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

August 6, 2021 updated by: Celgene

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).

Study Overview

Status

Completed

Conditions

Ulcerative Colitis

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1012

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, C1181ACH
    - Hospital Italiano
  - Cordoba, Argentina, X5003DCE
    - Instituto DAMIC Fundacion Rusculleda
  - La Plata, Argentina, 01900
    - Hospital Italiano de La Plata
  - Quilmes, Argentina, B1878DVB
    - Instituto Médico Cer
  - Rosario, Argentina, 2000
    - Instituto Médico de la Fundación Estudios Clínicos
Australia
- - Bentleigh East, Australia, 3165
    - Monash Medical Centre Clayton
  - Camperdown, Australia, 2050
    - Royal Prince Alfred Hospital
- New South Wales
  - Five Dock, New South Wales, Australia, 2046
    - Centre For Digestive Diseases
  - Kingswood, New South Wales, Australia, 2751
    - Nepean Hospital
- Queensland
  - South Brisbane, Queensland, Australia, 4101
    - Mater Hospital Brisbane
  - Woolloongabba, Queensland, Australia, 4102
    - Princess Alexandra Hospital
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - Royal Adelaide Hospital
- Victoria
  - Malvern, Victoria, Australia, 3144
    - Cabrini Hospital Malvern
  - Melbourne, Victoria, Australia, 3004
    - The Alfred Hospital
Austria
- - Vienna, Austria, 1090
    - Medical University Vienna
Belarus
- - Gomel, Belarus, 246029
    - Gomel Regional Clinical Hospital
  - Minsk, Belarus, 220096
    - City Clinical Hospital No 10
  - Vitebsk, Belarus, 210037
    - Vitebsk Regional Clinical Hospital
Belgium
- - Bonheiden, Belgium, 2820
    - Imeldaziekenhuis
  - Gent, Belgium, 9000
    - Universitair Ziekenhuis Gent
  - Gent, Belgium, 9000
    - AZ Maria Middelares
  - Leuven, Belgium, 3000
    - UZ Leuven
  - Liege, Belgium, 4000
    - CHC - Clinique St-Jospeh
Bulgaria
- - Dupnitsa, Bulgaria, 2600
    - Medical Centre "Asklepii", OOD
  - Pleven, Bulgaria, 5800
    - UMHAT 'Dr. Georgi Stranski', EAD
  - Plovdiv, Bulgaria, 4002
    - UMHAT "Kaspela", EOOD
  - Ruse, Bulgaria, 7013
    - MC Rusemed ltd.
  - Sofia, Bulgaria, 1407
    - MHAT 'Tokuda Hospital Sofia', EAD
  - Sofia, Bulgaria, 1233
    - NMTH "Tsar Boris III"
  - Sofia, Bulgaria, 1336
    - MHAT "Lyulin", EAD
  - Sofia, Bulgaria, 1527
    - UMHAT 'Tsaritsa Yoanna - ISUL', EAD
  - Sofia, Bulgaria, 1606
    - Fourth MHAT - Sofia EAD
  - Sofia, Bulgaria, 1750
    - UMHAT 'Sveta Anna' AD
  - Sofia, Bulgaria, 1797
    - UMHAT "SofiaMed", OOD
  - Sofia, Bulgaria, 1407
    - City Clinic UMHAC EOOD
  - Stara Zagora, Bulgaria, 6000
    - Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
  - Varna, Bulgaria, 9010
    - MHAT 'Sv. Marina', EAD
  - Veliko Tarnovo, Bulgaria, 5000
    - MC Medica Plus
Canada
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 1M9
    - Vancouver General Hospital
- Manitoba
  - Brandon, Manitoba, Canada, R7A 0N7
    - Brandon Medical Arts Clinic
- Ontario
  - Lindsay, Ontario, Canada, K9V 5G6
    - Viable Clinical Research - Lindsay
  - London, Ontario, Canada, N6A 5A5
    - LHSC - University Hospital
  - London, Ontario, Canada, N6A 5W9
    - LHSC - Victoria Hospital
  - Toronto, Ontario, Canada, M6H 3M1
    - Toronto Liver Centre
  - Toronto, Ontario, Canada, M3M 0B2
    - Humber River Hospital
  - Toronto, Ontario, Canada, M5T 3L9
    - Mount Sinai Hospital
  - Vaughan, Ontario, Canada, L4L 4Y7
    - Toronto Digestive Disease Associates, Inc.
- Quebec
  - Greenfield Park, Quebec, Canada, J4V 2H1
    - Centre integre de sante et de services sociaux de la Monteregie-Centre - Hopital Charles-Le Moyne
  - Ottawa, Quebec, Canada, K1H 8L6
    - The Ottawa Hospital - General Campus
  - Sherbrooke, Quebec, Canada, J1H5N4
    - CHUS - Hôpital Fleurimont
Croatia
- - Osijek, Croatia, 31000
    - Clinical Hospital Center Osijek
  - Rijeka, Croatia, 51000
    - Clinical Hospital Centre Rijeka
  - Zagreb, Croatia, 10000
    - Clinical Hospital Center Sestre milosrdnice Clinic of Internal Diseases
  - Zagreb, Croatia, 10000
    - Clinical Hospital "Sveti Duh", Clinic of Internal Diseases
  - Zagreb, Croatia, 10000
