A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 418
- 试验地点
- 108
- 主要终点
- Hidradenitis Suppurativa Clinical Response 75
研究概览
简要总结
This is a study to evaluate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa. Participants will be randomized 2:1 to either sonelokimab or matching placebo up to Week 16.
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
- Double (Participant, Care Provider)
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
- •Participants must be at least 18 years of age at the time of signing the informed consent.
- •Participants who are diagnosed with hidradenitis suppurativa as determined by the investigator and have a history of signs and symptoms of hidradenitis suppurativa for at least 6 months before signing the informed consent.
- •Participants who have had an inadequate response to appropriate systemic antibiotics for treatment of hidradenitis suppurativa (or demonstrated intolerance to, or had a contraindication to, systemic antibiotics for treatment of their HS), in the investigator's opinion.
- •Participants who have a total AN count of ≥
- •Participants who have HS lesions present in ≥2 distinct anatomical areas, at least one of which must contain single or multiple fistulas (ie, be Hurley Stage II or III).
排除标准
- •Participants with a known hypersensitivity to sonelokimab or any of its excipients.
- •Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS.
- •Participants with underlying conditions that, in the opinion of the investigator, potentially places the participant at unacceptable risk.
- •Participants with current severe or uncontrolled disease(s) that put(s) the participant at increased risk in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
- •Participants with any other known autoimmune disease or any medical condition that in the opinion of the investigator would interfere with an accurate assessment of clinical symptoms of HS.
- •Participants with a gastrointestinal condition including inflammatory bowel disease or diagnosis of ulcerative colitis or Crohn's disease.
研究组 & 干预措施
sonelokimab
Subjects randomized to this arm will receive sonelokimab 120 mg Q2W from Weeks 0 to 6 then 120 mg Q4W starting at Week 8 up to Week 48.
干预措施: Sonelokimab (Drug)
Placebo
Subjects randomized to this arm will receive placebo Q2W from Weeks 0 to 6 then Q4W starting at Week 8 up to Week 16. They will receive sonelokimab 120 mg Q2W for 4 doses from Weeks 16 to 22 then Q4W from Week 24 up to Week 48
干预措施: Placebo (Drug)
结局指标
主要结局
Hidradenitis Suppurativa Clinical Response 75
时间窗: Week 16
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75), where HiSCR75 is defined as at least a 75% reduction from baseline in abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining fistula count.
次要结局
- Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)(Week 16)
- Change in International Hidradenitis Suppurativa Severity Score System(Week 16)
- Dermatology Life Quality Index (DLQI)(Week 16)
- Reduction from Numerical Rating Scale (NRS30 & NRS50) in Patient's Global Assessment of Skin Pain (PGA Skin Pain)(week 16)
- Patient Global Impression - Severity of Illness - Hidradenitis Suppurativa at Week 16(Week 16)
- Resolution of draining tunnels (DT100)(Week 16 and Week 52)