A randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered GLPG3667 once daily for 24 weeks in adult subjects with dermatomyositis

dermatomyositis

Total improvement score [TIS] according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria at Week 24. Open Label Extension : Frequency and severity of TEAEs, treatment-emergent SAEs, and TEAEs leading to treatment discontinuation (over time up to Week 52).

At week 24 - - Proportion of subjects with at least minimal improvement according to the ACR/EULAR criteria (defined as TIS of >= 20 points) at Week 24. - Change from baseline in modified-Cutaneous DM Disease Area and Severity Index Activity Score (m-CDASI-A). - Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) - Change from baseline in the manual muscle test (MMT-8), Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation (over time up to Week 24)., Estimated GLPG3667 maximum plasma concentration (Cmax), area under the plasma concentration-time curve (AUC), and trough plasma concentration (Ctrough) at steady-state.

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Belgium, Bulgaria, Croatia, Czechia, France, Germany, Italy, Poland, Romania, Spain