Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis
1 other identifier
interventional
1,012
28 countries
360
Brief Summary
The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2015
Longer than P75 for phase_3
360 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2015
CompletedFirst Posted
Study publicly available on registry
May 6, 2015
CompletedStudy Start
First participant enrolled
June 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 17, 2020
CompletedResults Posted
Study results publicly available
September 1, 2021
CompletedSeptember 1, 2021
August 1, 2021
4.8 years
April 24, 2015
June 25, 2021
August 6, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants in Clinical Remission at 10 Weeks
Percentage of participants that are in Clinical remission at 10 weeks
At 10 Weeks
Percentage of Participants in Clinical Remission at 52 Weeks
Percentage of participants that are in Clinical remission at 52 weeks
At 52 Weeks
Secondary Outcomes (9)
Percentage of Participants With Clinical Response at 10 Weeks
At 10 Weeks
Percentage of Participants With Endoscopic Improvement at 10 Weeks
At 10 Weeks
Percentage of Participants With Mucosal Healing at 10 Weeks
At 10 Weeks
Percentage of Participants in Clinical Response at 52 Weeks
At 52 Weeks
Percentage of Participants With Endoscopic Improvement at 52 Weeks
At 52 Weeks
- +4 more secondary outcomes
Study Arms (2)
RPC1063 (Ozanimod)
EXPERIMENTAL1mg, daily oral administration during Induction and Maintenance periods.
Placebo
PLACEBO COMPARATORDaily oral administration during Induction and Maintenance periods.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (372)
Arizona Digestive Health
Sun City, Arizona, 85351, United States
Adobe Clinical Research LLC
Tucson, Arizona, 85712, United States
Arkansas Gastroenterology, P.A.
North Little Rock, Arkansas, 72117, United States
Anaheim Clinical Trials
Anaheim, California, 92801, United States
Aurora Care Clinic
Costa Mesa, California, 92627, United States
Valley View Internal Medicine
Garden Grove, California, 92843, United States
Davita Clinical Trials, LLC
Huntington Beach, California, 92646, United States
University of California San Diego Medical Center
La Jolla, California, 92037, United States
OM Research
Lancaster, California, 93534, United States
University of Southern California - Keck School of Medicine
Los Angeles, California, 90033, United States
Southern California Research Institute Medical Group, Inc.
Los Angeles, California, 90045, United States
Gastrointestinal Biosciences
Los Angeles, California, 90067, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
Facey Medical Foundation (Parent)
Mission Hills, California, 91345, United States
Alliance Clinical Research, LLC
Oceanside, California, 92056-4497, United States
Medical Associates Research Group, Inc.
San Diego, California, 92123, United States
University of California at San Francisco (PARENT)
San Francisco, California, 94115, United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, 06518, United States
Gastro Florida
Clearwater, Florida, 33756-3839, United States
Clinical Research of West Florida Inc - Clearwater
Clearwater, Florida, 33765, United States
Advanced Pharma Research, Inc
Delray Beach, Florida, 33445, United States
Universal Axon Clinical Research
Doral, Florida, 33166, United States
Dolphin Medical Research
Doral, Florida, 33172, United States
South Florida Clinical Trials
Hialeah, Florida, 33016, United States
Florida Center for Gastroenterology
Largo, Florida, 33777, United States
City Medical Group
Miami, Florida, 33126, United States
Advanced Clincial Research
Miami, Florida, 33134, United States
Advanced Clinical Research of Miami
Miami, Florida, 33155, United States
Regenerate Clinical Trials
Miami, Florida, 33155, United States
Advanced Research for Health Improvement
Naples, Florida, 34109, United States
Advanced Research Institute, Inc.
New Port Richey, Florida, 34653, United States
NSB Research
New Smyrna Beach, Florida, 32168, United States
Harmony Clinical Research
North Miami Beach, Florida, 33162, United States
Med-Care Research
North Miami Beach, Florida, 33162, United States
Center For Digestive Health
Orlando, Florida, 32803, United States
IMIC, Inc.
Palmetto Bay, Florida, 33157, United States
DBC Research, Corp
Pembroke Pines, Florida, 33029, United States
Theia Clinical Research, LLC
Pinellas Park, Florida, 33781, United States
Florida Medical Clinic, P.A.
