Cenerimod 4 mg
Sponsors
Viatris Innovation GmbH, Viatris Pharmaceuticals Co., Ltd.
Conditions
Healthy SubjectsModerate to severe systemic lupus erythematosusSLE - Systemic Lupus ErythematosusSystemic Lupus ErythematosusSystemic lupus erythematosus
Phase 1
Phase 2
Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
CompletedNCT03742037
Start: 2018-12-21End: 2022-08-25Updated: 2025-10-03
A Study to Evaluate the Safety,Tolerability,Pharmacokinetics and Pharmacodynamics of Cenerimod in Adult Chinese Participants With Moderate-to-severe Systemic Lupus Erythematosus (SLE)
Enrolling by invitationNCT07266090
Start: 2026-01-14End: 2027-10-08Target: 15Updated: 2026-03-09
Phase 3
A Phase 3, multicenter, open-label, single-arm, extension study to evaluate the long-term safety and tolerability of cenerimod in adult subjects with moderate-to-severe systemic lupus erythematosus (SLE) on top of background therapy (OPUS OLE)
RecruitingCTIS2024-514354-67-00
Start: 2024-11-01Target: 172Updated: 2026-01-09
OPUS-1 - Oral S1P1 Receptor ModUlation in SLE: A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in adult subjects with moderate-to-severe systemic lupus erythematosus (SLE) on top of background therapy
RecruitingCTIS2024-515870-28-00
Start: 2024-10-22Target: 100Updated: 2026-01-26
OPUS-2 - Oral S1P1 Receptor ModUlation in SLE: A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in adult subjects with moderate-to-severe systemic lupus erythematosus (SLE) on top of background therapy
Active, not recruitingCTIS2024-515871-37-00
Start: 2024-10-24Target: 92Updated: 2025-12-14