Efficacy and Safety of Vedolizumab Intravenous in Pediatric Chronic Pouchitis
- Conditions
- Active Chronic PouchitisMedDRA version: 20.0Level: PTClassification code: 10036463Term: Pouchitis Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- CTIS2023-504773-20-00
- Lead Sponsor
- Takeda Development Center Americas Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 28
In the opinion of the investigator, the subject, parent, or legal guardian is capable of understanding and complying with protocol requirements., The subject, parent or legal guardian has signed and dated a written, informed consent form and subject assent form and any required privacy authorization before the initiation of any study procedures., The subject is aged 2 to 17 years, inclusive, at the time of screening and first dose., The subject weighs =10 kg at the time of screening and first dose., The subject has a history of proctocolectomy and IPAA completed at least 1 year before the screening visit., The subject has active chronic pouchitis, defined by an mPDAI score =5 assessed using the average of subject-reported clinical symptoms from 3 days during a 5-day period immediately before screening endoscopy (ie, video pouchoscopy with biopsy) or bowel preparation for endoscopy, and a minimum mPDAI endoscopic subscore of 2 (outside the staple or suture line) and either: a) Has had =1 previous episodes of pouchitis within 1 year before the screening visit, with symptoms lasting at least 4 weeks, treated with =2 weeks of antibiotic or otherprescription therapy (ie, other antibiotics, probiotics, immunomodulators, or anti-TNFs within 1 year before screening). or b) Has had an inadequate response with, or lost response to, or is intolerant to antibiotic therapy (ie, requiring maintenance antibiotic therapy taken continuously for =4 weeks immediately before the baseline endoscopy visit or not able to receive or continue antibiotic treatment due to intolerance or other contraindication)., A male subject who is sexually active with a female partner of childbearing potential agrees to use a barrier method of contraception (ie, condom with spermicide)* from signing of parental informed consent/subject assent throughout the duration of the study and for 18 weeks after last dose. The female partner of a male subject should also be advised to use a highly effective method of contraception., A female subject of childbearing potential who is sexually active with a male partner agrees to use a highly effective method of contraception* from signing of parental informed consent/subject assent throughout the duration of the study and for 18 weeks after last dose.
The subject has symptoms believed to be predominantly due to irritable pouch syndrome., The subject has isolated cuffitis., The subject is found to have dysplasia at the screening endoscopy., The subject has any prior exposure to approved or investigational anti-integrins including, but not limited to natalizumab, efalizumab, etrolizumab, or AMG 181, or mucosal addressin cell adhesion molecule-1 (MAdCAM-1) antagonists, or rituximab as a treatment for pouchitis., The subject has received either (1) an investigational biologic agent (other than those listed in Exclusion Criterion #1) within 60 days or 5 half-lives before screening (whichever is longer); or (2) an approved biologic or biosimilar agent for inflammatory bowel disease within 2 weeks before the first dose of study drug or at any time during the screening period, The subject has mechanical complications of the pouch (ie, pouch stricture or pouch fistula)., The subject has a diverting stoma., The subject currently requires or has a planned surgical intervention during the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method