    - Clinical Hospital Dubrava, Clinic of Internal Medicine, Department of Gastroenterology
Czechia
- - Brno, Czechia, 63600
    - Vojenska nemocnice Brno
  - Hradec Kralove, Czechia, 50012
    - Hepato-Gastroenterologie HK, s.r.o.
  - Klatovy, Czechia, 399 01
    - GASTRO JeKa s.r.o.
  - Olomouc, Czechia, 779 00
    - Gregar s.r.o.
  - Olomouc, Czechia, 77900
    - PreventaMed
  - Prague 9, Czechia, 190 00
    - ISCARE, a.s.
  - Praha 4, Czechia, 14021
    - Institut klinicke a experimentalni mediciny
  - Praha 4, Czechia, 14059
    - Thomayerova nemocnice
  - Slany, Czechia, 274 01
    - Nemocnice Slany
Georgia
- - Tbilisi, Georgia, 0112
    - LTD Research Institute of Clinical Medicine
  - Tbilisi, Georgia, 0131
    - LLC Vivamedi
  - Tbilisi, Georgia, 0160
    - LTD Academician N.Kipshidze Central University Clinic
  - Tbilisi, Georgia, 0160
    - LTD Coloproctological Center
  - Tbilisi, Georgia, 0160
    - LTD Aversi Clinic
Germany
- - Berlin, Germany, 13353
    - Charite - Campus Virchow-Klinikum
  - Berlin, Germany, 14050
    - DRK Kliniken Berlin Westend
  - Berlin, Germany, 12203
    - Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin
  - Dachau, Germany, 85221
    - Medical Care Unit Dachau
  - Dresden, Germany, 01307
    - Universitaetsklinikum Carl Gustav Carus TU Dresden
  - Frankfurt, Germany, 60590
    - Klinikum der Johann Wolfgang Goethe-Universitaet
  - Frankfurt, Germany, 60594
    - Crohn Colitis Centrum Rhein Main
  - Freiburg, Germany, 79106
    - Universitaetsklinikum Freiburg
  - Hamburg, Germany, 22559
    - Asklepios Klinik Hamburg
  - Hamburg, Germany, 20426
    - Universitaetsklinikum Hamburg-Eppendorf
  - Hannover, Germany, 30625
    - Medizinische Hochschule Hannover
  - Koeln, Germany, 50937
    - Universitaetsklinikum Koeln
  - Leipzig, Germany, 4103
    - EUGASTRO GmbH
  - Luebeck, Germany, 23538
    - Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
  - Mainz, Germany, 55131
    - Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
  - Ulm, Germany, 89081
    - Universitätsklinikum Ulm
Greece
- - Athens, Greece, 11 527
    - Laiko General Hospital of Athens
  - Heraklion, Greece, 715 00
    - University General Hospital of Heraklion
  - Larissa Thessaly, Greece, 41110
    - University General Hospital of Larissa
  - Thessaloniki, Greece, 54642
    - General Hospital of Thessaloniki Hippokration
  - Thessaloniki, Greece, 56429
    - 424th Army General Hospital
Hungary
- - Balatonfured, Hungary, 8230
    - DRC Gyogyszervizsgalo Kozpont Kft
  - Bekescsaba, Hungary, 5600
    - Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház
  - Budapest, Hungary, 1083
    - Semmelweis Egyetem
  - Budapest, Hungary, 1062
    - Magyar Honvédség Egészségügyi Központ
  - Budapest, Hungary, 1136
    - Pannonia Maganorvosi Centrum
  - Budapest, Hungary, 1036
    - Obudai Egeszsegugyi Centrum Kft.
  - Budapest, Hungary, H-1032
    - Szent Margit Kórház
  - Debrecen, Hungary, 4032
    - Debreceni Egyetem Klinikai Központ
  - Gyula, Hungary, 5700
    - Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
  - Kaposvar, Hungary, 7400
    - Somogy Megyei Kaposi Mor Oktato Korhaz
  - Letavertes, Hungary, 4281
    - Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
  - Mohacs, Hungary, 7700
    - Mohacsi Korhaz
  - Nyiregyhaza, Hungary, 4400
    - SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
  - Szekesfehervar, Hungary, 8000
    - Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Israel
- - Holon, Israel, 58100
    - Wolfson Medical Center
  - Jerusalem, Israel, 91031
    - Shaare Zedek Medical Center
  - Kfar Saba, Israel, 44281
    - Meir Medical Center
  - Ramat Gan, Israel, 52621
    - Chaim Sheba Medical Center
  - Rechovot, Israel, 76100
    - Kaplan Medical Center
  - Tel Aviv, Israel, 64239
    - Tel Aviv Sourasky Medical Center
Italy
- - Bologna, Italy, 40138
    - Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi
  - Firenze, Italy, 50134
    - Azienda Ospedaliera Universitaria Careggi
  - Genova, Italy, 16132
    - Azienda Ospedaliero Universitaria San Martino
  - Milano, Italy, 20157
    - Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale Sacco
  - Modena, Italy, 41124
    - A.O.U. Policlinico di Modena
