NCT06398808

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Zydus Lifesciences Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Arm1	ZYIL1 capsules 25 mg for oral administration + 50 mg placebo
DRUG	Arm 2	ZYIL1 capsules 50 mg for oral administration + 25 mg placebo

Timeline

• Start date: 2024-04-08
• Primary completion: 2024-11-22
• Completion: 2024-11-28
• First posted: 2024-05-03
• Last updated: 2024-12-20

Locations

1 site across 1 country: India