Zephyrhills, Florida, 33613, United States
Atlanta Gastroenterology Associates LLC
Atlanta, Georgia, 30342, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, 30060, United States
Grand Teton Research Group, PLLC
Idaho Falls, Idaho, 83404, United States
Northwestern University Feinberg Sch of Medicine Division of Gastroenterology
Chicago, Illinois, 60611, United States
University of Chicago Medical Center
Chicago, Illinois, 60637-1447, United States
DM Clinical Research
Oak Lawn, Illinois, 60453-3767, United States
Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Indiana University Hospital
Indianapolis, Indiana, 46202, United States
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, 66606, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40504, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, 70809, United States
University of Maryland Medical Group
Baltimore, Maryland, 21201, United States
Woodholme Gastroenterology
Baltimore, Maryland, 21209, United States
Johns Hopkins Clinical Research Network
Baltimore, Maryland, 21287, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Gastro Center of Maryland
Columbia, Maryland, 21045, United States
Charm City Research Group
Towson, Maryland, 21204, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Commonwealth Clinical Studies, PLLC.
Brockton, Massachusetts, 02302, United States
Community Clinical Research Network
Marlborough, Massachusetts, 01752, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Center For Digestive Health
Troy, Michigan, 48098, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Ehrhardt Clinical Research, LLC
Belton, Missouri, 64012, United States
Clinical Research Professionals, LLC - De Paul Medical Dr
Bridgeton, Missouri, 63044, United States
Mercy Research
Springfield, Missouri, 65806, United States
Washington University
St Louis, Missouri, 63110, United States
Clinical Research Professionals LLC - The Pines Court
St Louis, Missouri, 63141, United States
Clinical Research Professionals, LLC - Olde Cabin Rd
St Louis, Missouri, 63141, United States
Mary Hitchcock Memorial Hospital
Lebanon, New Hampshire, 07756, United States
NY Scientific
Brooklyn, New York, 11235, United States
Long Island Clinical Research Associates
Great Neck, New York, 11021, United States
Icahn School of Medicine Mount Sinai Beth Isreal
New York, New York, 10003, United States
Concord Medical Group PRIME
New York, New York, 10016, United States
New York University School of Medicine
New York, New York, 10016, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Mount Sinai - PRIME
New York, New York, 10029, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina, 28801, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7305, United States
Carolinas HealthCare System Digestive Health
Charlotte, North Carolina, 28204, United States
East Carolina Gastroenterology, PA
Jacksonville, North Carolina, 28546, United States
Kinston Medical Specialists, PA
Kinston, North Carolina, 28501, United States
PMG Research of Rocky Mount, LLC
Rocky Mount, North Carolina, 27804, United States
UC Health Clinical Trials Office
Cincinnati, Ohio, 45206, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Clinical Trials Management Office
Columbus, Ohio, 43210, United States
Clinical Inquest Center Ltd
Springfield, Ohio, 45504, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
Digestive Disease Specialists
Oklahoma City, Oklahoma, 73112, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4206, United States
Consultants in Gastroenterology, PA
Columbia, South Carolina, 29203, United States
Gastroenterology Associates of Orangeburg
Orangeburg, South Carolina, 29118, United States
Gastro One
Germantown, Tennessee, 38138, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37203, United States
Baylor Research Institute
Dallas, Texas, 75246-1613, United States
Brooke-Army Medical Center
Fort Sam Houston, Texas, 78234, United States
Ventavia Research Group, LLC
Fort Worth, Texas, 76104, United States
Gulf Coast Research Group LLC
Houston, Texas, 77004, United States
The Methodist Hospital Research Institute
Houston, Texas, 77030, United States
Houston Endoscopy and Research Center
Houston, Texas, 77079, United States
Gastroenterology Research of San Antonio, LLC
San Antonio, Texas, 78229, United States
San Antonio Gastroenterology
San Antonio, Texas, 78229, United States
Texas Digestive Disease Consultants - Southlake
Southlake, Texas, 76092, United States
Spring Gastroenterology
Spring, Texas, 77379, United States
Digestive Health Specialists of Tyler
Tyler, Texas, 75701, United States
University of Utah
Salt Lake City, Utah, 84132, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320, United States
Gastroenterology, LTD
Virginia Beach, Virginia, 23454, United States
Benaroya Research Institute at Virginia Mason
Seattle, Washington, 98101, United States
University of Washington Medical Center
Seattle, Washington, 98109, United States
Hospital Italiano
Buenos Aires, C1181ACH, Argentina
Instituto DAMIC Fundacion Rusculleda
Córdoba, X5003DCE, Argentina
Hospital Italiano de La Plata
La Plata, 01900, Argentina
Instituto Medico CER
Quilmes, B1878DVB, Argentina
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, 2000, Argentina
Centre For Digestive Diseases
Five Dock, New South Wales, 2046, Australia
Nepean Hospital
Kingswood, New South Wales, 2751, Australia
Mater Hospital Brisbane
South Brisbane, Queensland, 4101, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Cabrini Hospital Malvern
Malvern, Victoria, 3144, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Monash Medical Centre Clayton
Bentleigh East, 3165, Australia
Royal Prince Alfred Hospital
Camperdown, 2050, Australia
Medical University Vienna
Vienna, 1090, Austria
Gomel Regional Clinical Hospital
Homyel, 246029, Belarus
City Clinical Hospital No 10
Minsk, 220096, Belarus
Vitebsk Regional Clinical Hospital
Vitebsk, 210037, Belarus
Imeldaziekenhuis
Bonheiden, 2820, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
CHC - Clinique St-Jospeh
Liège, 4000, Belgium
Medical Centre "Asklepii", OOD
Dupnitsa, 2600, Bulgaria
UMHAT 'Dr. Georgi Stranski', EAD
Pleven, 5800, Bulgaria
UMHAT "Kaspela", EOOD
Plovdiv, 4002, Bulgaria
MC Rusemed ltd.
Rousse, 7013, Bulgaria
NMTH "Tsar Boris III"
Sofia, 1233, Bulgaria
MHAT "Lyulin", EAD
Sofia, 1336, Bulgaria
City Clinic UMHAC EOOD
Sofia, 1407, Bulgaria
MHAT 'Tokuda Hospital Sofia', EAD
Sofia, 1407, Bulgaria
UMHAT 'Tsaritsa Yoanna - ISUL', EAD
Sofia, 1527, Bulgaria
Fourth MHAT - Sofia EAD
Sofia, 1606, Bulgaria
UMHAT 'Sveta Anna' AD
Sofia, 1750, Bulgaria
UMHAT "SofiaMed", OOD
Sofia, 1797, Bulgaria
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
Stara Zagora, 6000, Bulgaria
MHAT 'Sv. Marina', EAD
Varna, 9010, Bulgaria
MC Medica Plus
Veliko Tarnovo, 5000, Bulgaria
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Brandon Medical Arts Clinic
Brandon, Manitoba, R7A 0N7, Canada
Viable Clinical Research - Lindsay
Lindsay, Ontario, K9V 5G6, Canada
LHSC - University Hospital
London, Ontario, N6A 5A5, Canada
LHSC - Victoria Hospital
London, Ontario, N6A 5W9, Canada
Humber River Hospital
Toronto, Ontario, M3M 0B2, Canada
Mount Sinai Hospital
Toronto, Ontario, M5T 3L9, Canada
Toronto Liver Centre
Toronto, Ontario, M6H 3M1, Canada
Toronto Digestive Disease Associates, Inc.
Vaughan, Ontario, L4L 4Y7, Canada
Centre integre de sante et de services sociaux de la Monteregie-Centre - Hopital Charles-Le Moyne
Greenfield Park, Quebec, J4V 2H1, Canada
The Ottawa Hospital - General Campus
Ottawa, Quebec, K1H 8L6, Canada
CHUS - Hôpital Fleurimont
Sherbrooke, Quebec, J1H5N4, Canada
Clinical Hospital Center Osijek
Osijek, 31000, Croatia
Clinical Hospital Centre Rijeka
Rijeka, 51000, Croatia
Clinical Hospital "Sveti Duh", Clinic of Internal Diseases
Zagreb, 10000, Croatia
Clinical Hospital Center Sestre milosrdnice Clinic of Internal Diseases
Zagreb, 10000, Croatia
Clinical Hospital Dubrava, Clinic of Internal Medicine, Department of Gastroenterology
Zagreb, 10000, Croatia
Vojenska nemocnice Brno
Brno, 63600, Czechia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, 50012, Czechia
GASTRO JeKa s.r.o.
