At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Enpatoran low dose, Enpatoran medium dose, and 2 other interventions for Systemic Lupus Erythematosus. Completed, enrolled 456 participants across 153 sites in 22 countries.
Detailed 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.
Study Details
Timeline
Interventions
Participants will receive film-coated tablets of Enpatoran at a low dose orally, twice daily (BID) up to 24 weeks.
Participants will receive film-coated tablets of Enpatoran at a medium dose, orally, BID up to 24 weeks.
Participants will receive film-coated tablets of Enpatoran at a high dose, orally, BID up to 24 weeks.
Participants will receive placebo matched to Enpatoran up to 24 weeks.