An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis

NCT ID: NCT03290781

Last Updated: 2022-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 366 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-04
• Study Completion Date: 2021-07-01

Brief Summary

The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy treatment of remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ontamalimab 25 mg

Participants will receive 25 milligram (mg) of ontamalimab or placebo and achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) will receive 25 mg of ontamalimab as maintenance treatment subcutaneously using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52.

Group Type: EXPERIMENTAL

Ontamalimab

Intervention Type: DRUG

Participants will receive 1 milliliter (mL) of ontamalimab sterile aqueous buffered solution at an appropriate oncentration to provide an intended dose of drug (25 or 75 mg).

Ontamalimab 75 mg

Participants will receive 75 mg of ontamalimab or placebo and achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) will receive 75 mg of ontamalimab as maintenance treatment subcutaneously using a prefilled syringe Q4W up to Week 52.

Group Type: EXPERIMENTAL

Ontamalimab

Intervention Type: DRUG

Participants will receive 1 milliliter (mL) of ontamalimab sterile aqueous buffered solution at an appropriate oncentration to provide an intended dose of drug (25 or 75 mg).

Placebo

Participants will receive 25 mg or 75 mg ontamalimab or placebo matched to ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) will receive placebo matched to ontamalimab as maintenance treatment subcutaneously using a prefilled syringe Q4W up to Week 52.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Participants will receive 1 mL of sterile aqueous buffered solution.

Interventions

Ontamalimab

Participants will receive 1 milliliter (mL) of ontamalimab sterile aqueous buffered solution at an appropriate oncentration to provide an intended dose of drug (25 or 75 mg).

Intervention Type: DRUG

Placebo

Participants will receive 1 mL of sterile aqueous buffered solution.

Intervention Type: OTHER

Other Intervention Names

PF-00547659; SHP647

Eligibility Criteria

Inclusion Criteria

• Participants and/or their parent or legally authorized representative must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.
• Participants must be able to voluntarily provide written, signed, and dated (personally or via a legally authorized representative) informed consent and/or assent, as applicable, to participate in the study.
• Participants must have completed the 12-week induction treatment period (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
• Participants must have achieved clinical response in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). Clinical response is defined as:

i) A decrease from the induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) baseline in the composite score of patient reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the sub score for rectal bleeding greater than or equal to (>=) 1 point or a sub score for rectal bleeding less than or equal to (<=) 1 OR ii) A decrease from the induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) baseline in total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding sub score of at least 1 point or an absolute rectal bleeding sub score of 0 or 1.

For eligibility assessment, clinical response will be determined based on the centrally read endoscopy performed during screening and at Week 12 of induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).

• Participants receiving any treatment(s) for ulcerative colitis (UC) are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.

Exclusion Criteria

• Participants who had major protocol deviation(s) (as determined by the sponsor) in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
• Participants who permanently discontinued investigational product because of an adverse event (AE), regardless of relatedness to investigational product, in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
• Participants who are likely to require surgery for UC during the study period.
• Participants are females who became pregnant during induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]), females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue using appropriate contraception methods (that is [i.e,] highly effective methods for female and medically appropriate methods for male study participants) through the conclusion of study participation.
• Participants who do not agree to postpone donation of any organ or tissue, including male participants who are planning to bank or donate sperm and female participants who are planning to harvest or donate eggs, for the duration of the study and through 16 weeks after last dose of investigational product.
• Participants who, in the opinion of the investigator or the sponsor, will be uncooperative or unable to comply with study procedures.
• Participants who have a newly diagnosed malignancy or recurrence of malignancy (other than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix that has been treated with no evidence of recurrence).
• Participants who have developed any major illness/condition or evidence of an unstable clinical condition (example [eg], renal, hepatic, hematologic, gastrointestinal (except disease under study), endocrine, cardiovascular, pulmonary, immunologic [eg, Felty's syndrome], or local active infection/infectious illness) that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study.
• Participants with any other severe acute or chronic medical or psychiatric condition or laboratory or electrocardiogram (ECG) abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
• Participants with known exposure to Mycobacterium tuberculosis (TB) since testing at screening in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) and who are without a generally accepted course of treatment.
• Participants who are investigational site staff members or relatives of those site staff members or participants who are sponsor employees directly involved in the conduct of the study.
• Participants who are participating in or plan to participate in other investigational studies (other than induction study SHP647- 301 [NCT03259334] and SHP647-302 [NCT03259308]) during study SHP647-303 [NCT03290781].

