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

Completed · Phase 4 · Has a placebo group

Conditions studied: Pouchitis

In brief

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.

Key facts

Study ID: NCT02790138
Run by: Takeda
People needed: 102
Starts: 2016-10-12
Expected to finish: 2021-02-02
Last updated by the study team: 2022-02-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
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.
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.
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.
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).
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.
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.

You may not qualify if…

Gastrointestinal Exclusion Criteria
Has Crohn's disease (CD), or CD of the pouch.
Has irritable pouch syndrome (IPS).
Has isolated or predominant cuffitis.
Has mechanical complications of the pouch (e.g., pouch stricture or pouch fistula).
Currently requires or has a planned surgical intervention for UC during the study.
Has diverting stoma.
Infectious Disease Exclusion Criteria 1. Has evidence of an active infection (e.g., sepsis, cytomegalovirus, or listeriosis) during Screening.
Has active or latent tuberculosis (TB), regardless of treatment history, as evidenced by any of the following:
A diagnostic TB test performed within 30 days of Screening or during the Screening Period that is positive, as defined by:
A positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests. OR
A tuberculin skin test reaction ≥10 mm (≥5 mm in participants receiving the equivalent of >15 mg/day prednisone).
OR
Chest X-ray within 3 months prior to Day 1 that is suspicious for pulmonary TB, and a positive or 2 successive indeterminate QuantiFERON test within 30 days prior to Screening or during the Screening Period.
Has 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 participant is immunodeficient (e.g., due to organ transplantation, history of common variable immunodeficiency, etc).
Participants who are positive for hepatitis B virus surface antigen (HBsAg) will be excluded. For participants who are negative for HBsAg but are positive for either surface antibodies and/or core antibodies, HBV Deoxyribonucleic acid (DNA) polymerase chain reaction will be performed and if any test result meets or exceeds detection sensitivity, the participant will be excluded.
If participant is HCV antibody positive, then a viral load test will be performed. If the viral load test is positive then the participant will be excluded.
Has evidence of active infection with Clostridium (C) difficile during Screening (to be confirmed by laboratory test)
General Exclusion Criteria
Has any prior exposure to vedolizumab, natalizumab, efalizumab, rituximab, etrolizumab, or anti-mucosal addressin cell adhesion molecule-1 (MAdCAM-1) therapy.
Has a history of hypersensitivity or allergies to vedolizumab or its components.
Has allergies to and/or contraindications for ciprofloxacin, a history of tendon disorders related to quinolone administration and/or glucose-6-phosphate dehydrogenase (G6PD) deficiency. Further conditions requiring precautions for use of ciprofloxacin have to be considered based on local prescribing information.
Is taking, has taken, or is required to take any excluded medications.
Has received any investigational or approved biologic or biosimilar agent within 60 days prior to Randomization.
Has received an investigational nonbiologic therapy within 30 days prior to Randomization.

Where it is running

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
UZ Leuven - University Hospital Gasthuisberg — Leuven, Belgium
GIRI (GI Research Institute) — Vancouver, British Columbia, Canada
Ottawa Hospital - General Campus — Ottawa, Ontario, Canada
Mount Sinai Hospital — Toronto, Ontario, Canada
CHU de Rennes - Hopital de Pontchaillou — Rennes, France
CHU Saint Etienne - Hopital Nord — Saint-Priest-en-Jarez, France
CHU de Toulouse - Hopital Rangueil — Toulouse, France
CHRU Nancy Hopital de Brabois — Vandœuvre-lès-Nancy, France
Charite Universitatsmedizin Berlin -Campus Virchow Klinikum — Berlin, Germany
Asklepios Hospital Hamburg - West — Hamburg, Germany
Praxis fuer Gastroenterologie, Drs. Ehehalt/ Helmstaedter — Heidelberg, Germany
Universitatsklinikum Jena — Jena, Germany
Klinikum Mannheim GmbH Universitaetsklinikum — Mannheim, Germany
Azienda Ospedaliera S. Orsola-Malpighi — Bologna, Italy
Azienda Ospedaliera di Padova — Padova, Italy

Full record on ClinicalTrials.gov

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