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

NCT ID: NCT02531126

Last Updated: 2025-12-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

877 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-02

Study Completion Date

2024-12-19

Brief Summary

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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.

Detailed Description

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This is an extension study trial. Eligible participants from the RPC01-3101 and RPC01-202 trials were able to roll-over in this trial to receive study medication until March 2023 or until the Sponsor discontinues the development program, whichever comes first.

Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RPC0163 (Ozanimod)

Group Type EXPERIMENTAL

RPC1063

Intervention Type DRUG

Interventions

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RPC1063

Intervention Type DRUG

Other Intervention Names

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Ozanimod

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Receiving treatment with breast cancer resistance protein inhibitors
* Clinically relevant cardiovascular conditions
* Liver function impairment
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 144

Tucson, Arizona, United States

Site Status

Local Institution - 102

Anaheim, California, United States

Site Status

Local Institution - 117

Mission Hills, California, United States

Site Status

Local Institution - 112

Oak Lawn, Illinois, United States

Site Status

Local Institution - 119

Baton Rouge, Louisiana, United States

Site Status

Local Institution - 127

Jacksonville, North Carolina, United States

Site Status

Local Institution - 290

Oklahoma City, Oklahoma, United States

Site Status

Local Institution - 143

Portland, Oregon, United States

Site Status

Local Institution - 179

Germantown, Tennessee, United States

Site Status

Local Institution - 122

Dallas, Texas, United States

Site Status

Local Institution - 152

Camperdown, New South Wales, Australia

Site Status

Local Institution - 751

Vitebsk, , Belarus

Site Status

Local Institution - 600

Ghent, , Belgium

Site Status

Local Institution - 601

Leuven, , Belgium

Site Status

Local Institution - 450

Sofia, , Bulgaria

Site Status

Local Institution - 459

Sofia, , Bulgaria

Site Status

Local Institution - 451

Sofia, , Bulgaria

Site Status

Local Institution - 264

Lindsay, Ontario, Canada

Site Status

Local Institution - 611

Osijek, , Croatia

Site Status

Local Institution - 342

Klatovy, , Czechia

Site Status

Local Institution - 337

Prague, , Czechia

Site Status

Local Institution - 535

Berlin, , Germany

Site Status

Local Institution - 525

Berlin, , Germany

Site Status

Local Institution - 545

Frankfurt, , Germany

Site Status

Local Institution - 643

Athens, , Greece

Site Status

Local Institution - 816

Balatonfüred, , Hungary

Site Status

Local Institution - 808

Debrecen, , Hungary

Site Status

Local Institution - 505

Rehovot, , Israel

Site Status

Local Institution - 567

Florence, Tuscany, Italy

Site Status

Local Institution - 658

Chisinau, , Moldova

Site Status

Local Institution - 659

Chisinau, , Moldova

Site Status

Local Institution - 425

Kłodzko, , Poland

Site Status

Local Institution - 677

Bucharest, , Romania

Site Status

Local Institution - 673

Bucharest, , Romania

Site Status

Local Institution - 910

Bardejov, , Slovakia

Site Status

Local Institution - 364

Seongnam-si, , South Korea

Site Status

Local Institution - 354

Wŏnju, , South Korea

Site Status

Local Institution - 954

Kharkiv, , Ukraine

Site Status

Local Institution - 957

Vinnytsia, , Ukraine

Site Status

Local Institution - 236

London, GREATER LONDON, United Kingdom

Site Status

Local Institution - 243

London, , United Kingdom

Site Status

Countries

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

References

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

Reference Type DERIVED
PMID: 41003640 (View on PubMed)

Sands BE, Rubin DT, Loftus EV Jr, Wolf DC, Panaccione R, Colombel JF, Dignass A, Regueiro M, Vermeire S, Afzali A, Lawlor G, Ahmad HA, Wu H, Osterman MT, Jain A, D'Haens G. Impact of Prior Biologic Exposure on Ozanimod Efficacy and Safety in the Phase 3 True North Clinical Trial. Am J Gastroenterol. 2025 Oct 1;120(10):2339-2349. doi: 10.14309/ajg.0000000000003310. Epub 2025 Jan 8.

Reference Type DERIVED
PMID: 39773524 (View on PubMed)

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

Reference Type DERIVED
PMID: 39018016 (View on PubMed)

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

Reference Type DERIVED
PMID: 38723981 (View on PubMed)

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

Reference Type DERIVED
PMID: 38040274 (View on PubMed)

Sandborn WJ, Feagan BG, 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.

Reference Type DERIVED
PMID: 33438008 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.BMSClinicalTrials.com

BMS Clinical Trial Patient Recruiting

Other Identifiers

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2015-001600-64

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1218-0284

Identifier Type: REGISTRY

Identifier Source: secondary_id

RPC01-3102

Identifier Type: -

Identifier Source: org_study_id