The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)
Completed · Phase 2 · Has a placebo group
Conditions studied: Systemic Lupus Erythematosus
In brief
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.
Key facts
- Study ID
- NCT05162586
- Run by
- EMD Serono Research & Development Institute, Inc.
- People needed
- 456
- Starts
- 2022-03-31
- Expected to finish
- 2024-11-20
- Last updated by the study team
- 2025-12-01
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Active CLE (SCLE and/or DLE) with a CLE disease area and activity index (CLASI-A) >= 8
- Active SLE with presence of: CLASI-A >= 8 and BILAG 2004 1B, C, D (that is [i.e.], No BILAG 2004 A and No BILAG 2004 >= 2B) or BILAG 2004 >= 1A or 2B and 1 or 2 of the following: Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment (SELENA)-SLEDAI >= 6 at Screening Visit and confirmed clinical hybrid SELENA-SLEDAI >= 4 (excluding laboratory parameters) at Day 1 Visit and/or CLASI-A >= 8
- Receiving a stable dose of at least one of the following standards of care therapies for lupus: Immunomodulator/immunosuppressant, oral corticosteroids, and/or topical corticosteroids
- Other protocol defined inclusion criteria could apply
You may not qualify if…
- Autoimmune or rheumatic disease other than SLE or CLE
- Dermatological diseases other than cutaneous manifestations of SLE or CLE
- Uncontrolled medical conditions including significant cardiovascular events, active lupus nephritis, and active neurological disorder
- Ongoing or active clinically significant viral, bacterial, or fungal infection
- History of uncontrolled seizures or other neurological disorder
- History of or positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B virus
- History of malignancy
- Other protocol defined exclusion criteria could apply
Where it is running
- Bay Area Arthritis and Osteoporosis — Brandon, Florida, United States
- Advance Medical Research Center — Miami, Florida, United States
- New Horizon Research Center, Inc — Miami, Florida, United States
- Charisma Medical and Research Center — Miami Lakes, Florida, United States
- HMD Research, LLC — Orlando, Florida, United States
- D&H Tamarac Research Center, LLC — Tamarac, Florida, United States
- RNA America Health Sciences — Sugar Hill, Georgia, United States
- Dawes Fretzin Dermatology Group, LLC — Indianapolis, Indiana, United States
- AA MRC LLC Ahmed Arif Medical Research Center — Grand Blanc, Michigan, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- Across the Life Span — Smithfield, North Carolina, United States
- Ohio State University - CTMO Parent — Columbus, Ohio, United States
- Ramesh C Gupta, MD - Memphis, TN — Memphis, Tennessee, United States
- CINME - Centro De Investigaciones Metabolicas — Buenos Aires, Argentina
- Buenos Aires Skin — Ciudad Autonoma Buenos Aires, Argentina
- Centro Dermatologico Schejtman — Ciudad Autonoma Buenos Aires, Argentina
- Hospital Militar Central Dr. Cosme Argerich — Ciudad Autonoma Buenos Aires, Argentina
- Centro de Investigaciones Medicas Mar del Plata - CIM — Mar del Plata, Argentina
- Instituto de Reumatologia — Mendoza, Argentina
- Instituto Medico de la Fundacion Estudios Clinicos — Rosario, Argentina
- Instituto Medico de alta Complejidad San Isidro S.A (IMAC) — San Fernando, Argentina
- CER San Juan Centro Polivalente de Asistencia e Inv. Clinica — San Juan, Argentina
- PSORIAHUE-Medicina Interdisciplinar — San Miguel, Argentina
- Centro de Investigaciones Medicas Tucuman — San Miguel de Tucumán, Argentina
- The Lundquist Institute at Harbor-UCLA Medical Center — Torrance, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.