A Phase 3 Multicenter, Open-label, Single Arm Study of the Safety and Efficacy of Adalimumab in Japanese Subjects With Moderate to Severe Hidradenitis Suppurativa
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 8
- 主要终点
- Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
研究概览
简要总结
This study investigates efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with moderate to severe hidradenitis suppurativa (HS).
详细描述
Prior to initiation of this study, global Phase 2b study and pivotal Phase III studies were completed in the Western countries and market authorization of adalimumab was approved in United States (US) and European Union (EU) for the treatment of subjects with HS. The differences between this study and global studies include sample size, study design, duration, and race.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must have a diagnosis of HS;
- •Participant must have any HS symptom at least 6 months prior to Baseline;
- •HS lesions must be present in at least 2 distinct anatomic areas, one of which must be Hurley Stage II or Hurley Stage III;
- •Participant must have stable HS for at least 2 months (60 days) prior to Screening and also at the Baseline visit;
- •Participant must have a total abscess and inflammatory nodule (AN) count of greater than or equal to 3 at the Baseline visit.
排除标准
- •Prior treatment with adalimumab or other anti-tumor necrosis factor (TNF) therapy or participation in adalimumab trial;
- •Any other active skin lesion or condition that may interfere with assessment of HS;
- •Participants received antibiotic treatment for HS within 28 days prior to the Baseline visit other than those allowed per protocol. Participant on permitted oral antibiotic treatment (doxycycline or minocycline only) for HS who have not been on a stable dose for at least 28 days prior to the Baseline visit;
- •Participants received prescription topical therapies for the treatment for HS within 14 days prior to the Baseline visit;
- •Participants received systemic non-biologic therapies with potential therapeutic impact for HS less than 28 days prior to the Baseline visit;
- •Participants received oral concomitant analgesics (non-opioids and opioids) for HS-related pain within 14 days prior to the Baseline visit.
研究组 & 干预措施
Adalimumab
Open-label adalimumab 160 mg subcutaneous injection at Week 0 (Baseline), 80 mg at Week 2, and 40 mg every week starting at Week 4. After Week 52, Participants who consent to receive the 80 mg eow dose, will switch from 40 mg ew to 80 mg eow at Week 0x (80 mg eow period until the end of the study).
干预措施: adalimumab (Drug)
结局指标
主要结局
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
时间窗: Week 12
HiSCR 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 AN Count of 0, 1, or 2 at Week 12(Week 12)
- Percentage of Participants Achieving at Least 30% Reduction and at Least 1 Unit Reduction From Baseline in Patient's Global Assessment of Skin Pain (NRS30) - At Worst at Week 2 Among Participants With Baseline Numeric Rating Scale (NRS) >=3(Week 0 (Baseline), Week 2)
- Change From Baseline to Week 12 in Modified Sartorius Scale Score(Baseline (last non-missing value on or before the date of first dose of study drug), Week 2, Week 4, Week 8, Week 12)