  - Monza, Italy, 20900
    - Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)
  - Napoli, Italy, 80131
    - Azienda Ospedaliera Universitaria "Federico II"
  - Pavia, Italy, 27100
    - Fondazione IRCCS Policlinico San Matteo
  - Pisa, Italy, 56124
    - Azienda Ospedaliero Universitaria Pisana
  - Roma, Italy, 00168
    - Complesso Integrato Columbus
  - Rozzano (MI), Italy, 20089
    - Istituto Clinico Humanitas
  - San Giovanni Rotondo FG, Italy, 71013
    - IRCCS Ospedale Casa Sollievo della Sofferenza
Korea, Republic of
- - Busan, Korea, Republic of, 612-030
    - Inje university Haeundae Paik Hospital
  - Daegu, Korea, Republic of, 42415
    - Yeungnam University Hospital
  - Daejeon, Korea, Republic of, 302-718
    - Konyang University Hospital
  - Guri-si, Korea, Republic of, 471-701
    - Hanyang Univerisy Guri Hospital
  - Seongnam, Korea, Republic of, 463-707
    - Seoul National University Bundang Hospital
  - Seongnam-si,, Korea, Republic of, 13496
    - CHA Bundang Medical Center CHA University
  - Seoul, Korea, Republic of, 135-710
    - Samsung Medical Center
  - Seoul, Korea, Republic of, 138-736
    - Asan Medical Center
  - Seoul, Korea, Republic of, 110-744
    - Seoul National University Hospital
  - Seoul, Korea, Republic of, 3722
    - Severance Hospital, Yonsei University
  - Seoul, Korea, Republic of, 02447
    - Kyung Hee University Hospital
  - Seoul, Korea, Republic of, 136-705
    - Korea University Anam Hospital
  - Seoul, Korea, Republic of, 3181
    - Kangbuk Samsung Hospital
  - Seoul, Korea, Republic of, 7985
    - Ewha Womans University Mokdong Hospital
  - Suwon, Korea, Republic of, 442-723
    - The Catholic University of Korea, St.Vicent's Hospital
  - Wonju-Si, Korea, Republic of, 220701
    - Yonsei University Wonju Severance Christian Hospital
Latvia
- - Riga, Latvia, LV1002
    - Pauls Stradins Clinical University Hospital
Moldova, Republic of
- - Chisinau, Moldova, Republic of, MD-2068
    - "Sfanta Treime" Clinical Municipal Hospital
  - Chisinau, Moldova, Republic of, MD2005
    - Clinical Hospital of the Ministry of Health, Department of Endoscopic Surgery
  - Chisinau, Moldova, Republic of, MD2025
    - "Sf. Arhanghel Mihail" Municipal Clinical Hospital
  - Chisinau, Moldova, Republic of, MD2025
    - Republican Clinical Hospital
Netherlands
- - Amsterdam, Netherlands, 1105 AZ
    - Academisch Medisch Centrum
  - Amsterdam, Netherlands, 1081 HV
    - Vrije Universiteit Medisch Centrum (Vumc)
  - Groningen, Netherlands, 9700 RB
    - Universitair Medisch Centrum Groningen (UMCG)
  - Maastrich, Netherlands, 6202 AZ
    - Maastricht University Medical Center
  - Sittard-Geleen, Netherlands, 6162 BG
    - Zuyderland Medisch Centrum - Sittard-Geleen
  - Tilburg, Netherlands, 5022 GC
    - ETZ Elisabeth
New Zealand
- - Christchurch, New Zealand, 8011
    - Christchurch Hospital NZ
  - Dunedin, New Zealand, 9016
    - Dunedin Public Hospital
Poland
- - Bydgoszcz, Poland, 85-794
    - Clinsante S.C. Osrodek Badan Klinicznych
  - Chorzow, Poland, 41-500
    - Specjalistyczna Przychodnia Lekarska Medicus
  - Klodzko, Poland, 57-300
    - GLOBE Clinical Research Sp. z o.o. LLC
  - Krakow, Poland, 30-363
    - PLEJADY Sp. z o.o. (LLC) Medical Centre
  - Kraków, Poland, 31-315
    - Centrum Medyczne A-Z Clinic
  - Ksawerow, Poland, 95-054
    - Healthcare Center Orkan Med Stec Michalska Spolka Jawna
  - Lodz, Poland, 90-302
    - SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia
  - Lublin, Poland, 20-362
    - KO-MED Centra Kliniczne Lublin II
  - Piotrkow Trybunalski, Poland, 97-300
    - Trialmed Llc
  - Poznan, Poland, 60-529
    - SOLUMED Centrum Medyczne
  - Sopot, Poland, 81-756
    - Specjalistyczna Praktyka Lekarska dr med. Marek Horynski
  - Staszow, Poland, 28-200
    - KO-MED Centra Kliniczne Staszow
  - Torun, Poland, 87-100
    - GASTROMED Kopon, Zmudzinski and Partners Specialist Centre for Gastroenterology and Endoscopy, Spe
  - Warsaw, Poland, 00-632
    - MDM Healthcare Centre
  - Warsaw, Poland, 03-580
    - NZOZ Vivamed
  - Wierzchoslawice, Poland, 33-122
    - Health Centre Metabolic Diseases Outpatient Clinic in Wierzchoslawice
  - Wroclaw, Poland, 53-114
    - LexMedica Osrodek Badan Klinicznych
Romania
- - Bacau, Romania, 600114
    - Bacau County Emergency Hospital, Department of Gastroenterology
  - Bucharest, Romania, 010719
    - Hyperclinica MedLife Grivita
  - Bucharest, Romania, 050098
    - Bucharest University Emergency Hospital, Department of Internal Medicine II
  - Cluj-Napoca, Romania, 400132
    - TVM MED SERV SRL, Medical Center for Gastroenterology, Hepatology and Digestive Endoscopy
  - Constanta, Romania, 900591
    - Sf. Apostol Andrei Constanta Emergency Clinical County Hospital
  - Craiova, Romania, 200642
    - Craiova County Emergency Clinical Hospital
  - Timisoara, Romania, 300723
    - "Pius Brinzeu" County Emergency Clinical Hospital, Department of Gastroenterology and Hepatology
Russian Federation
- - Barnaul, Russian Federation, 656043
    - Multidisciplinary Medical Clinic "Anthurium"
  - Irkutsk, Russian Federation, 664005
    - Road Clinical Hospital on Station Irkutsk-Passazhirskiy of OJSC Russian Railways
  - Kazan, Russian Federation, 420012
    - SBEI HPE "Kazan State Medical University" of the MoH of the RF
  - Moscow, Russian Federation, 119333
    - FSBIH "Central Clinical Hospital of Russian Academy of Sciences"
  - Nizhniy Novgorod, Russian Federation, 603126
    - SBIH of Nizhniy Novgorod region " Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"
  - Novosibirsk, Russian Federation, 630117
    - FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS
  - Novosibirsk, Russian Federation, 630054
    - SBEIHPE Novosibirsk State Medical University
  - Omsk, Russian Federation, 644013
    - BHI of Omsk region "Clinical Oncology Dispensary"
  - Rostov-on-Don, Russian Federation, 344022
    - SBEI HPE Rostov State Medical University of the MoH of the RF
  - Saint Petersburg, Russian Federation, 194291
    - SBIH City Clinical Hospital #31
  - Saint-Peterburg, Russian Federation, 191119
    - Union Clinic
  - Saint-Petersburg, Russian Federation, 194044
    - FSMEI HPE "Military Medical Academy n.a. S.M.Kirov"of Ministry of Defense of Russia
  - Saint-Petersburg, Russian Federation, 196247
    - SPb SBIH City Hospital # 26
  - Saint-Petersburg, Russian Federation, 197022
    - Pavlov First Saint Petersburg State Medical University
  - Samara, Russian Federation, 443011
    - Private Educational Institution of Higher Education "Medical University "REAVIZ"
  - Samara, Russian Federation
    - LLC Medical Company Hepatologist
  - St. Petersburg, Russian Federation, 194044
    - FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine"
  - St.Petersburg, Russian Federation, 193312
    - SPb SBIH Alexandrovskaya City Hospital
  - Stavropol, Russian Federation, 355017
    - SBEI HPE "Stavropol State Medical Academy" MoH of RF
  - Vladimir, Russian Federation, 600023
    - Regional Clinical Hospital
Serbia
- - Belgrade, Serbia, 11000
    - Clinical Hospital Center Zvezdara Clinic of Internal Diseases
  - Belgrade, Serbia, 11080
    - Clinical Hospital Center Zemun Department of Gastroenterology
  - Belgrade, Serbia, 11 080
    - Clinical Hospital Center Bezanijska Kosa, Clinic of Internal Medicine
  - Belgrade, Serbia, 11000
    - Clinical Center of Serbia, Clinic of Gastroenterology and Hepatology, Department of Gastroenterology
  - Belgrade, Serbia, 11000
    - Military Medical Academy, Clinic of Gastroenterology and Hepatology
  - Kragujevac, Serbia, 34000
    - Clinical Center Kragujevac, Clinic of Internal Medicine, Center for Gastroenterohepatology
  - Nis, Serbia, 18 000
    - Clinical Center Nis, Clinic of Gastroenterology and Hepatology
  - Zrenjanin, Serbia, 23 000
    - General Hospital Djordje Jovanovic Zrenjanin
Slovakia
- - Banska Bystrica, Slovakia, 97517
    - Fakultna nemocnica s poliklinikou F.D. Roosevelta
  - Bardejov, Slovakia, 08501
    - Alian s.r.o.
  - Bratislava, Slovakia, 83104
    - IBDcentrum s.r.o.
  - Bratislava, Slovakia, 82107
    - PRO SANUS, a.s., Poliklinika ProCare Central
  - Ilava, Slovakia, 01901
    - Slovak Research Center-team member, Sukromna gastroenterologicka ambulancia
  - Kosice, Slovakia, 040 01
    - Gastroped s.r.o.
  - Malacky, Slovakia, 90122
    - Gastroeneterologicka ambulancia MUDr. Peter Hegyi, s.r.o.
  - Martin, Slovakia, 3601
    - Pigeas s.r.o.
  - Michalovce, Slovakia, 7101
    - Nemocnica s poliklinikou S. Kukuru Michalovce, a.s.
  - Nove Zamky, Slovakia, 94002
    - Gastromedic s.r.o.
  - Trnava, Slovakia, 917 75
    - EndoCorp s.r.o.
South Africa
- - Cape Town, South Africa, 7500
    - Dr MJ Prins Practice
  - Cape Town, South Africa, 7646
    - Endocare Research
  - Cape Town, South Africa, 7708
    - Dr JP Wright Practice
  - Cape Town, South Africa, 7550
    - Tiervlei Trial Centre
  - Johannesburg, South Africa, 2193
    - Dr YS Nanabhay Practice
  - Pretoria, South Africa, 0084
    - Emmed Research
Spain
- - Badalona, Spain, 08916
    - University Hospital Germans Trias i Pujol
  - La Laguna, Spain, 38320
    - University Hospital of the Canary Islands (HUC) La Laguna
  - Las Palmas de Gran Canaria, Spain, 35012
    - Hospital Universitario de Gran Canaria Dr. Negrin
  - Sevilla, Spain, 41013
    - University Hospital Virgen del Rocio
Ukraine
- - Chernivtsi, Ukraine, 58002
    - RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU
  - Dnipropetrovsk, Ukraine, 49027
    - Dnipropetrovsk I.I. Mechnykov Regional Clinical Hospital
  - Dnipropetrovsk, Ukraine, 49074
    - Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases
  - Ivano-Frankivsk, Ukraine, 76018
    - Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU
  - Ivano-Frankivsk, Ukraine, 76014
    - Ivano-Frankivsk City Clinical Hospital #1 Dep of Surgery SHEI Ivano-Frankivsk NMU
  - Kharkiv, Ukraine, 61037
    - CI of PH Kharkiv CCH #2
  - Kharkiv, Ukraine, 61039
    - GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
  - Kyiv, Ukraine, 04053
    - SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU
  - Kyiv, Ukraine, 04201
    - Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE
  - Kyiv, Ukraine, 1030
    - Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU
  - Kyiv, Ukraine, 02091
    - Kyiv City Clinical Hospital #1
  - Kyiv, Ukraine, 04073
    - CI of Kyiv RC Regional Clinical Hospital #2
  - Lviv, Ukraine, 79059
    - Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
  - Lviv, Ukraine, 79010
    - Lviv Regional Clinical Hospital
  - Sumy, Ukraine, 40021
    - CI Sumy City Clinical Hospital #1 Dept of Therapy Sumy SU
  - Sumy, Ukraine, 40022
    - Sumy Regional Clinical Hospital
  - Ternopil, Ukraine, 46002
    - CI of TRC Ternopil University Hospital
  - Uzhgorod, Ukraine, 88018
    - A. Novak Transcarpathian Regional Clinical Hospital
  - Vinnytsia, Ukraine, 21005
    - Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War
  - Vinnytsia, Ukraine, 21018
    - M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
  - Vinnytsia, Ukraine, 21029
    - Vinnytsia M.I. Pyrohov National Medical University
  - Vinnytsia, Ukraine, 21018
    - Vinnytsia M.I. Pyrohov Regional Clinical Hospital
  - Vinnytsia, Ukraine, 02029
    - MCIC MC LLC Health Clinic
  - Zaporizhia, Ukraine, 69000
    - City Clinical Hospital of Emergency and Urgent Care of Zaporizhzhya
  - Zaporizhia, Ukraine, 69104
    - CI City Hospital #1
  - Zaporizhia, Ukraine, 69065
    - Zaporizhia City Multispecialty Clinical Hospital #9, Department of Neurology
  - Zaporizhzhia, Ukraine, 69065
    - CI Zapor City Multifunctional CH#9 City Center of Gastroenterology SI Zapor MA of PGE of MOHU
  - Zaporizhzhia, Ukraine, 69600
    - Zaporizhia Regional Clinical Hospital
  - Zhytomyr, Ukraine, 12430
    - Central District Hospital under Zhytomyr District Council
United Kingdom
- - Coventry, United Kingdom, CV2 2DX
    - University Hospital Coventry
  - Exeter, United Kingdom, EX2 5DW
    - Royal Devon and Exeter Hospital (Wonford)
  - Gloucester, United Kingdom, GL1 3NN
    - Gloucestershire Royal Hospital
  - London, United Kingdom, E11 1NR
    - Whipps Cross University Hospital
  - London, United Kingdom, SE1 7EH
    - St Thomas' Hospital
  - Shrewsbury, United Kingdom, SY38XQ
    - Royal Shrewsbury Hospital
United States
- Arizona
  - Sun City, Arizona, United States, 85351
    - Arizona Digestive Health
  - Tucson, Arizona, United States, 85712
    - Adobe Clinical Research LLC
- Arkansas
  - North Little Rock, Arkansas, United States, 72117
