Vedolizumab IV 300 mg in the Treatment of Chronic Pouchitis

Phase 1

• Conditions: Chronic Pouchitis; MedDRA version: 20.0Level: PTClassification code 10036463Term: PouchitisSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-003472-78-BE
• Lead Sponsor: Takeda Development Centre Europe, Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-30
• Last Update Posted: 22 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

-Male or female subjects aged 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 94
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

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) 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 clinical trial of medicinal product
• Study Design: Not specified