jRCT2061230029招募中不适用
[M23-698] A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AbbVie GK
- 入组人数
- 1,328
- 主要终点
- Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 12age old over 至 No limit（—）
- 性别
- All
入选标准
- •Minimum Age:12 Years
- •Diagnosis of HS for at least 6 months prior to Baseline, as determined by the investigator (i.e.through medical history and interview of subject).
- •Documented history of previous use of or higher 1 TNF inhibitor for HS for at least 12 weeks and/or 1 approved non-anti-TNF biologic therapy for HS for at least 16 weeks characterized by inadequate response or for any duration characterized by intolerance as determined by the investigator.
- •Participant must have a total AN count of or higher 5 at Baseline.
- •HS lesions must be present in at least 2 distinct anatomic areas at Baseline.
- •At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.
- •Draining fistula count of or lower 20 at Baseline.
排除标准
- •History of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit.
- •Treatment with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug or be currently enrolled in another interventional clinical study. Investigational drugs are also prohibited during the study.
- •Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 (e.g., rituximab) within 12 months prior to Baseline or until B cell count returns to normal level or pre-treatment level.
- •Use of prescription topical therapies (including topical antibiotics) that can also be used to treat HS within 14 days prior to the Baseline visit.
- •Received any systemic (including oral) antibiotic treatment for HS or any other chronic inflammatory disorder within 14 days prior to the Baseline visit.
结局指标
主要结局
Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 50
时间窗: Baseline to Week 16
HiSCR 50 is defined as at least a 50% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline.
次要结局
- Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 75(Baseline to Week 16)
- Percentage of Participants Achieving Numeric Rating Scale 30 (NRS30) at Week 4 Among Subjects with NRS or higher 3 at Baseline(Baseline to Week 4)
- Incidence of Hidradenitis Suppurativa (HS) Flare During Period 1(Week 16)
- Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA)(Baseline to Week 16)
- Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA)(Baseline to Week 16)
- Change from Baseline in Dermatology Life Quality Index (DLQI) for Adult Subjects and Adolescent Subjects Age 17 Years Old or Children's DLQI (CDLQI) for Adolescent Subjects Ages 12 to 16 Years Old(Baseline to Week 16)
- Change from Baseline in Hidradenitis Suppurativa (HS)-Related Odor, Based on Hidradenitis Suppurativa Symptom Assessment (HSSA) Question 8(Baseline to Week 16)
研究者
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