Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus

Summary

International trial to evaluate the biological activity and safety of cenerimod (ACT-334441) in systemic lupus erythematosus (SLE) patients.

Timeline

Start

2015-06-01

Primary completion

2017-01-23

Completion

2017-02-28

Outcome

Met primary endpoint

registry analysis (superiority test); Cenerimod 2 mg (Part A) vs Matching Placebo; p = 0.004; Mean Difference (Final Values) -0.57 (95% CI -0.95 to -0.19); ANCOVA NCT02472795 ↗

Publications

• Results Hermann V, Batalov A, Smakotina S, Juif PE, Cornelisse P. First use of cenerimod, a selective S1P1 receptor modulator, for the treatment of SLE: a double-blind, randomised, placebo-controlled, proof-of-concept study. Lupus Sci Med. 2019 Nov 9;6(1):e000354. doi: 10.1136/lupus-2019-000354. eCollection 2019.

Drugs

Indications