CTRI/2024/02/062456已完成2 期
A randomised, double blind, parallel, interventional phase IIa proof of concept trial to evaluate the efficacy and safety of ZYIL1 for the treatment of patients with mild to moderately active Ulcerative Colitis resistant or intolerant to oral aminosalicylates
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 10
- 主要终点
- To assess the efficacy of ZYIL1 for
研究概览
简要总结
ZYIL1 capsules 25 mg / 50 mg for oral administration twice daily for 12 weeks for active ulcerative colitis for patients not responding to mesalamine. It is a proof of concept study to evaluate efficacy of ZYIL1
with 25 and 50 mg dose to select most efficacious and safe dose.
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
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female patients aged 18 to 75 years, both inclusive.
- •Have had ulcerative colitis (UC) diagnosed at least 3 months prior to screening.
- •The diagnosis of UC must be confirmed by endoscopic and histologic evidence.
- •Mild to Moderate active disease defined as total score of at least 4 on the mMS, endoscopy subscore of at least 2 and a rectal bleeding sub-score of at least
- •Demonstrated an inadequate response to, loss of response to, or intolerance to any of the Oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine, balsalazide) â—‹ Signs and symptoms of persistently active disease, in the opinion of the investigator, during a current or prior course of at least 4 weeks of treatment with 2.4 g/day mesalamine, 4 g/day sulfasalazine, 1 g/day olsalazine, or 6.75 g/day balsalazide.
- •Men and women of childbearing potential must agree to use adequate birth control measures during the study.
- •All patients aged 45 years or over must have had a colonoscopy to screen for adenomatous polyps within 5 years of screening or must have had a colonoscopy at screening to assess for polyps.
排除标准
- •Diagnosis of Crohn’s disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn’s disease.
- •Have positive stool culture for pathogens (O+P, bacteria) or positive test for C.
- •difficile at screening.
- •difficile is positive, the patient may be treated and retested.
- •Patients who have an evidence of pathogenic bowel infection.
- •History of recurrent or chronic infection (e.g., hepatitis B or C, syphilis, TB).
结局指标
主要结局
To assess the efficacy of ZYIL1 for
时间窗: Baseline to Week 6
induction of clinical remission in participants with mild to
时间窗: Baseline to Week 6
moderate active UC.
时间窗: Baseline to Week 6
次要结局
- To assess the overall safety and(tolerability of ZYIL1)
研究者
Dr Kevinkumar Kansagra
Zydus Research Centre
研究点 (10)
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