A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
Start Date
7/30/2026
Completion Date
12/7/2027
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.
Detailed 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. A safety follow up visit will occur approximately 30 days after the final dose.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
LOU064
Placebo
Conditions
Locations
Three A Research
El Paso, Texas 79902
United States
Novartis Investigative Site
London, Ontario N6H 5L5
Canada
Novartis Investigative Site
Markham, Ontario L3P 1X3
Canada
Novartis Investigative Site
Shanghai, 200040
China
Novartis Investigative Site
Singapore, 308205
Singapore
Novartis Investigative Site
Dongjak Gu, Seoul 07061
South Korea
Novartis Investigative Site
Icheon, 21431
South Korea