A multicenter, randomized, double-blind, placebo- controlled Phase 2 study to investigate the efficacy, safety and tolerability of remibrutinib (LOU064) in adult patients with Papulopustular Rosacea (PPR)

Condition studied

Papulopustular Rosacea (PPR)

Investigational medicinal product(s)

Eligibility

Primary endpoint

Absolute change from baseline in facial inflammatory lesion count (sum of papules, pustules, and nodules) at Week 16

Endpoint detail

Occurrence of treatment-emergent adverse events (AEs) including serious (SAEs), Proportion of subjects with Investigator's Global Assessment (IGA,modified scale without erythema) grade 0 or 1 at Week 16, with at least 2 grade reduction from baseline, in the remibrutinib group compared to placebo, Percentage change from baseline in facial inflammatory lesion count (sum of papules, pustules, and nodules) at Week 16