Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis

NCT ID: NCT02435992

Last Updated: 2021-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1012 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-17
• Study Completion Date: 2020-06-17

Brief Summary

The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).

Detailed Description

The trial is composed of 2 periods: Induction and Maintenance. In the Induction Period (IP), patients will be entered into the trial in 2 separate cohorts (Cohort 1 and Cohort 2).Patients from Cohort 1 and 2 in clinical response at the end of the IP will proceed through to the Maintenance Period (MP). Patients from Cohort 1 and 2 who participate in this trial may also qualify to participate in an optional Open-Label Extension (OLE) trial.

Conditions

Ulcerative Colitis

Study Design

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

Study Groups

RPC1063 (Ozanimod)

1mg, daily oral administration during Induction and Maintenance periods.

Group Type: EXPERIMENTAL

RPC1063

Intervention Type: DRUG

Placebo

Daily oral administration during Induction and Maintenance periods.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

RPC1063

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Aged 18 to 75 years (at screening for Cohort 1 and 2)
• UC confirmed on endoscopy
• Moderately to severely active UC (May score 6-12)
• Currently receiving treatment with aminosalisylate, prednisone, or budesonide
• Can be receiving azathioprine, mercaptopurine, or methotrexate, but treatment will be stopped prior to randomization

Exclusion Criteria

• Have severe extensive colitis as evidence by:
• Physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of baseline.
• Current or recent (within 3 months) evidence of fulminant colitis, toxic megacolon, or bowel perforation.
• Diagnosis of CD, indeterminate colitis, or the presence of fistula consistent with CD or microscopic colitis, radiation colitis, or ischemic colitis
• Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk
• History of uveitis or unknown macular edema
• Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG) measured during screening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AnnKatrin Petersen, M.D., MSc.

Role: STUDY_DIRECTOR

Celgene

Locations

Arizona Digestive Health

Sun City, Arizona, United States

Adobe Clinical Research LLC

Tucson, Arizona, United States

Arkansas Gastroenterology, P.A.

North Little Rock, Arkansas, United States

Anaheim Clinical Trials

Anaheim, California, United States

Aurora Care Clinic

Costa Mesa, California, United States

Valley View Internal Medicine

Garden Grove, California, United States

Davita Clinical Trials, LLC

Huntington Beach, California, United States

University of California San Diego Medical Center

La Jolla, California, United States

OM Research

Lancaster, California, United States

University of Southern California - Keck School of Medicine

Los Angeles, California, United States

Southern California Research Institute Medical Group, Inc.

Los Angeles, California, United States

Gastrointestinal Biosciences

Los Angeles, California, United States

UCLA Medical Center

Los Angeles, California, United States

Facey Medical Foundation (Parent)

Mission Hills, California, United States

Alliance Clinical Research, LLC

Oceanside, California, United States

Medical Associates Research Group, Inc.

San Diego, California, United States

University of California at San Francisco (PARENT)

San Francisco, California, United States

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, United States

Gastro Florida

Clearwater, Florida, United States

Clinical Research of West Florida Inc - Clearwater

Clearwater, Florida, United States

Advanced Pharma Research, Inc

Delray Beach, Florida, United States

Universal Axon Clinical Research

Doral, Florida, United States

Dolphin Medical Research

Doral, Florida, United States

South Florida Clinical Trials

Hialeah, Florida, United States

Florida Center for Gastroenterology

Largo, Florida, United States

City Medical Group

Miami, Florida, United States

Advanced Clincial Research

Miami, Florida, United States

Advanced Clinical Research of Miami

Miami, Florida, United States

Regenerate Clinical Trials

Miami, Florida, United States

Advanced Research for Health Improvement

Naples, Florida, United States

Advanced Research Institute, Inc.

New Port Richey, Florida, United States

NSB Research

New Smyrna Beach, Florida, United States

Harmony Clinical Research

North Miami Beach, Florida, United States

Med-Care Research

North Miami Beach, Florida, United States

Center For Digestive Health

Orlando, Florida, United States

IMIC, Inc.

Palmetto Bay, Florida, United States

DBC Research, Corp

Pembroke Pines, Florida, United States

Theia Clinical Research, LLC

Pinellas Park, Florida, United States

Florida Medical Clinic, P.A.

