Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 645
- 试验地点
- 353
- 主要终点
- Part A: Change in Robarts Histopathology Index (RHI)
研究概览
简要总结
This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.
详细描述
This platform study will evaluate the efficacy and safety of investigational treatments, including 3 monotherapies and 3 combination therapies, for moderately to severely active UC in adults. The study will progress in two parts.
Part A is the open-label portion of the study assessing safety and preliminary efficacy of monotherapies. Part A enrollment completed April 2026.
Part B, which will be open for enrollment after Part A, is the randomized, placebo-controlled portion of the study assessing the safety and efficacy of the 6 interventions (3 monotherapies and 3 combinations) compared to placebo. Part B enrollment commenced April 2026.
Intervention arms will be added to the study over time and may complete at different times.
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
- •Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening
- •Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis)
- •Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2
排除标准
- •Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined
- •Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and/or other conditions that will likely require surgery during induction
- •Failed 4 or more approved or investigational advanced therapy classes
研究组 & 干预措施
Intervention Specific Appendix - SPY120: Part B
Participants will receive double-blind dose of SPY001 and SPY002
干预措施: SPY002 (Drug)
Intervention Specific Appendix - SPY003: Part A
Participants will receive open-label dose of SPY003
干预措施: SPY003 (Drug)
Intervention Specific Appendix - SPY002 Dosing Regimen 1: Part B
Participants will receive double-blind dosing regimen 1 of SPY002
干预措施: SPY002 (Drug)
Intervention Specific Appendix - SPY230: Part B
Participants will receive double-blind dose of SPY002 and SPY003
干预措施: SPY003 (Drug)
Intervention Specific Appendix - SPY230: Part B
Participants will receive double-blind dose of SPY002 and SPY003
干预措施: SPY002 (Drug)
Placebo: Part B
Participants will receive matching placebo
干预措施: Placebo (Other)
Intervention Specific Appendix - SPY001: Part A
Participants will receive open-label dose of SPY001
干预措施: SPY001 (Drug)
Intervention Specific Appendix - SPY002: Part A
Participants will receive open-label dose of SPY002
干预措施: SPY002 (Drug)
Intervention Specific Appendix - SPY001 Dosing Regimen 2: Part B
Participants will receive double-blind dosing regimen 2 of SPY001
干预措施: SPY001 (Drug)
Intervention Specific Appendix - SPY120: Part B
Participants will receive double-blind dose of SPY001 and SPY002
干预措施: SPY001 (Drug)
Intervention Specific Appendix - SPY130: Part B
Participants will receive double-blind dose of SPY001 and SPY003
干预措施: SPY001 (Drug)
Intervention Specific Appendix - SPY001 Dosing Regimen 1: Part B
Participants will receive double-blind dosing regimen 1 of SPY001
干预措施: SPY001 (Drug)
Intervention Specific Appendix - SPY002 Dosing Regimen 2: Part B
Participants will receive double-blind dosing regimen 2 of SPY002
干预措施: SPY002 (Drug)
Intervention Specific Appendix - SPY003 Dosing Regimen 2: Part B
Participants will receive double-blind dosing regimen 2 of SPY003
干预措施: SPY003 (Drug)
Intervention Specific Appendix - SPY130: Part B
Participants will receive double-blind dose of SPY001 and SPY003
干预措施: SPY003 (Drug)
Intervention Specific Appendix - SPY003 Dosing Regimen 1: Part B
Participants will receive double-blind dosing regimen 1 of SPY003
干预措施: SPY003 (Drug)
结局指标
主要结局
Part A: Change in Robarts Histopathology Index (RHI)
时间窗: Week 12
Change in Robarts Histopathology Index (RHI) from baseline at Week 12 will be assessed. The RHI is used to quantify and assess histological activity of UC, comprising of scores for inflammatory infiltrates, neutrophils, erosions or ulceration. Scores are assigned to each of these features, with a total ranging from 0 (no disease activity) to 33 (most severe disease activity). Higher score indicates more severe disease.
Part B: Percentage of participants with clinical remission
时间窗: Week 12
Percentage of participants with clinical remission at Week 12 will be assessed. Clinical remission is based on the modified Mayo subscores, which consist of a rectal bleeding subscore (ranging from 0 to 3), stool frequency subscore (ranging from 0 to 3), and endoscopic subscore (ranging from 0 to 3), as assessed by central reading. Higher scores indicate more severe disease.
次要结局
- Part A: Percentage of participants with clinical remission(Week 12)
- Part A: Percentage of participants with endoscopic improvement(Week 12)
- Part B: Percentage of participants with endoscopic improvement(Week 12)
- Part B: Percentage of participants with clinical response(Week 12)
- Part B: Percentage of participants with histologic improvement(Week 12)
- Part B: Percentage of participants achieving histologic endoscopic mucosal improvement (HEMI).(Week 12)
- Part B: Percentage of participants with clinical remission(Week 48)