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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 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.

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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

Sponsor

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

4 total trials

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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, categorized as Phase 2. The registered enrollment target is 379 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 377-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target. The listed sponsor is Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, which has 4 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.