AzTrials
AzTrials

Ulcerative ColitisPhase 3NCT02435992

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

A Phase 3 study testing RPC1063 in people with Ulcerative Colitis, run by Celgene at 372 sites in 30 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
RPC1063
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,012 participants
Where
372 sitesin 30 countries
Study dates
17 Jun 2015to 17 Jun 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

372 sites in 30 countries.

372 sites in 30 countries

United States113 sites

  • Anaheim Clinical Trials

    Anaheim, California, 92801

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Asheville Gastroenterology Associates, P.A.

    Asheville, North Carolina, 28801

  • Atlanta Gastroenterology Associates LLC

    Atlanta, Georgia, 30342

  • University of Maryland Medical Group

    Baltimore, Maryland, 21201

  • Woodholme Gastroenterology

    Baltimore, Maryland, 21209

  • Johns Hopkins Clinical Research Network

    Baltimore, Maryland, 21287

  • Gastroenterology Associates, LLC

    Baton Rouge, Louisiana, 70809

  • Ehrhardt Clinical Research, LLC

    Belton, Missouri, 64012

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Clinical Research Professionals, LLC - De Paul Medical Dr

    Bridgeton, Missouri, 63044

  • Commonwealth Clinical Studies, PLLC.

    Brockton, Massachusetts, 02302

  • NY Scientific

    Brooklyn, New York, 11235

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-7305

  • Carolinas HealthCare System Digestive Health

    Charlotte, North Carolina, 28204

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia, 23320

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • Northwestern University Feinberg Sch of Medicine Division of Gastroenterology

    Chicago, Illinois, 60611

  • University of Chicago Medical Center

    Chicago, Illinois, 60637-1447

  • UC Health Clinical Trials Office

    Cincinnati, Ohio, 45206

  • Gastro Florida

    Clearwater, Florida, 33756-3839

  • Clinical Research of West Florida Inc - Clearwater

    Clearwater, Florida, 33765

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Gastro Center of Maryland

    Columbia, Maryland, 21045

  • Consultants in Gastroenterology, PA

    Columbia, South Carolina, 29203

  • Ohio State University Clinical Trials Management Office

    Columbus, Ohio, 43210

  • Aurora Care Clinic

    Costa Mesa, California, 92627

  • Baylor Research Institute

    Dallas, Texas, 75246-1613

  • Advanced Pharma Research, Inc

    Delray Beach, Florida, 33445

  • Universal Axon Clinical Research

    Doral, Florida, 33166

  • Dolphin Medical Research

    Doral, Florida, 33172

  • Brooke-Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Ventavia Research Group, LLC

    Fort Worth, Texas, 76104

  • Valley View Internal Medicine

    Garden Grove, California, 92843

  • Gastro One

    Germantown, Tennessee, 38138

  • Long Island Clinical Research Associates

    Great Neck, New York, 11021

  • Medical Research Center of Connecticut, LLC

    Hamden, Connecticut, 06518

  • South Florida Clinical Trials

    Hialeah, Florida, 33016

  • Gulf Coast Research Group LLC

    Houston, Texas, 77004

  • The Methodist Hospital Research Institute

    Houston, Texas, 77030

  • Houston Endoscopy and Research Center

    Houston, Texas, 77079

  • Davita Clinical Trials, LLC

    Huntington Beach, California, 92646

  • Grand Teton Research Group, PLLC

    Idaho Falls, Idaho, 83404

  • Indiana University Hospital

    Indianapolis, Indiana, 46202

  • East Carolina Gastroenterology, PA

    Jacksonville, North Carolina, 28546

  • Kinston Medical Specialists, PA

    Kinston, North Carolina, 28501

  • University of California San Diego Medical Center

    La Jolla, California, 92037

  • OM Research

    Lancaster, California, 93534

  • Florida Center for Gastroenterology

    Largo, Florida, 33777

  • Mary Hitchcock Memorial Hospital

    Lebanon, New Hampshire, 07756

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40504

  • University of Southern California - Keck School of Medicine

    Los Angeles, California, 90033

  • Southern California Research Institute Medical Group, Inc.

