NCT06516952进行中（未招募）3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 349
- 试验地点
- 227
- 主要终点
- Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at Week 24
研究概览
简要总结
The purpose of this study is to evaluate effect of povorcitinib on itch and skin lesions in participants with prurigo nodularis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants 18 to 75 years of age.
- •Clinical diagnosis of PN for at least 3 months prior to Screening visit.
- •Pruritus, defined as an average Itch NRS score ≥ 7 during the 7 days prior to Day 1/Baseline.
- •Total of ≥ 20 pruriginous lesions on ≥ 2 different body regions (both legs, and/or both arms, and/or trunk) at Screening and Day 1/Baseline.
- •Documented history of treatment failure, demonstrated intolerance, or contraindication to a previous PN treatment.
- •Willingness to avoid pregnancy or fathering children.
排除标准
- •Chronic pruritus due to a condition other than PN or neuropathic and psychogenic pruritus.
- •Diagnosis of PN secondary to medications.
- •Active AD lesions (signs and symptoms other than dry skin) within 3 months prior to Screening visit.
- •Women who are pregnant (or are considering pregnancy) or breastfeeding.
- •Medical history including thrombocytopenia, coagulopathy or platelet dysfunction; venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases; Q-wave interval abnormalities; disseminated herpes zoster or dermatomal herpes zoster; disseminated herpes simplex; chronic/recurrent infections; malignancies.
- •Evidence of infection with TB, HBV, HCV or HIV.
- •History of failure to any topical or systemic JAK or TYK2 inhibitor as treatment of PN or any inflammatory disease.
- •Laboratory values outside of the protocol-defined ranges.
- •Other protocol-defined Inclusion/Exclusion Criteria apply.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo at the protocol-defined dose.
干预措施: Placebo (Drug)
Povorcitinib Dose 2
Experimental
Povorcitinib at the protocol-defined dose.
干预措施: Povorcitinib (Drug)
Povorcitinib Dose 1
Experimental
Povorcitinib at the protocol-defined dose.
干预措施: Povorcitinib (Drug)
结局指标
主要结局
Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at Week 24
时间窗: Week 24
Defined as proportion of participants achieving a ≥ 4-point improvement \[reduction\] in Itch NRS score from baseline (Itch NRS4) and an IGA CPG-S score of 0 or 1 with a ≥ 2-grade improvement from baseline (IGA-CPG-S-TS).
次要结局
- Change from baseline in Skin Pain NRS score at each postbaseline visit(Up to 52 weeks)
- Change from baseline in EQ-5D-5L score at each postbaseline visit(Up to 52 weeks)
- Time to Itch NRS4(Up to 52 weeks)
- Proportion of participants achieving Itch NRS4 at Week 24(Week 24)
- Proportion of participants achieving IGA-CPG-S-TS at Week 24(Week 24)
- Proportion of participants achieving Itch NRS4 at Week 4(Week 4)
- Change from baseline in Itch NRS score at each postbaseline visit(Up to 52 weeks)
- Proportion of participants achieving IGA-CPG-S-TS at each postbaseline visit(Up to 52 weeks)
- Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at each postbaseline visit(Up to 52 weeks)
- Change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit.(Up to 52 weeks)
- Percent change from baseline in the HADS score at each postbaseline visit(Up to 52 weeks)
- Percent change from baseline in EQ-5D-5L score at each postbaseline visit(Up to 52 weeks)
- Percent change in FACIT-F score at each postbaseline visit(Up to 52 weeks)
- Percent change from baseline in NRS score at each postbaseline visit(Up to 52 weeks)
- Proportion of participants achieving Itch NRS4 at each postbaseline visit(Up to 52 weeks)
- Proportion of participants achieving Investigator's Global Assessment - Chronic Prurigo Activity (IGA-CPG-A) at each postbaseline visit(Up to 52 weeks)
- Proportion of participants achieving ≥ 75% healed lesions in Prurigo Activity Score (PAS) at each postbaseline visit(Up to 52 weeks)
- Percent change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit.(Up to 52 weeks)
- Proportion of participants with at least a 4-point decrease in DLQI score from baseline at each postbaseline visit for participants with DLQI score ≥ 4 at baseline(Up to 52 weeks)
- Percent change from baseline in Skin Pain NRS score at each postbaseline visit(Up to 52 weeks)
- Change from baseline in the Hospital Anxiety and Depression Scale (HADS) score at each postbasline visit(Up to 52 weeks)
- Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score at each postbaseline visit(Up to 52 weeks)
- Proportion of participants with at least a ≥ 4-point increase in FACIT-F score at each postbaseline visit for participants with FACIT-F score ≤ 48 at baseline(Up to 52 weeks)
- Number of Participants with Treatment Emergent Adverse Events (TEAE)(Up to 52 weeks)
研究者
研究点 (227)
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