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

Description

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

Systemic Lupus Erythematosus

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Study Overview

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Study Details

Study overview

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 \[NCT05162586\]).

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)

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

Condition
Systemic Lupus Erythematosus
Intervention / Treatment

-

Contacts and Locations

Torrance

The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, California, United States, 90502

Brandon

Bay Area Arthritis and Osteoporosis, Brandon, Florida, United States, 33511

Miami

Advance Medical Research Center, Miami, Florida, United States, 33135

Indianapolis

Dawes Fretzin Dermatology Group, LLC, Indianapolis, Indiana, United States, 46250

Grand Blanc

AA MRC LLC Ahmed Arif Medical Research Center, Grand Blanc, Michigan, United States, 48439

Minneapolis

University of Minnesota, Minneapolis, Minnesota, United States, 55455

Columbus

Ohio State University - CTMO Parent, Columbus, Ohio, United States, 43210

Memphis

Ramesh C Gupta, MD, Memphis, Tennessee, United States, 38119

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Are active SCLE, DLE and/or SLE that have completed the 24 week Treatment of the Willow Study
  • * Have a Body Mass Index (BMI) within the \>= 40 kilograms per meter square (inclusive) at Screening
  • * Other protocol defined inclusion criteria could apply
  • * Participants who experienced serious event(s) related to the study intervention during the WILLOW study
  • * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with Long Term Extension (LTE) study participation
  • * Ongoing or active clinically significant viral (including Severe acute respiratory syndrome coronavirus 2 \[(SARS-CoV-2)\], bacterial or fungal infection, or any major episode of infection requiring hospitalization
  • * Received LTE prohibited medication during the WILLOW study or after the WILLOW study Week 24
  • * Participation in any other investigational drug study after the WILLOW study Week 24
  • * Other protocol defined exclusion criteria could apply

Ages Eligible for Study

18 Years to 76 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

Medical Responsible, STUDY_DIRECTOR, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Study Record Dates

2025-04-15