A phase III, multicenter, double-blind, placebo-controlled, treat-through study to assess the efficacy and safetyof induction and maintenance therapy with RO7790121 in patients with moderately to severely active Crohnsdisease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 13
- 主要终点
- To evaluate the efficacy of afimkibart compared with placebo in maintaining response
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of RO7790121 referred to herein as afimkibart, in patients with moderately to severely active Crohn’s disease (CD). Afimkibart is a fully human neutralizing immunoglobulin G1 (IgG1) monoclonal antibody (mAb) against tumor necrosis factor-like ligand 1A (TL1A). TL1A plays a central role in the regulation of gut mucosal immunity and participates in immunological and fibrosis pathways involved in inflammatory bowel disease pathogenesis by binding its receptor, death receptor 3. Therapeutic options have expanded substantially over the past decade, with biologics and small molecule treatments now available in addition to conventional therapies. However, a high unmet medical need remains for treatments with better benefit risk profiles that attenuate inflammation and clinical sequelae and provide sustained control to improve the long-term prognosis of patients with CD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Males and females of childbearing potential who are abstinent or use contraception, and refrain from sperm or egg donation, during the treatment period and for 95 days after the final dose of drug.
- •Confirmed diagnosis of CD with supportive clinical, endoscopic, and histopathological evidence.
- •Moderate to severely Active CD with more than equal to 220 and less than equal to 450; SES-CD of more than equal to 6 confirmed through a centrally read endoscopy.
- •Involvement of ileum and/or colon, with at least 4 colonic segments traversable by an endoscope or a pediatric endoscope, or 3 segments for patients who have undergone a bowel resection among the following segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
- •Any adenomatous polyps must be completely removed according to routine practice prior to their first dose of study drug.
排除标准
- •Participant with a history of more than equal to 3 bowel resections.
- •2 missing segments of the following five segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
- •Diagnosis of short gut or short bowel syndrome.
- •Presence of ileostomy, colostomy, or ileo-anal pouch.
- •Patients with symptomatic bowel strictures, fulminant colitis, or toxic megacolon.
- •Current diagnosis of UC or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, or microscopic colitis.
- •Presence of abdominal or perianal abscess.
- •Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas, or perianal fistulas with more than 3 openings and/or the anticipated need for surgery during the study (except surgery for seton placement and/or removal).
- •Current diagnosis or suspicion of primary sclerosing cholangitis.
结局指标
主要结局
To evaluate the efficacy of afimkibart compared with placebo in maintaining response
时间窗: Clinical remission less than 150, at Week 52 | Endoscopic response more than equal to 50percent at Week 52
次要结局
- To evaluate the efficacy of afimkibart compared with placebo in inducing response(Clinical remission and Endoscopic response at Week 12.)
- To evaluate the efficacy of afimkibart compared with placebo in maintaining response(Endoscopic remission and Symptomatic remission at Week 52.)
研究者
Dr Mukesh Kalla
SR Kalla Memorial Gastro & General Hospital, Jaipur