Overview

The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)

Status:
Not yet recruiting
Trial end date:
2024-08-16
Target enrollment:
Participant gender:
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 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.
Phase:
Phase 2
Details
Lead Sponsor:
EMD Serono Research & Development Institute, Inc.
Collaborator:
Merck KGaA, Darmstadt, Germany