NCT07158242招募中3 期
A Phase III Randomized Double-Blind Multi-Center Treat-Through Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Children Aged 2 - 17 Years With Moderately to Severely Active Ulcerative Colitis
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 22
- 主要终点
- Percentage of Participants with Clinical Remission at Week 12
研究概览
简要总结
This Phase III, randomized, double-blind, multicenter, induction and maintenance study will evaluate the safety and efficacy of Afimkibart (RO7790121) in pediatric participants with moderate to severe 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
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bodyweight >= 10 kilogram (kg)
- •Confirmed diagnosis of UC
- •Moderately to severely active UC, defined as modified Mayo Score (mMS) or 5 to 9 points, including endoscopic score of 2 or 3, confirmed by centrally read endoscopy (flexible sigmoidoscopy or colonoscopy)
- •Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs: systemic corticosteroids, immunomodulators, and/or biologic therapies as outlined in the protocol
排除标准
- •Monogenic disorder pertaining to infant onset inflammatory bowel disease (IBD)
- •Current diagnosis of Crohn's disease (CD), abdominal/intrabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease
- •Presence of an ostomy or ileoanal pouch
- •Current diagnosis or suspicion of primary sclerosing cholangitis
- •Any major surgery within 6 weeks prior to screening or a major planned surgery during the study
- •Active tuberculosis (TB) infection suggested by positive TB testing, clinical symptoms, and/or chest imaging (X-ray or CT)
研究组 & 干预措施
Afimkibart Dose A
Experimental
Participants will receive Afimkibart intravenously (IV) followed by Afimkibart subcutaneous (SC) injection.
干预措施: Afimkibart (Drug)
Afimkibart Dose B
Experimental
Participants will receive Afimkibart IV followed by Afimkibart SC.
干预措施: Afimkibart (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 with Clinical Remission at Week 52
时间窗: At Week 52
Percentage of Participants With Clinical Remission at Week 52
时间窗: At Week 52
次要结局
- Percentage of Participants with PUCAI Remission(At Week 12)
- Change from Baseline in Tummy Ulcerative Colitis (TUMMY-UC) Scores(From Baseline to Week 12)
- Change from Baseline in Pediatric Ulcerative Colitis Activity Index (PUCAI) Response(From Baseline, at Week 12)
- Percentage of Participants with Endoscopic Improvement(At Week 52)
- Percentage of Participants with Histologic Improvement(At Week 52)
- Percentage of Participants with Histologic-endoscopic Mucosal Improvement(At Week 52)
- Percentage of Participants with Histologic-endoscopic Mucosal Remission(At Week 52)
- Change from Baseline in PUCAI Response at Week 52(From Baseline, at Week 52)
- Percentage of Participants with PUCAI Remission at Week 52(At Week 52)
- Change from Baseline in TUMMY-UC Scores(From Baseline to Week 52)
- Percentage of Participants with Clinical Remission without the use of Corticosteriods(At Week 52)
- Percetage of Participants with Adverse Events (AEs)(From Baseline up to approximately 4 years)
- Serum Concentartion of Afimkibart(Up to approximately 4 years)
- Change From Baseline in Pediatric Ulcerative Colitis Activity Index (PUCAI) Response(From Baseline, at Week 12)
- Percentage of Participants With PUCAI Remission(At Week 12)
- Change From Baseline in Tummy Ulcerative Colitis (TUMMY-UC) Scores(From Baseline to Week 12)
- Partial Modified Mayo Score (pmMS)(At Week 12)
- Percentage of Participants With Symptomatic Response(At Week 12)
- Percentage of Participants With Symptomatic Remission(At Week 12)
- Change From Baseline in PUCAI Response at Week 52(From Baseline, at Week 52)
- Percentage of Participants With PUCAI Remission at Week 52(At Week 52)
- Change From Baseline in TUMMY-UC Scores(From Baseline to Week 52)
- Percentage of Participants With Endoscopic Remission(At Week 52)
- Percentage of Participants With Endoscopic Improvement(At Week 52)
- Percentage of Participants With Histologic Improvement(At Week 52)
- Percentage of Participants With Histologic-endoscopic Mucosal Improvement(At Week 52)
- Percentage of Participants With Histologic-endoscopic Mucosal Remission(At Week 52)
- Percentage of Participants With Clinical Remission Without the use of Corticosteroids(At Week 52)
- Percentage of Participants With Adverse Events (AEs)(From Baseline up to approximately 4 years)
- Serum Concentration of Afimkibart(Up to approximately 4 years)
- Percentage of Participants with Endoscopic Improvement(At Week 12)
- Percentage of Participants with Histologic Improvement(At Week 12)
- Percentage of Participants with Histologic-endoscopic Mucosal Improvement(At Week 12)
- Percentage of Participants with Histologic-endoscopic Mucosal Remission(At Week 12)
研究者
研究点 (22)
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