NCT05620823已完成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
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 608
- 试验地点
- 199
- 主要终点
- Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Povorcitinib (INCB054707) in participants with moderate to severe Hidradenitis Suppurativa (HS) over a 12-week placebo controlled period, followed by a 42-week extension period.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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
- •Willing and able to comply with the study protocol and procedures.
- •Further inclusion criteria apply.
排除标准
- •Presence of > 20 draining tunnels (fistulas) at either the screening or baseline visit.
- •Women who are pregnant (or who are considering pregnancy) or breastfeeding.
- •Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
- •Laboratory values outside of the protocol-defined ranges.
- •Further exclusion criteria apply.
研究组 & 干预措施
Povorcitinib Dose A
Experimental
Participants will receive Povorcitinib Dose A for 54 weeks.
干预措施: Povorcitinib (Drug)
Povorcitinib Dose B
Experimental
Participants will receive Povorcitinib Dose B for 54 weeks.
干预措施: Povorcitinib (Drug)
Placebo
Placebo Comparator
Participants will receive Placebo for 12 weeks, followed by Povorcitinib (Dose A or Dose B) for 42 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR)
时间窗: Week 12
HiSCR is defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.
次要结局
- Proportion of participants with flare(12 weeks)
- Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)(Week 12)
- Proportion of participants who achieve Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3.(Week 12)
- Mean change from baseline in inflammatory nodule count at each visit(54 weeks)
- Mean change from baseline in draining tunnel count at each visit.(54 weeks)
- Proportion of participants with a ≥ 3-point decrease in Skin Pain Numeric Rating Scale (NRS) score among participants with baseline Skin Pain NRS score ≥ 3.(Week 12)
- Proportion of participants with a ≥ 4-point increase from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT F) score(Week 12)
- Mean change from baseline in Dermatology Life Quality Index (DLQI) score at each visit(54 weeks)
- Mean change from baseline in abscess count at each visit.(54 weeks)
- Percentage change from baseline in abscess count at every visit(54 weeks)
- Percentage change from baseline in inflammatory nodule count at each visit.(54 weeks)
- Percentage change from baseline in draining tunnel count at each visit.(54 weeks)
- Extension Period: Proportion of participants who achieve HiSCR(Week 54)
- Extension Period: Proportion of participants who achieve HiSCR75(Week 54)
- Extension Period: Proportion of participants with flare(From Week 12 through Week 24)
- Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3(Week 24)
- Extension Period : Proportion of participants with flare(From Week 12 through Week 54)
- Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3.(Week 54)
- Extension Period:Proportion of participants who achieve maintenance of HiSCR or greater response at each visit(From Week 12 through Week 54)
- Extension Period : Proportion of participants who achieve maintenance of HiSCR75 or greater response at each visit(From Week 12 through Week 54)
- Extension Period: Proportion of participants who achieve HiSCR(Week 24)
- Extension Period: Proportion of participants who achieve HiSCR75(Week 24)
研究者
研究点 (199)
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