ACTIVE_NOT_RECRUITING

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

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Conditions

Systemic Lupus ErythematosusToll-like Receptor 7Toll-like Receptor 8WILLOWAdultsSLECLELupusDiscoid lupus erythematosusSubacute cutaneous lupus erythematosusM5049EnpatoranLTE

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 \[NCT05162586\]).

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)

Quick Facts

Study Start:2022-09-16
Study Completion:2028-08-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05540327

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.

Ages Eligible for Study:18 Years to 76 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Are SCLE, DLE and/or SLE that have completed the 24 week Treatment of the Willow Study
  2. * Have a Body Mass Index (BMI) within the less than or equal to (\<=) 40 kilograms per meter square (inclusive) at Screening
  3. * Participants who had successfully completed Week 48 of the Part 1 will have the opportunity to participate in the LTE Part 2. In exceptional cases and after Sponsor review, participants who have completed the Week 48 visit of the Part 1 within the previous 4-weeks may be considered for Part 2 participation based on eligibility review. Previous 4-weeks will be calculated from the Week 48 visit of Part 1
  4. * Other protocol defined inclusion criteria could apply
  1. * Participants who experienced serious event(s) related to the study intervention during the WILLOW study
  2. * 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
  3. * 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
  4. * Received LTE prohibited medication during the WILLOW study or after the WILLOW study Week 24
  5. * Participation in any other investigational drug study after the WILLOW study Week 24
  6. * Other protocol defined exclusion criteria could apply

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

The Lundquist Institute at Harbor-UCLA Medical Center
Torrance, California, 90502
United States
Bay Area Arthritis and Osteoporosis
Brandon, Florida, 33511
United States
Advance Medical Research Center
Miami, Florida, 33135
United States
Dawes Fretzin Dermatology Group, LLC
Indianapolis, Indiana, 46250
United States
AA MRC LLC Ahmed Arif Medical Research Center
Grand Blanc, Michigan, 48439
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Ohio State University - CTMO Parent
Columbus, Ohio, 43210
United States
Ramesh C Gupta, MD
Memphis, Tennessee, 38119
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-16
Study Completion Date2028-08-12

Study Record Updates

Study Start Date2022-09-16
Study Completion Date2028-08-12

Terms related to this study

Keywords Provided by Researchers

  • Toll-like Receptor 7
  • Toll-like Receptor 8
  • WILLOW
  • Adults
  • SLE
  • CLE
  • Lupus
  • Discoid lupus erythematosus
  • Subacute cutaneous lupus erythematosus
  • M5049
  • Enpatoran
  • LTE

Additional Relevant MeSH Terms

  • Systemic Lupus Erythematosus