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Active, Not Recruiting

NCT Number: NCT05540327

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 Willow study (MS200569_0003 [NCT05162586]).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Cutaneous Lupus Erythematosus, Discoid Lupus Erythematosus, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CINME - Centro De Investigaciones Metabolicas, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Are SCLE, DLE and/or SLE that have completed the 24 week Treatment of the Willow Study
  • Have a Body Mass Index (BMI) within the less than or equal to (<=) 40 kilograms per meter square (inclusive) at Screening
  • 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
  • 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

Treatment and study plan

M5049 low dose

Drug

Participants will receive film-coated tablets of M5049 at a low dose orally, twice a day (BID) for up to 194 weeks.

Other names: Enpatoran

M5049 medium dose

Drug

Participants will receive film-coated tablets of M5049 at a medium dose orally, BID for up to 194 weeks.

Other names: Enpatoran

M5049 high dose

Drug

Participants will receive film-coated tablets of M5049 at a high dose orally, BID for up to 194 weeks.

Other names: Enpatoran

Placebo

Drug

Participants will receive M5049 matching placebo orally, BID for up to 194 weeks.

Primary outcomes

  1. Part 1: 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 (Long Term Extension Part 1)

  2. Part 2: 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 194 (LTE Part 1 and LTE Prolongation Part 2))

Secondary outcomes

  1. Part 1 and Part 2: Number of Participants with Abnormalities in Laboratory Parameters and QT Interval Corrected

    Time frame: Baseline up to Week 50 and LTE Prolongation up to Week 194 (Part 2)

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Sep 14, 2022
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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