NCT05162586

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

A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging, Parallel and Adaptive Study to Evaluate the Efficacy and Safety of Enpatoran in SLE and in CLE (SCLE and/or DLE) Participants Receiving Standard of Care (WILLOW)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 456 (actual)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Enpatoran low dose	Participants will receive film-coated tablets of Enpatoran at a low dose orally, twice daily (BID) up to 24 weeks.
DRUG	Enpatoran medium dose	Participants will receive film-coated tablets of Enpatoran at a medium dose, orally, BID up to 24 weeks.
DRUG	Enpatoran high dose	Participants will receive film-coated tablets of Enpatoran at a high dose, orally, BID up to 24 weeks.
DRUG	Placebo	Participants will receive placebo matched to Enpatoran up to 24 weeks.

Timeline

• Start date: 2022-03-31
• Primary completion: 2024-11-20
• Completion: 2024-11-20
• First posted: 2021-12-17
• Last updated: 2025-12-01
• Results posted: 2025-12-01

Locations

153 sites across 22 countries: United States, Argentina, Australia, Brazil, Bulgaria, Chile, China, Colombia, Greece, Israel, Japan, Mauritius, Mexico, Moldova, Philippines, Poland, Romania, Serbia, South Africa, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study