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Clinical Trials in the EU / 2025-524496-23-00
Authorised, recruiting Phase II

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)

2025-524496-23-00 · tracked via the Priya Life Science EU tracker
Sponsor
Novartis Pharma AG
Sponsor type
Pharmaceutical company
Therapeutic area
Skin and Connective Tissue Diseases
Decision date
14/09/2026
Enrollment target
60
Sites
Bulgaria, Spain, France, Italy, Germany

Condition studied

Papulopustular Rosacea (PPR)

Investigational medicinal product(s)

Placebo to remibrutinib (LOU064) 00 mg film-coated tabletLOU064

Every trial of Remibrutinib across our registers →

Eligibility

Age group
18-64 years, 65+ years
Sex
Female, Male

Primary endpoint

Absolute change from baseline in facial inflammatory lesion count (sum of papules, pustules, and nodules) at Week 16

Endpoint detail

Occurrence of treatment-emergent adverse events (AEs) including serious (SAEs), Proportion of subjects with Investigator's Global Assessment (IGA,modified scale without erythema) grade 0 or 1 at Week 16, with at least 2 grade reduction from baseline, in the remibrutinib group compared to placebo, Percentage change from baseline in facial inflammatory lesion count (sum of papules, pustules, and nodules) at Week 16

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-524496-23-00 on CTIS ↗ ← All trials in the EU