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Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307) (CARMEN CD 307)

Primary Purpose

Crohn's Disease

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ontamalimab

Placebo

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's disease

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants and/or their parent or legally authorized representative (LAR) 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 LAR) informed consent and/or assent, as applicable, to participate in the study.
Participants must have completed the 16-week induction treatment period from study SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) and met the following criteria at baseline in maintenance study SHP647-307:
1. Meet endoscopic response criteria of a reduction in SES-CD from induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline by greater than or equal to >=25% at Week 16 of induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) or
2. Meet at least 1 of the following 4 criteria at baseline in maintenance study SHP647-307, in addition to no worsening of endoscopic score as measured by SES-CD relative to induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline:
Achieving clinical remission as determined by meeting the criteria for clinical remission using the 2-item PRO, that is, 2-item PRO sub scores of average worst daily abdominal pain <=3 (based on 11-point NRS) over the 7 most recent days* and average daily stool type frequency <=2 of type 6/7 (very soft stools/liquid stools) as shown in the Bristol Stool Form Scale (BSFS) over the 7 most recent days*.
A decrease of at least 100 points in CDAI score (CDAI-100) from induction studies baseline.
A decrease of >=30% and at least 2 points from induction studies baseline in the average daily worst abdominal pain over the 7 most recent days*, with the average daily stool frequency of type 6/7 (very soft stools/liquid stools) either: (i) not worsening from induction studies baseline and/or (ii) meeting the criteria for clinical remission, that is, 2-item PRO subscore of average daily stool frequency <=2 of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days*.
A decrease of >=30% from induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline in the average daily stool frequency of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days*, with the average daily worst abdominal pain either: (i) not worsening from induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline and/or (ii) meeting the criteria for clinical remission, that is, 2-item PRO sub score of average worst daily abdominal pain <=3 (based on 11-point NRS) over the 7 most recent days*.
*Note: The 7 days may or may not be contiguous during the 10 days of data collection before colonoscopy preparation, depending on days to be excluded because of missing data. If fewer than 7 days are available, the criterion will be calculated on all available most recent 6 or 5 days. If fewer than 5 days are available, the criterion will be treated as missing.
Participants receiving any treatments for CD 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 deviations (as determined by the sponsor) in induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823).
Participants who permanently discontinued investigational product because of an AE, regardless of relatedness to investigational product, in induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823).
Participants who are likely to require surgery for CD during the study period, except minor interventions (eg, seton placement for anal fistulas).
Participants are females who became pregnant during induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823), females who are lactating, females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue acceptable contraception methods (ie, highly effective methods for female participants and medically appropriate methods for male 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 developed obstructive colonic stricture, or enterovesical or enterovaginal fistulae during the induction study SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823).
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 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 studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) and who have been advised to require treatment for latent or active disease but who are without a generally accepted course of treatment.
Participants with any of the following abnormalities in hematology and/or serum chemistry profiles during the evaluation of the last visit in the induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823). If the results are considered by the investigator to be transient and inconsistent with the participant's clinical condition, may be repeated once prior to enrollment in Study SHP647-307.
1. Alanine aminotransferase (ALT) and aspartate aminotransferase levels >= 3.0 × the upper limit of normal (ULN).
2. Total bilirubin level >=1.5 × ULN or >2.0 × ULN if the participant has a known documented history of Gilbert's syndrome.
3. Hemoglobin level <=80 gram per liter (g/L) (8.0 gram per deciliter [g/dL]).
4. Platelet count <=100 × 10^9/L (100,000 cells per cubic millimeter [mm^3]) or >=1000 × 10^9/L (1,000,000 cells/mm^3).
5. White blood cell count <=3.5 × 10^9/L (3500 cells/mm^3).
6. Absolute neutrophil count<2 × 10^9/L (<2000 cells/mm^3)
7. Serum creatinine level >1.5 × ULN or estimated glomerular filtration rate <30 milliliter per minute (mL/min)/1.73 m^2 based on the abbreviated Modification of Diet in Renal Disease Study Equation.
  - Note: If platelet count is <150,000 cells/mm^3, a further evaluation should be performed to rule out cirrhosis, unless another etiology has already been identified.
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 other investigational studies (other than induction studies SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) or plan to participate in other investigational studies during this study.

