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-IT
• Lead Sponsor: TAKEDA DEVELOPMENT CENTRE EUROPE LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-02-02
• Study Start: 2021-06-14
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

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

Inclusion Criteria

1.Male or female subjects aged 18 to 80 years, inclusive.
2.¿ History of IPAA for UC completed at least 1 year prior to the Day 1 (Randomization) Visit.
3.¿ 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

1.Crohn’s disease (CD), CD of the pouch, irritable pouch syndrome (IPS), isolated or predominant cuffitis, diverting stoma, or mechanical complications of the pouch.
2.¿ Previous treatment with vedolizumab, natalizumab, efalizumab, rituximab, etrolizumab, or anti-mucosal addressin cell adhesion molecule-1 (MAdCAM-1) therapy.
¿3. Any investigational or approved biologic or biosimilar agent within 60 days of randomization.
¿4. Nonbiologic investigational therapy within 30 days prior to randomization.
5. Active or latent tuberculosis.
6.¿ 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.
¿7. Active, severe infection.
8. Positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist at Screening.

Study & Design

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