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A Study to Evaluate the Efficacy and Safety of ZYIL1 Oral Capsules for the Treatment of Patients With Mild to Moderately Active Ulcerative Colitis Resistant or Intolerant to Oral Aminosalicylates

Ulcerative Colitis Clinical Trial

Official title:
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

Clinical Trial Summary

The purpose of this study is to evaluate efficacy and safety of ZYIL1 oral capsule twice a day for 12 weeks for treatment of mild to moderate active ulcerative colitis resistant or intolerant to oral aminosalicylates.

Clinical Trial Description

This is a Phase IIa, randomized, two arms, double blind, double dummy, parallel, multicentre study to evaluate efficacy and safety of ZYIL1 oral capsules for the treatment of mild to moderately active ulcerative colitis resistant or intolerant to oral aminosalicylates. The study consists The study consists of: screening period of upto 4 weeks, treatment period of 12 weeks (first 6 weeks period: Induction period and remaining 6 weeks: Maintenance period), and end of the study at Week 13. The total duration of the study will be 119 days including screening period of 28 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06398808
Study type Interventional
Source Zydus Lifesciences Limited
Contact Dr Kevin Kansagra, MD
Phone 02717-665555
Email kevinkumarkansagra@zyduslife.com
Status Recruiting
Phase Phase 2
Start date April 8, 2024
Completion date October 30, 2024
View Details
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