Sites / Locations

Arizona Digestive Health Mesa - East
Elite Clinical Studies - Phoenix - Clinedge - PPDS
CATS Research Center - University of Arizona
Atria Clinical Research - Clinedge - PPDS
Advanced Research Center
Kindred Medical Institute for Clinical Trials, LLC
OM Research LLC - Lancaster - ClinEdge - PPDS
Alliance Clinical Research-(Vestavia Hills)
Inland Empire Liver Foundation
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
SIH Research
Crystal Biomedical Research
Hi Tech and Global Research, LLc
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
East Coast Institute for Research, LLC
DBC Research
Bayside Clinical Research - New Port Richey
Atlanta Gastroenterology Specialists, PC
Infinite Clinical Trials
Atlanta Center For Gastroenterology PC
Loretto Hospital
IL Gastroenterology Group
Laporte County Institute For Clinical Research
Cotton O'Neil Clinical Research Center
Gastroenterology Associates of Hazard
CroNOLA, LLC.
Clinical Trials of SWLA, LLC
DelRicht Clinical Research, LLC - ClinEdge - PPDS
Louisiana Research Center LLC
Commonwealth Clinical Studies LLC
Winchester Gastroenterology Associates
UMass Memorial Medical Center
University of Michigan
Clinical Research Institute of Michigan
National Clinical, LLC
Gastroenterology Associates of Western Michigan, PLC
Mayo Clinic Health System - PPDS
Minnesota Gastroenterology PA
Washington University in St. Louis
Advanced Biomedical Research of America
Encompass Care
New York Total Medical Care PC
NYU Langone Long Island Clinical Research Associates
Southtowns Gastroenterology, PLLC
Piedmont Healthcare
Consultants For Clinical Research Inc
Consultants For Clinical Research Inc
Consultants For Clinical Research Inc
Penn State Hershey Medical Group
Digestive Disease Associates
Gastro One
Vanderbilt University Medical Center
Advanced Gastroenterology-Union City
Northside Gastroenterology
Digestive Health Associates of Texas, P.A.dba DHAT Research Institute
Precision Research Institute, LLC
Biopharma Informatic Inc.
Southwest Clinical Trials
BI Research Center
Southern Star Research Institute LLC
Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS
HP Clinical Research
Mid Atlantic Health Specialists
Fundación Favaloro
Hospital Privado Centro Médico de Córdoba
Concord Repatriation General Hospital
Liverpool Hospital
Mater Hospital Brisbane
Royal Adelaide Hospital
St Vincents Hospital Melbourne - PPDS
The Alfred Hospital
LKH-Universitätsklinikum Klinikum Graz
Klinikum Wels-Grieskirchen GmbH
Salzburger Landeskliniken
Medizinische Universitat Wien (Medical University of Vienna)
Academisch Medisch Centrum Amsterdam
UZ Gent
AZ Groeninge
CHU Mouscron
Clinical Center Banja Luka
Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD
Multiprofile Hospital for Active Treatment Eurohospital
Second Multiprofile Hospital for Active Treatment Sofia
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 Excelsior OOD - PPDS
Medical Center Convex EOOD
Diagnostic Consultative Centre Mladost - M OOD
Fundación Valle Del Lili
IPS Centro Médico Julián Coronel S.A.S. - PPDS
University Hospital Center Zagreb
Opca bolnica Bjelovar
Clinical Hospital Centre Osijek
General Hospital Virovitica
OÜ LV Venter
West Tallinn Central Hospital
Klinikum rechts der Isa der Technischen Universitaet Muenchen
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
Ippokrateio General Hospital of Athens
University General Hospital of Heraklion
Iatriko Palaiou Falirou
University General Hospital of Patras
Euromedica - PPDS
Bekes Megyei Kozponti Korhaz
Magyar Honvédség Egészségügyi Központ
Pannónia Magánorvosi Centrum Kft
ENDOMEDIX Kft.
Debreceni Egyetem Klinikai Kozpont
Mohacsi Korhaz
Tolna Megyei Balassa János Kórház
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
St Vincent's University Hospital
Shaare Zedek Medical Center
Hadassah Medical Center - PPDS
Galilee Medical Center
Baruch Padeh Poriya Medical Center
Azienda Ospedaliera Mater Domini Di Catanzaro
Azienda Ospedaliero Universitaria Di Modena Policlinico
Fondazione Policlinico Universitario A Gemelli
Azienda Ospedaliera Universitaria Careggi
IRCCS Ospedale Sacro Cuore Don Calabria
A.O.U. Maggiore della Carità
Fondazione IRCCS Policlinico San Matteo di Pavia
La Sapienza-Università di Roma-Policlinico Umberto I
Istituto Clinico Humanitas
Ospedale Casa Sollievo Della Sofferenza IRCCS
