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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
2026-09-28
Healthy Volunteers
No
Conditions
Interventions
LOU064
LOU064 administered by oral route
Placebo
Matching placebo
Locations (7)
Three A Research
El Paso, Texas, United States
Novartis Investigative Site
London, Ontario, Canada
Novartis Investigative Site
Markham, Ontario, Canada
Novartis Investigative Site
Shanghai, China
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Dongjak Gu, Seoul, South Korea
Novartis Investigative Site
Icheon, South Korea