A phase III, multicenter, double-blind, placebo-controlled study to assess the efficacy and safety of induction 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
- 15
- 主要终点
- Evaluate the efficacy of RO7790121 compared with placebo in inducing remission
研究概览
简要总结
The goal of this study is to evaluate how well and how safely RO7790121 works in people with moderate to severe ulcerative colitis (UC). RO7790121 is a type of antibody that targets a protein called TL1A, which is important for immune responses in the gut. By blocking TL1A, this treatment aims to reduce inflammation and prevent tissue damage in UC. Over the past decade, many new treatments have become available for UC, including biologics and small molecule drugs. Despite these advancements, there is still a need for treatments that are more effective and have fewer side effects, to help manage inflammation and improve long-term outcomes for patients with UC
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 donating sperm, during the treatment period and for 95 days after the final dose with Active UC confirmed by biopsy and endoscopy.
- •Participants must have experienced intolerance, inadequate response or loss of response to at least one amongst Steroids, Immunomodulators, Aminosalicylates, Anti-TNF agents, Anti-integrins, Anti-IL12/IL23, JAK inhibitors, S1P receptor modulators.
- •Confirmed diagnosis of UC with supportive clinical, endoscopic, and histopathological evidence.
- •Active UC confirmed by endoscopy (flexible sigmoidoscopy or colonoscopy) extending more than 15cm from the anal verge.
- •Participants with proctitis only at baseline will be capped at 10% of the total enrollment.
排除标准
- •Severe UC (fulminant colitis, toxic megacolon, bowel perforation), Crohn’s disease, IBD unclassified, sclerosing cholangitis CMV Colitis, treatment for Clostridioides difficile, positive HIV, HbsAg, TB during screening, Apheresis. Any major surgery within 6 weeks prior to screening or a major surgery planned during the study. History of malignancy within 5 years prior to screening visit, Organ transplant, congenital immunodeficiency. Clinically significant abnormality on laboratory tests during screening.
- •Platelet count less than 100,000/µL; Hemoglobin less than 8 g/dL; Absolute lymphocyte count less than 500/µL. Use of approved UC treatment, or any IMP, or IV corticosteroid, use of NSAID.
结局指标
主要结局
Evaluate the efficacy of RO7790121 compared with placebo in inducing remission
时间窗: Clinical remission, defined as mMS less than or equal to 2 with SFS equal to 0 or 1, RBS equal to 0, and ES equal to 0 or 1, at Week 12
次要结局
- Evaluate the efficacy of RO7790121 compared with placebo in inducing and maintaining response.(Evaluate the efficacy of RO7790121 compared with placebo in TL1A biomarker-defined subpopulations of participants.)
研究者
Dr Mukesh Kalla
SR Kalla Memorial Gastro & General Hospital, Jaipur