RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Novartis Pharmaceuticals • ClinicalTrials.gov ID: NCT07681271

Registry updated: 2026-10-15

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Description

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.

Interventions

LOU064 (Drug)
LOU064 administered by oral route
Placebo (Drug)
Matching placebo

Eligibility criteria

Key Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Adult ≥18 years with a clinical diagnosis of PPR. * Moderate-to-severe disease defined by a modified Investigator's Global Assessment (IGA) score of 3 or 4 * The presence of 15 - 60 inflammatory (papular/pustular, max. 2 nodular) facial lesions at screening, with at least 15 lesions present at Day 1 (Baseline). * Completed requisite washout of systemic antibiotics (30 days) and other prohibited systemic therapies before randomization. * Willingness to refrain from initiating treatments or undergoing procedures that target or impact PPR during the double-blind period, and to use only protocol-allowed products. Key Exclusion Criteria: * Presence of more than 2 nodular inflammatory lesions * Any active facial dermatoses or skin disease or condition that may interfere with assessment of PPR (e.g., seborrheic dermatitis, perioral dermatitis, acne, acneiform eruptions from biologic medications, steroid-induced dermatitis resembling rosacea or acne). * History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes * Use of biologics within five half-lives prior to screening or until the expected pharmacodynamic (PD) effect has returned to baseline, whichever is longer; or longer if required by local regulations * Use of small molecules and/or immunosuppressants that are not corticosteroids within 5 half-lives or within 30 days prior to screening, whichever is longer; or longer if required by local regulations * Any use of systemic corticosteroids, systemic antibiotics, or topical treatments (including corticosteroids, antibiotics, ivermectin, azelaic acid, or metronidazole) within 30 days prior to randomization, or any planned use of these agents during the study treatment period. * History of live attenuated vaccine within 6 weeks prior to randomization or requirement to receive these vaccinations at any time while on study treatment. * Use, planned use, or failure to meet the protocol-defined washout periods for prohibited therapies. In particular, patients with pretreatment with remibrutinib or another BTK-inhibitor within 4 months prior to randomization. Other protocol-defined inclusion/exclusion criteria may apply.

Conditions

Papulopustular Rosacea

Locations

Three A Research — El Paso, Texas, United States
Novartis Investigative Site — Sofia, Bulgaria
Novartis Investigative Site — Sofia, Bulgaria
Novartis Investigative Site — London, Ontario, Canada
Novartis Investigative Site — Markham, Ontario, Canada
Novartis Investigative Site — Shanghai, China
Novartis Investigative Site — Hamburg, Germany
Novartis Investigative Site — Singapore, Singapore
Novartis Investigative Site — Singapore, Singapore
Novartis Investigative Site — Dongjak Gu, Seoul, South Korea
Novartis Investigative Site — Icheon, South Korea
Novartis Investigative Site — Granada, Spain

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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