NCT07213973招募中2 期
A Phase 2, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Povorcitinib in Adolescents With Moderate to Severe Hidradenitis Suppurativa
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 51
- 主要终点
- Apparent clearance
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics, safety, and efficacy of povorcitinib in adolescent participants with moderate to severe hidradenitis suppurativa over a 54-week open-label treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 12 to < 18 years at the time of informed consent/assent signing.
- •Body weight ≥ 30 kg at both screening and baseline visits.
- •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 corresponding to refined Hurley Stage IB, IC, IIB, IIC, or 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 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 B
Experimental
Participants will receive povorcitinib dose B for 54 weeks.
干预措施: Povorcitinib (Drug)
Povorcitinib Dose A
Experimental
Participants will receive povorcitinib dose A for 54 weeks.
干预措施: Povorcitinib (Drug)
结局指标
主要结局
Apparent clearance
时间窗: Up to Week 24
Absorption lag time
时间窗: Up to Week 24
Proportion of participants with Treatment-Emergent Adverse Events (TEAEs)
时间窗: Baseline through Week 54
TEAE is defined as any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug up to 30 days after the last dose of study drug.
Apparent volume of distribution
时间窗: Up to Week 24
Apparent oral absorption rate constant
时间窗: Up to Week 24
Maximum plasma drug concentration at steady state
时间窗: Up to Week 24
Average plasma drug concentration at steady state
时间窗: Up to Week 24
Plasma concentration at steady state for the dosing interval
时间窗: Up to Week 24
Time to maximum plasma concentration at steady state
时间窗: Up to Week 24
Terminal half-life
时间窗: Up to Week 24
次要结局
- Mean change from baseline in inflammatory nodule count at each visit(54 weeks)
- Mean percentage 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)
- Mean percentage change from baseline in draining tunnel count at each visit(54 weeks)
- Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)30 among participants with baseline Skin Pain NRS score ≥ 3(54 weeks)
- Change from baseline in Children's Dermatology Life Quality Index (CDLQI) score at each visit(54 weeks)
- Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)(54 weeks)
- Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)(54 weeks)
- Mean change from baseline in abscess count at each visit(54 weeks)
- Mean percentage change from baseline in abscess count at each visit(54 weeks)
- Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)(54 weeks)
- Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)(54 weeks)
- Mean change from baseline in abscess count at each visit(54 weeks)
- Mean percentage change from baseline in abscess count at each visit(54 weeks)
- Mean change from baseline in inflammatory nodule count at each visit(54 weeks)
- Mean percentage 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)
- Mean percentage change from baseline in draining tunnel count at each visit(54 weeks)
- Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)30 among participants with baseline Skin Pain NRS score ≥ 3(54 weeks)
- Proportion of participants with a ≥ 3-point decrease in Skin Pain NRS score among participants with baseline Skin Pain NRS score ≥ 3(54 weeks)
- Change from baseline in Children's Dermatology Life Quality Index (CDLQI) score at each visit(54 weeks)
研究者
研究点 (51)
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