Systemic Lupus Erythematosus
Conditions
Keywords
Toll-like Receptor 7, Toll-like Receptor 8, WILLOW, Adults, SLE, CLE, Lupus, Discoid lupus erythematosus, Subacute cutaneous lupus erythematosus, M5049, Enpatoran, LTE
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 \[NCT05162586\]).
Interventions
DRUGM5049 low dose
Participants will receive film-coated tablets of M5049 at a low dose orally, twice a day (BID) for up to 194 weeks.
DRUGM5049 medium dose
Participants will receive film-coated tablets of M5049 at a medium dose orally, BID for up to 194 weeks.
DRUGM5049 high dose
Participants will receive film-coated tablets of M5049 at a high dose orally, BID for up to 194 weeks.
DRUGPlacebo
Participants will receive M5049 matching placebo orally, BID for up to 194 weeks.
Sponsors
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 76 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) |
Countries
Argentina, Australia, Brazil, Bulgaria, Chile, China, Colombia, Greece, Israel, Japan, Mauritius, Mexico, Moldova, Philippines, Poland, Romania, Serbia, South Africa, South Korea, Spain, Taiwan, United States
Contacts
STUDY_DIRECTORMedical Responsible
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Outcome results
None listed