125
Country
Romania
Facility Name
Prof. Dr. Matei Bals Institute of Infectious Diseases
City
Bucharest
ZIP/Postal Code
021105
Country
Romania
Facility Name
Fundeni Clinical Institute
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Centrul Medical Hifu Terramed Conformal S.R.L.
City
Bucuresti
ZIP/Postal Code
031864
Country
Romania
Facility Name
Affidea Romania SRL
City
Constanta
ZIP/Postal Code
RO-900591
Country
Romania
Facility Name
Gastromedica SRL
City
Iasi
ZIP/Postal Code
700506
Country
Romania
Facility Name
Dr. Tirnaveanu Amelita Private Practice
City
Oradea
ZIP/Postal Code
410066
Country
Romania
Facility Name
Dr. Goldis Gastroenterology Center SRL
City
Timisoara
ZIP/Postal Code
300002
Country
Romania
Facility Name
Kazan State Medical University
City
Kazan
ZIP/Postal Code
420097
Country
Russian Federation
Facility Name
Moscow Clinical Scientific Center
City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation
Facility Name
Moscow Regional Research Clinical Institute Na Mfvladimirskiy
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
Nizhegorodskaya Regional Clinical Hospital n.a. Semashko
City
Nizhny Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Research Institute of Physiology and Basic Medicine
City
Novosibirsk
ZIP/Postal Code
630117
Country
Russian Federation
Facility Name
Rostov State Medical University
City
Rostov-on-Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
Rostov State Medical University
City
Rostov-on-Don
ZIP/Postal Code
344091
Country
Russian Federation
Facility Name
Union Clinic, LLC
City
Saint Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Russian Medical Military Academy n.a. S.M. Kirov
City
Saint Petersburg
Country
Russian Federation
Facility Name
Medical University Reaviz
City
Samara
ZIP/Postal Code
443011
Country
Russian Federation
Facility Name
Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city
City
Samara
ZIP/Postal Code
443029
Country
Russian Federation
Facility Name
Medical Company Hepatolog, LLC
City
Samara
ZIP/Postal Code
443063
Country
Russian Federation
Facility Name
SHI Regional Clinical Hospital
City
Saratov
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
Smolensk Regional Clinical Hospital
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
St. Elizabeth Municipal Clinical Hospital
City
St. Petersburg
ZIP/Postal Code
195257
Country
Russian Federation
Facility Name
First St. Petersburg State Medical University n.a. I.P Pavlov
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Stavropol State Medical University
City
Stavropol
ZIP/Postal Code
355017
Country
Russian Federation
Facility Name
Regional Consulting and Diagnostics Centre
City
Tyumen
ZIP/Postal Code
625026
Country
Russian Federation
Facility Name
Clinical Hospital Center Bezanijska Kosa
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
University Clinical Center Nis
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
General Hospital Vrsac
City
Vrsac
ZIP/Postal Code
26300
Country
Serbia
Facility Name
University Clinical Center Kragujevac
City
Kragujevac
State/Province
Šumadijski Okrug
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Univerzitna nemocnica Bratislava
City
Bratislava
ZIP/Postal Code
851 07
Country
Slovakia
Facility Name
KM Management, spol. s r.o.
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Gastro LM, s.r.o.