Zephyrhills, Florida, United States

Atlanta Gastroenterology Associates LLC

Atlanta, Georgia, United States

Gastrointestinal Specialists of Georgia, PC

Marietta, Georgia, United States

Grand Teton Research Group, PLLC

Idaho Falls, Idaho, United States

Northwestern University Feinberg Sch of Medicine Division of Gastroenterology

Chicago, Illinois, United States

University of Chicago Medical Center

Chicago, Illinois, United States

DM Clinical Research

Oak Lawn, Illinois, United States

Carle Foundation Hospital

Urbana, Illinois, United States

Indiana University Hospital

Indianapolis, Indiana, United States

Cotton-O'Neil Clinical Research Center, Digestive Health

Topeka, Kansas, United States

University of Kentucky Medical Center

Lexington, Kentucky, United States

University of Louisville

Louisville, Kentucky, United States

Gastroenterology Associates, LLC

Baton Rouge, Louisiana, United States

University of Maryland Medical Group

Baltimore, Maryland, United States

Woodholme Gastroenterology

Baltimore, Maryland, United States

Johns Hopkins Clinical Research Network

Baltimore, Maryland, United States

Chevy Chase Clinical Research

Chevy Chase, Maryland, United States

Gastro Center of Maryland

Columbia, Maryland, United States

Charm City Research Group

Towson, Maryland, United States

Boston Medical Center

Boston, Massachusetts, United States

Commonwealth Clinical Studies, PLLC.

Brockton, Massachusetts, United States

Community Clinical Research Network

Marlborough, Massachusetts, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Center For Digestive Health

Troy, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Ehrhardt Clinical Research, LLC

Belton, Missouri, United States

Clinical Research Professionals, LLC - De Paul Medical Dr

Bridgeton, Missouri, United States

Mercy Research

Springfield, Missouri, United States

Washington University

St Louis, Missouri, United States

Clinical Research Professionals LLC - The Pines Court

St Louis, Missouri, United States

Clinical Research Professionals, LLC - Olde Cabin Rd

St Louis, Missouri, United States

Mary Hitchcock Memorial Hospital

Lebanon, New Hampshire, United States

NY Scientific

Brooklyn, New York, United States

Long Island Clinical Research Associates

Great Neck, New York, United States

Icahn School of Medicine Mount Sinai Beth Isreal

New York, New York, United States

Concord Medical Group PRIME

New York, New York, United States

New York University School of Medicine

New York, New York, United States

Weill Cornell Medical College

New York, New York, United States

Mount Sinai - PRIME

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Asheville Gastroenterology Associates, P.A.

Asheville, North Carolina, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Carolinas HealthCare System Digestive Health

Charlotte, North Carolina, United States

East Carolina Gastroenterology, PA

Jacksonville, North Carolina, United States

Kinston Medical Specialists, PA

Kinston, North Carolina, United States

PMG Research of Rocky Mount, LLC

Rocky Mount, North Carolina, United States

UC Health Clinical Trials Office

Cincinnati, Ohio, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio State University Clinical Trials Management Office

Columbus, Ohio, United States

Clinical Inquest Center Ltd

Springfield, Ohio, United States

University of Oklahoma

Oklahoma City, Oklahoma, United States

Digestive Disease Specialists

Oklahoma City, Oklahoma, United States

Oregon Health & Science University

Portland, Oregon, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Consultants in Gastroenterology, PA

Columbia, South Carolina, United States

Gastroenterology Associates of Orangeburg

Orangeburg, South Carolina, United States

Gastro One

Germantown, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Baylor Research Institute

Dallas, Texas, United States

Brooke-Army Medical Center

Fort Sam Houston, Texas, United States

Ventavia Research Group, LLC

Fort Worth, Texas, United States

Gulf Coast Research Group LLC

Houston, Texas, United States

The Methodist Hospital Research Institute

Houston, Texas, United States

Houston Endoscopy and Research Center

Houston, Texas, United States

Gastroenterology Research of San Antonio, LLC

San Antonio, Texas, United States

San Antonio Gastroenterology

San Antonio, Texas, United States

Texas Digestive Disease Consultants - Southlake

Southlake, Texas, United States

Spring Gastroenterology

Spring, Texas, United States

Digestive Health Specialists of Tyler

Tyler, Texas, United States

University of Utah

Salt Lake City, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, United States