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 81 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Shire

Locations

Arizona Digestive Health Mesa - East

Mesa, Arizona, United States

Elite Clinical Studies - Phoenix - Clinedge - PPDS

Phoenix, Arizona, United States

Atria Clinical Research - Clinedge - PPDS

Little Rock, Arkansas, United States

Advanced Research Center

Anaheim, California, United States

Kindred Medical Institute for Clinical Trials, LLC

Corona, California, United States

United Medical Doctors

Encinitas, California, United States

University of California San Diego

La Jolla, California, United States

OM Research LLC - Lancaster - ClinEdge - PPDS

Lancaster, California, United States

VA Long Beach Healthcare System - NAVREF - PPDS

Long Beach, California, United States

Facey Medical Foundation

Mission Hills, California, United States

United Medical Doctors

Murrieta, California, United States

Alliance Clinical Research-(Vestavia Hills)

Poway, California, United States

Inland Empire Liver Foundation

Rialto, California, United States

University of California San Francisco

San Francisco, California, United States

Care Access Research, San Pablo

San Pablo, California, United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Asthma and Allergy Associates PC - CRN - PPDS

Colorado Springs, Colorado, United States

Renaissance Research Medical Group, INC

Cape Coral, Florida, United States

Gastro Florida

Clearwater, Florida, United States

Advanced Clinical Research Network

Coral Gables, Florida, United States

Alliance Medical Research LLC

Coral Springs, Florida, United States

ENCORE Borland-Groover Clinical Research - ERN - PPDS

Jacksonville, Florida, United States

SIH Research

Kissimmee, Florida, United States

Hi Tech and Global Research, LLc

Miami, Florida, United States

Nuren Medical and Research Center

Miami, Florida, United States

Sanchez Clinical Research, Inc

Miami, Florida, United States

Crystal Biomedical Research

Miami Lakes, Florida, United States

Gastroenterology Group of Naples

Naples, Florida, United States

Pharma Research International Inc

Naples, Florida, United States

Omega Research Consultants LLC - Clinedge - PPDS

Orlando, Florida, United States

Accel Research Sites - St. Petersburg - ERN - PPDS

Pinellas Park, Florida, United States

BRCR Medical Center, Inc

Plantation, Florida, United States

East Coast Institute for Research, LLC

Saint Augustine, Florida, United States

DBC Research

Tamarac, Florida, United States

Bayside Clinical Research - New Port Richey

Tampa, Florida, United States

Atlanta Gastroenterology Specialists, PC

Atlanta, Georgia, United States

Infinite Clinical Trials

Atlanta, Georgia, United States

Gastrointestinal Diseases, Inc Research - IACT- HyperCore - PPDS

Columbus, Georgia, United States

Atlanta Center For Gastroenterology PC

Decatur, Georgia, United States

Loretto Hospital

Chicago, Illinois, United States

IL Gastroenterology Group

Gurnee, Illinois, United States

Edward Hines Jr VA Hospital - NAVREF - PPDS

Hines, Illinois, United States

Dupage Medical Group

Oakbrook Terrace, Illinois, United States

Medisphere Medical Research Center LLC

Evansville, Indiana, United States

Laporte County Institute For Clinical Research

Michigan City, Indiana, United States

Gastroenterology Associates of Hazard

Hazard, Kentucky, United States

CroNOLA, LLC.

Houma, Louisiana, United States

Clinical Trials of SWLA, LLC

Lake Charles, Louisiana, United States

Louisiana Research Center LLC

Shreveport, Louisiana, United States

Chevy Chase Clinical Research

Chevy Chase, Maryland, United States

Commonwealth Clinical Studies LLC

Brockton, Massachusetts, United States

UMass Memorial Medical Center

Worcester, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Clinical Research Institute of Michigan

