The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)
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- STATUS
- Recruiting
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- End date
- Aug 16, 2024
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- participants needed
- 532
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- sponsor
- EMD Serono Research & Development Institute, Inc.
Summary
The purpose of this Proof of Concept (PoC) and Dose-finding (DF) basket study is to evaluate the efficacy and safety of orally administered Enpatoran 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 Enpatoran is not available through an expanded access program.
Details
| Condition | Systemic Lupus Erythematosus |
|---|---|
| Treatment | Placebo, M5049 low dose, M5049 medium dose, M5049 high dose, Enpatoran low dose, Enpatoran medium dose, Enpatoran high dose |
| Clinical Study Identifier | NCT05162586 |
| Sponsor | EMD Serono Research & Development Institute, Inc. |
| Last Modified on | 21 August 2023 |
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