CTRI/2024/01/061432进行中（未招募）2 期
A Phase 2b Multicenter, Randomized, Placebo- Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderately to Severely Active Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Clinical response is defined as decrease from baseline in the modified Mayo score by greater than or equal to 30 percent and greater than or equal to 2 points, with either a greater than or equal to 1 point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.
研究概览
简要总结
Ulcerative colitis (UC) is a chronic disease of the large intestine (colon) in which the lining of the colon becomes inflamed and develops tiny open sores (ulcers).The purpose of this study is to evaluate the safety and effectiveness of JNJ-77242113 compared with placebo in participants with moderately to severely active ulcerative colitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Signed informed consent form 18 years of age or older.
- •Documented diagnosis of ulcerative colitis of at least 12 weeks prior to screening.
- •Moderately to severely active UC as per the modified Mayo score.
- •Demonstrated inadequate response to or intolerance of conventional therapy and or or advanced therapy as defined in the protocol.
排除标准
- •Participants with current or prior diagnosis of fulminant colitis and or or toxic megacolon.
- •UC limited to rectum only or to less than 15 centimeters (cm) of colon.
- •Presence of a stoma.
- •Presence or history of fistula.
- •History of extensive colonic resection (example, less than 30 cm of colon remaining).
- •Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn’s colitis or clinical findings suggestive of Crohn’s disease.
结局指标
主要结局
Clinical response is defined as decrease from baseline in the modified Mayo score by greater than or equal to 30 percent and greater than or equal to 2 points, with either a greater than or equal to 1 point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.
时间窗: Week 12
次要结局
- Symptomatic remission is defined as stool frequency subscore of 0 or 1, where the stool frequency subscore has not increased from baseline, and a rectal bleeding subscore of 0.(Week 12)
- Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.(Week 12)
- Histologic-endoscopic mucosal improvement is defined as a combination of histologic remission and endoscopic improvement. Histologic remission and endoscopic improvement are based on the histologic grading and the Mayo endoscopy subscore.(Week 12)
- Clinical remission is defined as stool frequency subscore of 0 or 1, where the stool frequency subscore has not increased from baseline, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.(Week 12)
- An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical product. An AE does not necessarily have a causal relationship with the intervention. A SAE is any untoward medical occurrence that at any dose- results in death, is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important.(Up to Week 76)
研究者
Dr Sanish Davis
Janssen Pharmaceutical Companies of Johnson and Johnson Pvt Ltd.
研究点 (4)
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