A Phase III, multicenter, double-blind, placebo-controlled, treat-through study to assess the efficacy and safety of induction and maintenance 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
- - To evaluate efficacy of RO7790121 compared with placebo in inducing remission.
研究概览
简要总结
This study aims to see how well and how safely a drug called RO7790121 works for people with moderate to severe ulcerative colitis (UC). RO7790121 is a type of medicine made from human antibodies that targets a protein called TL1A. TL1A is important for controlling immune responses in the gut and is involved in the development of inflammatory bowel disease by interacting with another protein called death receptor 3. This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of RO7790121 compared with placebo in patients with moderately to severely active 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.
- •Moderately to severely active UC (mMS of 5-9), including an ES of ≥
- •Patients at risk of colon cancer must have had surveillance colonoscopy within two years prior to baseline; if not, they must be willing to have a colonoscopy at screening.
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
- To evaluate efficacy of RO7790121 compared with placebo in inducing remission.
时间窗: - Clinical remission defined as Mms less than equal to 2 with SFS equal to 0 or 1, RBS equal to 0, and ES equal to 0 or 1, at week 12. | - Clinical remission, as defined above, at Week 52.
- To evaluate the efficacy of RO7790121 compared with placebo in maintaining remission.
时间窗: - Clinical remission defined as Mms less than equal to 2 with SFS equal to 0 or 1, RBS equal to 0, and ES equal to 0 or 1, at week 12. | - Clinical remission, as defined above, at Week 52.
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