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A Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis | Clinical Trials | Clareo Health

COMPLETEDPHASE4

A Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis

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)

NCT02790138•Takeda

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the efficacy of vedolizumab intravenous (IV) and placebo in terms of the percentage of participants with chronic or recurrent pouchitis achieving clinically relevant remission.

Detailed Description

Vedolizumab is being tested to treat people who have chronic pouchitis. This study will look at the healing of inflammation of ileal pouch in people who take vedolizumab as compared to those receiving a matching placebo. The study will enroll approximately 110 patients. Participants will be randomly assigned to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): * Vedolizumab 300 mg IV * Placebo IV All participants will receive an intravenous infusion at Day 1, Weeks 2, 6, 14, 22, and 30 along with concomitant antibiotic treatment with ciprofloxacin 500 mg twice daily through Week 4. This multicenter trial will be conducted in North America and Europe. The overall time to participate in treatment and efficacy assessment of this study is 34 weeks. Participants will make multiple visits to the clinic, plus a final visit 18 weeks after the last dose of study drug for a safety follow-up assessment (up to Week 48). Participants will also participate in a long-term follow-up, by phone after the last dose of study drug up to Week 56.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
•2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
•3. Has a history of ileal pouch anal anastomosis (IPAA) for ulcerative colitis (UC) completed at least 1 year prior to the Day 1 (Randomization) Visit.
•4. Has pouchitis that is chronic or recurrent, defined by an modified pouchitis disease activity index (mPDAI) score ≥5 assessed as 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.
•5. Agrees to take ciprofloxacin (500 mg twice daily) on Day 1 and through Week 4, regardless of the previous treatment and to stop any previous antibiotic therapy on Day 1 of the study (additional courses of antibiotics will be allowed, as needed, for flares after Week 14).
•6. A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use a barrier method of contraception (e.g., condom with spermicide) from signing of informed consent throughout the duration of the study and for 18 weeks after last dose. The female partner of a male participant should also be advised to use a highly effective method of contraception.
•7. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective method of contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.

Exclusion Criteria

•1. Has Crohn's disease (CD), or CD of the pouch.
•2. Has irritable pouch syndrome (IPS).
•3. Has isolated or predominant cuffitis.
•4. Has mechanical complications of the pouch (e.g., pouch stricture or pouch fistula).
•5. Currently requires or has a planned surgical intervention for UC during the study.
•6. Has diverting stoma.
•2\. Has active or latent tuberculosis (TB), regardless of treatment history, as evidenced by any of the following:
•1. A diagnostic TB test performed within 30 days of Screening or during the Screening Period that is positive, as defined by:
•1. A positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests. OR
•2. A tuberculin skin test reaction ≥10 mm (≥5 mm in participants receiving the equivalent of \>15 mg/day prednisone).
+33 more criteria

Locations (34)

University of Chicago Medical Center

Chicago, Illinois, United States

Northshore University HealthSystem

Evanston, Illinois, United States

University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

University of North Carolina GI

Chapel Hill, North Carolina, United States

Carolinas HealthCare System Digestive Health

Charlotte, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Texas Digestive Disease Consultants

Southlake, Texas, United States

University of Utah Health Sciences Center

Salt Lake City, Utah, United States

Key Dates

Start Date

October 12, 2016

Primary Completion Date

June 11, 2020

Completion Date

February 2, 2021

Last Updated

February 24, 2022

Enrollment

102

ACTUAL participants

Conditions

Pouchitis

Interventions

Vedolizumab Placebo

DRUG

Ciprofloxacin

DRUG

Vedolizumab

DRUG

CLF065 for Chronic Pouchitis

NCT07226050

Pouchitis

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RECRUITINGPHASE3

A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis

NCT06443502

Pouchitis

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RECRUITINGEARLY_PHASE1

Fecal Microbiota Transplant for Patients With Chronic Pouchitis

NCT05829109

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis

Inclusion Criteria

Exclusion Criteria

CLF065 for Chronic Pouchitis

A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis

Fecal Microbiota Transplant for Patients With Chronic Pouchitis

Fecal Microbiota Transplantation for Pouchitis

Inflammatory Bowel Diseases Remission Registry

The Role of Secondary Bile Acids in Intestinal Inflammation