CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 427 enrolled
Drug / intervention
Cenerimod 0.5 mg +5 moredrug
Likely dose
Cenerimod 0.5 mgfrom 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/NCT03742037
NCT03742037Phase 2Completed

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Subjects With Moderate to Severe Systemic Lupus Erythematosus (SLE)

Viatris Innovation GmbH·interventional·Posted Nov 15, 2018·Updated Oct 3, 2025

In Brief

A Phase 2 clinical trial evaluating Cenerimod 0.5 mg, Cenerimod 1 mg, and 4 other interventions for Systemic Lupus Erythematosus. Completed, enrolled 427 participants across 148 sites in 24 countries.

Detailed Summary

The purpose of the study is to assess the efficacy and safety of 4 doses of cenerimod versus placebo in adult subjects with systemic lupus erythematosus (SLE).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBulgaria, Chile, Czechia, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Japan, Mexico, Philippines, Poland, Puerto Rico, Romania, Russia, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedNov 15, 2018
Enrollment StartDec 21, 2018
Primary CompletionAug 31, 2021
Study CompletionAug 25, 2022
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 7.6 years ago

Interventions

Cenerimod 0.5 mgdrug

Cenerimod will be supplied as a film-coated tablets at the dose of 0.5 mg

Cenerimod 1 mgdrug

Cenerimod will be supplied as a film-coated tablets at the dose of 1 mg

Cenerimod 2 mgdrug

Cenerimod will be supplied as a film-coated tablets at the dose of 2 mg

Cenerimod 4 mgdrug

Cenerimod will be supplied as a film-coated tablets at the dose of 4 mg

Placebodrug

Matching placebo will be supplied as identical film-coated tablets formulated with the same excipients but without the active ingredient, cenerimod

cenerimod 2 mg (ex-4 mg)drug

Cenerimod will be supplied as a film-coated tablets at the dose of 2 mg