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Sapporo Medical University Hospital
Medical Corporation Aoyama Clinic
Hyogo College of Medicine
Jikei University Hospital
Ome Municipal General Hospital
Kunimoto Hospital
Hidaka Coloproctology Clinic
Aichi Medical University Hospital
Nishinomiya Municipal Central Hospital
Onomichi General Hospital
Kinshukai Infusion Clinic
Chiinkai Dojima General & Gastroenterology Clinic
Yodogawa Christian Hospital
Shiga University of Medical Science Hospital
Toho University Sakura Medical Center
Sapporo Tokushukai Hospital
Sapporo Higashi Tokushukai Hospital
Dokkyo Medical University Hospital
Nihonbashi Egawa Clinic
Colo-Proctology Center Matsushima Clinic
Ishida Clinic of IBD and Gastroenterology
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
Kyungpook National University Hospital
Kyungpook National University Chilgok Hospital
Gachon University Gil Medical Center
Seoul National University Hospital
Kangbuk Samsung Hospital
Inje University Seoul Paik Hospital
Al Zahraa University Hospital
Hammoud Hospital University Medical Center
Vilnius University Hospital Santaros Klinikos
Vilnius City Clinical Hospital
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
Clinica de Higado y Gastroenterologia Integral, S.C.
JM Research S.C
Accelerium, S. de R.L. de C.V.
Unidad de Atencion Medica e Investigacion en Salud
Centro de Investigacion Clinica Acelerada, S.C.
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
ETZ-Elisabeth
NWZ, location Alkmaar
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
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Niepubliczny Zakład Opieki Zdrowotnej VIVAMED
Miedzyleski Szpital Specjalistyczny w Warszawie
Uniwersytecki Szpital Kliniczny w Bialymstoku
Endoskopia Sp. z o.o.
Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
Centrum Medyczne Czestochowa - PRATIA - PPDS
Centrum Medyczne Gdynia - PRATIA - PPDS
NZOZ All Medicus
Med Gastr Sp.z.o.o Sp.k
Instytut Centrum Zdrowia Matki Polki
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością, Medic-R Spółka Komandytowa
Centrum Medyczne Warszawa - PRATIA - PPDS
Korczowski Bartosz, Gabinet Lekarski
Sonomed Sp. z o.o.
Centrum Zdrowia M D M
Centralny Szpital Kliniczny MSW
BioVirtus Centrum Medyczne
Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
Hospital Senhora da Oliveira - Guimaraes, E.P.E
Hospital da Luz
Centro Hospitalar do Algarve - Hospital de Portimao
Sana Monitoring SRL
Cluj-Napoca Emergency Clinical County Hospital
Dr.Carol Davila Emergency University Central Military Hospital
Colentina Clinical Hospital
Prof. Dr. Matei Bals Institute of Infectious Diseases
Fundeni Clinical Institute
Emergency University Hospital
Centrul Medical Hifu Terramed Conformal S.R.L.
Affidea Romania SRL
Gastromedica SRL
Dr. Tirnaveanu Amelita Private Practice
Dr. Goldis Gastroenterology Center SRL
Rostov State Medical University
Russian Medical Military Academy n.a. S.M. Kirov
Medical University Reaviz
Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city
SHI Regional Clinical Hospital
St. Elizabeth Municipal Clinical Hospital
Clinical Hospital Center Bezanijska Kosa
University Clinical Center Nis
General Hospital Vrsac
Clinical Hospital Center Zemun
University Clinical Center Kragujevac
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 General Universitario Gregorio Maranon
Hospital Universitario de Fuenlabrada
CHUVI - H.U. Alvaro Cunqueiro
Centro Medico Teknon - Grupo Quironsalud
Hospital Universitario Juan Ramon Jimenez
Hospital Universitario Fundacion Jimenez Diaz
Hospital Universitario La Paz - PPDS
Hospital Universitario Virgen del Rocio - PPDS
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
LLC Medical Center Family Medicine Clinic
Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital
Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh
Medical Center of LLC Medical Clinic Blagomed
Medical Center OK!Clinic+LLC International Institute of Clinical Research
Medical Center of LLC Medical Center Dopomoga-Plus
Municipal Institution of KRC Kyiv Regional Hospital #2
Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital
Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1
MNPE City Hospital No. 6 of Zaporizhzhia City Council
North Tyneside General Hospital
Aberdeen Royal Infirmary - PPDS
Royal Gwent Hospital - PPDS
New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Ontamalimab 25 mg

