CTRI/2024/02/062456招募中2 期
A randomised, double blind, parallel, interventionalphase IIa proof of concept trial to evaluate the efficacyand safety of ZYIL1 for the treatment of patients withmild to moderately active Ulcerative Colitis resistant orintolerant to oral aminosalicylates - NI
试验速览
- 阶段
- 2 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1) Male and female patients aged 18 to 75 years, both inclusive.
- •2) 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.
- •3) 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 1.
- •4) Demonstrated an inadequate response to, loss of response to, or intolerance to any of
- •the Oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine, balsalazide)
- •? 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.
- •5)Men and women of childbearing potential must agree to use adequate birth control
- •measures during the study. Acceptable methods of birth control in this study include:
- •surgical sterilization, intrauterine device, oral contraceptive, contraceptive patch, long
- •acting injectable contraceptive, partner’s vasectomy, double-barrier method (condom
- •or diaphragm with spermicide) or abstinence for at least 4 weeks prior to study drug
- •administration, during study participation and for 30 days after their last dose of study
- •6) 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
- •1)Diagnosis of Crohn’s disease or indeterminate colitis or the presence or history of a
- •fistula consistent with Crohn’s disease.
- •2)Have positive stool culture for pathogens (O+P, bacteria) or positive test for C.
- •difficile at screening. If C. difficile is positive, the patient may be treated and retested.
- •3)Patients who have an evidence of pathogenic bowel infection.
- •4) History of recurrent or chronic infection (e.g., hepatitis B or C, syphilis, TB).
- •5) Laboratory test positive for HBsAg, HCV or HIV at screening.
研究者
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