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

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат LOU064
  LOU064 administered by oral route
• Препарат Placebo
  Matching placebo

Первичные конечные точки

• Absolute change from baseline in facial inflammatory lesion count [Срок оценки: Baseline, Week 16]

Вторичные конечные точки (2)

• 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 [Срок оценки: Baseline, Week 16]
• Percentage change from baseline in facial inflammatory lesion count [Срок оценки: Baseline, Week 16]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Three A Research — El Paso

Канада · 1 центр

• Novartis Investigative Site — London

South Korea · 1 центр

• Novartis Investigative Site — Dongjak Gu

Идентификаторы

NCT: NCT07681271 · CLOU064Q12201 · 2025-524496-23-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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