    Los Angeles, California, 90045

  • Gastrointestinal Biosciences

    Los Angeles, California, 90067

  • UCLA Medical Center

    Los Angeles, California, 90095

  • University of Louisville

    Louisville, Kentucky, 40202

  • Gastrointestinal Specialists of Georgia, PC

    Marietta, Georgia, 30060

  • Community Clinical Research Network

    Marlborough, Massachusetts, 01752

  • City Medical Group

    Miami, Florida, 33126

  • Advanced Clincial Research

    Miami, Florida, 33134

  • Advanced Clinical Research of Miami

    Miami, Florida, 33155

  • Regenerate Clinical Trials

    Miami, Florida, 33155

  • Facey Medical Foundation (Parent)

    Mission Hills, California, 91345

  • Advanced Research for Health Improvement

    Naples, Florida, 34109

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37203

  • Advanced Research Institute, Inc.

    New Port Richey, Florida, 34653

  • NSB Research

    New Smyrna Beach, Florida, 32168

  • Icahn School of Medicine Mount Sinai Beth Isreal

    New York, New York, 10003

  • Concord Medical Group PRIME

    New York, New York, 10016

  • New York University School of Medicine

    New York, New York, 10016

  • Weill Cornell Medical College

    New York, New York, 10021

  • Mount Sinai - PRIME

    New York, New York, 10029

  • Arkansas Gastroenterology, P.A.

    North Little Rock, Arkansas, 72117

  • Harmony Clinical Research

    North Miami Beach, Florida, 33162

  • Med-Care Research

    North Miami Beach, Florida, 33162

  • DM Clinical Research

    Oak Lawn, Illinois, 60453-3767

  • Alliance Clinical Research, LLC

    Oceanside, California, 92056-4497

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • Digestive Disease Specialists

    Oklahoma City, Oklahoma, 73112

  • Gastroenterology Associates of Orangeburg

    Orangeburg, South Carolina, 29118

  • Center For Digestive Health

    Orlando, Florida, 32803

  • IMIC, Inc.

    Palmetto Bay, Florida, 33157

  • DBC Research, Corp

    Pembroke Pines, Florida, 33029

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-4206

  • Theia Clinical Research, LLC

    Pinellas Park, Florida, 33781

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • PMG Research of Rocky Mount, LLC

    Rocky Mount, North Carolina, 27804

  • University of Utah

    Salt Lake City, Utah, 84132

  • Gastroenterology Research of San Antonio, LLC

    San Antonio, Texas, 78229

  • San Antonio Gastroenterology

    San Antonio, Texas, 78229

  • Medical Associates Research Group, Inc.

    San Diego, California, 92123

  • University of California at San Francisco (PARENT)

    San Francisco, California, 94115

  • Benaroya Research Institute at Virginia Mason

    Seattle, Washington, 98101

  • University of Washington Medical Center

    Seattle, Washington, 98109

  • Texas Digestive Disease Consultants - Southlake

    Southlake, Texas, 76092

  • Spring Gastroenterology

    Spring, Texas, 77379

  • Mercy Research

    Springfield, Missouri, 65806

  • Clinical Inquest Center Ltd

    Springfield, Ohio, 45504

  • Washington University

    St Louis, Missouri, 63110

  • Clinical Research Professionals LLC - The Pines Court

    St Louis, Missouri, 63141

  • Clinical Research Professionals, LLC - Olde Cabin Rd

    St Louis, Missouri, 63141

  • Arizona Digestive Health

    Sun City, Arizona, 85351

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Cotton-O'Neil Clinical Research Center, Digestive Health

    Topeka, Kansas, 66606

  • Charm City Research Group

    Towson, Maryland, 21204

  • Center For Digestive Health

    Troy, Michigan, 48098

  • Adobe Clinical Research LLC

    Tucson, Arizona, 85712

  • Digestive Health Specialists of Tyler

    Tyler, Texas, 75701

  • Carle Foundation Hospital

    Urbana, Illinois, 61801

  • Gastroenterology, LTD

    Virginia Beach, Virginia, 23454

  • Florida Medical Clinic, P.A.

    Zephyrhills, Florida, 33613

Other trials in United States

Ukraine29 sites

  • RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU

    Chernivtsi, 58002

  • Dnipropetrovsk I.I. Mechnykov Regional Clinical Hospital

    Dnipropetrovsk, 49027

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

    Dnipropetrovsk, 49074

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

    Ivano-Frankivsk, 76014

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

    Ivano-Frankivsk, 76018

  • CI of PH Kharkiv CCH #2

    Kharkiv, 61037

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

    Kharkiv, 61039

  • Kyiv City Clinical Hospital #1

    Kyiv, 02091

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

    Kyiv, 04053

  • CI of Kyiv RC Regional Clinical Hospital #2

    Kyiv, 04073

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

    Kyiv, 04201

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

    Kyiv, 1030

  • Lviv Regional Clinical Hospital

    Lviv, 79010

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

    Lviv, 79059

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

    Sumy, 40021

  • Sumy Regional Clinical Hospital

    Sumy, 40022

  • CI of TRC Ternopil University Hospital

    Ternopil, 46002

  • A. Novak Transcarpathian Regional Clinical Hospital

    Uzhhorod, 88018

  • MCIC MC LLC Health Clinic

    Vinnytsia, 02029

  • Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War

    Vinnytsia, 21005

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

    Vinnytsia, 21018

  • Vinnytsia M.I. Pyrohov Regional Clinical Hospital

    Vinnytsia, 21018

  • Vinnytsia M.I. Pyrohov National Medical University

    Vinnytsia, 21029

  • City Clinical Hospital of Emergency and Urgent Care of Zaporizhzhya

    Zaporizhia, 69000

  • Zaporizhia City Multispecialty Clinical Hospital #9, Department of Neurology

    Zaporizhia, 69065

  • CI City Hospital #1

    Zaporizhia, 69104

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

    Zaporizhzhya, 69065

  • Zaporizhia Regional Clinical Hospital

    Zaporizhzhya, 69600

  • Central District Hospital under Zhytomyr District Council

    Zhytomyr, 12430

Other trials in Ukraine

Russia20 sites

  • Multidisciplinary Medical Clinic "Anthurium"

    Barnaul, 656043

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

    Irkutsk, 664005

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

    Kazan', 420012

  • FSBIH "Central Clinical Hospital of Russian Academy of Sciences"

    Moscow, 119333

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

    Nizhny Novgorod, 603126

  • SBEIHPE Novosibirsk State Medical University

    Novosibirsk, 630054

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

    Novosibirsk, 630117

  • BHI of Omsk region "Clinical Oncology Dispensary"

    Omsk, 644013

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

    Rostov-on-Don, 344022

  • SPb SBIH Alexandrovskaya City Hospital

    Saint Petersburg, 193312

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

    Saint Petersburg, 194044

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

    Saint Petersburg, 194044

  • SBIH City Clinical Hospital #31

    Saint Petersburg, 194291

  • SPb SBIH City Hospital # 26

    Saint Petersburg, 196247

  • Pavlov First Saint Petersburg State Medical University

    Saint Petersburg, 197022

  • Union Clinic

    Saint-Peterburg, 191119

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

    Samara, 443011

  • LLC Medical Company Hepatologist

    Samara

  • SBEI HPE "Stavropol State Medical Academy" MoH of RF

    Stavropol, 355017

  • Regional Clinical Hospital

    Vladimir, 600023

Other trials in Russia

Poland17 sites

  • Clinsante S.C. Osrodek Badan Klinicznych

    Bydgoszcz, 85-794

  • Specjalistyczna Przychodnia Lekarska Medicus

    Chorzów, 41-500

  • GLOBE Clinical Research Sp. z o.o. LLC

    Kłodzko, 57-300

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

    Krakow, 30-363

  • Centrum Medyczne A-Z Clinic

    Krakow, 31-315

  • Healthcare Center Orkan Med Stec Michalska Spolka Jawna

    Ksawerów, 95-054

  • Santa Familia Centrum Badan, Profilaktyki i Leczenia

    Lodz, 90-302

  • KO-MED Centra Kliniczne Lublin II

    Lublin, 20-362

  • Trialmed Llc

    Piotrkow Trybunalski, 97-300

  • SOLUMED Centrum Medyczne

    Poznan, 60-529

  • Specjalistyczna Praktyka Lekarska dr med. Marek Horynski

    Sopot, 81-756

  • KO-MED Centra Kliniczne Staszow

    Staszów, 28-200

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

    Torun, 87-100

  • MDM Healthcare Centre

    Warsaw, 00-632

  • Nzoz Vivamed

    Warsaw, 03-580

  • Health Centre Metabolic Diseases Outpatient Clinic in Wierzchoslawice

    Wierzchosławice, 33-122

  • LexMedica Osrodek Badan Klinicznych

    Wroclaw, 53-114

Other trials in Poland

Germany16 sites

  • Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin

    Berlin, 12203

  • Charite - Campus Virchow-Klinikum

    Berlin, 13353

  • DRK Kliniken Berlin Westend

    Berlin, 14050

  • Universitaetsklinikum Koeln

    Cologne, 50937

  • Medical Care Unit Dachau

    Dachau, 85221

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, 01307

  • Klinikum der Johann Wolfgang Goethe-Universitaet

    Frankfurt, 60590

  • Crohn Colitis Centrum Rhein Main

    Frankfurt, 60594

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20426

  • Asklepios Klinik Hamburg

    Hamburg, 22559

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • EUGASTRO GmbH

    Leipzig, 4103

  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

    Lübeck, 23538

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

    Mainz, 55131

  • Universitatsklinikum Ulm

    Ulm, 89081

Other trials in Germany

South Korea16 sites

  • Inje University Haeundae Paik Hospital

    Busan, 612-030

  • Yeungnam University Hospital

    Daegu, 42415

  • Konyang University Hospital

    Daejeon, 302-718

  • Hanyang Univerisy Guri Hospital

    Guri-si, 471-701

  • Seoul National University Bundang Hospital

    Seongnam, 463-707

  • CHA Bundang Medical Center CHA University

    Seongnam-si, 13496

  • Kyung Hee University Hospital

    Seoul, 02447

  • Seoul National University Hospital

    Seoul, 110-744

  • Samsung Medical Center

    Seoul, 135-710

  • Korea University Anam Hospital

    Seoul, 136-705

  • Asan Medical Center

    Seoul, 138-736

  • Kangbuk Samsung Hospital

    Seoul, 3181

  • Severance Hospital, Yonsei University

    Seoul, 3722

  • Ewha Womans University Mokdong Hospital

    Seoul, 7985

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

    Suwon, 442-723

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju, 220701

Other trials in South Korea

Bulgaria15 sites

  • Medical Centre "Asklepii", OOD

    Dupnitsa, 2600

  • UMHAT 'Dr. Georgi Stranski', EAD

    Pleven, 5800

  • UMHAT "Kaspela", EOOD

    Plovdiv, 4002

  • MC Rusemed ltd.

    Rousse, 7013

  • NMTH "Tsar Boris III"

    Sofia, 1233

  • MHAT "Lyulin", EAD

    Sofia, 1336

  • City Clinic UMHAC EOOD

    Sofia, 1407

  • MHAT 'Tokuda Hospital Sofia', EAD

    Sofia, 1407

  • UMHAT 'Tsaritsa Yoanna - ISUL', EAD

    Sofia, 1527

  • Fourth MHAT - Sofia EAD

    Sofia, 1606

  • UMHAT 'Sveta Anna' AD

    Sofia, 1750

  • UMHAT "SofiaMed", OOD

    Sofia, 1797

  • Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

    Stara Zagora, 6000

  • MHAT 'Sv. Marina', EAD

    Varna, 9010

  • MC Medica Plus

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Hungary14 sites

  • DRC Gyogyszervizsgalo Kozpont Kft

    Balatonfüred, 8230

  • Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz

    Békéscsaba, 5600

  • Obudai Egeszsegugyi Centrum Kft.

    Budapest, 1036

  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest, 1062

  • Semmelweis Egyetem

    Budapest, 1083

  • Pannonia Maganorvosi Centrum

    Budapest, 1136

  • Szent Margit Korhaz

    Budapest, H-1032

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

    Gyula, 5700

  • Somogy Megyei Kaposi Mor Oktato Korhaz

    Kaposvár, 7400

  • Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont

    Létavértes, 4281

  • Mohacsi Korhaz

    Mohács, 7700

  • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

    Nyíregyháza, 4400

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár, 8000

Other trials in Hungary

Canada12 sites

  • Brandon Medical Arts Clinic

    Brandon, Manitoba, R7A 0N7

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

    Greenfield Park, Quebec, J4V 2H1

  • Viable Clinical Research - Lindsay

    Lindsay, Ontario, K9V 5G6

  • LHSC - University Hospital

    London, Ontario, N6A 5A5

  • LHSC - Victoria Hospital

    London, Ontario, N6A 5W9

  • The Ottawa Hospital - General Campus

    Ottawa, Quebec, K1H 8L6

  • CHUS - Hôpital Fleurimont

    Sherbrooke, Quebec, J1H5N4

  • Humber River Hospital

    Toronto, Ontario, M3M 0B2

  • Mount Sinai Hospital

    Toronto, Ontario, M5T 3L9

  • Toronto Liver Centre

    Toronto, Ontario, M6H 3M1

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

  • Toronto Digestive Disease Associates, Inc.

    Vaughan, Ontario, L4L 4Y7

Other trials in Canada

Italy12 sites

  • Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi

    Bologna, 40138

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134

  • Azienda Ospedaliero Universitaria San Martino

    Genova, 16132

  • Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale Sacco

    Milan, 20157

  • A.O.U. Policlinico di Modena

    Modena, 41124

  • Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

    Monza, 20900

  • Azienda Ospedaliera Universitaria "Federico II"

    Naples, 80131

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56124

  • Complesso Integrato Columbus

    Roma, 00168

  • Istituto Clinico Humanitas

    Rozzano (MI), 20089

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo FG, 71013

Other trials in Italy

Slovakia11 sites

  • Fakultna nemocnica s poliklinikou F.D. Roosevelta

    Banská Bystrica, 97517

  • Alian s.r.o.

    Bardejov, 08501

  • PRO SANUS, a.s., Poliklinika ProCare Central

    Bratislava, 82107

  • IBDcentrum s.r.o.

    Bratislava, 83104

  • Slovak Research Center-team member, Sukromna gastroenterologicka ambulancia

    Ilava, 01901

  • Gastroped s.r.o.

    Košice, 040 01

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

    Malacky, 90122

  • PIGEAS s.r.o.

    Martin, 3601

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

    Michalovce, 7101

  • Gastromedic s.r.o.

    Nové Zámky, 94002

  • EndoCorp s.r.o.

    Trnava, 917 75

Other trials in Slovakia

Australia9 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Monash Medical Centre Clayton

    Bentleigh East, 3165

  • Royal Prince Alfred Hospital

    Camperdown, 2050

  • Centre For Digestive Diseases

    Five Dock, New South Wales, 2046

  • Nepean Hospital

    Kingswood, New South Wales, 2751

  • Cabrini Hospital Malvern

    Malvern, Victoria, 3144

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Mater Hospital Brisbane

    South Brisbane, Queensland, 4101

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Czechia9 sites

  • Vojenska nemocnice Brno

    Brno, 63600

  • Hepato-Gastroenterologie HK, s.r.o.

    Hradec Králové, 50012

  • GASTRO JeKa s.r.o.

    Klatovy, 399 01

  • Gregar s.r.o.

    Olomouc, 779 00

  • PreventaMed

    Olomouc, 77900

  • Institut klinicke a experimentalni mediciny

    Prague, 14021

  • Thomayerova nemocnice

    Prague, 14059

  • ISCARE, a.s.

    Prague, 190 00

  • Nemocnice Slany

    Slaný, 274 01

Other trials in Czechia

Serbia8 sites

  • Clinical Hospital Center Bezanijska Kosa, Clinic of Internal Medicine

    Belgrade, 11 080

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

    Belgrade, 11000

  • Clinical Hospital Center Zvezdara Clinic of Internal Diseases

    Belgrade, 11000

  • Military Medical Academy, Clinic of Gastroenterology and Hepatology

    Belgrade, 11000

  • Clinical Hospital Center Zemun Department of Gastroenterology

    Belgrade, 11080

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

    Kragujevac, 34000

  • Clinical Center Nis, Clinic of Gastroenterology and Hepatology

    Niš, 18 000

  • General Hospital Djordje Jovanovic Zrenjanin

    Zrenjanin, 23 000

Other trials in Serbia

Romania7 sites

  • Bacau County Emergency Hospital, Department of Gastroenterology

    Bacau, 600114

  • Hyperclinica MedLife Grivita

    Bucharest, 010719

  • Bucharest University Emergency Hospital, Department of Internal Medicine II

    Bucharest, 050098

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

    Cluj-Napoca, 400132

  • Sf. Apostol Andrei Constanta Emergency Clinical County Hospital

    Constanța, 900591

  • Craiova County Emergency Clinical Hospital

    Craiova, 200642

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

    Timișoara, 300723

Other trials in Romania

Israel6 sites

  • Wolfson Medical Center

    Holon, 58100

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Meir Medical Center

    Kfar Saba, 44281

  • Chaim Sheba Medical Center

    Ramat Gan, 52621

  • Kaplan Medical Center

    Rehovot, 76100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Netherlands6 sites

  • Vrije Universiteit Medisch Centrum (VUMC)

    Amsterdam, 1081 HV

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ

  • Universitair Medisch Centrum Groningen (UMCG)

    Groningen, 9700 RB

  • Maastricht University Medical Center

    Maastrich, 6202 AZ

  • Zuyderland Medisch Centrum - Sittard-Geleen

    Sittard-Geleen, 6162 BG

  • ETZ Elisabeth

    Tilburg, 5022 GC

Other trials in Netherlands

South Africa6 sites

  • Dr MJ Prins Practice

    Cape Town, 7500

  • Tiervlei Trial Centre

    Cape Town, 7550

  • Endocare Research

    Cape Town, 7646

  • Dr JP Wright Practice

    Cape Town, 7708

  • Dr YS Nanabhay Practice

    Johannesburg, 2193

  • Emmed Research

    Pretoria, 0084

Other trials in South Africa

United Kingdom6 sites

  • University Hospital Coventry

    Coventry, CV2 2DX

  • Royal Devon and Exeter Hospital (Wonford)

    Exeter, EX2 5DW

  • Gloucestershire Royal Hospital

    Gloucester, GL1 3NN

  • Whipps Cross University Hospital

    London, E11 1NR

  • St Thomas' Hospital

    London, SE1 7EH

  • Royal Shrewsbury Hospital

    Shrewsbury, SY38XQ

Other trials in United Kingdom

Argentina5 sites

  • Hospital Italiano

    Buenos Aires, C1181ACH

  • Instituto DAMIC Fundacion Rusculleda

    Córdoba, X5003DCE

  • Hospital Italiano de La Plata

    La Plata, 01900

  • Instituto Medico CER

    Quilmes, B1878DVB

  • Instituto Medico de la Fundacion Estudios Clinicos

    Rosario, 2000

Other trials in Argentina

Belgium5 sites

  • Imeldaziekenhuis

    Bonheiden, 2820

  • AZ Maria Middelares

    Ghent, 9000

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

  • CHC - Clinique St-Jospeh

    Liège, 4000

Other trials in Belgium

Croatia5 sites

  • Clinical Hospital Center Osijek

    Osijek, 31000

  • Clinical Hospital Centre Rijeka

    Rijeka, 51000

  • Clinical Hospital "Sveti Duh", Clinic of Internal Diseases

    Zagreb, 10000

  • Clinical Hospital Center Sestre milosrdnice Clinic of Internal Diseases

    Zagreb, 10000

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

    Zagreb, 10000

Other trials in Croatia

Georgia5 sites

  • LTD Research Institute of Clinical Medicine

    Tbilisi, 0112

  • LLC Vivamedi

    Tbilisi, 0131

  • LTD Academician N.Kipshidze Central University Clinic

    Tbilisi, 0160

  • LTD Aversi Clinic

    Tbilisi, 0160

  • LTD Coloproctological Center

    Tbilisi, 0160

Other trials in Georgia

Greece5 sites

  • Laiko General Hospital of Athens

    Athens, 11 527

  • University General Hospital of Heraklion

    Heraklion, 715 00

  • University General Hospital of Larissa

    Larissa Thessaly, 41110

  • General Hospital of Thessaloniki Hippokration

    Thessaloniki, 54642

  • 424th Army General Hospital

    Thessaloniki, 56429

Other trials in Greece

Moldova4 sites

  • "Sfanta Treime" Clinical Municipal Hospital

    Chisinau, MD-2068

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

    Chisinau, MD2005

  • "Sf. Arhanghel Mihail" Municipal Clinical Hospital

    Chisinau, MD2025

  • Republican Clinical Hospital

    Chisinau, MD2025

Other trials in Moldova

Spain4 sites

  • University Hospital Germans Trias i Pujol

    Badalona, 08916

  • Hospital Universitario de Gran Canaria Dr. Negrin

    Las Palmas de Gran Canaria, 35012

  • University Hospital of the Canary Islands (HUC) La Laguna

    San Cristóbal de La Laguna, 38320

  • University Hospital Virgen del Rocio

    Seville, 41013

Other trials in Spain

Belarus3 sites

  • Gomel Regional Clinical Hospital

    Homyel, 246029

  • City Clinical Hospital No 10

    Minsk, 220096

  • Vitebsk Regional Clinical Hospital

    Vitebsk, 210037

Other trials in Belarus

New Zealand2 sites

  • Christchurch Hospital NZ

    Christchurch, 8011

  • Dunedin Public Hospital

    Dunedin, 9016

Other trials in New Zealand

Austria1 site

  • Medical University Vienna

    Vienna, 1090

Other trials in Austria

Latvia1 site

  • Pauls Stradins Clinical University Hospital

    Riga, LV1002

Other trials in Latvia

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis

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

Read the 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.