Chesterfield, Michigan, United States

National Clinical, LLC

Hamtramck, Michigan, United States

Mayo Clinic Health System - PPDS

Duluth, Minnesota, United States

Digestive Health Center PA

Ocean Springs, Mississippi, United States

Washington University School of Medicine

St Louis, Missouri, United States

St Louis Center For Clinical Research

St Louis, Missouri, United States

Advanced Biomedical Research of America

Las Vegas, Nevada, United States

Encompass Care

North Las Vegas, Nevada, United States

New York Total Medical Care PC

Brooklyn, New York, United States

NYU Langone Long Island Clinical Research Associates

Lake Success, New York, United States

Weill Cornell Medical College

New York, New York, United States

Southtowns Gastroenterology, PLLC

Orchard Park, New York, United States

East Carolina Gastroenterology

Jacksonville, North Carolina, United States

Piedmont Healthcare

Statesville, North Carolina, United States

Consultants For Clinical Research Inc

Cincinnati, Ohio, United States

Consultants For Clinical Research Inc

Cincinnati, Ohio, United States

Consultants For Clinical Research Inc

Fairfield, Ohio, United States

Prestige Clinical Research

Franklin, Ohio, United States

Ohio Clinical Research Partners LLC

Mentor, Ohio, United States

Veteran's Research and Education Foundation - NAVREF - PPDS

Oklahoma City, Oklahoma, United States

Veterans Research Foundation of Pittsburgh - NAVREF - PPDS

Pittsburgh, Pennsylvania, United States

Digestive Disease Associates

Wyomissing, Pennsylvania, United States

Gastro One

Germantown, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Advanced Gastroenterology-Union City

Union City, Tennessee, United States

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

Baytown, Texas, United States

Northside Gastroenterology

Cypress, Texas, United States

Digestive Health Associates of Texas, P.A.dba DHAT Research Institute

Garland, Texas, United States

Precision Research Institute, LLC

Houston, Texas, United States

Biopharma Informatic Inc.

Houston, Texas, United States

Southwest Clinical Trials

Houston, Texas, United States

Aztec Medical Research

Houston, Texas, United States

BI Research Center

Houston, Texas, United States

Southern Star Research Institute LLC

San Antonio, Texas, United States

DM Clinical Research - ERN - PPDS

Tomball, Texas, United States

HP Clinical Research

Bountiful, Utah, United States

Mid Atlantic Health Specialists

Galax, Virginia, United States

Winchester Gastroenterology Associates

Winchester, Virginia, United States

CHI Franciscan Digestive Care Associates

Tacoma, Washington, United States

Exemplar Research, Inc. - Elkins

Elkins, West Virginia, United States

West Virginia University Hospital

Morgantown, West Virginia, United States

Fundación Favaloro

Buenos Aires, , Argentina

Hospital Privado Centro Médico de Córdoba

Córdoba, , Argentina

Sanatorio 9 de Julio SA

San Miguel de Tucumán, , Argentina

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

Royal Brisbane & Women's Hospital

Herston, Queensland, Australia

Mater Hospital Brisbane

South Brisbane, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

The Alfred Hospital

Box Hill, Victoria, Australia

St Vincents Hospital Melbourne - PPDS

Melbourne, Victoria, Australia

A.ö. Krankenhaus der Barmherzigen Brüder

Sankt Veit an der Glan, Carinthia, Austria

Universitätsklinikum St. Pölten

Sankt Pölten, Saint Pölten, Austria

LKH-Universitätsklinikum Klinikum Graz

Graz, Styria, Austria

Klinikum Klagenfurt Am Woerthersee

Klagenfurt, , Austria

Salzburger Landeskliniken

Salzburg, , Austria

Medizinische Universitat Wien (Medical University of Vienna)

