The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)
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)
Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Listed as NCT05540327, this observational or N/A phase trial focuses on Systemic Lupus Erythematosus and remains ongoing. Sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, it has been updated 19 times since 2022, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
19 versions recorded-
Apr 17, 2026 — Present [daily]
Active Not Recruiting
Phase: PHASE2 → None
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Feb 2026 — Apr 2026 [monthly]
Active Not Recruiting PHASE2
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Oct 2025 — Feb 2026 [monthly]
Active Not Recruiting PHASE2
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Sep 2025 — Oct 2025 [monthly]
Active Not Recruiting PHASE2
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Aug 2025 — Sep 2025 [monthly]
Active Not Recruiting PHASE2
Status: Recruiting → Active Not Recruiting
▶ Show 14 earlier versions
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Sep 2024 — Aug 2025 [monthly]
Recruiting PHASE2
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Aug 2024 — Sep 2024 [monthly]
Recruiting PHASE2
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Jul 2024 — Aug 2024 [monthly]
Recruiting PHASE2
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Mar 2024 — Jul 2024 [monthly]
Recruiting PHASE2
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Jan 2024 — Mar 2024 [monthly]
Recruiting PHASE2
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Dec 2023 — Jan 2024 [monthly]
Recruiting PHASE2
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Nov 2023 — Dec 2023 [monthly]
Recruiting PHASE2
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Oct 2023 — Nov 2023 [monthly]
Recruiting PHASE2
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Jun 2023 — Oct 2023 [monthly]
Recruiting PHASE2
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May 2023 — Jun 2023 [monthly]
Recruiting PHASE2
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Mar 2023 — May 2023 [monthly]
Recruiting PHASE2
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Jan 2023 — Mar 2023 [monthly]
Recruiting PHASE2
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Nov 2022 — Jan 2023 [monthly]
Recruiting PHASE2
Status: Not Yet Recruiting → Recruiting
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Sep 2022 — Nov 2022 [monthly]
Not Yet Recruiting PHASE2
First recorded
Eligibility 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 \[NCT05162586\]).
Contact Information
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Asahikawa-shi, Japan , Athens, Greece , Baotou, China , Barranquilla, Colombia , Beijing, China , Belgrade, Serbia , Belgrade, Serbia , Belgrade, Serbia , Belo Horizonte, Brazil , Bialystok, Poland and 112 more locations