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

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.

Timeline

Start

2022-03-31

Primary completion

2024-11-20

Completion

2024-11-20

Publications

• Morand EF, Werth VP, Wenzel J, Furie R, Dall'Era M, Sanchez-Guerrero J, Roy S, Goodson SG, Moreau F, Guhring H, Sgouroudi E, Klopp-Schulze L, Pearson DR. Efficacy and safety of enpatoran, a Toll-like receptor 7/8 inhibitor, in patients with skin manifestations of cutaneous lupus erythematosus or systemic lupus erythematosus: findings from Cohort A of a multicentre, international, double-blind, placebo-controlled, dose-finding phase 2 trial. Lancet Rheumatol. 2026 Jul;8(7):e513-e527. doi: 10.1016/S2665-9913(25)00337-6. Epub 2026 May 7.
• Morand EF, Dall'Era M, Sanchez-Guerrero J, Pearson DR, Werth VP, Wenzel J, Roy S, Kleinmond C, Guhring H, Sgouroudi E, Klopp-Schulze L, Moreau F, Fernandez-Ruiz R, Furie R. Enpatoran, a Toll-like receptor 7/8 inhibitor, in moderate-to-severe systemic lupus erythematosus: findings from Cohort B of a multicentre, international, double-blind, placebo-controlled dose-finding phase 2 trial. Lancet. 2026 May 9;407(10541):1809-1824. doi: 10.1016/S0140-6736(26)00463-0.

Drugs

Indications