    - Arkansas Gastroenterology, P.A.
- California
  - Anaheim, California, United States, 92801
    - Anaheim Clinical Trials
  - Costa Mesa, California, United States, 92627
    - Aurora Care Clinic
  - Garden Grove, California, United States, 92843
    - Valley View Internal Medicine
  - Huntington Beach, California, United States, 92646
    - DaVita Clinical Trials, LLC
  - La Jolla, California, United States, 92037
    - University of California San Diego Medical Center
  - Lancaster, California, United States, 93534
    - Om Research
  - Los Angeles, California, United States, 90095
    - UCLA Medical Center
  - Los Angeles, California, United States, 90033
    - University of Southern California - Keck School of Medicine
  - Los Angeles, California, United States, 90045
    - Southern California Research Institute Medical Group, Inc.
  - Los Angeles, California, United States, 90067
    - GastroIntestinal BioSciences
  - Mission Hills, California, United States, 91345
    - Facey Medical Foundation (Parent)
  - Oceanside, California, United States, 92056-4497
    - Alliance Clinical Research, LLC
  - San Diego, California, United States, 92123
    - Medical Associates Research Group, Inc.
  - San Francisco, California, United States, 94115
    - University of California at San Francisco (PARENT)
- Connecticut
  - Hamden, Connecticut, United States, 06518
    - Medical Research Center of Connecticut, LLC
- Florida
  - Clearwater, Florida, United States, 33765
    - Clinical Research of West Florida Inc - Clearwater
  - Clearwater, Florida, United States, 33756-3839
    - Gastro Florida
  - Delray Beach, Florida, United States, 33445
    - Advanced Pharma Research, Inc
  - Doral, Florida, United States, 33172
    - Dolphin Medical Research
  - Doral, Florida, United States, 33166
    - Universal Axon Clinical Research
  - Hialeah, Florida, United States, 33016
    - South Florida Clinical Trials
  - Largo, Florida, United States, 33777
    - Florida Center for Gastroenterology
  - Miami, Florida, United States, 33155
    - Regenerate Clinical Trials
  - Miami, Florida, United States, 33126
    - City Medical Group
  - Miami, Florida, United States, 33134
    - Advanced Clincial Research
  - Miami, Florida, United States, 33155
    - Advanced Clinical Research of Miami
  - Naples, Florida, United States, 34109
    - Advanced Research for Health Improvement
  - New Port Richey, Florida, United States, 34653
    - Advanced Research Institute, Inc.
  - New Smyrna Beach, Florida, United States, 32168
    - NSB Research
  - North Miami Beach, Florida, United States, 33162
    - Harmony Clinical Research
  - North Miami Beach, Florida, United States, 33162
    - Med-Care Research
  - Orlando, Florida, United States, 32803
    - Center for Digestive Health
  - Palmetto Bay, Florida, United States, 33157
    - IMIC, Inc.
  - Pembroke Pines, Florida, United States, 33029
    - DBC Research, Corp
  - Pinellas Park, Florida, United States, 33781
    - Theia Clinical Research, LLC
  - Zephyrhills, Florida, United States, 33613
    - Florida Medical Clinic, P.A.
- Georgia
  - Atlanta, Georgia, United States, 30342
    - Atlanta Gastroenterology Associates LLC
  - Marietta, Georgia, United States, 30060
    - Gastrointestinal Specialists of Georgia, PC
- Idaho
  - Idaho Falls, Idaho, United States, 83404
    - Grand Teton Research Group, PLLC
- Illinois
  - Chicago, Illinois, United States, 60611
    - Northwestern University Feinberg Sch of Medicine Division of Gastroenterology
  - Chicago, Illinois, United States, 60637-1447
    - University of Chicago Medical Center
  - Oak Lawn, Illinois, United States, 60453-3767
    - DM Clinical Research
  - Urbana, Illinois, United States, 61801
    - Carle Foundation Hospital
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Indiana University Hospital
- Kansas
  - Topeka, Kansas, United States, 66606
    - Cotton-O'Neil Clinical Research Center, Digestive Health
- Kentucky
  - Lexington, Kentucky, United States, 40504
    - University of Kentucky Medical Center
  - Louisville, Kentucky, United States, 40202
    - University Of Louisville
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Gastroenterology Associates, LLC
