The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)
Public ClinicalTrials.gov record NCT05162586. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging, Parallel and Adaptive Study to Evaluate the Efficacy and Safety of Enpatoran in SLE and in CLE (SCLE and/or DLE) Participants Receiving Standard of Care (WILLOW)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05162586
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 456 participants
Conditions and interventions
Conditions
Interventions
- Enpatoran low dose Drug
- Enpatoran medium dose Drug
- Enpatoran high dose Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2022 (Actual)
- Primary completion
- Nov 20, 2024 (Actual)
- Completion
- Nov 20, 2024 (Actual)
- Last update posted
- Dec 1, 2025
2022 – 2024
United States locations
- U.S. sites
- 14
- U.S. states
- 9
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Lundquist Institute at Harbor-UCLA Medical Center | Torrance | California | 90509 | — |
| Bay Area Arthritis and Osteoporosis | Brandon | Florida | 33511 | — |
| Advance Medical Research Center | Miami | Florida | 33135 | — |
| New Horizon Research Center, Inc | Miami | Florida | 33165 | — |
| Charisma Medical and Research Center | Miami Lakes | Florida | 33014 | — |
| HMD Research, LLC | Orlando | Florida | 32819 | — |
| D&H Tamarac Research Center, LLC | Tamarac | Florida | 33321 | — |
| RNA America Health Sciences | Sugar Hill | Georgia | 30518 | — |
| Dawes Fretzin Dermatology Group, LLC | Indianapolis | Indiana | 46256 | — |
| AA MRC LLC Ahmed Arif Medical Research Center | Grand Blanc | Michigan | 48439 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Across the Life Span | Smithfield | North Carolina | 27577 | — |
| Ohio State University - CTMO Parent | Columbus | Ohio | 43215 | — |
| Ramesh C Gupta, MD - Memphis, TN | Memphis | Tennessee | 38119 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 139 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05162586, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 1, 2025 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05162586 live on ClinicalTrials.gov.