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RECRUITING
NCT07681271
PHASE2

A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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

Interventions

DRUG

LOU064

LOU064 administered by oral route

DRUG

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