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NCT06398808Recruiting

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
Zydus Lifesciences LimitedPhase 2ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Ulcerative Colitis
Drug/Device/Intervention
Arm1
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Zydus Lifesciences Limited
Location
Ahmedabad, India
Timeline & enrollment
Phase
Phase 2
Start date
Apr 08, 2024
End date
Oct 30, 2024
Enrollment
24 participants
Primary outcome

To assess the efficacy of ZYIL1 for induction of clinical remission

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.

ICD-10 classifications
Ulcerative colitisOther ulcerative colitisUlcerative colitis, unspecifiedArthropathy in ulcerative colitisJuvenile arthritis in ulcerative colitis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06398808
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06398808 through Pure Global AI's free database. This Phase 2 trial is sponsored by Zydus Lifesciences Limited and is currently Recruiting. The study focuses on Ulcerative Colitis. Target enrollment is 24 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.