2024-511879-16-00招募中3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Incyte Corp.
- 入组人数
- 162
- 试验地点
- 54
- 主要终点
- Proportion of participants achieving Itch NRS4 (≥ 4-point improvement [reduction] in Itch NRS score from baseline) and IGA-CPG-S-TS (IGA CPG-S score of 0 or 1 with a ≥ 2-grade improvement from baseline) at Week 24
研究概览
简要总结
To evaluate the effect of povorcitinib on itch and skin lesions in participants with PN
研究设计
- 分配方式
- Randomized
- 主要目的
- Extension treatment period
- 盲法
- Double (Subject, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Ability to comprehend and willingness to sign a written ICF for the study.
- •18 to 75 years of age. Note: For South Korea, 19 years of age or older.
- •Clinical diagnosis of PN for at least 3 months before screening.
- •Pruritus, defined as an average Itch NRS score ≥ 7 during the 7 days prior to Day
- •≥ 20 pruriginous lesions in total on ≥ 2 different body regions (both legs, and/or both arms, and/or trunk) at screening and Day
- •IGA-CPG-S score ≥ 3 at screening and Day
- •Documented history of treatment failure, demonstrated intolerance, or contraindication to a previous PN treatment (eg, TCS or TCI) with the exception of treatment failure with prior topical or systemic JAK or TYK2 inhibitors (see Exclusion Criterion 10).
- •Willingness to avoid pregnancy or fathering children based on the criteria detailed in section 5.
- •of the protocol (under inclusion criteria 8).
- •Willing and able to comply with the study protocol and procedures.
排除标准
- •Chronic pruritus due to a condition other than PN.
- •Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib (refer to the IB) and/or other products in the same class.
- •Any condition, laboratory result, or result of screening assessments that would, in the investigator's and sponsor's (or designee's) judgment, interfere with full participation in the study, including administration of study drug and attending required study visits, pose a significant risk to the participant, or interfere with interpretation of study data.
- •Neuropathic and psychogenic pruritus.
- •The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code, not affiliated to a social security per article L.1121-8-1 of the French Public Health Code.
- •Diagnosis of PN secondary to medications.
- •Active AD lesions within 3 months of screening.
- •Pregnant (or are considering pregnancy) or breastfeeding.
- •Concurrent conditions or history of other diseases detailed in section 5.
- •of the protocol (under exclusion criteria 6).
- •A screening 12-lead ECG that demonstrates clinically significant abnormalities requiring treatment (eg, acute myocardial infarction, serious tachyarrhythmias or bradyarrhythmias) or that is indicative of serious underlying heart disease (eg, cardiomyopathy, major congenital heart disease, low voltage in all leads, Wolff Parkinson-White syndrome) or criteria associated with QT/QTcF abnormalities.
- •Significant trauma or major surgery (per investigator's assessment) within 30 days prior to screening.
- •History of treatment failure for PN or any other inflammatory condition.
- •Planned or expected major surgery during the initial 24 weeks of treatment with study drug (ie, during the PC period of the study).
- •Receipt of medical treatment or investigational drugs within intervals specified in section 5.2 of the protocol (under exclusion criteria 13)
- •History of clinically significant (per investigator's judgment) drug or alcohol abuse within 6 months prior to screening.
- •Initiation or changing the dose of any of the treatments listed in section 5.
- •of the protocol (under exclusion criteria 12) within 3 months of Day 1 or expected dose change of any of the following treatments during the initial 24 weeks of treatment with study drug (ie, during the PC period).
- •Concurrent enrollment in another clinical study.
- •At the screening visit, any of the laboratory abnormalities defined in Table 6 of the protocol.
- •Evidence of infection with Mycobacterium tuberculosis (ie, TB) as defined in Section 8.3.5.
- •Active HIV or acquired immunodeficiency syndrome. Active HIV is defined as a confirmed positive anti-HIV antibody test (see Section 8.3.5.3).
- •Evidence of HBV or HCV infection or risk of reactivation (see Section 8.3.5.4).
结局指标
主要结局
Proportion of participants achieving Itch NRS4 (≥ 4-point improvement [reduction] in Itch NRS score from baseline) and IGA-CPG-S-TS (IGA CPG-S score of 0 or 1 with a ≥ 2-grade improvement from baseline) at Week 24
Proportion of participants achieving Itch NRS4 (≥ 4-point improvement [reduction] in Itch NRS score from baseline) and IGA-CPG-S-TS (IGA CPG-S score of 0 or 1 with a ≥ 2-grade improvement from baseline) at Week 24
次要结局
- Proportion of participants achieving Itch NRS4 at Week 24
- Proportion of participants achieving IGA CPG S-TS at Week 24
- Proportion of participants achieving Itch NRS4 at Week 4
研究者
Clinical Trial Information
Scientific
Incyte Corp.
研究点 (54)
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