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A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
Sponsor: 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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-07-30
Completion Date
2027-12-07
Last Updated
2026-08-12
Healthy Volunteers
No
Conditions
Interventions
LOU064
LOU064 administered by oral route
Placebo
Matching placebo
Locations (4)
Three A Research
El Paso, Texas, United States
Novartis Investigative Site
London, Ontario, Canada
Novartis Investigative Site
Markham, Ontario, Canada
Novartis Investigative Site
Dongjak Gu, Seoul, South Korea