Vienna, , Austria

Klinikum Wels-Grieskirchen GmbH

Wels, , Austria

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

UZ Gasthuisberg

Leuven, Vlaams Brabant, Belgium

AZ Groeninge

Kortrijk, West-Vlaanderen, Belgium

CHU Mouscron

Mouscron, , Belgium

Clinical Center Banja Luka

Banja Luka, , Bosnia and Herzegovina

University Multiprofile Hospital for Active Treatment Sveta Anna

Sofia, Sofia-Grad, Bulgaria

Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD

Sofia, Sofia-Grad, Bulgaria

University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD

Pleven, , Bulgaria

Multiprofile Hospital for Active Treatment Eurohospital

Plovdiv, , Bulgaria

Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr.D.Gramatikov- Ruse- PPDS

Rousse, , Bulgaria

Medical Center-1-Sevlievo EOOD

Sevlievo, , Bulgaria

Second Multiprofile Hospital for Active Treatment Sofia

Sofia, , Bulgaria

Medical Center Excelsior OOD - PPDS

Sofia, , Bulgaria

Diagnostic and Consulting Center Aleksandrovska EOOD

Sofia, , Bulgaria

University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD

Sofia, , Bulgaria

University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

Sofia, , Bulgaria

Medical Center Convex EOOD

Sofia, , Bulgaria

Diagnostic Consultative Centre Mladost - M OOD

Varna, , Bulgaria

Percuro Clinical Research LTD

Victoria, British Columbia, Canada

Toronto Digestive Disease Associates Inc

Toronto, Ontario, Canada

Hospital Pablo Tobón Uribe

Medellín, Antioquia, Colombia

Servimed S.A.S

Bucaramanga, Santander Department, Colombia

IPS Centro Médico Julián Coronel S.A.S. - PPDS

Cali, , Colombia

University Hospital Center Zagreb

Zagreb, City of Zagreb, Croatia

Opca Bolnica Karlovac

Karlovac, Karlovacka Županija, Croatia

Opca bolnica Bjelovar

Bjelovar, , Croatia

Clinical Hospital Centre Osijek

Osijek, , Croatia

University Hospital Centre Split

Split, , Croatia

General Hospital Virovitica

Virovitica, , Croatia

General County Hospital Vukovar and Croatian Veterans Hospital

Vukovar, , Croatia

General Hospital Zadar

Zadar, , Croatia

Hepato-Gastroenterologie HK, s. r. o.

Hradec Králové, Královéhradecký kraj, Czechia

PreventaMed s.r.o.

Olomouc, Olomoucký kraj, Czechia

Institut Klinicke A Experimentalni Mediciny

Prague, , Czechia

ISCARE I.V.F. a.s.

Prague, , Czechia

Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice

Ústi Nad Orlici, , Czechia

Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.

Ústí nad Labem, , Czechia

East Viru Central Hospital

Kohta-Järve, , Estonia

OÜ LV Venter

Pärnu, , Estonia

West Tallinn Central Hospital

Tallinn, , Estonia

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Universitätsklinikum der RWTH Aachen

Aachen, North Rhine-Westphalia, Germany

Uniklinik Köln

Cologne, North Rhine-Westphalia, Germany

Gastro Campus Research GbR

Münster, North Rhine-Westphalia, Germany

Universitatsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, Germany

Universitatsklinikum Jena

Jena, Thuringia, Germany

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Gastroenterologische Facharztpraxis am Mexikoplatz

Berlin-Zehlendorf, , Germany

Sana Klinikum Biberach

Biberach an der Riss, , Germany

Universitätsklinikum Frankfurt

Frankfurt, , Germany

Asklepios Westklinikum Hamburg Ggmbh

Hamburg, , Germany

Klinikum rechts der Isa der Technischen Universitaet Muenchen

Munich, , Germany

Ippokrateio General Hospital of Athens

Athens, Attica, Greece

University General Hospital of Patras

Pátrai, , Greece

Theageneio Anticancer Oncology Hospital of Thessaloniki

Thessaloniki, , Greece

Euromedica - PPDS

Thessaloniki, , Greece

Bekes Megyei Kozponti Korhaz

Békéscsaba, , Hungary

Magyar Honvédség Egészségügyi Központ

Budapest, , Hungary

Pannónia Magánorvosi Centrum Kft

Budapest, , Hungary

ENDOMEDIX Kft.

Budapest, , Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

Bekes Megyei Kozponti Korhaz

Gyula, , Hungary

Mohacsi Korhaz

Mohács, , Hungary

Tolna Megyei Balassa János Kórház

Szekszárd, , Hungary

Csongrad Megyei Dr. Bugyi Istvan Korhaz

Szentes, , Hungary

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, , Hungary

Jávorszky Ödön Kórház

Vác, , Hungary

Csolnoky Ferenc Korhaz

Veszprém, , Hungary

St Vincent's University Hospital

Dublin, , Ireland

Shaare Zedek Medical Center

Jerusalem, , Israel

Hadassah Medical Center - PPDS

Jerusalem, , Israel

Galilee Medical Center

Nahariya, , Israel

Nazareth EMMS Hospital

Nazareth, , Israel

Tel Aviv Sourasky Medical Center PPDS

Tel Aviv, , Israel

Baruch Padeh Poriya Medical Center

Tiberias, , Israel

Ospedale Casa Sollievo Della Sofferenza IRCCS

San Giovanni Rotondo, Apulia, Italy

Azienda Ospedaliera Mater Domini Di Catanzaro

Catanzaro, Calabria, Italy

Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

Bologna, Emilia-Romagna, Italy

Azienda Ospedaliero Universitaria Di Modena Policlinico

Modena, Emilia-Romagna, Italy

Azienda Ospedaliera San Camillo Forlanini

Rome, Lazio, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany, Italy

IRCCS Ospedale Sacro Cuore Don Calabria

Negrar, Veneto, Italy

Azienda Ospedale Università Padova - Dipartimento Salute della Donna e del Bambino

Padua, Veneto, Italy

A.O.U. Maggiore della Carità

Novara, , Italy

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, , Italy

La Sapienza-Università di Roma-Policlinico Umberto I

Roma, , Italy

Fondazione Policlinico Universitario A Gemelli

Roma, , Italy

Istituto Clinico Humanitas

Rozzano (MI), , Italy

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Torino, , Italy

Azienda Ospedaliera Ordine Mauriziano di Torino

Torino, , Italy

Sapporo Medical University Hospital

Sapporo, Hokkaidô, Japan

Medical Corporation Aoyama Clinic

Kobe, Hyôgo, Japan

Hyogo College of Medicine

Nishinomiya-shi, Hyôgo, Japan

Sagamihara Kyodo Hospital

Sagamihara, Kanagawa, Japan

Dokkyo Medical University Saitama Medical Center

Koshigaya, Saitama, Japan

Nihonbashi Egawa Clinic

Chuo-Ku, Tokyo, Japan

Jikei University Hospital

Minato-ku, Tokyo, Japan

Kitasato University Kitasato Institute Hospital

Minato-ku, Tokyo, Japan

Ome Municipal General Hospital

Ōme, Tokyo, Japan

Tokatsu Tsujinaka Hospital

Abiko, , Japan

Kunimoto Hospital

Asahikawa, , Japan

Fukuoka University Chikushi Hospital

Chikushino-shi, , Japan

Hakodate Koseiin Hakodate Goryoukaku Hospital

Hakodate, , Japan

Yuai Memorial Hospital

Koga, , Japan

Kawabe Clinic

Koganei, , Japan

Hidaka Coloproctology Clinic

Kurume-shi, , Japan

Aizawa Hospital

Matsumoto-shi, , Japan

Aichi Medical University Hospital

Nagakute, , Japan

Nishinomiya Municipal Central Hospital

Nishinomiya, , Japan

Onomichi General Hospital

Onomichi, , Japan

Chiinkai Dojima General & Gastroenterology Clinic

Osaka, , Japan

Kinshukai Infusion Clinic

Osaka, , Japan

Ishida Clinic of IBD and Gastroenterology

Ōita, , Japan

Shiga University of Medical Science Hospital

Ōtsu, , Japan

Bellland General Hospital

Sakai, , Japan

Toho University Sakura Medical Center

Sakura, , Japan

Sapporo Higashi Tokushukai Hospital

Sapporo, , Japan

Sapporo Tokushukai Hospital

Sapporo, , Japan

Tohoku Rosai Hospital

Sendai, , Japan

Dokkyo Medical University Hospital

Shimotsuga-gun, , Japan

Medical Corporation Shoyu-kai Fujita Gastroenterology Hospital

Takatsuki, , Japan

Koukokukai Ebisu Clinic

Tokyo, , Japan

Shinbeppu Hospital

Beppu, Ôita, Japan

Yodogawa Christian Hospital

Osaka, Ôsaka, Japan

Rafik Hariri University Hospital

Beirut, , Lebanon

Hammoud Hospital University Medical Center

Saida, , Lebanon

Hospital of Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, , Lithuania

Vilnius University Hospital Santaros Klinikos

Vilnius, , Lithuania

Vilnius City Clinical Hospital

Vilnius, , Lithuania

Clinica de Higado y Gastroenterologia Integral, S.C.

Cuernavaca, Morelos, Mexico

JM Research S.C

Cuernavaca, Morelos, Mexico

Unidad de Atencion Medica e Investigacion en Salud

Mérida, Yucatán, Mexico

Centro de Investigación Médica Aguascalientes

Aguascalientes, , Mexico

Phylasis Clinicas Research S. de R.L. de C.V.

Cuautitlán Izcalli, , Mexico

Centro de Investigacion Clinica Acelerada, S.C.

Distrito Federal, , Mexico

Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

Durango, , Mexico

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

Monterrey, , Mexico

Clinical Research Institute

Tlalnepantla, , Mexico

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

Zapopan, , Mexico

ETZ-Elisabeth

Tilburg, North Brabant, Netherlands

NWZ, location Alkmaar

Alkmaar, North Holland, Netherlands

Leids Universitair Medisch Centrum

Leiden, South Holland, Netherlands

VU Medisch Centrum

Amsterdam, , Netherlands

Academisch Medisch Centrum Amsterdam

Amsterdam, , Netherlands

Auckland City Hospital

Grafton, Auckland, New Zealand

Dunedin Hospital

Dunedin, South Island, New Zealand

Wellington Hospital

Newtown, Wellington Region, New Zealand

Waikato Hospital

Hamilton, , New Zealand

Vitamed Galaj i Cichomski sp.j.

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj

Torun, Kuyavian-Pomeranian Voivodeship, Poland

Centrum Diagnostyczno - Lecznicze Barska sp. z o.o.

Włocławek, Kuyavian-Pomeranian Voivodeship, Poland

Krakowskie Centrum Medyczne

Krakow, Lesser Poland Voivodeship, Poland

Melita Medical

Wroclaw, Lower Silesian Voivodeship, Poland

Lexmedica

Wroclaw, Lower Silesian Voivodeship, Poland

Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny

Lódz, Lódzkie, Poland

Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow

Lódz, Lódzkie, Poland

Instytut Centrum Zdrowia Matki Polki

Lódz, Lódzkie, Poland

BioVirtus Centrum Medyczne

Józefów, Masovian Voivodeship, Poland

Niepubliczny Zakład Opieki Zdrowotnej VIVAMED

Warsaw, Masovian Voivodeship, Poland

Miedzyleski Szpital Specjalistyczny w Warszawie

Warsaw, Masovian Voivodeship, Poland

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Podlaskie Voivodeship, Poland

Endoskopia Sp. z o.o.

Sopot, Pomeranian Voivodeship, Poland

Szpital Zakonu Bonifratrow pw. Aniolow Strozow w Katowicach

Katowice, Silesian Voivodeship, Poland

Twoja Przychodnia - Szczecińskie Centrum Medyczne

Szczecin, West Pomeranian Voivodeship, Poland

Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

Bydgoszcz, , Poland

Centrum Medyczne Pratia Bydgoszcz

Bydgoszcz, , Poland

Centrum Medyczne Czestochowa - PRATIA - PPDS

Częstochowa, , Poland

Centrum Medyczne Gdynia - PRATIA - PPDS

Gdynia, , Poland

NZOZ All Medicus

Katowice, , Poland

Centrum Medyczne A-Z Clinic Mateusz Sidor, Piotr Puc-Lekarze Spolka Partnerska

Krakow, , Poland

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

Ksawerów, , Poland

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

Lodz, , Poland

Twoja Przychodnia - Centrum Medyczne Nowa Sol

Nowa Sól, , Poland

Centrum Innowacyjnych Terapii

Piaseczno, , Poland

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

Poznan, , Poland

Korczowski Bartosz, Gabinet Lekarski

Rzeszów, , Poland

Bandurskiego 98/U12

Szczecin, , Poland

Sonomed Sp. z o.o.

Szczecin, , Poland

H-T. Centrum Medyczne Endoterapia

Tychy, , Poland

Centrum Zdrowia MDM

Warsaw, , Poland

Centrum Medyczne Warszawa - PRATIA - PPDS

Warsaw, , Poland

Centralny Szpital Kliniczny MSW

Warsaw, , Poland

Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II

Zamość, , Poland

Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii

Gmina Końskie, Świętokrzyskie Voivodeship, Poland

Hospital da Luz

Lisbon, Lisbon District, Portugal

Hospital de Braga

Braga, , Portugal

Centro Hospitalar do Algarve - Hospital de Portimao

Faro, , Portugal

Hospital Senhora da Oliveira - Guimaraes, E.P.E

Guimarães, , Portugal

Hospital de São Bernardo

Setúbal, , Portugal

Cluj-Napoca Emergency Clinical County Hospital

Cluj-Napoca, Cluj, Romania

Dr.Carol Davila Emergency University Central Military Hospital

Bucharest, , Romania

Sana Monitoring SRL

Bucharest, , Romania

Colentina Clinical Hospital

Bucharest, , Romania

Prof. Dr. Matei Bals Institute of Infectious Diseases

Bucharest, , Romania

Fundeni Clinical Institute

Bucharest, , Romania

Centrul Medical Hifu Terramed Conformal S.R.L.

Bucharest, , Romania

Affidea Romania SRL

Constanța, , Romania

Gastromedica SRL

Iași, , Romania

Dr. Tirnaveanu Amelita Private Practice

Oradea, , Romania

Dr. Goldis Gastroenterology Center SRL

Timișoara, , Romania

Kazan State Medical University

Kazan', , Russia

Moscow Clinical Scientific Center

Moscow, , Russia

Moscow Regional Research Clinical Institute Na Mfvladimirskiy

Moscow, , Russia

Nizhegorodskaya Regional Clinical Hospital n.a. Semashko

Nizhny Novgorod, , Russia

Research Institute of Physiology and Basic Medicine

Novosibirsk, , Russia

Rostov State Medical University

Rostov-on-Don, , Russia

Rostov State Medical University

Rostov-on-Don, , Russia

St. Elizabeth Municipal Clinical Hospital

Saint Petersburg, , Russia

First St. Petersburg State Medical University n.a. I.P Pavlov

Saint Petersburg, , Russia

Union Clinic, LLC

Saint Petersburg, , Russia

Russian Medical Military Academy n.a. S.M. Kirov

Saint Petersburg, , Russia

Medical University Reaviz

Samara, , Russia

Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city

Samara, , Russia

Medical Company Hepatolog, LLC

Samara, , Russia

SHI Regional Clinical Hospital

Saratov, , Russia

Smolensk Regional Clinical Hospital

Smolensk, , Russia

Stavropol State Medical University

Stavropol, , Russia

Regional Consulting and Diagnostics Centre

Tyumen, , Russia

Clinical Hospital Center Bezanijska Kosa

Belgrade, , Serbia

University Clinical Center Nis

Niš, , Serbia

General Hospital Vrsac

Vršac, , Serbia

University Clinical Center Kragujevac

Kragujevac, Šumadijski Okrug, Serbia

Univerzitna nemocnica Bratislava

Bratislava, , Slovakia

KM Management, spol. s r.o.

Nitra, , Slovakia

Gastro LM, s.r.o.

Prešov, , Slovakia

CLINRESCO, ARWYP Medical Suites

Johannesburg, Gauteng, South Africa

Dr. J Breedt

Pretoria, Gauteng, South Africa

Dr JP Wright

Claremont, Western Cape, South Africa

Kyungpook National University Hospital

Daegu, Daegu Gwang'yeogsi, South Korea

Yonsei University Wonju Severance Christian Hospital

Wŏnju, Gang'weondo, South Korea

CHA Bundang Medical Center, CHA University

Seongnam, Gyeonggido, South Korea

The Catholic University of Korea, St. Vincent's Hospital

Suwon, Gyeonggido, South Korea

Inje University Haeundae Paik Hospital

Busan, , South Korea

Pusan National University Hospital

Busan, , South Korea

Yeungnam University Hospital

Daegu, , South Korea

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Gachon University Gil Medical Center

Incheon, , South Korea

Kyung Hee University Hospital

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Kangbuk Samsung Hospital

Seoul, , South Korea

Severance Hospital Yonsei University Health System - PPDS

Seoul, , South Korea

Asan Medical Center - PPDS

Seoul, , South Korea

Samsung Medical Center PPDS

Seoul, , South Korea

Inje University Seoul Paik Hospital

Seoul, , South Korea

C.H. Regional Reina Sofia - PPDS

Córdoba, Córdoba, Spain

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, Spain

CHUVI - H.U. Alvaro Cunqueiro

Vigo, Pontevedra, Spain

Centro Medico Teknon - Grupo Quironsalud

Barcelona, , Spain

Hospital Universitario Juan Ramon Jimenez

Huelva, , Spain

Hospital Universitario de La Princesa

Madrid, , Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, , Spain

Hospital Universitario La Paz - PPDS

Madrid, , Spain

Hospital Universitario Virgen del Rocio - PPDS

Seville, , Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, , Spain

Universität Zürich

Zurich, Zürich (de), Switzerland

Istanbul Universitesi Cerrahpasa Tip Fakultesi

Istanbul, , Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, , Turkey (Türkiye)

Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital"

Chernivtsi, Chernivtsi Oblast, Ukraine

Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council

Kharkiv, Kharkivs’ka Oblast’, Ukraine

Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital

Kyiv, Kyïv, Ukraine

Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC

Vinnytsia, Vinnytsia Oblast, Ukraine

Municipal Non-profit Enterprise City Emergency Care Hospital of Zaporizhzhia Regional Council

Zaporizhzhia, Zaporizhzhia Oblast, Ukraine

ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council

Dnipro, , Ukraine

LLC Medical Center Family Medicine Clinic

Dnipro, , Ukraine

State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"

Dnipro, , Ukraine

Clinic of SI National Institute of Therapy n.a. L.T. Mala of NAMS of Ukraine

Kharkiv, , Ukraine

Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital

Kharkiv, , Ukraine

MNPE of Kharkiv Regional Council Regional Clinical Specialized Dispensary of Radiation Protection

Kharkiv, , Ukraine

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

Kherson, , Ukraine

Municipal Enterprise Kryvyi Rih City Clinical Hospital #2 of Kryvyi Rih City Council

Kryvyi Rih, , Ukraine

Medical Center of LLC Medical Clinic Blagomed

Kyiv, , Ukraine

Kyiv City Clinical Hospital #18

Kyiv, , Ukraine

Treatment and Diagnostic Center "Healthy and Happy" of LLC "Healthy and Happy"

Kyiv, , Ukraine

Municipal Institution of KRC Kyiv Regional Hospital #2

Kyiv, , Ukraine

Lviv Railway Clinical Hospital of branch Health Center of Joint Stock Co. Ukrainian Railway

Lviv, , Ukraine

Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital

Lviv, , Ukraine

Municipal Non-profit Enterprise Odessa Regional Clinical Hospital of Odessa Regional Council

Odesa, , Ukraine

MNPE Central City Clinical Hospital of Uzhhorod City Council

Uzhhorod, , Ukraine

Medical Clinical Research Center of Medical Center LLC Health Clinic

Vinnytsia, , Ukraine

Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC

Vinnytsia, , Ukraine

Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1

Vinnytsia, , Ukraine

MNPE City Hospital No. 6 of Zaporizhzhia City Council

Zaporizhzhia, , Ukraine

Aberdeen Royal Infirmary - PPDS

Aberdeen, Aberdeen City, United Kingdom

Fairfield General Hospital - PPDS

Lancashire, Bury, United Kingdom

Whipps Cross University Hospital

London, London, City of, United Kingdom

North Tyneside General Hospital

North Shields, Northumberland, United Kingdom

Royal Shrewsbury Hospital

Shrewsbury, Shropshire, United Kingdom

Western General Hospital Edinburgh - PPDS

Edinburh, , United Kingdom

Royal Gwent Hospital - PPDS

Newport, , United Kingdom

New Cross Hospital

Wolverhampton, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Belgium; Bosnia and Herzegovina; Bulgaria; Canada; Colombia; Croatia; Czechia; Estonia; Germany; Greece; Hungary; Ireland; Israel; Italy; Japan; Lebanon; Lithuania; Mexico; Netherlands; New Zealand; Poland; Portugal; Romania; Russia; Serbia; Slovakia; South Africa; South Korea; Spain; Switzerland; Turkey (Türkiye); Ukraine; United Kingdom

References

Vermeire S, Danese S, Sandborn WJ, Schreiber S, Hanauer S, D'Haens G, Nagy P, Thakur M, Bliss C, Cataldi F, Goetsch M, Gorelick KJ, Reinisch W. Efficacy and Safety of the Anti-mucosal Addressin Cell Adhesion Molecule-1 Antibody Ontamalimab in Patients with Moderate-to-Severe Ulcerative Colitis or Crohn's Disease. J Crohns Colitis. 2024 May 31;18(5):708-719. doi: 10.1093/ecco-jcc/jjad199.

Reference Type: DERIVED

PMID: 38096402 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://clinicaltrials.takeda.com/study-detail/5f6b5fdf4db2bf003ab47502

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

Other Identifiers

2017-000573-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SHP647-303

Identifier Type: -

Identifier Source: org_study_id