2022-501752-29-00招募中3 期
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa
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
- 388
- 试验地点
- 45
- 主要终点
- Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
研究概览
简要总结
To evaluate the efficacy and safety of povorcitinib for the treatment of hidradenitis suppurativa
研究设计
- 分配方式
- Randomized
- 主要目的
- Extension period (EXT)
- 盲法
- Double (Subject, Investigator)
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
- 是
入选标准
- •Ability to comprehend and willingness to sign a written ICF for the study.
- •Willing and able to comply with the study protocol and procedures.
- •Age ≥ 18 years at the time of signing the ICF.
- •Diagnosis of moderate to severe HS for at least 3 months prior to the screening visit.
- •Total abscess and inflammatory nodule count of at least 5 at both the screening and baseline visits
- •HS lesions in at least 2 distinct anatomical areas (examples include but are not limited to left and right axilla or left and right inguinocrural fold), 1 of which must be at least Hurley Stage II or Hurley Stage III, at both the screening and baseline visits.
- •Documented history of inadequate response to at least a 3-month course of at least 1 conventional systemic therapy (oral antibiotic or biologic drug) for HS (or demonstrated intolerance to, or have a contraindication to, a conventional systemic therapy for treatment of their HS)
- •Agreement to NOT use topical and systemic antibiotics for treatment of HS during the placebo-controlled period (unless the systemic antibiotic rescue criterion is met).
- •Agreement to NOT use a diluted bleach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the placebo-controlled period. Note: Over-the-counter soap and water is allowed.
- •Agreement to use contraception
排除标准
- •Presence of > 20 draining tunnels (fistulas) at either the screening or baseline visit.
- •Evidence of infection with Mycobacterium tuberculosis
- •Active HIV or acquired immunodeficiency syndrome. Active HIV is defined as confirmed positive anti-HIV antibody test
- •Evidence of HBV or HCV infection or risk of reactivation
- •Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib 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.
- •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.
- •Women who are pregnant (or who are considering pregnancy) or breastfeeding.
- •Concurrent conditions or history of other diseases (as per section 5.2 of the protocol)
- •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 Q wave interval (QT)/Fridericia-corrected Q wave interval (QTcF) abnormalities.
- •Have undergone significant trauma or major surgery (per investigator's assessment) within 30 days preceding the screening visit.
- •History of clinically significant (per investigator's judgment) drug or alcohol abuse within 6 months preceding the screening visit.
- •History of treatment failure with any systemic or topical JAK inhibitor for HS or any other inflammatory condition
- •Receipt of medical treatment or investigational drugs before the baseline visit within the intervals specified in section 5.2 of the protocol
- •At the screening visit, any of the laboratory abnormalities defined in the protocol Table 9
结局指标
主要结局
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
次要结局
- Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 12.
- Proportion of participants with flare by Week 12.
- Proportion of participants who achieve Skin Pain NRS30 at Week 12 among participants with baseline Skin Pain NRS score ≥ 3.
- Proportion of participants with a ≥ 3-point decrease in Skin Pain NRS score at Week 12 among participants with baseline Skin Pain NRS score ≥ 3.
- Proportion of participants with at least a 4-point increase from baseline in Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) score at Week 12.
- Mean change from baseline in Dermatology Life Quality Index (DLQI) score at each visit.
- Mean change from baseline in abscess count at each visit.
- Percentage change from baseline in abscess count at each visit.
- Mean change from baseline in inflammatory nodule count at each visit.
- Percentage change from baseline in inflammatory nodule count at each visit.
- Mean change from baseline in draining tunnel count at each visit.
- Percentage change from baseline in draining tunnel count at each visit.
- Proportion of participants who achieve HiSCR at Week 24.
- Proportion of participants who achieve HiSCR75 at Week 24.
- Proportion of participants with flare by Week 24.
- Proportion of participants who achieved Skin Pain NRS30 at Week 24 among participants with baseline Skin Pain NRS score ≥ 3.
- Proportion of participants who achieve HiSCR at Week 54.
- Proportion of participants who achieve HiSCR75 at Week 54.
- Proportion of participants with flare by Week 54.
- Proportion of participants who achieved Skin Pain NRS30 at Week 54 among participants with baseline Skin Pain NRS score ≥ 3.
- Proportion of participants who achieve maintenance of HiSCR or greater response at each visit during the EXT period.
- Proportion of participants who achieve maintenance of HiSCR75 or greater response at each visit during the EXT period.
研究者
Clinical Trial Information
Scientific
Incyte Corp.
研究点 (45)
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