A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Risankizumab in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 243
- 试验地点
- 59
- 主要终点
- Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
研究概览
简要总结
The primary objective of this study is to assess the safety and efficacy of risankizumab 180 mg and 360 mg versus placebo for the treatment of signs and symptoms of moderate to severe hidradenitis suppurativa (HS) in adult participants diagnosed for at least one year before the Baseline visit.
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
- •Participant with moderate to severe HS for at least 1 year prior to baseline visit.
- •HS lesions present in at least two distinct anatomical areas.
- •Draining fistula count of ≤ 20 at Baseline visit.
- •Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline visit.
- •Participants are required to use a daily antiseptic wash on their HS lesions.
- •Participant must have a history of inadequate response or intolerance to an adequate trial of oral antibiotics for treatment of HS.
排除标准
- •Participant has a history of active skin disease other than HS that could interfere with the assessment of HS.
- •Participant has active tuberculosis (TB) or concurrent treatment for latent TB or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection.
- •Participant has prior exposure to anti-interleukin-1 (anti-IL-1) treatment within 3 months or 5 half-lives, whichever is longer, prior to baseline.
- •Participant has received prescription topical therapies (including topical antibiotics) within 14 days prior to the Baseline visit.
- •Participant has received systemic non-biologic therapies that can also be used to treat HS within 4 weeks prior to the Baseline visit.
- •Participant has received any systemic (including oral) antibiotic treatment within 4 weeks prior to the Baseline visit.
研究组 & 干预措施
Risankizumab 180 mg
In Period A, participants receive blinded risankizumab 180 mg via a subcutaneous (SC) injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
干预措施: Risankizumab (Drug)
Risankizumab 360 mg
In Period A, participants receive blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
干预措施: Risankizumab (Drug)
Placebo
In Period A, participants receive blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
干预措施: Placebo for risankizumab (Drug)
Risankizumab 180 mg / Risankizumab 360 mg
In Period A, participants receive blinded risankizumab 180 mg via a subcutaneous (SC) injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period B, participants receive blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg every 8 weeks (q8w) at Weeks 20, 28, 36, 44, 52, and 60.
干预措施: Risankizumab (Drug)
Risankizumab 180 mg / Risankizumab 360 mg
In Period A, participants receive blinded risankizumab 180 mg via a subcutaneous (SC) injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period B, participants receive blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg every 8 weeks (q8w) at Weeks 20, 28, 36, 44, 52, and 60.
干预措施: Placebo for risankizumab (Drug)
Risankizumab 360 mg / Risankizumab 360 mg
In Period A, participants receive blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period B, participants receive blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.
干预措施: Risankizumab (Drug)
Risankizumab 360 mg / Risankizumab 360 mg
In Period A, participants receive blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period B, participants receive blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.
干预措施: Placebo for risankizumab (Drug)
Placebo / Risankizumab 360 mg
In Period A, participants receive blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period B, participants receive blinded risankizumab 360 mg at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.
干预措施: Risankizumab (Drug)
Placebo / Risankizumab 360 mg
In Period A, participants receive blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period B, participants receive blinded risankizumab 360 mg at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.
干预措施: Placebo for risankizumab (Drug)
结局指标
主要结局
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
时间窗: Baseline (Week 0), Week 16
HiSCR is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase in abscess or draining fistula counts.
次要结局
- Change From Baseline in HS-Related Worst Drainage Based on the HSSA Worst Drainage Score at Week 16(Baseline (Week 0) to Week 16)
- Change From Baseline in HS-Related Odor Based on the HSSA Bad Smell Score at Week 16(Baseline (Week 0) to Week 16)
- Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16(Baseline (Week 0) to Week 16)
- Change From Baseline in HS-Related Swelling Based on the Hidradenitis Suppurativa Symptom Assessment (HSSA) Swollen Skin Score at Week 16(Baseline (Week 0) to Week 16)
- Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in Patient's Global Assessment (PGA) of Skin Pain Numerical Rating Scale (NRS30) at Week 8 Among Participants With Baseline Numerical Rating Scale (NRS) ≥ 3(Baseline (Week 0) to Week 8)
- Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in PGA of Skin Pain Numerical Rating Scale (NRS30) at Week 16 Among Participants With Baseline Numerical Rating Scale (NRS) ≥ 3(Baseline (Week 0) to Week 16)
- Percentage of Participants Who Experienced ≥ 25% Increase in Abscess and Inflammatory Nodule (AN) Counts in Period A With a Minimum Increase of 2 Relative to Baseline(Baseline (Week 0) to Week 16)