An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

NCT02531126 | Completed Phase 3 Results DMC

• 3 other identifiers: RPC01-31022015-001600-64U1111-1218-0284
• Study Type: interventional
• Target: 877
• Locations: 19 countries
• Sites: 39

Brief Summary

The purpose of this study is to evaluate the long-term safety and efficacy of RPC1063 in participants with moderately to severely active ulcerative colitis. Only those participants who have previously participated in a trial of RPC1063, being either RPC01-3101 or completed at least 1 year of the open-label period of RPC01-202 will be eligible.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Treatment-Emergent Adverse Event (TEAEs)

  Number of participants experiencing TEAEs, Serious TEAEs, TEAEs leading to discontinuation and TEAEs of special interest. TEAE is defined as any event with an onset date on or after the first dose date, or any ongoing event on the first dose date that worsens in severity on or after the first dose date, and until 90 days following the last dose of treatment with the study drug.

  From first dose to 90 days post last dose (Up to approximately 92 months)

Secondary Outcomes (12)

• Percentage of Participants With Clinical Remission

  Week 46, 94, 142, 190, 238

• Percentage of Participants With Clinical Response

  Week 46, 94, 142, 190, 238

• Percentage of Participants With Endoscopic Improvement

  Week 46, 94, 142, 190, 238

• Percentage of Participants With Corticosteroid-free Remission

  Week 46, 94, 142, 190, 238

• Percentage of Participants With Histologic Remission

  Week 46, 94, 142, 190, 238

Study Arms (1)

RPC0163 (Ozanimod)

EXPERIMENTAL

Drug: RPC1063

Interventions

RPC1063 DRUG

Also known as: Ozanimod

RPC0163 (Ozanimod)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously participated in a trial of RPC1063 and meets the criteria for participation in the open-label extension as outlined in the prior trial

You may not qualify if:

• Receiving treatment with breast cancer resistance protein inhibitors
• Clinically relevant cardiovascular conditions
• Liver function impairment

Sponsors & Collaborators

• Celgene: lead

Study Sites (41)

Local Institution - 144

Tucson, Arizona, 85712, United States

Location

Local Institution - 102

Anaheim, California, 92801, United States

Location

Local Institution - 117

Mission Hills, California, 91345, United States

Location

Local Institution - 112

Oak Lawn, Illinois, 60453, United States

Location

Local Institution - 119

Baton Rouge, Louisiana, 70809, United States

Location

Local Institution - 127

Jacksonville, North Carolina, 28546, United States

Location

Local Institution - 290

Oklahoma City, Oklahoma, 73112, United States

Location

Local Institution - 143

Portland, Oregon, 97239, United States

Location

Local Institution - 179

Germantown, Tennessee, 38138, United States

Location

Local Institution - 122

Dallas, Texas, 75246, United States

Location

Local Institution - 152

Camperdown, New South Wales, 2050, Australia

Location

Local Institution - 751

Vitebsk, 210037, Belarus

Location

Local Institution - 600

Ghent, 9000, Belgium

Location

Local Institution - 601

Leuven, 3000, Belgium

Location

Local Institution - 450

Sofia, 1233, Bulgaria

Location

Local Institution - 459

Sofia, 1336, Bulgaria

Location

Local Institution - 451

Sofia, 1606, Bulgaria

Location

Local Institution - 264

Lindsay, Ontario, K9V 5G6, Canada

Location

Local Institution - 611

Osijek, 31000, Croatia

Location

Local Institution - 342

Klatovy, 399 01, Czechia

Location

Local Institution - 337

Prague, 14021, Czechia

Location

Local Institution - 535

Berlin, 12200, Germany

Location

Local Institution - 525

Berlin, 13353, Germany

Location

Local Institution - 545

Frankfurt, 60594, Germany

Location

Local Institution - 643

Athens, 10676, Greece

Location

Local Institution - 816

Balatonfüred, 8230, Hungary

Location

Local Institution - 808

Debrecen, 4032, Hungary

Location

Local Institution - 505

Rehovot, 76100, Israel

Location

Local Institution - 567

Florence, Tuscany, 50134, Italy

Location

Local Institution - 658

Chisinau, MD-2068, Moldova

Location

Local Institution - 659

Chisinau, MD2025, Moldova

Location

Local Institution - 425

Kłodzko, 57-300, Poland

Location

Local Institution - 677

Bucharest, 010719, Romania

Location

Local Institution - 673

Bucharest, 050098, Romania

Location

Local Institution - 910

Bardejov, 08501, Slovakia

Location

Local Institution - 364

Seongnam-si, 13620, South Korea

Location

Local Institution - 354

Wŏnju, 26426, South Korea

Location

Local Institution - 954

Kharkiv, 61039, Ukraine

Location

Local Institution - 957

Vinnytsia, 21018, Ukraine

Location

Local Institution - 236

London, GREATER LONDON, E11 1NR, United Kingdom

Location

Local Institution - 243

London, SE1 9RT, United Kingdom

Location

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: 41003640 DERIVED

• 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.

  PMID: 39773524 DERIVED

• 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.

  PMID: 39018016 DERIVED

• 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.

  PMID: 38723981 DERIVED

• 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.

  PMID: 38040274 DERIVED

• Sandborn WJ, Feagan BG, Hanauer S, Vermeire S, Ghosh S, Liu WJ, Petersen A, Charles L, Huang V, Usiskin K, Wolf DC, D'Haens G. Long-Term Efficacy and Safety of Ozanimod in Moderately to Severely Active Ulcerative Colitis: Results From the Open-Label Extension of the Randomized, Phase 2 TOUCHSTONE Study. J Crohns Colitis. 2021 Jul 5;15(7):1120-1129. doi: 10.1093/ecco-jcc/jjab012.

  PMID: 33438008 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

ozanimod

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2015
• First Posted: August 24, 2015
• Study Start: December 2, 2015
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: December 31, 2025
• Results First Posted: December 31, 2025

Record last verified: 2025-12

Locations

PL (1); SL (1); GB (2); AU (1); CZ (2); IL (1); RO (2); MO (2); BU (3); CA (1); BE (1); US (10); KR (2); GR (1); UA (2); IT (1); HU (2); DE (3); CR (1)