NCT07700056招募中3 期
A 52-week Multi-center, Randomized, Double-blind, Placebo Controlled Phase 3 Study to Evaluate the Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 5
- 主要终点
- Proportion of participants achieving ≥4 point reduction from baseline in Worst itch Numerical Rating Scale (WI NRS)
研究概览
简要总结
The purpose of this phase 3 study is to establish the efficacy, safety and tolerability of remibrutinib in adult participants with severe chronic pruritus of unknown origin (CPUO).
详细描述
This is a global, phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety, and tolerability of remibrutinib in adult participants with severe CPUO.
The design includes 4 periods, for a total duration of up to 60 weeks:
- Screening period: up to 4 weeks.
- Double-blind treatment period (treatment period 1, TP1): 24 weeks of double-blind treatment with remibrutinib or matching placebo
- Open-label treatment period (treatment period 2, TP2): 28 weeks of open-label treatment with remibrutinib. The participants randomized to the placebo arm will be switched to remibrutinib at Week 24.
- Safety follow-up period: 4 weeks of treatment-free safety follow-up.
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
- •Participant must be ≥ 18 years of age, at the time of signing the informed consent.
- •Participants with chronic pruritus for at least 4 months prior to screening.
- •Chronic pruritus considered of unknown origin as assessed by the investigator at baseline (e.g., excluding chronic pruritus related to primary dermatological or systemic conditions, neuropathic or psychogenic origin or secondary to drugs or other allergen exposures).
- •Chronic pruritus must affect at least 2 of the following body areas: trunk, arms, or legs (cannot be unilateral and/or dermatomal in distribution).
- •Participants with ongoing, severe chronic pruritus despite the use of emollients and who are candidates for systemic therapy.
- •Participants must have severe itch defined by a WI-NRS ≥7 at screening; score scale ranges from 0 to 10; higher score indicates worse itch.
- •Participants must have an average WI-NRS ≥7 over the 7 days prior to randomization/baseline visit.
- •The average WI-NRS score over the preceding 7 days prior to the randomization/baseline visit will be calculated based on the daily WI-NRS scores (0-10).
- •Participants must have PGIS of pruritus scored as 3 "severe" at screening and baseline visits.
排除标准
- •Any active skin conditions (e.g., atopic dermatitis, psoriasis, etc.) that may interfere with the assessment of CPUO.
- •Known systemic condition(s) or medication(s) that are considered by the investigator to be the primary cause of current pruritus.
- •Known or suspected infectious disease that is active, chronic or recurrent which precludes the participant from participating in the clinical trial as per Investigator´s assessment. These infectious diseases include but are not limited to opportunistic infections (e.g., tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis) and/or known or suspected HIV infection.
- •History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- •Significant bleeding risk or coagulation disorders. History of gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory drugs (NSAIDs), that was clinically relevant (e.g., where intervention was indicated or requiring hospitalization or blood transfusion). Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited.
- •History or current hepatic disease, including but not limited to, acute or chronic hepatitis, cirrhosis or hepatic failure or aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) levels of more than 1.5 x upper limit of normal (ULN) or International Normalized Ratio (INR) of more than 1.5 at screening.
研究组 & 干预措施
Remibrutinib
Experimental
Remibrutinib film coated tablets
干预措施: Remibrutinib (Drug)
Placebo followed by remibrutinib
Experimental
Matching placebo. At the Week 24 visit, all participants will receive active treatment (remibrutinib).
干预措施: Placebo (Drug)
Placebo followed by remibrutinib
Experimental
Matching placebo. At the Week 24 visit, all participants will receive active treatment (remibrutinib).
干预措施: Remibrutinib (Drug)
结局指标
主要结局
Proportion of participants achieving ≥4 point reduction from baseline in Worst itch Numerical Rating Scale (WI NRS)
时间窗: Baseline, Week 12
The WI-NRS is a patient-reported outcome (PRO) instrument consisting of a single question that asks participants to rate the severity of their worst itch over a defined period. The score range is from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicate worse itch severity.
次要结局
- Proportion of participants achieving ≥4 point reduction from baseline in WI NRS(Baseline, Week 4)
- Proportion of participants achieving Patient Global Impression of Severity (PGIS) score of 0 (none) or 1 (mild)(Week 12)
- Proportion of participants achieving Patient Global Impression of Severity (PGIS) score of 0 (none) or 1 (mild)(Week 24)
- Change from baseline in Pruritus-related Sleep Disturbance Numerical Rating Scale (SD-NRS)(Week 12)
- Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to Week 52)
研究者
研究点 (5)
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