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NCT05540327 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Systemic Lupus Erythematosus, sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany.

Active
Registry status
Phase 2
Development phase
379
Enrollment target
20
Study locations

NCT05540327: Active Phase 2 study of Systemic Lupus Erythematosus, sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany.

NCT05540327 is a Phase 2 study of Systemic Lupus Erythematosus that is active but no longer recruiting, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany. The registered enrollment target is 379 participants, roughly in line with the 377-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target. The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05540327, a Phase 2 study of Systemic Lupus Erythematosus, is active but no longer recruiting, sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
379 participants
Enrollment target
20
Study locations

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 \[NCT05162586\]).

Conditions Studied

Systemic Lupus Erythematosus

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
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

4 total trials

What the registry record for NCT05540327 still lists

NCT05540327 is an interventional study that assigns participants to a tested intervention. The registered 379 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 377-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target.

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.

NCT05540327 names 20 study sites across 8 states, led by Other, Florida, California.

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.

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).

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 4 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Systemic Lupus Erythematosus

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05540327's enrollment target sits among peer trials

379 22nd of 99 higher than 78 of 99 other Systemic Lupus Erythematosus trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT05540327, the US trial registry maintained by the National Library of Medicine. NCT05540327 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.