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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Three A Research
El Paso, Texas, United States
RECRUITINGNovartis Investigative Site
London, Ontario, Canada
RECRUITINGNovartis Investigative Site
Markham, Ontario, Canada
Absolute change from baseline in facial inflammatory lesion count
The facial inflammatory lesion count is defined as the sum of papules, pustules, and nodules present on the face. Lesions are visually counted across the full facial area (forehead, cheeks, nose, chin). A negative value indicates a reduction in lesions (clinical improvement), as lower counts reflect less inflammatory activity.
Time frame: Baseline, Week 16
Proportion of participants with Investigator's Global Assessment (IGA,modified scale without erythema) grade 0 or 1, with at least 2 grade reduction from baseline
The Investigator's Global Assessment is a clinician-reported outcome using a 5-point ordinal scale (0-4). Higher scores indicate more severe disease; lower scores indicate improvement. 0 = Clear 1. = Near clear 2. = Mild 3. = Moderate 4. = Severe
Time frame: Baseline, Week 16
Percentage change from baseline in facial inflammatory lesion count
The facial inflammatory lesion count is defined as the sum of papules, pustules, and nodules present on the face. Lesions are visually counted across the full facial area (forehead, cheeks, nose, chin). Lower values indicate fewer lesions. A reduction from baseline represents clinical improvement.
Time frame: Baseline, Week 16
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Novartis Investigative Site
Shanghai, China
RECRUITINGNovartis Investigative Site
Singapore, Singapore
RECRUITINGNovartis Investigative Site
Dongjak Gu, Seoul, South Korea
RECRUITINGNovartis Investigative Site
Icheon, South Korea
RECRUITING