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 \[NCT05162586\]).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
379
Participants will receive film-coated tablets of M5049 at a low dose orally, twice a day (BID) for up to 194 weeks.
Participants will receive film-coated tablets of M5049 at a medium dose orally, BID for up to 194 weeks.
Participants will receive film-coated tablets of M5049 at a high dose orally, BID for up to 194 weeks.
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)
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))
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Participants will receive M5049 matching placebo orally, BID for up to 194 weeks.
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
Buenos Aires, Argentina
CINME - Centro De Investigaciones Metabolicas
Buenos Aires, Argentina
...and 112 more locations