Phase 2 Study of Remibrutinib LOU064 to Assess Safety and Effectiveness in Adults with Moderate-to-Severe Papulopustular Rosacea

What this Trial Is About

Researchers are evaluating remibrutinib, a drug that inhibits Brutons tyrosine kinase BTK, to see if it can reduce inflammatory skin lesions in adults with moderate-to-severe papulopustular rosacea PPR. This Phase 2 study also assesses the safety and tolerability of remibrutinib for this condition. The study is randomized, double-blind, placebo-controlled, and conducted across multiple centers. After a screening period of up to 30 days, which may be extended by 2 weeks for washout from prior rosacea or systemic treatments, participants will be randomly assigned to receive either oral remibrutinib or a matching placebo. The treatment phase lasts 16 weeks, followed by a safety follow-up visit about 30 days after the last dose. Participants are asked to avoid other treatments targeting PPR during the study. Participants will have their facial inflammatory lesion counts measured at baseline and after 16 weeks to evaluate changes. The Investigators Global Assessment IGA of disease severity will also be recorded. Safety and tolerability will be monitored throughout treatment and during the follow-up visit. The study involves regular visits for assessments and questionnaires over the treatment period, with total participation lasting approximately 20 weeks including screening and follow-up.

A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)