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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. 4 versions Re-verified since Sep 19, 2025, no change to tracked fieldsv15-v18
  2. Primary and study completion dates: Apr 15, 2025 to Aug 12, 2028 Primary endpoints: 1 to 2 · Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 532 to confirmed 379 · 5 morev14 Show 8 more changesShow less
    • Primary endpoints: 1 to 2
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 532 to confirmed 379
    • Study sites: 123 to 122
    • Interventions: M5049 high dose (Drug), M5049 low dose (Drug), M5049 medium dose (Drug), M5049 very high dose (Drug), Placebo (Drug) to M5049 high dose (Drug), M5049 low dose (Drug), M5049 medium dose (Drug), Placebo (Drug)
    • Eligibility criteria expanded, about 73 words
    • Secondary endpoints: 5 to 1
    • Study arms: 4 to 3

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv13
  4. Study sites: 67 to 123v12
  5. 3 versions Re-verified since Nov 9, 2023, no change to tracked fieldsv9-v11
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 49 to 67v8
  2. Enrollment target: 440 to 532 Study sites: 22 to 49 · Interventions: M5049 high dose (Drug), M5049 low dose (Drug), M5049 medium dose (Drug), Placebo (Drug) to M5049 high dose (Drug), M5049 low dose (Drug), M5049 medium dose (Drug), M5049 very high dose (Drug), Placebo (Drug) · Study arms: 3 to 4 · 1 morev7 Show 4 more changesShow less
    • Study sites: 22 to 49
    • Interventions: M5049 high dose (Drug), M5049 low dose (Drug), M5049 medium dose (Drug), Placebo (Drug) to M5049 high dose (Drug), M5049 low dose (Drug), M5049 medium dose (Drug), M5049 very high dose (Drug), Placebo (Drug)
    • Study arms: 3 to 4
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 12 to 22v6
  4. Study sites: 7 to 12v5
  5. Study sites: 2 to 7v4
  6. Study sites: 1 to 2v3
  7. Trial status: Not Yet Recruiting to Recruiting Study sites: 161 to 1 · Primary completion date: May 26, 2025 to Apr 15, 2025 · Completion date: Jun 14, 2025 to Apr 15, 2025 · 1 morev2 Show 4 more changesShow less
    • Study sites: 161 to 1
    • Primary completion date: May 26, 2025 to Apr 15, 2025
    • Completion date: Jun 14, 2025 to Apr 15, 2025
    • Start date changed from estimate of Sep 15, 2022 to Sep 16, 2022
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Merck KGaA
43 trials monitored
See 4 trials at risk
Lupus (SLE)
651 trials monitored
See 25 trials at risk
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 \[NCT05162586\]).
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov