A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Ulcerative Colitis
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 试验地点
- 470
- 主要终点
- Percentage of Participants with Clinical Remission at Week 12
研究概览
简要总结
This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of UC
- •Moderately to severely active UC assessed by mMS
- •Bodyweight >= 40 kilogram (kg)
- •Up to date with colorectal cancer (CRC) screening performed according to local standards
- •Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy
- •Males and females of childbearing potential must meet protocol criteria for contraception requirements
排除标准
- •Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)
- •Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis
- •Presence of an ostomy or ileoanal pouch
- •Current diagnosis or suspicion of primary sclerosing cholangitis
- •Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- •Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed
- •History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer
- •Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
- •Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
- •Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy
研究组 & 干预措施
Afimkibart
Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.
干预措施: Afimkibart (Drug)
Placebo
Participants will receive placebo IV followed by placebo SC.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants with Clinical Remission at Week 12
时间窗: At Week 12
Percentage of participants achieving Modified Mayo Score (mMS) \<=2 with stool frequency subscore (SFS) = 0 or 1 (up to 1-2 stools more than normal), rectal bleeding subscore (RBS) = 0 (no blood seen) and endoscopic subscore (ES) = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. Each subscore is measured on a scale from 0 to 3, with higher values associated with greater severity.
Percentage of Participants with Clinical Remission at Week 52
时间窗: At Week 52
Percentage of participants achieving mMS \<= 2 with SFS = 0 or 1 (up to 1-2 stools more than normal), RBS = 0 (no blood seen) and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 52. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. Each subscore is measured on a scale from 0 to 3, with higher values associated with greater severity.
次要结局
- Change in Partial Modified Mayo Score (pmMS)(Baseline to Week 2)
- Percentage of Participants with Endoscopic Improvement(At Week 52)
- Percentage of Participants with Endoscopic Remission(At Week 52)
- Percentage of Participants with Clinical Response(At Week 12)
- Percentage of Participants with Histologic Improvement(At Week 52)
- Percentage of Participants with Histologic Remission(At Week 52)
- Percentage of Participants with Histologic-Endoscopic Mucosal Improvement(At Week 52)
- Percentage of Participants with Histologic-Endoscopic Remission(At Week 52)
- Percentage of Participants with Maintenance of Remission(Week 12 and Week 52)
- Percentage of Participants with Corticosteroid-Free Remission(At Week 52)
- Percentage of Participants with Clinical remission: Among Biomarker-Defined Subgroups of Participants(At Week 52)
- Percentage of Participants with Endoscopic Improvement: Among Biomarker-Defined Subgroups of Participants(At Week 52)
- Change in Bowel Urgency(Baseline through Week 52)
- Change in Abdominal Pain(Baseline through Week 52)
- Change in Fatigue(Baseline to Week 12 and Week 52)
- Change in Health-Related Quality of Life(Baseline to Week 12 and Week 52)
- Overall Change in UC Symptoms(Baseline to Week 2, Week 12, and Week 52)
- Overall Severity in UC Symptoms(Baseline to Week 2, Week 12, and Week 52)
- Incidence and Severity of Adverse Events (AEs)(Up to 70 Weeks after Baseline)
- Percentage of Participants with Endoscopic Improvement(At Week 12)
- Percentage of Participants with Endoscopic Remission(At Week 12)
- Percentage of Participants with Histologic Improvement(At Week 12)
- Percentage of Participants with Histologic Remission(At Week 12)
- Percentage of Participants with Histologic-Endoscopic Mucosal Improvement(At Week 12)
- Percentage of Participants with Histologic-Endoscopic Remission(At Week 12)
- Percentage of Participants with Clinical remission: Among Biomarker-Defined Subgroups of Participants(At Week 12)
- Percentage of Participants with Endoscopic Improvement: Among Biomarker-Defined Subgroups of Participants(At Week 12)