clinical trial · NCT05540327
The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany·phase2·active not recruiting·n = 379
Systemic Lupus ErythematosusM5049 low doseM5049 medium doseM5049 high dosePlacebo
brief 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 \[NCT05162586\]).
started
Sep 16, 2022
primary completion
Aug 12, 2028
completion
Aug 12, 2028
last updated
Apr 16, 2026
official title
A Phase II, Double-blind, Dose-Ranging, Parallel, Long-term Extension Study to Evaluate the Safety and Efficacy of Enpatoran in Participants With Subacute Cutaneous Lupus Erythematosus, Discoid Lupus Erythematosus and/or Systemic Lupus Erythematosus Having Completed the WILLOW (MS200569_0003) Study Treatment (WILLOW LTE)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol