2025-524496-23-00招募中2 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 10
- 主要终点
- Absolute change from baseline in facial inflammatory lesion count (sum of papules, pustules, and nodules) at Week 16
研究概览
简要总结
To assess the efficacy of remibrutinib compared to placebo at Week 16
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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 (see Section 6.6.2).
- •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 History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes 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 as detailed in Section 6.6.
- •In particular, patients with pretreatment with remibrutinib or another BTK-inhibitor within 4 months prior to randomization.
研究组 & 干预措施
LOU064
Test
干预措施: LOU064 (Drug)
Placebo to remibrutinib (LOU064) 00 mg film-coated tablet
Placebo
干预措施: Placebo to remibrutinib (LOU064) 00 mg film-coated tablet (Drug)
结局指标
主要结局
Absolute change from baseline in facial inflammatory lesion count (sum of papules, pustules, and nodules) at Week 16
Absolute change from baseline in facial inflammatory lesion count (sum of papules, pustules, and nodules) at Week 16
次要结局
- 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
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (10)
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