Clinical Trial

The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)

Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
The purpose of the study is to evaluate the long term safety and efficacy of orally administered M5049 in participants with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE) and/or systemic lupus erythematosus (SLE) who have completed the 24 week treatment period of Willow study (MS200569\_0003 \[NCT05162586\]).
Protocol Amendment History 17 amendments
This ClinicalTrials.gov record has been amended 17 times since 2022-09-12; most recent amendment 2026-07-16.
Status change: Recruiting → Active, Not Recruiting 2025-06-27
Status change: Not Yet Recruiting → Recruiting 2022-10-06
Trial Details
NCT Number NCT05540327
Lead Sponsor Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Conditions Systemic Lupus Erythematosus
Enrollment 379 participants
Start Date 2022-09-16
Primary Completion 2028-08-12 (estimated)
Study Completion 2028-08-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-20