Health Condition 1: K519- Ulcerative colitis, unspecified
Conditions
Interventions
Intervention1: Arm 1: Dose:- ZYIL1 25 mg + Placebo 50 mg
Route:- Oral
Duration: 12 week
Intervention2: Arm 2: Dose:- ZYIL1 50 mg + Placebo 25 mg
Route:- Oral
Duration: 12 week
Control Intervention1:
Sponsors
Zydus Lifesciences Limited
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of ZYIL1 for induction of clinical remission in participants with mild to moderate active UC.Timepoint: Baseline to Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the overall safety and tolerability of ZYIL1Timepoint: Baseline to End of study | — |
Countries
India
Contacts
Public ContactDr Suchi Shah
Zydus Research Centre
Outcome results
None listed