A study to evaluate the efficacy and safety of ZYIL1oral capsules for the treatment of patients with mild tomoderately active Ulcerative Colitis resistant orintolerant to oral aminosalicylates

Phase 2

• Conditions: Health Condition 1: K519- Ulcerative colitis, unspecified

• Registration Number: CTRI/2024/02/062456
• Lead Sponsor: Zydus Lifesciences Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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

drug.

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified