Trials / Completed
CompletedNCT03742037
Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 427 (actual)
- Sponsor
- Viatris Innovation GmbH · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
This is a Phase 2b, multicenter, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 4 doses of cenerimod versus placebo in adult subjects with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cenerimod 0.5 mg | Cenerimod will be supplied as a film-coated tablets at the dose of 0.5 mg |
| DRUG | Cenerimod 1 mg | Cenerimod will be supplied as a film-coated tablets at the dose of 1 mg |
| DRUG | Cenerimod 2 mg | Cenerimod will be supplied as a film-coated tablets at the dose of 2 mg |
| DRUG | Cenerimod 4 mg | Cenerimod will be supplied as a film-coated tablets at the dose of 4 mg |
| DRUG | Placebo | Matching placebo will be supplied as identical film-coated tablets formulated with the same excipients but without the active ingredient, cenerimod |
| DRUG | cenerimod 2 mg (ex-4 mg) | Cenerimod will be supplied as a film-coated tablets at the dose of 2 mg |
Timeline
- Start date
- 2018-12-21
- Primary completion
- 2021-08-31
- Completion
- 2022-08-25
- First posted
- 2018-11-15
- Last updated
- 2025-10-03
- Results posted
- 2023-09-22
Locations
148 sites across 24 countries: United States, Bulgaria, 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
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03742037. Inclusion in this directory is not an endorsement.