- Maryland
  - Baltimore, Maryland, United States, 21209
    - Woodholme Gastroenterology
  - Baltimore, Maryland, United States, 21287
    - Johns Hopkins Clinical Research Network
  - Baltimore, Maryland, United States, 21201
    - University of Maryland Medical Group
  - Chevy Chase, Maryland, United States, 20815
    - Chevy Chase Clinical Research
  - Columbia, Maryland, United States, 21045
    - Gastro Center of Maryland
  - Towson, Maryland, United States, 21204
    - Charm City Research Group
- Massachusetts
  - Boston, Massachusetts, United States, 02118
    - Boston Medical Center
  - Brockton, Massachusetts, United States, 02302
    - Commonwealth Clinical Studies, PLLC.
  - Marlborough, Massachusetts, United States, 01752
    - Community Clinical Research Network
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - University of Michigan Health System
  - Troy, Michigan, United States, 48098
    - Center for Digestive Health
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic
- Missouri
  - Belton, Missouri, United States, 64012
    - Ehrhardt Clinical Research, LLC
  - Bridgeton, Missouri, United States, 63044
    - Clinical Research Professionals, LLC - De Paul Medical Dr
  - Saint Louis, Missouri, United States, 63110
    - Washington University
  - Saint Louis, Missouri, United States, 63141
    - Clinical Research Professionals, LLC - Olde Cabin Rd
  - Saint Louis, Missouri, United States, 63141
    - Clinical Research Professionals LLC - The Pines Court
  - Springfield, Missouri, United States, 65806
    - Mercy Research
- New Hampshire
  - Lebanon, New Hampshire, United States, 07756
    - Mary Hitchcock Memorial Hospital
- New York
  - Bronx, New York, United States, 10467
    - Montefiore Medical Center
  - Brooklyn, New York, United States, 11235
    - NY Scientific
  - Great Neck, New York, United States, 11021
    - Long Island Clinical Research Associates
  - New York, New York, United States, 10016
    - New York University School of Medicine
  - New York, New York, United States, 10021
    - Weill Cornell Medical College
  - New York, New York, United States, 10016
    - Concord Medical Group PRIME
  - New York, New York, United States, 10029
    - Mount Sinai - PRIME
  - New York, New York, United States, 10003
    - Icahn School of Medicine Mount Sinai Beth Isreal
- North Carolina
  - Asheville, North Carolina, United States, 28801
    - Asheville Gastroenterology Associates, P.A.
  - Chapel Hill, North Carolina, United States, 27599-7305
    - University of North Carolina at Chapel Hill
  - Charlotte, North Carolina, United States, 28204
    - Carolinas HealthCare System Digestive Health
  - Jacksonville, North Carolina, United States, 28546
    - East Carolina Gastroenterology, PA
  - Kinston, North Carolina, United States, 28501
    - Kinston Medical Specialists, PA
  - Rocky Mount, North Carolina, United States, 27804
    - PMG Research of Rocky Mount, LLC
- Ohio
  - Cincinnati, Ohio, United States, 45206
    - UC Health Clinical Trials Office
  - Cleveland, Ohio, United States, 44195
    - The Cleveland Clinic Foundation
  - Columbus, Ohio, United States, 43210
    - Ohio State University Clinical Trials Management Office
  - Springfield, Ohio, United States, 45504
    - Clinical Inquest Center Ltd
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73112
    - Digestive Disease Specialists
  - Oklahoma City, Oklahoma, United States, 73104
    - University of Oklahoma
- Oregon
  - Portland, Oregon, United States, 97239
    - Oregon Health & Science University
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104-4206
    - Hospital of the University of Pennsylvania
- South Carolina
  - Columbia, South Carolina, United States, 29203
    - Consultants in Gastroenterology, PA
  - Orangeburg, South Carolina, United States, 29118
    - Gastroenterology Associates of Orangeburg
- Tennessee
  - Germantown, Tennessee, United States, 38138
    - Gastro One
  - Nashville, Tennessee, United States, 37203
    - Vanderbilt University Medical Center
- Texas
  - Dallas, Texas, United States, 75246-1613
    - Baylor Research Institute
  - Fort Sam Houston, Texas, United States, 78234
