NCT03742037

https://clinicaltrials.gov/ct2/show/NCT03742037

Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

ClinicalTrials.gov Identifier: NCT03742037

Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : December 24, 2018Sponsor:
Idorsia Pharmaceuticals Ltd.

Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

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).

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus
Drug: Cenerimod 0.5 mg
Drug: Cenerimod 1 mg
Drug: Cenerimod 2 mg
Drug: Cenerimod 4 mg
Drug: Placebo
Phase 2

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 Design
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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