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)
Novartis Pharmaceuticals
Summary
This Phase 2 study aims to evaluate whether Bruton's tyrosine kinase (BTK) inhibition with remibrutinib can produce a clinically meaningful reduction in inflammatory lesions in adults with moderate-to-severe papulopustular rosacea, while also assessing safety and tolerability of remibrutinib in this indication.
Description
This is a multicenter, randomized, participant and Investigator-blinded, placebo-controlled, parallel-group Phase 2 study designed to evaluate the efficacy, safety, and tolerability of remibrutinib in adults with moderate-to-severe PPR. Following a screening period of up to 30 days, which can be extended by a further 2 weeks only to allow washout from rosacea treatments and other systemic therapies as specified in the prohibited medication section, eligible participants will be randomized at baseline to receive either remibrutinib or matching placebo for a 16-week double-blind treatment phase.…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Adult ≥18 years with a clinical diagnosis of PPR. * Moderate-to-severe disease defined by a modified Investigator's Global Assessment (IGA) score of 3 or 4 * The presence of 15 - 60 inflammatory (papular/pustular, max. 2 nodular) facial lesions at screening, with at least 15 lesions present at Day 1 (Baseline). * Completed requisite washout of systemic antibiotics (30 days) and other prohibited systemic therapies before randomization. * Willingness to refrain from initiating treatments or…
Interventions
- DrugLOU064
LOU064 administered by oral route
- DrugPlacebo
Matching placebo
Location
- Three A ResearchEl Paso, Texas