Being tested
RPC1063, Placebo
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RPC1063Drug

  • PlaceboDrug

Study groups in NCT02435992
Study groupRoleWhat they receive
RPC1063 (Ozanimod)Experimental1mg, daily oral administration during Induction and Maintenance periods.
Receives: Drug: RPC1063
PlaceboPlacebo comparatorDaily oral administration during Induction and Maintenance periods.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants in Clinical Remission at 10 Weeks

    Percentage of participants that are in Clinical remission at 10 weeks

    Measured: At 10 Weeks

  2. Percentage of Participants in Clinical Remission at 52 Weeks

    Percentage of participants that are in Clinical remission at 52 weeks

    Measured: At 52 Weeks

Secondary outcomes (9)

  1. Percentage of Participants With Clinical Response at 10 Weeks

    Percentage of participants that are in Clinical response at 10 weeks

    Measured: At 10 Weeks

  2. Percentage of Participants With Endoscopic Improvement at 10 Weeks

    Percentage of participants with endoscopic improvement at 10 weeks

    Measured: At 10 Weeks

  3. Percentage of Participants With Mucosal Healing at 10 Weeks

    Percentage of participants with mucosal healing at 10 weeks

    Measured: At 10 Weeks

  4. Percentage of Participants in Clinical Response at 52 Weeks

    Percentage of participants that are in Clinical response at 52 weeks

    Measured: At 52 Weeks

  5. Percentage of Participants With Endoscopic Improvement at 52 Weeks

    Percentage of participants with endoscopic improvement at 52 weeks

    Measured: At 52 Weeks

  6. Percentage of Participants in Clinical Remission at Week 52 Who Were in Remission at Week 10

    Percentage of participants in clinical remission at week 52 who were in clinical remission at week 10

    Measured: At 52 Weeks

  7. Percentage of Participants With Corticosteroid Free Remission at 52 Weeks

    Percentage of participants with corticosteroid free remission at 52 weeks

    Measured: At 52 Weeks

  8. Percentage of Participants With Mucosal Healing at 52 Weeks

    Percentage of participants with Mucosal Healing at 52 weeks

    Measured: At 52 Weeks

  9. Percentage of Participants With Durable Clinical Remission at 52 Weeks

    Percentage of participants with durable clinical remission at 52 weeks

    Measured: At 52 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2015 (estimated)
  2. Study start17 Jun 2015
  3. Primary completion27 Mar 2020
  4. Study completion17 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,012 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02435992
Sponsor's protocol ID
RPC01-3101
Status last verified
Aug 2021
First submitted
24 Apr 2015
Last updated
1 Sep 2021
Data monitoring committee
Yes

Publications

  • Rubin DT, Danese S, Nakase H, Ungaro RC, Wolf DC, Alekseeva O, Petersen A, Liu Z, Mehra D, Jain A, Osterman MT, Krakovich A, Riolo JV, DeBoer E, Appio J, Sinh P, Cree BAC, Cohen JA, Irving P. Integrated long-term safety of 10-year ozanimod treatment: results from clinical trials in patients with moderate-to-severe ulcerative colitis or relapsing multiple sclerosis. Inflamm Bowel Dis. 2026 May 1;32(5):954-962. doi: 10.1093/ibd/izaf319.

    PubMed 41677183

  • 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.

    PubMed 41003640

  • 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 Oct 1;120(10):2339-2349. doi: 10.14309/ajg.0000000000003310. Epub 2025 Jan 8.

    PubMed 39773524

  • 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.

    PubMed 39018016

  • 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.

    PubMed 38723981

  • 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.

    PubMed 38040274

  • 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.

    PubMed 34587385

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RPC1063 in people with Ulcerative Colitis, run by Celgene at 372 sites in 30 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 372 sites in United States, Ukraine, Russia, Poland, Germany and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants in Clinical Remission at 10 Weeks (time frame: At 10 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02435992, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.

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