Klatovy, 399 01, Czechia
Gregar s.r.o.
Olomouc, 779 00, Czechia
PreventaMed
Olomouc, 77900, Czechia
Institut klinicke a experimentalni mediciny
Prague, 14021, Czechia
Thomayerova nemocnice
Prague, 14059, Czechia
ISCARE, a.s.
Prague, 190 00, Czechia
Nemocnice Slany
Slaný, 274 01, Czechia
LTD Research Institute of Clinical Medicine
Tbilisi, 0112, Georgia
LLC Vivamedi
Tbilisi, 0131, Georgia
LTD Academician N.Kipshidze Central University Clinic
Tbilisi, 0160, Georgia
LTD Aversi Clinic
Tbilisi, 0160, Georgia
LTD Coloproctological Center
Tbilisi, 0160, Georgia
Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin
Berlin, 12203, Germany
Charite - Campus Virchow-Klinikum
Berlin, 13353, Germany
DRK Kliniken Berlin Westend
Berlin, 14050, Germany
Universitaetsklinikum Koeln
Cologne, 50937, Germany
Medical Care Unit Dachau
Dachau, 85221, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, 01307, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt, 60590, Germany
Crohn Colitis Centrum Rhein Main
Frankfurt, 60594, Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20426, Germany
Asklepios Klinik Hamburg
Hamburg, 22559, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
EUGASTRO GmbH
Leipzig, 4103, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Lübeck, 23538, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, 55131, Germany
Universitatsklinikum Ulm
Ulm, 89081, Germany
Laiko General Hospital of Athens
Athens, 11 527, Greece
University General Hospital of Heraklion
Heraklion, 715 00, Greece
University General Hospital of Larissa
Larissa Thessaly, 41110, Greece
General Hospital of Thessaloniki Hippokration
Thessaloniki, 54642, Greece
424th Army General Hospital
Thessaloniki, 56429, Greece
DRC Gyogyszervizsgalo Kozpont Kft
Balatonfüred, 8230, Hungary
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz
Békéscsaba, 5600, Hungary
Obudai Egeszsegugyi Centrum Kft.
Budapest, 1036, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, 1062, Hungary
Semmelweis Egyetem
Budapest, 1083, Hungary
Pannonia Maganorvosi Centrum
Budapest, 1136, Hungary
Szent Margit Korhaz
Budapest, H-1032, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
Gyula, 5700, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400, Hungary
Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
Létavértes, 4281, Hungary
Mohacsi Korhaz
Mohács, 7700, Hungary
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
Nyíregyháza, 4400, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, 8000, Hungary
Wolfson Medical Center
Holon, 58100, Israel
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Meir Medical Center
Kfar Saba, 44281, Israel
Chaim Sheba Medical Center
Ramat Gan, 52621, Israel
Kaplan Medical Center
Rehovot, 76100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi
Bologna, 40138, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, 50134, Italy
Azienda Ospedaliero Universitaria San Martino
Genova, 16132, Italy
Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale Sacco
Milan, 20157, Italy
A.O.U. Policlinico di Modena
Modena, 41124, Italy
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
Monza, 20900, Italy
Azienda Ospedaliera Universitaria "Federico II"
Napoli, 80131, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56124, Italy
Complesso Integrato Columbus
Roma, 00168, Italy
Istituto Clinico Humanitas
Rozzano (MI), 20089, Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo FG, 71013, Italy
Pauls Stradins Clinical University Hospital
Riga, LV1002, Latvia
"Sfanta Treime" Clinical Municipal Hospital
