A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
Crohn's Disease, Ulcerative Colitis
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Immunosuppressants, Mesalamine, Ulcerative Colitis, Crohn's disease, Gastroenteritis
Eligibility Criteria
Inclusion Criteria:
Participants with Ulcerative Colitis (UC):
- 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 been enrolled previously in study SHP647-301 (NCT03259334), SHP647-302 (NCT03259308), and are in the treatment period of Study SHP647-303, completed the early termination (ET) or Week 52 visit in maintenance study SHP647-303 (NCT03290781), had responded to ontamalimab treatment (in the induction and/or maintenance studies), and meet one of the following criteria:
a. Participants are on placebo at the maintenance study ET or Week 52 visit: they received ontamalimab in the induction studies and fulfilled the maintenance study response criteria, OR b. Participants have received ontamalimab at the maintenance study ET or Week 52 visit: i) Clinical composite score that has decreased by >or=2 points and >or=30%, with an accompanying decrease in the subscore for RB >or=1 point or a subscore for RB <or=1, compared to the baseline value for induction studies, and/or ii) Composite score that has decreased by >or=30% and >or=3 points compared to the baseline value for induction studies.
- Participants receiving any treatment(s) for UC are eligible provided they have been on a stable dose for the designated period of time.
Participants with Crohn's Disease:
- 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 been enrolled previously in Study SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) and are in the treament period of Study SHP647-307 (NCT03627091), completed the ET or Week 52 visit in maintenance study SHP647-307, had responded to ontamalimab treatment (in the induction or maintenance studies) and meet one of the following criteria:
- Participants are on placebo at the maintenance study ET or Week 52 visit: they received ontamalimab in the induction study and fulfilled the maintenance study response criteria, OR
- Participants have received ontamalimab at the maintenance study ET or Week 52 visit:
i) CDAI score that has decreased by >or=100 points at EOT visit compared to the baseline value for induction studies, and/or ii) SES-CD that has decreased by >or=25% compared to the baseline value for induction studies.
- Participants receiving any treatment(s) for CD are eligible provided they have been on a stable dose for the designated period of time.
Exclusion Criteria:
Participants with UC:
- Participants who had major protocol deviation(s) (as determined by the sponsor) in study SHP647-301, SHP647-302, or SHP647-303.
- Participants who permanently discontinued investigational product because of an AE, regardless of relatedness to investigational product, in study SHP647-301, SHP647-302, or SHP647-303.
- Participants who are likely to require major surgery for UC.
- Participants are females who became pregnant during study SHP647-301, SHP647-302, or SHP647-303, 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 using appropriate contraception methods (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 [e.g.], renal, hepatic, hematologic, gastrointestinal [except disease under study], endocrine, cardiovascular, pulmonary, immunologic [e.g. 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 study SHP647-301 (NCT03259334) or SHP647-302 (NCT03259308) and who have been advised to require treatment for latent or active disease, but 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 other investigational studies (other than SHP647-301, SHP647-302, or SHP647-303) or plan to participate in other investigational studies during long-term extension study SHP647-304.
Participants with Crohn's Disease:
- Participants who had major protocol deviation(s) (as determined by the sponsor) in study SHP647-305, SHP647-306 or SHP647-307.
- Participants who permanently discontinued investigational product because of an adverse events (AE), regardless of relatedness to investigational product, in study SHP647-305, SHP647-306 or SHP647-307.
- Participants who are likely to require major surgery for CD or developed acute severe complications of CD (with or without fulfilling the treatment failure criteria in the maintenance study) that required immediate intervention (e.g. need for immediate biologic treatment with proven effect) and/or Crohn's Disease Activity Index (CDAI) score more than (>) 450.
- Participants are females who became pregnant during study SHP647-305, SHP647-306 or SHP647-307, 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 appropriate contraception methods (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.
