MedTrace Logo

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

NCT06398808 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-12-20

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Dr. Deven Parmar, MD,FCP · Zydus Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-08
Primary Completion
2024-11-22
Completion
2024-11-28

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06398808 on ClinicalTrials.gov