NL-OMON47815
Completed
Phase 4
A Randomized, Double-Blind, Placebo-Controlled Phase 4 Study to Evaluate the Efficacy and Safety of Entyvio (Vedolizumab IV) in the Treatment of Chronic Pouchitis (EARNEST) - Vedolizumab IV in the treatment of chronic pouchitis
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- inflamatory bowel disease
- Sponsor
- Takeda Development Centre Europe, Ltd
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Male or female subjects 18 to 80 years, inclusive.
- •\- History of IPAA for UC completed at least 1 year prior to the Day 1
- •(Randomization) Visit.
- •Pouchitis that is chronic or recurrent, defined by an mPDAI score \>\=5 assessed
- •as the average from 3 days immediately prior to the Baseline endoscopy and a
- •minimum endoscopic subscore of 2 (outside the staple or suture line) with
- •either (a) \>\=3 recurrent episodes within 1 year prior to the Screening Period
- •treated with \>\=2 weeks of antibiotic or other prescription therapy, or (b)
- •requiring maintenance antibiotic therapy taken continuously for \>\=4 weeks
- •immediately prior to the Baseline Endoscopy Visit.
Exclusion Criteria
- •\- Crohn\*s disease (CD), CD of the pouch, irritable pouch syndrome (IPS),
- •isolated or predominant cuffitis, diverting stoma, or mechanical complications
- •of the pouch.
- •\- Previous treatment with vedolizumab, natalizumab, efalizumab, rituximab,
- •etrolizumab, or anti\-mucosal addressin cell adhesion molecule\-1 (MAdCAM\-1\)
- •\- Any investigational or approved biologic or biosimilar agent within 60 days
- •of randomization.
- •\- Nonbiologic investigational therapy within 30 days prior to randomization.
- •\- Active or latent tuberculosis.
- •\- Chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV)
Outcomes
Primary Outcomes
Not specified
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