Ontamalimab 75 mg

Placebo

Arm Description

Participants will receive 25 mg of ontamalimab subcutaneous (SC) injection using a prefilled syringe once every 4 weeks for 52 weeks; starting at Day/Week 1 Baseline Visit (Week 16 of the SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]).

Participants will receive 75 mg of ontamalimab SC injection using a prefilled syringe once every 4 weeks for 52 weeks; starting at Day/Week 1 Baseline Visit (Week 16 of the SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]).

Participants will receive placebo matched with ontamalimab SC injection using prefilled syringe once every 4 weeks for 52 weeks; starting at Day/Week 1 Baseline Visit (Week 16 of the SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]).

Outcomes

Primary Outcome Measures

Number of Participants With Clinical Remission at Week 52

Clinical remission was defined by 2-item PRO sub-scores of average worst daily abdominal pain less than or equal to (<=) 3 (based on 11 point numerical rating scale [NRS] ranging from 0 [no pain] to 10 [worst imaginable pain]); and average daily stool frequency <=2 of type 6/7 (very soft stools/liquid stools) as per the Bristol Stool Form Scale (BSFS) over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like a sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, a mushy stool), 7 (watery, no solid pieces, entirely liquid). Participants with missing data at Week 52 or discontinuation before Week 52 were considered failures. Number of participants with clinical remission at Week 52 were reported.

Number of Participants With Enhanced Endoscopic Response at Week 52

Enhanced endoscopic response was defined as a decrease in Simple Endoscopic Score for Crohn's disease (SES-CD) of at least 50 percent (%) from induction study (either SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823] baseline. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease. Participants with missing data at Week 52 or who discontinued before Week 52 were considered non responders. Number of participants with enhanced endoscopic response at Week 52 were reported.

Secondary Outcome Measures

Number of Participants With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score at Week 52

Clinical remission was defined as a CDAI score of <150. CDAI assessed CD based on clinical signs/symptoms such as number of liquid stools, intensity of abdominal pain, general well-being (subjective), and presence of complications, use of antidiarrheal, presence of abdominal mass, physical examination and hematocrit (objective). CDAI score is equal to sum of weighted scores for subjective and objective items which range from 0-149 points: asymptomatic remission, 150-220 points: mild to moderate active CD, 221-450 points: moderate to severe active CD, >451 points: severely active to fulminant disease. Higher score indicating more severity. Participants with missing data at Week 52 or who discontinued before Week 52 were considered failures. Number of participants with clinical remission as measured by CDAI at Week 52 were reported.

Number of Participants With Glucocorticoid-free Clinical Remission at Week 52

Glucocorticoid-free clinical remission defined as clinical remission by 2-item PRO not requiring any treatment with glucocorticoids for at least 12 weeks prior to Week 52 visit. Clinical remission defined by 2-item PRO sub-scores of average worst daily abdominal pain <=3 (based on 11 point NRS ranging from 0 [no pain] to 10 [worst imaginable pain]); and average daily stool frequency<=2 of type 6/7 (very soft stools/liquid stools) as per the BSFS over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, mushy stool), 7 (watery, no solid pieces, entirely liquid). Participants with missing data at Week 52 or who discontinued before Week 52 were non-responders. Number of participants with glucocorticoid-free clinical remission response at Week 52 were reported.

Number of Participants With Clinical Remission Defined by Crohn's Disease (CD) E-diary Sub-scores- at Week 52

Clinical remission was defined by CD daily e-diary 2-item PRO subscores of average daily abdominal pain <=1 (based on the 4 point scale, with scores ranging from 0 [none] to 3 [severe]) over the 7 most recent days and average daily stool frequency <=3 of type 6/7 (very soft stools/liquid stools) as per the BSFS over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like a sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, a mushy stool), 7 (watery, no solid pieces, entirely liquid). Participants with missing data at Week 52 or who discontinued before Week 52 were considered failures. Number of participants with clinical remission based on Crohn's Disease (CD) e-diary Sub-scores for abdominal pain was was reported.

Number of Participants With Sustained Clinical Remission at Week 52

Sustained clinical remission was defined as clinical remission by 2-item PRO at both Week 52 visit and the maintenance baseline in this Study. Clinical remission was defined by 2-item PRO sub-scores of average worst daily abdominal pain less than or equal to (<=) 3 (based on 11 point NRS ranging from 0 [no pain] to 10 [worst imaginable pain]); and average daily stool frequency <=2 of type 6/7 (very soft stools/liquid stools) as per the BSFS over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like a sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, a mushy stool), 7 (watery, no solid pieces, entirely liquid). Number of participants with sustained clinical remission at Week 52 were reported.

Number of Participants With Sustained Enhanced Endoscopic Response at Week 52

Sustained enhanced endoscopic response was defined as enhanced endoscopic response at both Week 52 visit and the maintenance baseline in this study. Enhanced endoscopic response was defined as a decrease in SES-CD of at least 50 % from induction study (either SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) baseline. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease. Number of participants with sustained enhanced endoscopic response at Week 52 were reported.

Number of Participants With Clinical Remission Based on 2-item PRO With Enhanced Endoscopic Response at Week 52

Clinical remission was defined by 2-item PRO sub-scores of average worst daily abdominal pain <=3 (based on 11-point NRS) over the 7 most recent days and average daily stool frequency <= 2 of Type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days. Participants with missing data at Week 52 or who discontinued before Week 52 were considered failures. Enhanced endoscopic response was defined as a decrease in SES-CD of at least 50% from induction study (either SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) baseline. Participants with missing data at Week 52 or who discontinued before Week 52 were considered non-responders.

Number of Participants With Complete Endoscopic Healing at Week 52

Complete endoscopic healing was defined as SES-CD scale score from 0-2. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease. Participants with missing data at Week 52 or who discontinued before Week 52 were considered failures. Number of participants with complete endoscopic healing at Week 52 were reported.

Full Information

NCT ID

NCT03627091

First Posted

July 24, 2018

Last Updated

March 3, 2022

Sponsor

Shire

1. Study Identification

Unique Protocol Identification Number

NCT03627091

Brief Title

Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307)

Acronym

CARMEN CD 307

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 Crohn's Disease (CARMEN CD 307)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Terminated

Why Stopped

Sponsor decision to discontinue the SHP647 (ontamalimab) clinical trial development program for inflammatory bowel diseases (IBD) early.

Study Start Date

February 6, 2019 (Actual)

Primary Completion Date

June 21, 2021 (Actual)

Study Completion Date

September 13, 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

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of ontamalimab as maintenance treatment in participants with moderate to severe Crohn's disease (CD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn's Disease

Keywords

Crohn's disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ontamalimab 25 mg

Arm Type

Experimental

Arm Description

Arm Title

Ontamalimab 75 mg

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ontamalimab

Other Intervention Name(s)

SHP647, PF-00547659

Intervention Description

SC injection of 25 mg or 75 mg ontamalimab will be administered using a prefilled syringe.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

SC injection of placebo matched with ontamalimab will be administered using a prefilled syringe.

Primary Outcome Measure Information:

Title

Number of Participants With Clinical Remission at Week 52

Description

Time Frame

At Week 52

Title

Number of Participants With Enhanced Endoscopic Response at Week 52

Description

Time Frame

At Week 52

Secondary Outcome Measure Information:

Title

Number of Participants With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score at Week 52

Description

Time Frame

At Week 52

Title

Number of Participants With Glucocorticoid-free Clinical Remission at Week 52

Description

Time Frame

At Week 52

Title

Number of Participants With Clinical Remission Defined by Crohn's Disease (CD) E-diary Sub-scores- at Week 52

Description

Time Frame

At Week 52

Title

Number of Participants With Sustained Clinical Remission at Week 52

Description

Time Frame

At Week 52

Title

Number of Participants With Sustained Enhanced Endoscopic Response at Week 52

Description

Time Frame

At Week 52

Title

Number of Participants With Clinical Remission Based on 2-item PRO With Enhanced Endoscopic Response at Week 52

Description

Time Frame

At Week 52

Title

Number of Participants With Complete Endoscopic Healing at Week 52

Description

Time Frame

At Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants and/or their parent or legally authorized representative (LAR) 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 LAR) informed consent and/or assent, as applicable, to participate in the study. Participants must have completed the 16-week induction treatment period from study SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) and met the following criteria at baseline in maintenance study SHP647-307: Meet endoscopic response criteria of a reduction in SES-CD from induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline by greater than or equal to >=25% at Week 16 of induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) or Meet at least 1 of the following 4 criteria at baseline in maintenance study SHP647-307, in addition to no worsening of endoscopic score as measured by SES-CD relative to induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline: Achieving clinical remission as determined by meeting the criteria for clinical remission using the 2-item PRO, that is, 2-item PRO sub scores of average worst daily abdominal pain <=3 (based on 11-point NRS) over the 7 most recent days* and average daily stool type frequency <=2 of type 6/7 (very soft stools/liquid stools) as shown in the Bristol Stool Form Scale (BSFS) over the 7 most recent days*. A decrease of at least 100 points in CDAI score (CDAI-100) from induction studies baseline. A decrease of >=30% and at least 2 points from induction studies baseline in the average daily worst abdominal pain over the 7 most recent days*, with the average daily stool frequency of type 6/7 (very soft stools/liquid stools) either: (i) not worsening from induction studies baseline and/or (ii) meeting the criteria for clinical remission, that is, 2-item PRO subscore of average daily stool frequency <=2 of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days*. A decrease of >=30% from induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline in the average daily stool frequency of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days*, with the average daily worst abdominal pain either: (i) not worsening from induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline and/or (ii) meeting the criteria for clinical remission, that is, 2-item PRO sub score of average worst daily abdominal pain <=3 (based on 11-point NRS) over the 7 most recent days*. *Note: The 7 days may or may not be contiguous during the 10 days of data collection before colonoscopy preparation, depending on days to be excluded because of missing data. If fewer than 7 days are available, the criterion will be calculated on all available most recent 6 or 5 days. If fewer than 5 days are available, the criterion will be treated as missing. Participants receiving any treatments for CD 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 deviations (as determined by the sponsor) in induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823). Participants who permanently discontinued investigational product because of an AE, regardless of relatedness to investigational product, in induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823). Participants who are likely to require surgery for CD during the study period, except minor interventions (eg, seton placement for anal fistulas). Participants are females who became pregnant during induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823), females who are lactating, females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue acceptable contraception methods (ie, highly effective methods for female participants and medically appropriate methods for male 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 developed obstructive colonic stricture, or enterovesical or enterovaginal fistulae during the induction study SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823). 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 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 studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) and who have been advised to require treatment for latent or active disease but who are without a generally accepted course of treatment. Participants with any of the following abnormalities in hematology and/or serum chemistry profiles during the evaluation of the last visit in the induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823). If the results are considered by the investigator to be transient and inconsistent with the participant's clinical condition, may be repeated once prior to enrollment in Study SHP647-307. Alanine aminotransferase (ALT) and aspartate aminotransferase levels >= 3.0 × the upper limit of normal (ULN). Total bilirubin level >=1.5 × ULN or >2.0 × ULN if the participant has a known documented history of Gilbert's syndrome. Hemoglobin level <=80 gram per liter (g/L) (8.0 gram per deciliter [g/dL]). Platelet count <=100 × 10^9/L (100,000 cells per cubic millimeter [mm^3]) or >=1000 × 10^9/L (1,000,000 cells/mm^3). White blood cell count <=3.5 × 10^9/L (3500 cells/mm^3). Absolute neutrophil count<2 × 10^9/L (<2000 cells/mm^3) Serum creatinine level >1.5 × ULN or estimated glomerular filtration rate <30 milliliter per minute (mL/min)/1.73 m^2 based on the abbreviated Modification of Diet in Renal Disease Study Equation. Note: If platelet count is <150,000 cells/mm^3, a further evaluation should be performed to rule out cirrhosis, unless another etiology has already been identified. 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 other investigational studies (other than induction studies SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) or plan to participate in other investigational studies during this study.

