A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis

Summary

The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with relapsing multiple sclerosis.

Timeline

Start

2015-10-16

Primary completion

2023-01-05

Completion

2023-01-05

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.
• Selmaj KW, Steinman L, Comi G, Bar-Or A, Arnold DL, Hartung HP, Montalban X, Havrdova EK, Sheffield JK, Krakovich A, Cheng CY, Riolo JV, Pachai C, Thorpe A, DeBoer E, Kappos L, Cohen JA, Cree BA. Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis: Final analysis of the DAYBREAK open-label extension trial. Mult Scler. 2025 Nov;31(13):1557-1571. doi: 10.1177/13524585251382796. Epub 2025 Nov 5.
• Cohen JA, Arnold DL, DeLuca J, Hartung HP, Kappos L, Comi G, Selmaj K, Steinman L, Bar-Or A, Montalban X, Havrdova EK, Sheffield JK, Pachai C, Cheng CY, Riolo JV, Cree BA. Brain atrophy and associations with long-term disability and cognitive function in participants with relapsing multiple sclerosis treated with ozanimod: Results from phase 3 and open-label extension trials. Mult Scler. 2025 Sep;31(10):1218-1230. doi: 10.1177/13524585251355842. Epub 2025 Jul 23.
• 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.
• Naismith RT, Cohen JA, Bar-Or A, Comi G, Selmaj KW, Hartung HP, Sheffield JK, Krakovich A, Tatosian D, Cheng CY, Reardon J, Khaychuk V, Riolo JV, Silva D, Cree BA. Concurrent administration of serotonergic antidepressants and ozanimod in participants with relapsing multiple sclerosis from the open-label extension DAYBREAK trial. Mult Scler. 2024 Feb;30(2):177-183. doi: 10.1177/13524585231216854. Epub 2023 Dec 21.
• Cree BAC, Maddux R, Bar-Or A, Hartung HP, Kaur A, Brown E, Li Y, Hu Y, Sheffield JK, Silva D, Harris S. SARS-CoV-2 vaccination and infection in ozanimod-treated participants with relapsing multiple sclerosis. Ann Clin Transl Neurol. 2023 Oct;10(10):1725-1737. doi: 10.1002/acn3.51862. Epub 2023 Aug 7.

Drugs

Indications