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Not recruiting
Phase 2

M5049

Sponsor:

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

Code:

NCT05540327

Conditions

Systemic Lupus Erythematosus

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

M5049 low dose

M5049 medium dose

M5049 high dose

Placebo

M5049 very high dose

Study Details

Brief 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

Systemic Lupus Erythematosus

Study ID

NCT05540327

Start date

Sep 16, 2022

Status verified date

Aug, 2024

Completion date

Apr 15, 2025

Anticipated

Primary completion date

Apr 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

532 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: M5049 low dose + Placebo

Participants with CLE (active SCLE and/or DLE) or SLE who received low dose of M5049 in WILLOW study will continue to receive M5049 low dose and matching placebo.

experimental: M5049 medium dose+ Placebo

Participants with CLE (active SCLE and/or DLE) or SLE who received medium dose of M5049 in WILLOW study will continue to receive M5049 medium dose and matching placebo.

experimental: M5049 high dose + Placebo

Participants with CLE (active SCLE and/or DLE) or SLE who received M5049 matched placebo or high dose of M5049 in WILLOW study will receive M5049 high dose .

experimental: M5049 very high dose + Placebo

Participants with CLE (active SCLE and/or DLE) or SLE who received M5049 matched placebo or very high dose of M5049 in WILLOW study will receive M5049 very high dose.

Interventions

M5049 low dose

Participants will receive film-coated tablets of M5049 at a low dose orally, twice a day (BID) for up to 48 weeks.

M5049 medium dose

Participants will receive film-coated tablets of M5049 at a medium dose orally, BID for up to 48 weeks.

M5049 high dose

Participants will receive film-coated tablets of M5049 at a high dose orally, BID for up to 48 weeks.

Placebo

Participants will receive M5049 matching placebo orally, BID for up to 48 weeks.

M5049 very high dose

Participants will receive film-coated tablets of M5049 at a very high dose orally, BID for up to 48 weeks.

Primary outcome measure

  • Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) [ Time Frame: Baseline up to Week 50 ]

Central Contacts and Locations

Central contacts

Communication Center

+49 6151 72 5200service@emdgroup.com

Locations

The Lundquist Institute at Harbor-UCLA Medical Center

Recruiting

Torrance, California, United States, 90502

Contacts

gkarpouzas@lundquist.org

Principal Investigator:

George Karpouzas

Bay Area Arthritis and Osteoporosis

Recruiting

Brandon, Florida, United States, 33511

Contacts

baao2010@msn.com

Principal Investigator:

Vipul Joshi

Advance Medical Research Center

Recruiting

Miami, Florida, United States, 33135

Contacts

advancemedicalresearchcenter@gmail.com

Principal Investigator:

Ana M Acosta

Dawes Fretzin Dermatology Group, LLC

Recruiting

Indianapolis, Indiana, United States, 46250

Contacts

dfcrgfretzin@ecommunity.com

Principal Investigator:

Scott Fretzin

AA MRC LLC Ahmed Arif Medical Research Center

Recruiting

Grand Blanc, Michigan, United States, 48439

Contacts

akarrar@aamrc.net

Principal Investigator:

Ali A Karrar

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

pearsond@umn.edu

Principal Investigator:

David R Pearson

Ohio State University - CTMO Parent

Recruiting

Columbus, Ohio, United States, 43210

Contacts

jessica.kaffenberger@osumc.edu

Principal Investigator:

Jessica Kaffenberger

Ramesh C Gupta, MD

Recruiting

Memphis, Tennessee, United States, 38119

Contacts

rcgupta42001@yahoo.com

Principal Investigator:

Ramesh Gupta

More Information

Sponsor

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

Last update posted

Aug 9, 2024

Last verified

Aug, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-14. This information was provided to ClinicalTrials.gov by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany on 2024-08-09.