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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 is a Phase 2 study that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 456 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05162586
The ClinicalTrials.gov registry entry for NCT05162586 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 456 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono Research & Development Institute, which has 81 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT05162586 reports 0 study locations.
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.
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