Gastroenterology, LTD

Virginia Beach, Virginia, United States

Benaroya Research Institute at Virginia Mason

Seattle, Washington, United States

University of Washington Medical Center

Seattle, Washington, United States

Hospital Italiano

Buenos Aires, , Argentina

Instituto DAMIC Fundacion Rusculleda

Córdoba, , Argentina

Hospital Italiano de La Plata

La Plata, , Argentina

Instituto Medico CER

Quilmes, , Argentina

Instituto Medico de la Fundacion Estudios Clinicos

Rosario, , Argentina

Centre For Digestive Diseases

Five Dock, New South Wales, Australia

Nepean Hospital

Kingswood, New South Wales, Australia

Mater Hospital Brisbane

South Brisbane, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Cabrini Hospital Malvern

Malvern, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Monash Medical Centre Clayton

Bentleigh East, , Australia

Royal Prince Alfred Hospital

Camperdown, , Australia

Medical University Vienna

Vienna, , Austria

Gomel Regional Clinical Hospital

Homyel, , Belarus

City Clinical Hospital No 10

Minsk, , Belarus

Vitebsk Regional Clinical Hospital

Vitebsk, , Belarus

Imeldaziekenhuis

Bonheiden, , Belgium

AZ Maria Middelares

Ghent, , Belgium

Universitair Ziekenhuis Gent

Ghent, , Belgium

UZ Leuven

Leuven, , Belgium

CHC - Clinique St-Jospeh

Liège, , Belgium

Medical Centre "Asklepii", OOD

Dupnitsa, , Bulgaria

UMHAT 'Dr. Georgi Stranski', EAD

Pleven, , Bulgaria

UMHAT "Kaspela", EOOD

Plovdiv, , Bulgaria

MC Rusemed ltd.

Rousse, , Bulgaria

NMTH "Tsar Boris III"

Sofia, , Bulgaria

MHAT "Lyulin", EAD

Sofia, , Bulgaria

City Clinic UMHAC EOOD

Sofia, , Bulgaria

MHAT 'Tokuda Hospital Sofia', EAD

Sofia, , Bulgaria

UMHAT 'Tsaritsa Yoanna - ISUL', EAD

Sofia, , Bulgaria

Fourth MHAT - Sofia EAD

Sofia, , Bulgaria

UMHAT 'Sveta Anna' AD

Sofia, , Bulgaria

UMHAT "SofiaMed", OOD

Sofia, , Bulgaria

Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

Stara Zagora, , Bulgaria

MHAT 'Sv. Marina', EAD

Varna, , Bulgaria

MC Medica Plus

Veliko Tarnovo, , Bulgaria

Vancouver General Hospital

Vancouver, British Columbia, Canada

Brandon Medical Arts Clinic

Brandon, Manitoba, Canada

Viable Clinical Research - Lindsay

Lindsay, Ontario, Canada

LHSC - University Hospital

London, Ontario, Canada

LHSC - Victoria Hospital

London, Ontario, Canada

Humber River Hospital

Toronto, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

Toronto Liver Centre

Toronto, Ontario, Canada

Toronto Digestive Disease Associates, Inc.

Vaughan, Ontario, Canada

Centre integre de sante et de services sociaux de la Monteregie-Centre - Hopital Charles-Le Moyne

Greenfield Park, Quebec, Canada

The Ottawa Hospital - General Campus

Ottawa, Quebec, Canada

CHUS - Hôpital Fleurimont

Sherbrooke, Quebec, Canada

Clinical Hospital Center Osijek

Osijek, , Croatia

Clinical Hospital Centre Rijeka

Rijeka, , Croatia

Clinical Hospital "Sveti Duh", Clinic of Internal Diseases

Zagreb, , Croatia

Clinical Hospital Center Sestre milosrdnice Clinic of Internal Diseases

Zagreb, , Croatia

Clinical Hospital Dubrava, Clinic of Internal Medicine, Department of Gastroenterology

Zagreb, , Croatia

Vojenska nemocnice Brno

Brno, , Czechia

Hepato-Gastroenterologie HK, s.r.o.

Hradec Králové, , Czechia

GASTRO JeKa s.r.o.

Klatovy, , Czechia

Gregar s.r.o.

Olomouc, , Czechia

PreventaMed

Olomouc, , Czechia

Institut klinicke a experimentalni mediciny

Prague, , Czechia

Thomayerova nemocnice

Prague, , Czechia

ISCARE, a.s.

Prague, , Czechia

Nemocnice Slany

Slaný, , Czechia

LTD Research Institute of Clinical Medicine

Tbilisi, , Georgia

LLC Vivamedi

Tbilisi, , Georgia

LTD Academician N.Kipshidze Central University Clinic

Tbilisi, , Georgia

LTD Aversi Clinic

Tbilisi, , Georgia

LTD Coloproctological Center

Tbilisi, , Georgia

Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin

Berlin, , Germany

Charite - Campus Virchow-Klinikum

Berlin, , Germany

DRK Kliniken Berlin Westend

Berlin, , Germany

Universitaetsklinikum Koeln

Cologne, , Germany

Medical Care Unit Dachau

Dachau, , Germany

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, , Germany

Klinikum der Johann Wolfgang Goethe-Universitaet

Frankfurt, , Germany

Crohn Colitis Centrum Rhein Main

Frankfurt, , Germany

Universitaetsklinikum Freiburg

Freiburg im Breisgau, , Germany

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Asklepios Klinik Hamburg

Hamburg, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

EUGASTRO GmbH

Leipzig, , Germany

Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

Lübeck, , Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

Mainz, , Germany

Universitatsklinikum Ulm

Ulm, , Germany

Laiko General Hospital of Athens

Athens, , Greece

University General Hospital of Heraklion

Heraklion, , Greece

University General Hospital of Larissa

Larissa Thessaly, , Greece

General Hospital of Thessaloniki Hippokration

Thessaloniki, , Greece

424th Army General Hospital

Thessaloniki, , Greece

DRC Gyogyszervizsgalo Kozpont Kft

Balatonfüred, , Hungary

Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz

Békéscsaba, , Hungary

Obudai Egeszsegugyi Centrum Kft.

Budapest, , Hungary

Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, , Hungary

Semmelweis Egyetem

Budapest, , Hungary

Pannonia Maganorvosi Centrum

Budapest, , Hungary

Szent Margit Korhaz

Budapest, , Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

Gyula, , Hungary

Somogy Megyei Kaposi Mor Oktato Korhaz

Kaposvár, , Hungary

Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont

Létavértes, , Hungary

Mohacsi Korhaz

Mohács, , Hungary

SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

Nyíregyháza, , Hungary

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, , Hungary

Wolfson Medical Center

Holon, , Israel

Shaare Zedek Medical Center

Jerusalem, , Israel

Meir Medical Center

Kfar Saba, , Israel

Chaim Sheba Medical Center

Ramat Gan, , Israel

Kaplan Medical Center

Rehovot, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi

Bologna, , Italy

Azienda Ospedaliera Universitaria Careggi

Florence, , Italy

Azienda Ospedaliero Universitaria San Martino

Genova, , Italy

Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale Sacco

Milan, , Italy

A.O.U. Policlinico di Modena

Modena, , Italy

Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

Monza, , Italy

Azienda Ospedaliera Universitaria "Federico II"

Napoli, , Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, , Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

Complesso Integrato Columbus

Roma, , Italy

Istituto Clinico Humanitas

Rozzano (MI), , Italy

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo FG, , Italy

Pauls Stradins Clinical University Hospital

Riga, , Latvia

"Sfanta Treime" Clinical Municipal Hospital

Chisinau, , Moldova

Clinical Hospital of the Ministry of Health, Department of Endoscopic Surgery

Chisinau, , Moldova

"Sf. Arhanghel Mihail" Municipal Clinical Hospital

Chisinau, , Moldova

Republican Clinical Hospital

Chisinau, , Moldova

Vrije Universiteit Medisch Centrum (VUMC)

Amsterdam, , Netherlands

Academisch Medisch Centrum

Amsterdam, , Netherlands

Universitair Medisch Centrum Groningen (UMCG)

Groningen, , Netherlands

Maastricht University Medical Center

Maastrich, , Netherlands

Zuyderland Medisch Centrum - Sittard-Geleen

Sittard-Geleen, , Netherlands

ETZ Elisabeth

Tilburg, , Netherlands

Christchurch Hospital NZ

Christchurch, , New Zealand

Dunedin Public Hospital

Dunedin, , New Zealand

Clinsante S.C. Osrodek Badan Klinicznych

Bydgoszcz, , Poland

Specjalistyczna Przychodnia Lekarska Medicus

Chorzów, , Poland

PLEJADY Sp. z o.o. (LLC) Medical Centre

Krakow, , Poland

Centrum Medyczne A-Z Clinic

Krakow, , Poland

Healthcare Center Orkan Med Stec Michalska Spolka Jawna

Ksawerów, , Poland

GLOBE Clinical Research Sp. z o.o. LLC

Kłodzko, , Poland

Santa Familia Centrum Badan, Profilaktyki i Leczenia

Lodz, , Poland

KO-MED Centra Kliniczne Lublin II

Lublin, , Poland

Trialmed Llc

Piotrkow Trybunalski, , Poland

SOLUMED Centrum Medyczne

Poznan, , Poland

Specjalistyczna Praktyka Lekarska dr med. Marek Horynski

Sopot, , Poland

KO-MED Centra Kliniczne Staszow

Staszów, , Poland

GASTROMED Kopon, Zmudzinski and Partners Specialist Centre for Gastroenterology and Endoscopy, Spe

Torun, , Poland

MDM Healthcare Centre

Warsaw, , Poland

Nzoz Vivamed

Warsaw, , Poland

Health Centre Metabolic Diseases Outpatient Clinic in Wierzchoslawice

Wierzchosławice, , Poland

LexMedica Osrodek Badan Klinicznych

Wroclaw, , Poland

Bacau County Emergency Hospital, Department of Gastroenterology

Bacau, , Romania

Hyperclinica MedLife Grivita

Bucharest, , Romania

Bucharest University Emergency Hospital, Department of Internal Medicine II

Bucharest, , Romania

TVM MED SERV SRL, Medical Center for Gastroenterology, Hepatology and Digestive Endoscopy

Cluj-Napoca, , Romania

Sf. Apostol Andrei Constanta Emergency Clinical County Hospital

Constanța, , Romania

Craiova County Emergency Clinical Hospital

Craiova, , Romania

"Pius Brinzeu" County Emergency Clinical Hospital, Department of Gastroenterology and Hepatology

Timișoara, , Romania

Multidisciplinary Medical Clinic "Anthurium"

Barnaul, , Russia

Road Clinical Hospital on Station Irkutsk-Passazhirskiy of OJSC Russian Railways

Irkutsk, , Russia

SBEI HPE "Kazan State Medical University" of the MoH of the RF

Kazan', , Russia

FSBIH "Central Clinical Hospital of Russian Academy of Sciences"

Moscow, , Russia

SBIH of Nizhniy Novgorod region " Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"

Nizhny Novgorod, , Russia

SBEIHPE Novosibirsk State Medical University

Novosibirsk, , Russia

FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS

Novosibirsk, , Russia

BHI of Omsk region "Clinical Oncology Dispensary"

Omsk, , Russia

SBEI HPE Rostov State Medical University of the MoH of the RF

Rostov-on-Don, , Russia

SPb SBIH Alexandrovskaya City Hospital

Saint Petersburg, , Russia

FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine"

Saint Petersburg, , Russia

FSMEI HPE "Military Medical Academy n.a. S.M.Kirov"of Ministry of Defense of Russia

Saint Petersburg, , Russia

SBIH City Clinical Hospital #31

Saint Petersburg, , Russia

SPb SBIH City Hospital # 26

Saint Petersburg, , Russia

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, , Russia

Union Clinic

Saint-Peterburg, , Russia

Private Educational Institution of Higher Education "Medical University "REAVIZ"

Samara, , Russia

LLC Medical Company Hepatologist

Samara, , Russia

SBEI HPE "Stavropol State Medical Academy" MoH of RF

Stavropol, , Russia

Regional Clinical Hospital

Vladimir, , Russia

Clinical Hospital Center Bezanijska Kosa, Clinic of Internal Medicine

Belgrade, , Serbia

Clinical Center of Serbia, Clinic of Gastroenterology and Hepatology, Department of Gastroenterology

Belgrade, , Serbia

Clinical Hospital Center Zvezdara Clinic of Internal Diseases

Belgrade, , Serbia

Military Medical Academy, Clinic of Gastroenterology and Hepatology

Belgrade, , Serbia

Clinical Hospital Center Zemun Department of Gastroenterology

Belgrade, , Serbia

Clinical Center Kragujevac, Clinic of Internal Medicine, Center for Gastroenterohepatology

Kragujevac, , Serbia

Clinical Center Nis, Clinic of Gastroenterology and Hepatology

Niš, , Serbia

General Hospital Djordje Jovanovic Zrenjanin

Zrenjanin, , Serbia

Fakultna nemocnica s poliklinikou F.D. Roosevelta

Banská Bystrica, , Slovakia

Alian s.r.o.

