CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 105 enrolled
Drug / intervention
Matching placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02472795
NCT02472795Phase 2Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-response Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus

Viatris Innovation GmbH·interventional·Posted Jun 16, 2015·Updated Oct 3, 2025

In Brief

A Phase 2 clinical trial evaluating Matching placebo and Cenerimod for Systemic Lupus Erythematosus. Completed, enrolled 105 participants across 18 sites in 6 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus
CountriesBelarus, Bulgaria, Georgia, Russia, Ukraine, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 16, 2015
Enrollment StartJun 1, 2015
Primary CompletionJan 23, 2017
Study CompletionFeb 28, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.0 years ago

Interventions

Matching placebodrug

One capsule of cenerimod to be taken once daily, irrespective of food intake. The capsule is to be swallowed whole. The capsule should be taken each day at approximately the same time (preferably each morning).

Cenerimoddrug

One capsule of cenerimod to be taken once daily, irrespective of food intake. The capsule is to be swallowed whole. The capsule should be taken each day at approximately the same time (preferably each morning).