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)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- Absolute change from baseline in facial inflammatory lesion count
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
Matching placebo
干预措施: Placebo (Drug)
LOU064
LOU064 administered by oral route
干预措施: LOU064 (Drug)
结局指标
主要结局
Absolute change from baseline in facial inflammatory lesion count
时间窗: Baseline, Week 16
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.
次要结局
- 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(Baseline, Week 16)
- Percentage change from baseline in facial inflammatory lesion count(Baseline, Week 16)