The purpose of this Proof of Concept (PoC) and Dose-finding (DF) basket study is to evaluate the efficacy and safety of orally administered M5049 over 24 weeks in systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE; subacute cutaneous lupus erythematosus [SCLE] and/or discoid lupus erythematosus [DLE]) participants in a randomized, double-blind, placebo-controlled, parallel, adaptive and dose-ranging setting. Study Duration: 33 weeks Visit Frequency: every 2 or 4 weeks M5049 is not available through an expanded access program.
|Condition||Systemic Lupus Erythematosus|
|Treatment||Placebo, M5049 low dose, M5049 medium dose, M5049 high dose|
|Clinical Study Identifier||NCT05162586|
|Sponsor||EMD Serono Research & Development Institute, Inc.|
|Last Modified on||18 September 2022|
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