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)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524496-23-00

Enrollment

Registered

2026-09-14

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Papulopustular Rosacea (PPR)

Brief summary

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

Detailed description

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

Interventions

DRUGPlacebo to remibrutinib (LOU064) 00 mg film-coated tablet

DRUGLOU064

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 15, 2026