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

CATS Research Center - University of Arizona

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

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

OM Research LLC - Lancaster - ClinEdge - PPDS

City

Lancaster

State/Province

California

ZIP/Postal Code

93534

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

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

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

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

34110

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

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

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

Laporte County Institute For Clinical Research

City

Michigan City

State/Province

Indiana

ZIP/Postal Code

46360

Country

United States

Facility Name

Cotton O'Neil Clinical Research Center

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

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

DelRicht Clinical Research, LLC - ClinEdge - PPDS

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70115

Country

United States

Facility Name

Louisiana Research Center LLC

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71103

Country

United States

Facility Name

Commonwealth Clinical Studies LLC

City

Brockton

State/Province

Massachusetts

ZIP/Postal Code

02302

Country

United States

Facility Name

Winchester Gastroenterology Associates

City

Winchester

State/Province

Massachusetts

ZIP/Postal Code

22601

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

Gastroenterology Associates of Western Michigan, PLC

City

Wyoming

State/Province

Michigan

ZIP/Postal Code

49519

Country

United States

Facility Name

Mayo Clinic Health System - PPDS

City

Duluth

State/Province

Minnesota

ZIP/Postal Code

55805

Country

United States

Facility Name

Minnesota Gastroenterology PA

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55114

Country

United States

Facility Name

Washington University in St. Louis

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

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

Great Neck

State/Province

New York

ZIP/Postal Code

11021

Country

United States

Facility Name

Southtowns Gastroenterology, PLLC

City

Orchard Park

State/Province

New York

ZIP/Postal Code

14127

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

Penn State Hershey Medical Group

City

State College

State/Province

Pennsylvania

ZIP/Postal Code

16803

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

38261

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

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

Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS

City

Webster

State/Province

Texas

ZIP/Postal Code

77598

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

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

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

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

St Vincents Hospital Melbourne - PPDS

City

Fitzroy

State/Province

Victoria

ZIP/Postal Code

3065

Country

Australia

Facility Name

The Alfred Hospital

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

Facility Name

LKH-Universitätsklinikum Klinikum Graz

City

Graz

State/Province

Steiermark

ZIP/Postal Code

8036

Country

Austria

Facility Name

Klinikum Wels-Grieskirchen GmbH

City

Vienna

State/Province

Wien

ZIP/Postal Code

A-1090

Country

Austria

Facility Name

Salzburger Landeskliniken

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Medizinische Universitat Wien (Medical University of Vienna)

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Academisch Medisch Centrum Amsterdam

City

Bonheiden

State/Province

Antwerpen

ZIP/Postal Code

2820

Country

Belgium

Facility Name

UZ Gent

City

Gent

State/Province

Oost-Vlaanderen

ZIP/Postal Code

9000

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

Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD

City

Sofia

State/Province

Sofia-Grad

ZIP/Postal Code

1784

Country

Bulgaria

Facility Name

Multiprofile Hospital for Active Treatment Eurohospital

City

Plovdiv

ZIP/Postal Code

4004

Country

Bulgaria

Facility Name

Second Multiprofile Hospital for Active Treatment Sofia

City

Sofia

ZIP/Postal Code

1202

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 Excelsior OOD - PPDS

City

Sofia

ZIP/Postal Code

1632

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

9000

Country

Bulgaria

Facility Name

Fundación Valle Del Lili

City

Cali

State/Province

Valle Del Cauca

ZIP/Postal Code

760026

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 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

