Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-24 @ 1:21 PM
NCT ID:
NCT02472795
Brief Summary:
International trial to evaluate the biological activity and safety of cenerimod (ACT-334441) in systemic lupus erythematosus (SLE) patients.
Detailed Description:
This multicentre, double-blind, placebo-controlled study will have a staggered approach (Part A and B).
In part A, eligible patients will be randomly assigned (1:1:1:1) to once daily oral administration of cenerimod (0.5, 1, 2 mg) or placebo. After all patients have completed 4 weeks of treatment during part A, an Independent Data Monitoring Committee will review non-blinded data in an interim analysis to evaluate the safety profile of cenerimod and recommend whether the study could proceed to part B.
In part B, additional patients will be randomized (3:1) to once daily oral administration of cenerimod 4 mg or placebo.
All participants will receive study medication for 12 weeks.
Study:
NCT02472795
Study Brief:
Protocol Section:
NCT02472795