Bardejov, , Slovakia

PRO SANUS, a.s., Poliklinika ProCare Central

Bratislava, , Slovakia

IBDcentrum s.r.o.

Bratislava, , Slovakia

Slovak Research Center-team member, Sukromna gastroenterologicka ambulancia

Ilava, , Slovakia

Gastroped s.r.o.

Košice, , Slovakia

Gastroeneterologicka ambulancia MUDr. Peter Hegyi, s.r.o.

Malacky, , Slovakia

PIGEAS s.r.o.

Martin, , Slovakia

Nemocnica s poliklinikou S. Kukuru Michalovce, a.s.

Michalovce, , Slovakia

Gastromedic s.r.o.

Nové Zámky, , Slovakia

EndoCorp s.r.o.

Trnava, , Slovakia

Dr MJ Prins Practice

Cape Town, , South Africa

Tiervlei Trial Centre

Cape Town, , South Africa

Endocare Research

Cape Town, , South Africa

Dr JP Wright Practice

Cape Town, , South Africa

Dr YS Nanabhay Practice

Johannesburg, , South Africa

Emmed Research

Pretoria, , South Africa

Inje University Haeundae Paik Hospital

Busan, , South Korea

Yeungnam University Hospital

Daegu, , South Korea

Konyang University Hospital

Daejeon, , South Korea

Hanyang Univerisy Guri Hospital

Guri-si, , South Korea

Seoul National University Bundang Hospital

Seongnam, , South Korea

CHA Bundang Medical Center CHA University

Seongnam-si, , South Korea

Kyung Hee University Hospital

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Kangbuk Samsung Hospital

Seoul, , South Korea

Severance Hospital, Yonsei University

Seoul, , South Korea

Ewha Womans University Mokdong Hospital

Seoul, , South Korea

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

Suwon, , South Korea

Yonsei University Wonju Severance Christian Hospital

Wŏnju, , South Korea

University Hospital Germans Trias i Pujol

Badalona, , Spain

Hospital Universitario de Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, , Spain

University Hospital of the Canary Islands (HUC) La Laguna

San Cristóbal de La Laguna, , Spain

University Hospital Virgen del Rocio

Seville, , Spain

RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU

Chernivtsi, , Ukraine

Dnipropetrovsk I.I. Mechnykov Regional Clinical Hospital

Dnipropetrovsk, , Ukraine

Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases

Dnipropetrovsk, , Ukraine

Ivano-Frankivsk City Clinical Hospital #1 Dep of Surgery SHEI Ivano-Frankivsk NMU

Ivano-Frankivsk, , Ukraine

Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU

Ivano-Frankivsk, , Ukraine

CI of PH Kharkiv CCH #2

Kharkiv, , Ukraine

GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine

Kharkiv, , Ukraine

Kyiv City Clinical Hospital #1

Kyiv, , Ukraine

SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU

Kyiv, , Ukraine

CI of Kyiv RC Regional Clinical Hospital #2

Kyiv, , Ukraine

Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE

Kyiv, , Ukraine

Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU

Kyiv, , Ukraine

Lviv Regional Clinical Hospital

Lviv, , Ukraine

Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU

Lviv, , Ukraine

CI Sumy City Clinical Hospital #1 Dept of Therapy Sumy SU

Sumy, , Ukraine

Sumy Regional Clinical Hospital

Sumy, , Ukraine

CI of TRC Ternopil University Hospital

Ternopil, , Ukraine

A. Novak Transcarpathian Regional Clinical Hospital

Uzhhorod, , Ukraine

MCIC MC LLC Health Clinic

Vinnytsia, , Ukraine

Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War

Vinnytsia, , Ukraine

M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU

Vinnytsia, , Ukraine

Vinnytsia M.I. Pyrohov Regional Clinical Hospital

Vinnytsia, , Ukraine

Vinnytsia M.I. Pyrohov National Medical University

Vinnytsia, , Ukraine

City Clinical Hospital of Emergency and Urgent Care of Zaporizhzhya

Zaporizhia, , Ukraine

Zaporizhia City Multispecialty Clinical Hospital #9, Department of Neurology

Zaporizhia, , Ukraine

CI City Hospital #1

Zaporizhia, , Ukraine

CI Zapor City Multifunctional CH#9 City Center of Gastroenterology SI Zapor MA of PGE of MOHU

