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Completed Phase 2 Interventional Results available

The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)

ClinicalTrials.gov ID: NCT05162586

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.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 9:54 AM EDT

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)

Study identification

NCT ID
NCT05162586
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
EMD Serono Research & Development Institute, Inc.
Industry
Enrollment
456 participants

Conditions and interventions

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 30, 2022
Primary completion
Nov 19, 2024
Completion
Nov 19, 2024
Last update posted
Nov 30, 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 Nov 30, 2025 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05162586 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →