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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

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

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

Study 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 \[NCT05162586\]).

Eligibility

Primary outcome measure(s)

• 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))

Trial sites (122)

+ 82 more sites — see the full list on the official registry below.

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