Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
Brief 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).
Approximately 500 adult subjects with SLE will be randomized in a 1:1:1:1:1 ratio to placebo, 0.5, 1, 2, or 4 mg o.d. of cenerimod, in addition to background SLE therapy.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date: December 21, 2018
Estimated Primary Completion Date: May 17, 2021
Estimated Study Completion Date: September 15, 2021
Arm:
- Experimental: Cenerimod 0.5 mg
- Experimental: Cenerimod 1 mg
- Experimental: Cenerimod 2 mg
- Experimental: Cenerimod 4 mg
- Placebo Comparator: Placebo
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Expected enrolment | 500 |
| Actual Study start date | 21 December 2018 |
| Estimated Study Completion Date | 15 September 2021 |