NCT07298421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 Crohn's Disease
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 14
- 主要终点
- Percentage of Participants With Clinical Remission per Pediatric Crohn's Disease Activity Index (PCDAI)
研究概览
简要总结
This phase III, double-blind, multi-center treat-through study will evaluate the efficacy and safety of Afimkibart (also known as RO7790121) in children with moderately to severely active Crohn's Disease (CD).
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
- •Body weight >= 10 kilogram (kg)
- •Active CD confirmed by endoscopy (ileocolonoscopy)
- •Moderately to severely active CD, defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score >= 30, and Simple Endoscopic Score Crohn's Disease (SES-CD) >=6 (or >=4 for isolated ileal disease) confirmed through centrally-read ileocolonoscopy
- •Inadequate response, loss of response, and/or intolerance to at least one of the following conventional therapies (aminosalicylates, corticosteroids and/or immunosuppressants) or advanced therapies (including anti-tumor necrosis factor, anti-interleukin, anti-integrin, or Janus Kinase (JAK) inhibitors)
排除标准
- •Monogenic disorder pertaining to infant onset Inflammatory Bowel Disease (IBD)
- •History of >= 3 bowel resections: > 2 missing segments of the following five segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum
- •Current diagnosis of ulcerative colitis (UC), abdominal/intraabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease.
- •Symptomatic bowel strictures, fulminant colitis, or toxic megacolon
- •Presence of abdominal or perianal abscess
- •Current diagnosis or suspicion of primary sclerosing cholangitis
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 per Pediatric Crohn's Disease Activity Index (PCDAI)
时间窗: At Week 52
Percentage of Participants With Endoscopic Response
时间窗: At Week 52
次要结局
- Percentage of Participants With Clinical Remission(At Week 12 and Week 52)
- Percentage of Participants With Clinical Response(At Week 12 and Week 52)
- Percentage of Participants With CDAI Remission(At Week 12 and Week 52)
- Change From Baseline in Fecal Calprotectin(Baseline, Week 12 and Week 52)
- Change From Baseline in Mucosal Inflammation Noninvasive Index (MINI) Score(Baseline, Week 12 and Week 52)
- Percentage of Participants With Endoscopic Remission(At Week 52)
- Percentage of Participants With Corticosteroid-Free Clinical Remission(At Week 52)
- Percentage of Participants with Maintenance of Remission(At Week 12 and Week 52)
- Percentage of Participants With Histologic Improvement(At Week 52)
- Percentage of Participants With Ulcer-Free Endoscopy(At Week 52)
- Incidence and Severity of Adverse Events (AEs)(Up to Approximately 5.5 Years)
- Serum Concentration of Afimkibart(Up to Approximately 5.5 Years)
研究者
研究点 (14)
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