A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-concept Trial to Assess the Efficacy and Safety of SPY072 in Adults With Moderate to Severe Hidradenitis Suppurativa Receiving Standard of Care Treatment
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 12
- 主要终点
- Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
研究概览
简要总结
This Phase 2 study will test whether the investigational medicine, SPY072, improves hidradenitis suppurativa (HS) in adults with moderate to severe disease receiving advanced standard of care treatment. About 150 participants will be assigned by chance to receive either SPY072 or placebo for 16 weeks. Participants will be followed after the treatment period to evaluate safety and how long treatment effects may last.
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, proof-of-concept study of SPY072 in adults 18 to 75 years of age with moderate to severe HS who are receiving advanced standard of care treatment. After a screening period, approximately 150 eligible participants will be randomized to SPY072 or matching placebo through Week 16. After completion of treatment, participants will then enter a follow-up period.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Hidradenitis Suppurativa with symptoms for at least 6 months before screening.
- •Hidradenitis suppurativa lesions in at least 2 distinct anatomical areas, with at least 1 area meeting Hurley Stage II or III criteria at screening and Day
- •Total abscess and/or inflammatory nodule count of at least 5 at screening and Day
- •Documented inadequate response, intolerance, or contraindication to at least 1 systemic therapy for hidradenitis suppurativa.
排除标准
- •More than 20 draining tunnels at screening or Day
- •Hidradenitis suppurativa lesion expected to require incision and drainage within 4 weeks before Day 1, or major hidradenitis suppurativa surgery within 12 weeks before Day
- •Another inflammatory or skin condition that could interfere with assessment of hidradenitis suppurativa.
研究组 & 干预措施
SPY072 + bimekizumab
Participants receive SPY072 + bimekizumab
干预措施: SPY072 (Drug)
Placebo + bimekizumab
Participants receive matching placebo for SPY072 + bimekizumab
干预措施: Placebo (Drug)
SPY072 + bimekizumab
Participants receive SPY072 + bimekizumab
干预措施: bimekizumab (Drug)
Placebo + bimekizumab
Participants receive matching placebo for SPY072 + bimekizumab
干预措施: bimekizumab (Drug)
结局指标
主要结局
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
时间窗: Week 16
HiSCR75 is defined as at least a 75% reduction from baseline in total abscess and inflammatory nodule count, with no increase in abscess count and no increase in draining tunnel count
次要结局
- Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)(Week 16)
- Treatment-emergent Adverse Events (TEAEs)(Up to 52 weeks)