Zaporizhzhia, , Ukraine

Zaporizhia Regional Clinical Hospital

Zaporizhzhia, , Ukraine

Central District Hospital under Zhytomyr District Council

Zhytomyr, , Ukraine

University Hospital Coventry

Coventry, , United Kingdom

Royal Devon and Exeter Hospital (Wonford)

Exeter, , United Kingdom

Gloucestershire Royal Hospital

Gloucester, , United Kingdom

Whipps Cross University Hospital

London, , United Kingdom

St Thomas' Hospital

London, , United Kingdom

Royal Shrewsbury Hospital

Shrewsbury, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Belarus; Belgium; Bulgaria; Canada; Croatia; Czechia; Georgia; Germany; Greece; Hungary; Israel; Italy; Latvia; Moldova; Netherlands; New Zealand; Poland; Romania; Russia; Serbia; Slovakia; South Africa; South Korea; Spain; Ukraine; United Kingdom

References

Yarur A, Irving P, Siegmund B, Dubinsky MC, Ananthakrishnan AN, Regueiro M, Ungaro RC, Ritter T, Nakase H, Liu Z, Mehra D, Osterman MT, Jain A, Rubin DT, Hibi T. Long-Term Ozanimod Therapy in Patients With Moderately Active Ulcerative Colitis After Failure of 5-Aminosalicylic Acid. Inflamm Bowel Dis. 2025 Sep 26:izaf195. doi: 10.1093/ibd/izaf195. Online ahead of print.

Reference Type: DERIVED

PMID: 41003640 (View on PubMed)

Sands BE, Rubin DT, Loftus EV Jr, Wolf DC, Panaccione R, Colombel JF, Dignass A, Regueiro M, Vermeire S, Afzali A, Lawlor G, Ahmad HA, Wu H, Osterman MT, Jain A, D'Haens G. Impact of Prior Biologic Exposure on Ozanimod Efficacy and Safety in the Phase 3 True North Clinical Trial. Am J Gastroenterol. 2025 Jan 8;120(10):2339-49. doi: 10.14309/ajg.0000000000003310. Online ahead of print.

Reference Type: DERIVED

PMID: 39773524 (View on PubMed)

Regueiro M, Siegmund B, Horst S, Moslin R, Charles L, Petersen A, Tatosian D, Wu H, Lawlor G, Fischer M, D'Haens G, Colombel JF. Concomitant Administration of Ozanimod and Serotonergic Antidepressants in Patients With Ulcerative Colitis or Relapsing Multiple Sclerosis. Inflamm Bowel Dis. 2025 Apr 10;31(4):1010-1017. doi: 10.1093/ibd/izae136.

Reference Type: DERIVED

PMID: 39018016 (View on PubMed)

Sands BE, D'Haens G, Panaccione R, Regueiro M, Ghosh S, Hudesman D, Ahmad HA, Mehra D, Wu H, Jain A, Petersen A, Osterman MT, Afzali A, Danese S. Ozanimod in Patients With Moderate to Severe Ulcerative Colitis Naive to Advanced Therapies. Clin Gastroenterol Hepatol. 2024 Oct;22(10):2084-2095.e4. doi: 10.1016/j.cgh.2024.03.042. Epub 2024 May 8.

Reference Type: DERIVED

PMID: 38723981 (View on PubMed)

Armuzzi A, Cross RK, Lichtenstein GR, Hou J, Deepak P, Regueiro M, Wolf DC, Akukwe L, Ahmad HA, Jain A, Kozinn M, Wu H, Petersen A, Charles L, Long M. Cardiovascular Safety of Ozanimod in Patients With Ulcerative Colitis: True North and Open-Label Extension Analyses. Clin Gastroenterol Hepatol. 2024 May;22(5):1067-1076.e3. doi: 10.1016/j.cgh.2023.11.018. Epub 2023 Nov 30.

Reference Type: DERIVED

PMID: 38040274 (View on PubMed)

Sandborn WJ, Feagan BG, D'Haens G, Wolf DC, Jovanovic I, Hanauer SB, Ghosh S, Petersen A, Hua SY, Lee JH, Charles L, Chitkara D, Usiskin K, Colombel JF, Laine L, Danese S; True North Study Group. Ozanimod as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2021 Sep 30;385(14):1280-1291. doi: 10.1056/NEJMoa2033617.

Reference Type: DERIVED

PMID: 34587385 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

RPC01-3101

Identifier Type: -

Identifier Source: org_study_id