General Hospital Virovitica

City

Virovitica

ZIP/Postal Code

33000

Country

Croatia

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

Klinikum rechts der Isa der Technischen Universitaet Muenchen

City

Munich

State/Province

Bayern

ZIP/Postal Code

81675

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

Ippokrateio General Hospital of Athens

City

Athens

State/Province

Attiki

ZIP/Postal Code

11527

Country

Greece

Facility Name

University General Hospital of Heraklion

City

Heraklion

ZIP/Postal Code

71110

Country

Greece

Facility Name

Iatriko Palaiou Falirou

City

Paliao Faliro

ZIP/Postal Code

17562

Country

Greece

Facility Name

University General Hospital of Patras

City

Patras

ZIP/Postal Code

26504

Country

Greece

Facility Name

Euromedica - PPDS

City

Thessaloniki

ZIP/Postal Code

54645

Country

Greece

Facility Name

Bekes Megyei Kozponti Korhaz

City

Bekescsaba

ZIP/Postal Code

5600

Country

Hungary

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

1135

Country

Hungary

Facility Name

ENDOMEDIX Kft.

City

Budapest

ZIP/Postal Code

1139

Country

Hungary

Facility Name

Debreceni Egyetem Klinikai Kozpont

City

Debrecen

ZIP/Postal Code

4032

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

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

City

Székesfehérvár

ZIP/Postal Code

8000

Country

Hungary

Facility Name

St Vincent's University Hospital

City

Dublin

ZIP/Postal Code

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

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 Modena Policlinico

City

Modena

State/Province

Emilia-Romagna

ZIP/Postal Code

41100

Country

Italy

Facility Name

Fondazione Policlinico Universitario A Gemelli

City

Roma

State/Province

Lazio

ZIP/Postal Code

00168

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

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

Istituto Clinico Humanitas

City

Rozzano (MI)

ZIP/Postal Code

20089

Country

Italy

Facility Name

Ospedale Casa Sollievo Della Sofferenza IRCCS

City

San Giovanni Rotondo

ZIP/Postal Code

71013

Country

Italy

Facility Name

Azienda Ospedaliera Città della Salute e della Scienza di Torino

City

Torino

ZIP/Postal Code

10126

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

Jikei University Hospital

City

Minato-ku

State/Province

Tokyo

ZIP/Postal Code

105-8471

Country

Japan

Facility Name

Ome Municipal General Hospital

City

Ome

State/Province

Tokyo

ZIP/Postal Code

198-0042

Country

Japan

Facility Name

Kunimoto Hospital

City

Asahikawa

ZIP/Postal Code

070-0061

Country

Japan

Facility Name

Hidaka Coloproctology Clinic

City

Kurume-shi

ZIP/Postal Code

839-0809

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

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

Yodogawa Christian Hospital

City

Osaka

ZIP/Postal Code

533-0024

Country

Japan

Facility Name

Shiga University of Medical Science Hospital

City

Otsu-Shi

ZIP/Postal Code

520-2192

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

Dokkyo Medical University Hospital

City

Shimotsuga-gun

ZIP/Postal Code

321-0293

Country

Japan

Facility Name

Nihonbashi Egawa Clinic

City

Tokyo

ZIP/Postal Code

103-0028

Country

Japan

Facility Name

Colo-Proctology Center Matsushima Clinic

City

Yokohama

ZIP/Postal Code

220-0045

Country

Japan

Facility Name

Ishida Clinic of IBD and Gastroenterology

City

Oita-city

State/Province

Ôita

ZIP/Postal Code

870-0823

Country

Japan

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

Kyungpook National University Hospital

City

Daegu

ZIP/Postal Code

41944

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

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

Inje University Seoul Paik Hospital

City

Seoul

ZIP/Postal Code

04551

Country

Korea, Republic of

Facility Name

Al Zahraa University Hospital

City

Beirut

Country

Lebanon

Facility Name

Hammoud Hospital University Medical Center

City

Saida

Country

Lebanon

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

Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.

City

Zapopan

State/Province

Jalisco

ZIP/Postal Code

45030

Country

Mexico

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

Accelerium, S. de R.L. de C.V.

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64000

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 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

ETZ-Elisabeth

City

Tilburg

State/Province

Noord-Brabant

ZIP/Postal Code

5022 GC

Country

Netherlands

Facility Name

NWZ, location Alkmaar

City

Den Helder

State/Province

Noord-Holland

ZIP/Postal Code

1782 GZ

Country

Netherlands

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

Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.

