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ACTIVE NOT RECRUITING Phase 2

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

NCT05540327 · View on ClinicalTrials.gov ↗

Study Summary

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 \[NCT05162586\]).

Interventions

  • DRUG Placebo
  • DRUG M5049 low dose
  • DRUG M5049 medium dose
  • DRUG M5049 high dose

Study Locations (20)

Other

  • 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

Florida

  • Bay Area Arthritis and Osteoporosis — Brandon
  • Advance Medical Research Center — Miami

California

  • The Lundquist Institute at Harbor-UCLA Medical Center — Torrance

Indiana

  • Dawes Fretzin Dermatology Group, LLC — Indianapolis

Michigan

  • AA MRC LLC Ahmed Arif Medical Research Center — Grand Blanc

Minnesota

  • University of Minnesota — Minneapolis

Ohio

  • Ohio State University - CTMO Parent — Columbus

Tennessee

  • Ramesh C Gupta, MD — Memphis

Trial Details

FieldValue
Enrollment Target 379 participants
Start Date 2022-09-16
Est. Completion 2028-08-12
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05540327

The ClinicalTrials.gov registry entry for NCT05540327 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 379 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, which has 29 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 4 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05540327 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, Florida, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05540327 about?

NCT05540327 is a clinical study titled "The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)". 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 Wi...

What is the current status of trial NCT05540327?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 379 participants. The study started on 2022-09-16. Estimated completion is 2028-08-12.

What conditions does trial NCT05540327 study?

This clinical trial studies the following conditions: Systemic Lupus Erythematosus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05540327?

The interventions under investigation include: Placebo (DRUG), M5049 low dose (DRUG), M5049 medium dose (DRUG), M5049 high dose (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05540327?

This trial is sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, which has 29 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05540327 being conducted?

This trial has 20 study locations across California, Florida, Indiana, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial