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)
- Conditions
- inflamatory bowel diseaseUlcerative Colitis10017969
- Registration Number
- NL-OMON47815
- Lead Sponsor
- Takeda Development Centre Europe, Ltd
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
- 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.
- 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)
therapy.
- 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)
infection or a known history of human immunodeficiency virus (HIV) infection
(or is found to be seropositive at Screening) or subject is immunodeficient.
- Active, severe infection.
- Positive progressive multifocal leukoencephalopathy (PML) subjective symptom
checklist at Screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy endpoint is the percentage of subjects with chronic or<br /><br>recurrent pouchitis achieving clinically relevant remission after 14 weeks of<br /><br>treatment. Clinically relevant remission will be defined as an mPDAI score <5<br /><br>and a recution in overall score by >=2 points from Baseline.</p><br>
- Secondary Outcome Measures
Name Time Method