City

Lódz

State/Province

Lódzkie

ZIP/Postal Code

90-647

Country

Poland

Facility Name

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

City

Warszawa

State/Province

Mazowieckie

ZIP/Postal Code

02-781

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 Specjalistyczny sw Lukasza - Oddzial Gastroenterologii

City

Konskie

State/Province

Swietokrzyskie

ZIP/Postal Code

26-200

Country

Poland

Facility Name

Twoja Przychodnia - Szczecinskie 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 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

40-660

Country

Poland

Facility Name

Med Gastr Sp.z.o.o Sp.k

City

Lodz

ZIP/Postal Code

91-034

Country

Poland

Facility Name

Instytut Centrum Zdrowia Matki Polki

City

Lodz

ZIP/Postal Code

93-338

Country

Poland

Facility Name

Twoja Przychodnia - Centrum Medyczne Nowa Sol

City

Nowa Sól

ZIP/Postal Code

67-100

Country

Poland

Facility Name

Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością, Medic-R Spółka Komandytowa

City

Poznan

ZIP/Postal Code

60-848

Country

Poland

Facility Name

Centrum Medyczne Warszawa - PRATIA - PPDS

City

Rzeszow

ZIP/Postal Code

35-068

Country

Poland

Facility Name

Korczowski Bartosz, Gabinet Lekarski

City

Rzeszow

ZIP/Postal Code

35-302

Country

Poland

Facility Name

Sonomed Sp. z o.o.

City

Szczecin

ZIP/Postal Code

71-685

Country

Poland

Facility Name

Centrum Zdrowia M D M

City

Warszawa

ZIP/Postal Code

00-635

Country

Poland

Facility Name

Centralny Szpital Kliniczny MSW

City

Warszawa

ZIP/Postal Code

02-507

Country

Poland

Facility Name

BioVirtus Centrum Medyczne

City

Warszawa

ZIP/Postal Code

02-797

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 Senhora da Oliveira - Guimaraes, E.P.E

City

Guimarães

ZIP/Postal Code

4835-044

Country

Portugal

Facility Name

Hospital da Luz

City

Lisboa

ZIP/Postal Code

1500-650

Country

Portugal

Facility Name

Centro Hospitalar do Algarve - Hospital de Portimao

City

Portimão

ZIP/Postal Code

8500-338

Country

Portugal

Facility Name

Sana Monitoring SRL

City

Bucharest

State/Province

Bucuresti

ZIP/Postal Code

011025

Country

Romania

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

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

Emergency University Hospital

City

Bucharest

ZIP/Postal Code

050098

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

Rostov State Medical University

City

Rostov-on-Don

ZIP/Postal Code

344091

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

SHI Regional Clinical Hospital

City

Saratov

ZIP/Postal Code

410012

Country

Russian Federation

Facility Name

St. Elizabeth Municipal Clinical Hospital

City

St. Petersburg

ZIP/Postal Code

195067

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

Clinical Hospital Center Zemun

City

Zemun

Country

Serbia

Facility Name

University Clinical Center Kragujevac

City

Kragujevac

State/Province

Šumadijski Okrug

ZIP/Postal Code

34000

Country

Serbia

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

0084

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 General Universitario Gregorio Maranon

City

Madrid

State/Province

Madrid, Communidad Delaware

ZIP/Postal Code

28007

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 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

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

LLC Medical Center Family Medicine Clinic

City

Dnipro

ZIP/Postal Code

49038

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

Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh

City

Kherson

ZIP/Postal Code

73000

Country

Ukraine

Facility Name

Medical Center of LLC Medical Clinic Blagomed

City

Kyiv

ZIP/Postal Code

01023

Country

Ukraine

Facility Name

Medical Center OK!Clinic+LLC International Institute of Clinical Research

City

Kyiv

ZIP/Postal Code

02091

Country

Ukraine

Facility Name

Medical Center of LLC Medical Center Dopomoga-Plus

City

Kyiv

ZIP/Postal Code

02132

Country

Ukraine

Facility Name

Municipal Institution of KRC Kyiv Regional Hospital #2

City

Kyiv

ZIP/Postal Code

04073

Country

Ukraine

Facility Name

Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital

City

Lviv

ZIP/Postal Code

79059

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

North Tyneside General Hospital

City

North Shields

State/Province

Northumberland

ZIP/Postal Code

NE29 8NH

Country

United Kingdom

Facility Name

Aberdeen Royal Infirmary - PPDS

City

Aberdeen

ZIP/Postal Code

AB25 2ZN

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

Plan to Share IPD

Yes

IPD Sharing Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing URL

https://vivli.org/ourmember/takeda/

Links:

URL

https://clinicaltrials.takeda.com/study-detail/5f6b5fe64db2bf003ab479ae

Description

To obtain more information on the study, click here/on this link

Learn more about this trial

Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307)

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