Vedolizumab IV 300 mg in the Treatment of Chronic Pouchitis

Phase 1

• Conditions: Chronic Pouchitis; MedDRA version: 19.0Level: PTClassification code 10036463Term: PouchitisSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-003472-78-ES
• 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: 2016-08-01
• Study Completion: 2021-02-02
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

1. Male or female subjects 18 to 80 years of age.
2. History of IPAA for UC that was created at least 1 year before Screening.
3. Diagnosis of pouchitis that is recurrent, defined by an mPDAI =5 and >2 episodes within 1 year of Screening or requiring long-term continuous low-dose antibiotic therapy (taken daily on an ongoing basis) or frequent pulse antibiotic therapy.
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 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1. The subject has Crohn’s disease (CD), CD of the pouch, irritable pouch syndrome (IPS), cuffitis, or mechanical complications of the pouch.
2. The subject has received previous treatment with vedolizumab, natalizumab, efalizumab, rituximab, etrolizumab, or anti-mucosal addressin cell adhesion molecule-1(MAdCAM-1) therapy.
3. The subject has received any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives of randomization (whichever is longer).
4. The subject has received nonbiologic investigational therapy within 30 days prior to randomization.
5. The subject has active or latent tuberculosis.
6. The subject has a known history of hepatitis B virus (HBV), hepatitis C virus (HCV), acquired human immunodeficiency virus (HIV), or is found to be seropositive at Screening.
7. The subject has an active, severe infection.
8. The subject has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of study drug.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified