The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE) (NCT05540327)
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)
🩺 Plain-English Summary (8th-Grade Level)
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 \[NCT05162586\]).
Who can join: Review the eligibility criteria below.
Location: The Lundquist Institute at Harbor-UCLA Medical Center — Torrance, California
Age range: 18 Years to 76 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (122 Sites)
Showing the first 25 of 122 sites.
- The Lundquist Institute at Harbor-UCLA Medical Center — Torrance, California
- Bay Area Arthritis and Osteoporosis — Brandon, Florida
- Advance Medical Research Center — Miami, Florida
- Dawes Fretzin Dermatology Group, LLC — Indianapolis, Indiana
- AA MRC LLC Ahmed Arif Medical Research Center — Grand Blanc, Michigan
- University of Minnesota — Minneapolis, Minnesota
- Ohio State University - CTMO Parent — Columbus, Ohio
- Ramesh C Gupta, MD — Memphis, Tennessee
- Centro de Investigaciones Medicas Mar del Plata - CIM — Buenos Aires,
- CINME - Centro De Investigaciones Metabolicas — Buenos Aires,
- Buenos Aires Skin — Ciudad Autonoma Buenos Aires,
- Hospital Militar Central Dr. Cosme Argerich — Ciudad Autonoma Buenos Aires,
- Centro de Investigaciones Medicas Mar del Plata - CIM — Mar del Plata,
- Instituto de Reumatologia — Mendoza,
- Instituto Medico de alta Complejidad San Isidro S.A (IMAC) — San Fernando,
- CER San Juan Centro Polivalente de Asistencia e Inv. Clinica — San Juan,
- Centro Dermatologico Schejtman — San Miguel,
- PSORIAHUE-Medicina Interdisciplinar — San Miguel,
- Centro de Investigaciones Medicas Tucuman — San Miguel de Tucumán,
- Investigaciones Clinicas Tucuman — San Miguel de Tucumán,
- Monash Medical Centre Clayton — Clayton,
- Veracity Clinical Research — Woolloongabba,
- Santa Casa de Misericórdia de Belo Horizonte — Belo Horizonte,
- Oncovida - Centro de Onco-Hematologia de Mato Grosso — Cuiabá,
- Clínica SER da Bahia — Graça,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Systemic Lupus Erythematosus
- A Study of Obexelimab in Patients With Systemic Lupus Erythematosus — Peoria, Arizona
- A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus — Anniston, Alabama
- REACH (Restore Energy, Activity Can Help) Lupus Study — Boston, Massachusetts
- Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus — Birmingham, Alabama
- A Treatment Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice — Innsbruck, Tyrol
- A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) — Birmingham, Alabama
Explore by condition: All Systemic Lupus Erythematosus clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.