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

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.

Timeline

Start

2015-12-02

Primary completion

2024-12-19

Completion

2024-12-19

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Drugs

Indications