A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 132
- 试验地点
- 99
- 主要终点
- Mean change in modified Mayo Score (mMs) from Baseline to Week 12
研究概览
简要总结
ROSETTA STUDY: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe ulcerative colitis (UC)
详细描述
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of rosnilimab in subjects with moderate to severe ulcerative colitis (UC).
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
- •Male or female ≥18
- •Participants with a clinical diagnosis of UC for prior to Day 1
- •Subject has moderate to severe, active UC, defined as a mMS ≥ 5 with an endoscopy subscore ≥2
- •Subject has had a surveillance colonoscopy that did not detect potential dysplasia or colon cancer performed within 1 year of Day
- •Subject has a history of an inadequate response, loss of response, or intolerance to any combination of at least 2 UC therapy classes defined as, but not limited to, aminosalicylates, corticosteroids, immunomodulators, calcineurin inhibitors, or advanced UC therapies (e.g., biologics, JAK inhibitors, oral S1P receptor modulators, etc.)
排除标准
- •Subject has a diagnosis of Crohn's disease or indeterminate colitis.
- •Subject has a diagnosis of fulminant colitis and/or toxic megacolon.
- •Subject has a history of an inadequate response, loss of response, or intolerance to any combination of 3 or more advanced UC therapy classes but not limited to, 1) anti-TNF antibodies (e.g., adalimumab, golimumab, infliximab), 2) other biologics (e.g., ustekinumab, vedolizumab), 3) oral JAK inhibitors (e.g., tofacitinib, upadacitinib), and 4) oral S1P receptor modulators (e.g., ozanimod).
- •Subject has disease limited to the rectum (ulcerative proctitis)
- •Subject has a history of colectomy (total or subtotal), ileoanal pouch, Kock pouch, or ileostomy or is planning bowel surgery.
- •The subject had prior exposure to a PD-1 or PD-L1 agonist, antagonist, or modulator.
研究组 & 干预措施
Rosnilimab SC Dose 1
This arm will receive High dose Rosnilimab SC
干预措施: Rosnilimab (Drug)
Rosnilimab SC Dose 2
This arm will receive low dose Rosnilimab SC
干预措施: Rosnilimab (Drug)
Placebo
This arm will receive Placebo SC
干预措施: Placebo (Drug)
结局指标
主要结局
Mean change in modified Mayo Score (mMs) from Baseline to Week 12
时间窗: Baseline to Week 12
The mMS is an endoscopic and clinical scale, which ranges in scores from 0-9, with higher numbers indicating increased disease severity. It is used to assess UC disease activity. It consists of three subscores: RBS, SFS and an endoscopy subscore.
次要结局
- Proportion of subjects showing endoscopic treatment improvement at Week 12(Baseline to Week 12)
- Proportion of subjects achieving clinical remission at Week 12(Baseline to Week 12)
- Proportion of subjects achieving a clinical response at Week 12(Baseline to Week 12)