    - Brooke-Army Medical Center
  - Fort Worth, Texas, United States, 76104
    - Ventavia Research Group, LLC
  - Houston, Texas, United States, 77030
    - The Methodist Hospital Research Institute
  - Houston, Texas, United States, 77079
    - Houston Endoscopy and Research Center
  - Houston, Texas, United States, 77004
    - Gulf Coast Research Group LLC
  - San Antonio, Texas, United States, 78229
    - San Antonio Gastroenterology
  - San Antonio, Texas, United States, 78229
    - Gastroenterology Research of San Antonio, LLC
  - Southlake, Texas, United States, 76092
    - Texas Digestive Disease Consultants - Southlake
  - Spring, Texas, United States, 77379
    - Spring Gastroenterology
  - Tyler, Texas, United States, 75701
    - Digestive Health Specialists of Tyler
- Utah
  - Salt Lake City, Utah, United States, 84132
    - University of Utah
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - University of Virginia
  - Chesapeake, Virginia, United States, 23320
    - Gastroenterology Associates of Tidewater
  - Virginia Beach, Virginia, United States, 23454
    - Gastroenterology, LTD
- Washington
  - Seattle, Washington, United States, 98101
    - Benaroya Research Institute at Virginia Mason
  - Seattle, Washington, United States, 98109
    - University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RPC1063 (Ozanimod) 1mg, daily oral administration during Induction and Maintenance periods.	Drug: RPC1063
Placebo Comparator: Placebo Daily oral administration during Induction and Maintenance periods.	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants in Clinical Remission at 10 Weeks Time Frame: 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 Time Frame: At 52 Weeks	Percentage of participants that are in Clinical remission at 52 weeks	At 52 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Clinical Response at 10 Weeks Time Frame: At 10 Weeks	Percentage of participants that are in Clinical response at 10 weeks	At 10 Weeks
Percentage of Participants With Endoscopic Improvement at 10 Weeks Time Frame: At 10 Weeks	Percentage of participants with endoscopic improvement at 10 weeks	At 10 Weeks
Percentage of Participants With Mucosal Healing at 10 Weeks Time Frame: At 10 Weeks	Percentage of participants with mucosal healing at 10 weeks	At 10 Weeks
Percentage of Participants in Clinical Response at 52 Weeks Time Frame: At 52 Weeks	Percentage of participants that are in Clinical response at 52 weeks	At 52 Weeks
Percentage of Participants With Endoscopic Improvement at 52 Weeks Time Frame: At 52 Weeks	Percentage of participants with endoscopic improvement at 52 weeks	At 52 Weeks
Percentage of Participants in Clinical Remission at Week 52 Who Were in Remission at Week 10 Time Frame: At 52 Weeks	Percentage of participants in clinical remission at week 52 who were in clinical remission at week 10	At 52 Weeks
Percentage of Participants With Corticosteroid Free Remission at 52 Weeks Time Frame: At 52 Weeks	Percentage of participants with corticosteroid free remission at 52 weeks	At 52 Weeks
Percentage of Participants With Mucosal Healing at 52 Weeks Time Frame: At 52 Weeks	Percentage of participants with Mucosal Healing at 52 weeks	At 52 Weeks
Percentage of Participants With Durable Clinical Remission at 52 Weeks Time Frame: At 52 Weeks	Percentage of participants with durable clinical remission at 52 weeks	At 52 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

Study Director: AnnKatrin Petersen, M.D., MSc., Celgene

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Helpful Links

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2015

Primary Completion (Actual)

March 27, 2020

Study Completion (Actual)

June 17, 2020

Study Registration Dates

First Submitted

April 24, 2015

First Submitted That Met QC Criteria

May 1, 2015

First Posted (Estimate)

May 6, 2015

Study Record Updates

Last Update Posted (Actual)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 6, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

RPC01-3101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Ulcerative Colitis

Clinical Trials on Placebo

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