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NCT05162586 · ClinicalTrials.gov registry record · Phase 2
The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)
A Phase 2 study, sponsored by EMD Serono Research & Development Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 456
- Enrollment target
NCT05162586: Completed Phase 2 study, sponsored by EMD Serono Research & Development Institute.
NCT05162586 is a Phase 2 study that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 456 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (243% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05162586, a Phase 2 study, has completed, sponsored by EMD Serono Research & Development Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 456 participants
- Enrollment target
Study 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.
Primary Outcome
The CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index) was a validated instrument used to assess disease activity (CLASI-A) and damage in lupus erythematosus. The activity scale included erythema, scale/hypertrophy, active alopecia, recent hair loss, and mucous membrane disease, while the damage scale measured dyspigmentation, atrophy, and scarring. CLASI-A scores ranged from 0 to 70, with mild, moderate, and severe disease corresponding to scores of 0-9, 10-20, and 21-70, res
Interventions
- DRUG Placebo
- DRUG Enpatoran low dose
- DRUG Enpatoran medium dose
- DRUG Enpatoran high dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 456 participants |
| Start Date | 2022-03-31 |
| Est. Completion | 2024-11-20 |
| Phase | Phase 2 |
What the finished NCT05162586 record still lists
NCT05162586 is an interventional study that assigns participants to a tested intervention. The registered 456 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (243% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT05162586 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05162586 about?
NCT05162586 is a clinical study titled "The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)". 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 dis...
What is the current status of trial NCT05162586?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 456 participants. The study started on 2022-03-31. Estimated completion is 2024-11-20.
What interventions are being tested in trial NCT05162586?
The interventions under investigation include: Placebo (DRUG), Enpatoran low dose (DRUG), Enpatoran medium dose (DRUG), Enpatoran high dose (DRUG).
Who is sponsoring clinical trial NCT05162586?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05162586's enrollment target sits among peer trials
456 84th of 2000 higher than 1,916 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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