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Active, not recruiting Phase 2 Interventional

The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)

ClinicalTrials.gov ID: NCT05540327

Public ClinicalTrials.gov record NCT05540327. 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, 7:50 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, 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)

Study identification

NCT ID
NCT05540327
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Industry
Enrollment
379 participants

Conditions and interventions

Interventions

  • M5049 low dose Drug
  • M5049 medium dose Drug
  • M5049 high dose Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 76 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
Sep 15, 2022
Primary completion
Aug 11, 2028
Completion
Aug 11, 2028
Last update posted
Jul 19, 2026

2022 – 2028

United States locations

U.S. sites
8
U.S. states
7
U.S. cities
8
Facility City State ZIP Site status
The Lundquist Institute at Harbor-UCLA Medical Center Torrance California 90502
Bay Area Arthritis and Osteoporosis Brandon Florida 33511
Advance Medical Research Center Miami Florida 33135
Dawes Fretzin Dermatology Group, LLC Indianapolis Indiana 46250
AA MRC LLC Ahmed Arif Medical Research Center Grand Blanc Michigan 48439
University of Minnesota Minneapolis Minnesota 55455
Ohio State University - CTMO Parent Columbus Ohio 43210
Ramesh C Gupta, MD 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 114 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05540327, 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 Jul 19, 2026 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05540327 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →