NCT07846683尚未招募3 期
A Phase III, Multicenter, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Subcutaneous Induction Therapy With Afimkibart in Patients With Moderately to Severely Active Ulcerative Colitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 350
- 主要终点
- Percentage of Participants With Clinical Remission
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of subcutaneous induction with afimkibart 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 modified Mayo Score (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.
- •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
Experimental
Participants will receive afimkibart administered as subcutaneous (SC) injection.
干预措施: Afimkibart (Drug)
Placebo
Placebo Comparator
Participants will receive placebo adminsitered as SC injection.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Clinical Remission
时间窗: At Week 12
次要结局
- Percentage of Participants With Clinical Remission(At Week 24)
- Change From Baseline in Stool Frequency Subscore (SFS)(From Baseline up to Week 12)
- Change From Baseline in Rectal Bleeding Subscore (RBS)(From Baseline up to Week 12)
- Percentage of Participants With Symptomatic Response(At Week 4)
- Percentage of Participants With Endoscopic Improvement(At Week 12 and Week 24)
- Percentage of Participants With Endoscopic Remission(At Week 12 and Week 24)
- Percentage of Participants With Clinical Response(At Week 12)
- Percentage of Participants With Histologic-Endoscopic Mucosal Improvement(At Week 12 and Week 24)
- Percentage of Participants With Maintenance of Remission(At Week 12 and Week 24)
- Percentage of Participants With Histologic Improvement(At Week 24)
- Change From Baseline in Bowel Urgency(From Baseline through Week 12 and Week 24)
- Change From Baseline in Abdominal Pain(From Baseline through Week 12 and Week 24)
- Change From Baseline in Fatigue(From Baseline through Week 12 and Week 24)
- Change From Baseline in Health-Related Quality of Life(From Baseline through Week 12 and Week 24)
- Change From Baseline in Overall UC Symptoms(Baseline, Week 2, Week 12 and Week 24)
- Change From Baseline in Overall Severity in UC Symptoms(Baseline, Week 2, Week 12 and Week 24)
- Incidence and Severity of Adverse Events (AEs)(From Baseline up to approximately 42 Weeks)
研究者
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