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
CLINRESCO, ARWYP Medical Suites
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1619
Country
South Africa
Facility Name
Dr. J Breedt
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Dr JP Wright
City
Claremont
State/Province
Western Cape
ZIP/Postal Code
7708
Country
South Africa
Facility Name
C.H. Regional Reina Sofia - PPDS
City
Cordoba
State/Province
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario de Fuenlabrada
City
Fuenlabrada
State/Province
Madrid
ZIP/Postal Code
28942
Country
Spain
Facility Name
CHUVI - H.U. Alvaro Cunqueiro
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36312
Country
Spain
Facility Name
Centro Medico Teknon - Grupo Quironsalud
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
Hospital Universitario Juan Ramon Jimenez
City
Huelva
ZIP/Postal Code
21005
Country
Spain
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario La Paz - PPDS
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio - PPDS
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Universität Zürich
City
Zürich
State/Province
Zürich (de)
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Istanbul Universitesi Cerrahpasa Tip Fakultesi
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Mersin University Medical Faculty
City
Mersin
ZIP/Postal Code
33169
Country
Turkey
Facility Name
Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital"
City
Chernivtsi
State/Province
Chernivets'ka Oblast
ZIP/Postal Code
58001
Country
Ukraine
Facility Name
Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council
City
Kharkiv
State/Province
Kharkivs'ka Oblast
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital
City
Kyiv
State/Province
Kyïv
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC
City
Vinnytsia
State/Province
Vinnyts'ka Oblast
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Municipal Non-profit Enterprise City Emergency Care Hospital of Zaporizhzhia Regional Council
City
Zaporizhzhia
State/Province
Zaporiz'ka Oblast
ZIP/Postal Code
69005
Country
Ukraine
Facility Name
ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
LLC Medical Center Family Medicine Clinic
City
Dnipro
ZIP/Postal Code
49038
Country
Ukraine
Facility Name
State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"
City
Dnipro
ZIP/Postal Code
49074
Country
Ukraine
Facility Name
Clinic of SI National Institute of Therapy n.a. L.T. Mala of NAMS of Ukraine
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital
City
Kharkiv
ZIP/Postal Code
61058
Country
Ukraine
Facility Name
MNPE of Kharkiv Regional Council Regional Clinical Specialized Dispensary of Radiation Protection
City
Kharkiv
ZIP/Postal Code
61166
Country
Ukraine
Facility Name
Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh
City
Kherson
ZIP/Postal Code
73000
Country
Ukraine
Facility Name
Municipal Enterprise Kryvyi Rih City Clinical Hospital #2 of Kryvyi Rih City Council
City
Kryvyi Rih
ZIP/Postal Code
50056
Country
Ukraine
Facility Name
Medical Center of LLC Medical Clinic Blagomed
City
Kyiv
ZIP/Postal Code
01023
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital #18
City
Kyiv
ZIP/Postal Code
01030
Country
Ukraine
Facility Name
Treatment and Diagnostic Center "Healthy and Happy" of LLC "Healthy and Happy"
City
Kyiv
ZIP/Postal Code
01033
Country
Ukraine
Facility Name
Municipal Institution of KRC Kyiv Regional Hospital #2
City
Kyiv
ZIP/Postal Code
04073
Country
Ukraine
Facility Name
Lviv Railway Clinical Hospital of branch Health Center of Joint Stock Co. Ukrainian Railway
City
Lviv
ZIP/Postal Code
79007
Country
Ukraine
Facility Name
Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital
City
Lviv
ZIP/Postal Code
79059
Country
Ukraine
Facility Name
Municipal Non-profit Enterprise Odessa Regional Clinical Hospital of Odessa Regional Council
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
MNPE Central City Clinical Hospital of Uzhhorod City Council
City
Uzhhorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Medical Clinical Research Center of Medical Center LLC Health Clinic
City
Vinnytsia
ZIP/Postal Code
21009
Country
Ukraine
Facility Name
Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
MNPE City Hospital No. 6 of Zaporizhzhia City Council
City
Zaporizhzhia
ZIP/Postal Code
69035
Country
Ukraine
Facility Name
Aberdeen Royal Infirmary - PPDS
City
Aberdeen
State/Province
Aberdeen City
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Fairfield General Hospital - PPDS
City
Lancashire
State/Province
Bury
ZIP/Postal Code
BL9 7TD
Country
United Kingdom
Facility Name
Whipps Cross University Hospital
City
London
State/Province
London, City Of
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
North Tyneside General Hospital
City
North Shields
State/Province
Northumberland
ZIP/Postal Code
NE29 8NH
Country
United Kingdom
Facility Name
Royal Shrewsbury Hospital
City
Shrewsbury
State/Province
Shropshire
ZIP/Postal Code
SY3 8XQ
Country
United Kingdom
Facility Name
Western General Hospital Edinburgh - PPDS
City
Edinburh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Royal Gwent Hospital - PPDS
City
Newport
ZIP/Postal Code
NP20 2UB
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://clinicaltrials.takeda.com/study-detail/5f6b5fdf4db2bf003ab47502
Description
To obtain more information on the study, click here/on this link
Learn more about this trial
An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis
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