Chisinau, MD-2068, Moldova
Clinical Hospital of the Ministry of Health, Department of Endoscopic Surgery
Chisinau, MD2005, Moldova
"Sf. Arhanghel Mihail" Municipal Clinical Hospital
Chisinau, MD2025, Moldova
Republican Clinical Hospital
Chisinau, MD2025, Moldova
Vrije Universiteit Medisch Centrum (VUMC)
Amsterdam, 1081 HV, Netherlands
Academisch Medisch Centrum
Amsterdam, 1105 AZ, Netherlands
Universitair Medisch Centrum Groningen (UMCG)
Groningen, 9700 RB, Netherlands
Maastricht University Medical Center
Maastrich, 6202 AZ, Netherlands
Zuyderland Medisch Centrum - Sittard-Geleen
Sittard-Geleen, 6162 BG, Netherlands
ETZ Elisabeth
Tilburg, 5022 GC, Netherlands
Christchurch Hospital NZ
Christchurch, 8011, New Zealand
Dunedin Public Hospital
Dunedin, 9016, New Zealand
Clinsante S.C. Osrodek Badan Klinicznych
Bydgoszcz, 85-794, Poland
Specjalistyczna Przychodnia Lekarska Medicus
Chorzów, 41-500, Poland
PLEJADY Sp. z o.o. (LLC) Medical Centre
Krakow, 30-363, Poland
Centrum Medyczne A-Z Clinic
Krakow, 31-315, Poland
Healthcare Center Orkan Med Stec Michalska Spolka Jawna
Ksawerów, 95-054, Poland
GLOBE Clinical Research Sp. z o.o. LLC
Kłodzko, 57-300, Poland
Santa Familia Centrum Badan, Profilaktyki i Leczenia
Lodz, 90-302, Poland
KO-MED Centra Kliniczne Lublin II
Lublin, 20-362, Poland
Trialmed Llc
Piotrkow Trybunalski, 97-300, Poland
SOLUMED Centrum Medyczne
Poznan, 60-529, Poland
Specjalistyczna Praktyka Lekarska dr med. Marek Horynski
Sopot, 81-756, Poland
KO-MED Centra Kliniczne Staszow
Staszów, 28-200, Poland
GASTROMED Kopon, Zmudzinski and Partners Specialist Centre for Gastroenterology and Endoscopy, Spe
Torun, 87-100, Poland
MDM Healthcare Centre
Warsaw, 00-632, Poland
Nzoz Vivamed
Warsaw, 03-580, Poland
Health Centre Metabolic Diseases Outpatient Clinic in Wierzchoslawice
Wierzchosławice, 33-122, Poland
LexMedica Osrodek Badan Klinicznych
Wroclaw, 53-114, Poland
Bacau County Emergency Hospital, Department of Gastroenterology
Bacau, 600114, Romania
Hyperclinica MedLife Grivita
Bucharest, 010719, Romania
Bucharest University Emergency Hospital, Department of Internal Medicine II
Bucharest, 050098, Romania
TVM MED SERV SRL, Medical Center for Gastroenterology, Hepatology and Digestive Endoscopy
Cluj-Napoca, 400132, Romania
Sf. Apostol Andrei Constanta Emergency Clinical County Hospital
Constanța, 900591, Romania
Craiova County Emergency Clinical Hospital
Craiova, 200642, Romania
"Pius Brinzeu" County Emergency Clinical Hospital, Department of Gastroenterology and Hepatology
Timișoara, 300723, Romania
Multidisciplinary Medical Clinic "Anthurium"
Barnaul, 656043, Russia
Road Clinical Hospital on Station Irkutsk-Passazhirskiy of OJSC Russian Railways
Irkutsk, 664005, Russia
SBEI HPE "Kazan State Medical University" of the MoH of the RF
Kazan', 420012, Russia
FSBIH "Central Clinical Hospital of Russian Academy of Sciences"
Moscow, 119333, Russia
SBIH of Nizhniy Novgorod region " Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"
Nizhny Novgorod, 603126, Russia
SBEIHPE Novosibirsk State Medical University
Novosibirsk, 630054, Russia
FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS
Novosibirsk, 630117, Russia
BHI of Omsk region "Clinical Oncology Dispensary"
Omsk, 644013, Russia
SBEI HPE Rostov State Medical University of the MoH of the RF
Rostov-on-Don, 344022, Russia
SPb SBIH Alexandrovskaya City Hospital
Saint Petersburg, 193312, Russia
FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine"
Saint Petersburg, 194044, Russia
