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

Phase 2

Active, not recruiting

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: M5049 low dose; Drug: M5049 medium dose; Drug: M5049 high dose; Drug: Placebo; Drug: M5049 very high dose

• Registration Number: NCT05540327
• Lead Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

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 \[NCT05162586\]).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-12
• Study First Submitted QC: 2022-09-12
• Study First Posted: 2022-09-14
• Study Start: 2022-09-16
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-27
• Last Update Posted: 2025-07-02
• Primary Completion: 2028-08-12
• Study Completion: 2028-08-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 379

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
M5049 low dose + Placebo	M5049 low dose	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.
M5049 low dose + Placebo	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.
M5049 medium dose+ Placebo	M5049 medium dose	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.
M5049 medium dose+ Placebo	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.
M5049 high dose + Placebo	M5049 high dose	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 .
M5049 high dose + Placebo	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 .
M5049 low dose + Placebo	M5049 low dose	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.
M5049 medium dose+ Placebo	M5049 medium dose	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.
M5049 high dose + Placebo	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 .
M5049 medium dose+ Placebo	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.
M5049 high dose + Placebo	M5049 high dose	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 .
M5049 very high dose + Placebo	M5049 very high dose	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.
M5049 low dose + Placebo	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.
M5049 very high dose + Placebo	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.

Primary Outcome Measures

Name	Time	Method
Part 1: Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs)	Baseline up to Week 50 (Long Term Extension Part 1)
Part 2: Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs)	Baseline up to Week 194 (LTE Part 1 and LTE Prolongation Part 2))

Secondary Outcome Measures

Name	Time	Method
Part 1 and Part 2: Number of Participants with Abnormalities in Laboratory Parameters and QT Interval Corrected	Baseline up to Week 50 and LTE Prolongation up to Week 194 (Part 2)

Trial Locations

Locations (121)

The Lundquist Institute at Harbor-UCLA Medical Center; 🇺🇸 Torrance, California, United States

Bay Area Arthritis and Osteoporosis; 🇺🇸 Brandon, Florida, United States

Advance Medical Research Center; 🇺🇸 Miami, Florida, United States

Dawes Fretzin Dermatology Group, LLC; 🇺🇸 Indianapolis, Indiana, United States

AA MRC LLC Ahmed Arif Medical Research Center; 🇺🇸 Grand Blanc, Michigan, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Ohio State University - CTMO Parent; 🇺🇸 Columbus, Ohio, United States

Ramesh C Gupta, MD; 🇺🇸 Memphis, Tennessee, United States

Centro de Investigaciones Medicas Mar del Plata - CIM; 🇦🇷 Mar del Plata, Argentina

Buenos Aires Skin; 🇦🇷 Ciudad Autonoma Buenos Aires, Argentina

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