Sites / Locations
- Arizona Digestive Health Mesa - East
- Elite Clinical Studies - Phoenix - Clinedge - PPDS
- Arizona Digestive Health
- CATS Research Center - University of Arizona
- 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
- Tibor Rubin VA Medical Center - NAVREF
- 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
- Advanced Clinical Research Network
- Gastroenterology Group of Naples
- Pharma Research International Inc
- Bayside Clinical Research - New Port Richey
- 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
- Gastrointestinal Diseases, Inc Research - IACT- HyperCore - PPDS
- Atlanta Center For Gastroenterology PC
- Infinite Clinical Trials
- Atlanta Gastroenterology Specialists, 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
- 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
- Chevy Chase Clinical Research
- Commonwealth Clinical Studies LLC
- UMass Memorial Medical Center
- University of Michigan
- Clinical Research Institute of Michigan, LLC
- National Clinical, LLC
- Gastroenterology Associates of Western Michigan, PLC
- Mayo Clinic Health System - PPDS
- Minnesota Gastroenterology PA
- 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
- Gastro Health Research
- 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
- 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
- Aztec Medical Research
- Biopharma Informatic Research Center
- Southern Star Research Institute LLC
- DM Clinical Research - ERN - PPDS
- Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - 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
- LKH-Universitätsklinikum Klinikum Graz
- Klinikum Klagenfurt Am Woerthersee
- Salzburger Landeskliniken
- Universitätsklinikum St. Pölten
- Klinikum Wels-Grieskirchen GmbH
- Medizinische Universitat Wien (Medical University of Vienna)
- UZ Gent
- UZ Leuven- Gasthuisberg Campus
- AZ Groeninge
- CHU Mouscron
- Clinical Center Banja Luka
- 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
- Medical Center Excelsior OOD - PPDS
- 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 Convex EOOD
- University Multiprofile Hospital for Active Treatment Sveta Anna
- Diagnostic Consultative Centre Mladost - M OOD
- Percuro Clinical Research LTD
- Toronto Digestive Disease Associates Inc
- Hospital Pablo Tobón Uribe
- Servimed S.A.S
- Fundación Valle Del Lili
- 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
- OÜ LV Venter
- East Viru Central Hospital
- 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 Heraklion
- Iatriko Palaiou Falirou
- 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
- 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 Tokushukai Hospital
- 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
- 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 Higashi Tokushukai Hospital
- Tohoku Rosai Hospital
- Dokkyo Medical University Hospital
- Medical Corporation Shoyu-kai Fujita Gastroenterology Hospital
- Koukokukai Ebisu Clinic
- Colo-Proctology Center Matsushima Clinic
- Shinbeppu Hospital
- Ishida Clinic of IBD and Gastroenterology
- 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
- 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
- Al Zahraa University 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
- Centro de Investigacion Clinica Acelerada, S.C.
- 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. - PPDS
- Unidad de Atencion Medica e Investigacion en Salud
- Centro de Investigación Médica Aguascalientes
- Phylasis Clinicas Research S. de R.L. de C.V.
- Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
- Accelerium, S. de R.L. de C.V.
- Clinical Research Institute
- ETZ-Elisabeth
- NWZ, location Alkmaar
- Leids Universitair Medisch Centrum
- VU Medisch Centrum
- Amsterdam UMC - Meibergdreef 9
- Auckland City Hospital
- Dunedin Hospital
- Wellington Hospital
- Waikato Hospital
- Melita Medical
- Lexmedica
- Vitamed Galaj i Cichomski sp.j.
- 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
- 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 Zakonu Bonifratrow pw. Aniolow Strozow w Katowicach
- Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii
- Twoja Przychodnia SCM
- Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
- Centrum Medyczne Bydgoszcz- PRATIA - PPDS
- 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 NCM
- Centrum Innowacyjnych Terapii
- Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością, Medic-R Spółka Komandytowa
- Korczowski Bartosz, Gabinet Lekarski
- Sonomed Sp. z o.o.
- 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 de Braga
- Centro Hospitalar do Algarve - Hospital de Portimao
- Hospital Senhora da Oliveira - Guimaraes, E.P.E
- Hospital da Luz
- Hospital de São Bernardo
- 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
- Emergency University Hospital
- SC Centrul Medical MEDICUM S.R.L.
- Cluj-Napoca Emergency Clinical County Hospital
- Affidea Romania SRL
- Gastromedica SRL
- Dr. Tirnaveanu Amelita Private Practice
- Dr. Goldis Gastroenterology Center SRL
- St. Elizabeth Municipal Clinical Hospital
- 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
- 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
- Clinical Hospital Center Zemun
- 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 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 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
- Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VR
- 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
- Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital
- MNPE of Kharkiv Regional Council Regional Clinical Specialised 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"
- Medical Center OK!Clinic+LLC International Institute of Clinical Research
- Medical Center of LLC Medical Center Dopomoga-Plus
- Communal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Hospital
- Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital
- Lviv Railway Clinical Hospital of branch Health Center of Joint Stock Co. Ukrainian Railway
- MNE Lviv Territorial Med Ass-n Multidisciplinary Clinical Hospital for Intensive Care and Ambulance
- 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
- Fairfield General Hospital - PPDS
- Whipps Cross University Hospital
- North Tyneside General Hospital
- Royal Shrewsbury Hospital
- Aberdeen Royal Infirmary - PPDS
- Western General Hospital Edinburgh - PPDS
- Royal Gwent Hospital - PPDS
- New Cross Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
25 mg Ontamalimab
75 mg Ontamalimab
Participants will be receiving 25 milligram (mg) of ontamalimab solution for injection subcutaneously (SC) every 4 weeks until the participant withdraws from the study, or the investigator or sponsor decide to withdraw the participant, or the sponsor decides to close the study, or the program is stopped.
Participants will be receiving 75 mg of ontamalimab solution for injection SC every 4 weeks until the participant withdraws from the study, or the investigator or sponsor decide to withdraw the participant, or the sponsor decides to close the study, or the program is stopped.