FSMEI HPE "Military Medical Academy n.a. S.M.Kirov"of Ministry of Defense of Russia
Saint Petersburg, 194044, Russia
SBIH City Clinical Hospital #31
Saint Petersburg, 194291, Russia
SPb SBIH City Hospital # 26
Saint Petersburg, 196247, Russia
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, 197022, Russia
Union Clinic
Saint-Peterburg, 191119, Russia
Private Educational Institution of Higher Education "Medical University "REAVIZ"
Samara, 443011, Russia
LLC Medical Company Hepatologist
Samara, Russia
SBEI HPE "Stavropol State Medical Academy" MoH of RF
Stavropol, 355017, Russia
Regional Clinical Hospital
Vladimir, 600023, Russia
Clinical Hospital Center Bezanijska Kosa, Clinic of Internal Medicine
Belgrade, 11 080, Serbia
Clinical Center of Serbia, Clinic of Gastroenterology and Hepatology, Department of Gastroenterology
Belgrade, 11000, Serbia
Clinical Hospital Center Zvezdara Clinic of Internal Diseases
Belgrade, 11000, Serbia
Military Medical Academy, Clinic of Gastroenterology and Hepatology
Belgrade, 11000, Serbia
Clinical Hospital Center Zemun Department of Gastroenterology
Belgrade, 11080, Serbia
Clinical Center Kragujevac, Clinic of Internal Medicine, Center for Gastroenterohepatology
Kragujevac, 34000, Serbia
Clinical Center Nis, Clinic of Gastroenterology and Hepatology
Niš, 18 000, Serbia
General Hospital Djordje Jovanovic Zrenjanin
Zrenjanin, 23 000, Serbia
Fakultna nemocnica s poliklinikou F.D. Roosevelta
Banská Bystrica, 97517, Slovakia
Alian s.r.o.
Bardejov, 08501, Slovakia
PRO SANUS, a.s., Poliklinika ProCare Central
Bratislava, 82107, Slovakia
IBDcentrum s.r.o.
Bratislava, 83104, Slovakia
Slovak Research Center-team member, Sukromna gastroenterologicka ambulancia
Ilava, 01901, Slovakia
Gastroped s.r.o.
Košice, 040 01, Slovakia
Gastroeneterologicka ambulancia MUDr. Peter Hegyi, s.r.o.
Malacky, 90122, Slovakia
PIGEAS s.r.o.
Martin, 3601, Slovakia
Nemocnica s poliklinikou S. Kukuru Michalovce, a.s.
Michalovce, 7101, Slovakia
Gastromedic s.r.o.
Nové Zámky, 94002, Slovakia
EndoCorp s.r.o.
Trnava, 917 75, Slovakia
Dr MJ Prins Practice
Cape Town, 7500, South Africa
Tiervlei Trial Centre
Cape Town, 7550, South Africa
Endocare Research
Cape Town, 7646, South Africa
Dr JP Wright Practice
Cape Town, 7708, South Africa
Dr YS Nanabhay Practice
Johannesburg, 2193, South Africa
Emmed Research
Pretoria, 0084, South Africa
Inje University Haeundae Paik Hospital
Busan, 612-030, South Korea
Yeungnam University Hospital
Daegu, 42415, South Korea
Konyang University Hospital
Daejeon, 302-718, South Korea
Hanyang Univerisy Guri Hospital
Guri-si, 471-701, South Korea
Seoul National University Bundang Hospital
Seongnam, 463-707, South Korea
CHA Bundang Medical Center CHA University
Seongnam-si, 13496, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Korea University Anam Hospital
Seoul, 136-705, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Kangbuk Samsung Hospital
Seoul, 3181, South Korea
Severance Hospital, Yonsei University
Seoul, 3722, South Korea
Ewha Womans University Mokdong Hospital
Seoul, 7985, South Korea
The Catholic University of Korea, St.Vicent's Hospital
Suwon, 442-723, South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, 220701, South Korea
University Hospital Germans Trias i Pujol
Badalona, 08916, Spain
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, 35012, Spain
University Hospital of the Canary Islands (HUC) La Laguna
San Cristóbal de La Laguna, 38320, Spain
University Hospital Virgen del Rocio
Seville, 41013, Spain
RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU
Chernivtsi, 58002, Ukraine
Dnipropetrovsk I.I. Mechnykov Regional Clinical Hospital
Dnipropetrovsk, 49027, Ukraine
Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases
Dnipropetrovsk, 49074, Ukraine
Ivano-Frankivsk City Clinical Hospital #1 Dep of Surgery SHEI Ivano-Frankivsk NMU
Ivano-Frankivsk, 76014, Ukraine
Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU
Ivano-Frankivsk, 76018, Ukraine
CI of PH Kharkiv CCH #2
Kharkiv, 61037, Ukraine
GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
Kharkiv, 61039, Ukraine
Kyiv City Clinical Hospital #1
Kyiv, 02091, Ukraine
SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU
Kyiv, 04053, Ukraine
CI of Kyiv RC Regional Clinical Hospital #2
Kyiv, 04073, Ukraine
Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE
Kyiv, 04201, Ukraine
Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU
Kyiv, 1030, Ukraine
Lviv Regional Clinical Hospital
Lviv, 79010, Ukraine
Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
Lviv, 79059, Ukraine
CI Sumy City Clinical Hospital #1 Dept of Therapy Sumy SU
Sumy, 40021, Ukraine
Sumy Regional Clinical Hospital
Sumy, 40022, Ukraine
CI of TRC Ternopil University Hospital
Ternopil, 46002, Ukraine
A. Novak Transcarpathian Regional Clinical Hospital
Uzhhorod, 88018, Ukraine
MCIC MC LLC Health Clinic
Vinnytsia, 02029, Ukraine
Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War
Vinnytsia, 21005, Ukraine
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
Vinnytsia, 21018, Ukraine
Vinnytsia M.I. Pyrohov Regional Clinical Hospital
Vinnytsia, 21018, Ukraine
Vinnytsia M.I. Pyrohov National Medical University
Vinnytsia, 21029, Ukraine
City Clinical Hospital of Emergency and Urgent Care of Zaporizhzhya
Zaporizhia, 69000, Ukraine
Zaporizhia City Multispecialty Clinical Hospital #9, Department of Neurology
Zaporizhia, 69065, Ukraine
CI City Hospital #1
Zaporizhia, 69104, Ukraine
CI Zapor City Multifunctional CH#9 City Center of Gastroenterology SI Zapor MA of PGE of MOHU
Zaporizhzhia, 69065, Ukraine
Zaporizhia Regional Clinical Hospital
Zaporizhzhia, 69600, Ukraine
Central District Hospital under Zhytomyr District Council
Zhytomyr, 12430, Ukraine
University Hospital Coventry
Coventry, CV2 2DX, United Kingdom
Royal Devon and Exeter Hospital (Wonford)
Exeter, EX2 5DW, United Kingdom
Gloucestershire Royal Hospital
Gloucester, GL1 3NN, United Kingdom
Whipps Cross University Hospital
London, E11 1NR, United Kingdom
St Thomas' Hospital
London, SE1 7EH, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, SY38XQ, United Kingdom
Related Publications (6)
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. 2026 Jan 1;32(1):77-86. doi: 10.1093/ibd/izaf195.
PMID: 41003640DERIVEDSands 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 Oct 1;120(10):2339-2349. doi: 10.14309/ajg.0000000000003310. Epub 2025 Jan 8.
PMID: 39773524DERIVEDRegueiro 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.
PMID: 39018016DERIVEDSands 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.
PMID: 38723981DERIVEDArmuzzi 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.
PMID: 38040274DERIVEDSandborn 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.
PMID: 34587385DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
AnnKatrin Petersen, M.D., MSc.
Celgene
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2015
First Posted
May 6, 2015
Study Start
June 17, 2015
Primary Completion
March 27, 2020
Study Completion
June 17, 2020
Last Updated
September 1, 2021
Results First Posted
September 1, 2021
Record last verified: 2021-08