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

• Status: Not yet recruiting
• Trial end date: 2025-06-14
• Target enrollment: 0
• Participant gender: All

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]).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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 range 18.5 to 35 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