RecruitingPhase 3NCT06443502

A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis

An Open-label Single-Arm Phase 3 Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Vedolizumab Intravenous in the Treatment of Pediatric Subjects With Active Chronic Pouchitis


Sponsor

Takeda

Enrollment

30 participants

Start Date

Nov 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

When some people have their large bowel removed, a surgeon can make a "pouch" from part of the small bowel to connect it to the back passage (anus). Pouchitis is when the pouch becomes inflamed (swollen) or infected. The main aim of this study is to find out if vedolizumab improves pouchitis symptoms and pouch inflammation. Other aims include to find out if vedolizumab is well tolerated and if it causes any medical problems (adverse events or side effects) and to look for any changes in the well-being of participants during their treatment with vedolizumab. This study consists of two parts: Part 1 includes the induction and maintenance periods, and Part 2 includes the continued maintenance period. Participants will receive up to 12 infusions of vedolizumab. In Part 1 of the study, first 3 infusions are in first 6 weeks (Day 1, Week 2 and Week 6). Participants who are getting benefit may continue with the treatment for up to 7.5 months (30 weeks) in the maintenance period for Part 1. After completing treatment with vedolizumab in Part 1, participants will visit their clinic for a health check at Week 34. Participants who show clinical response at Week 34 will continue to Part 2, receiving vedolizumab every 8 weeks for an additional 40 weeks, starting at Week 38 and ending with the last dose being at Week 78. Final efficacy assessments, including a pouchoscopy will be performed at Week 82.


Eligibility

Min Age: 2 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Concomitant Antibiotic Therapy and a drug called Vedolizumab for people with pouchitis. The study is currently recruiting participants at 14 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVedolizumab

Vedolizumab intravenous infusion.

DRUGConcomitant Antibiotic Therapy

Ciprofloxacin, metronidazole, vancomycin, amoxicillin clavulanate or rifaximin.


Locations(14)

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Children's Hospital Zagreb

Zagreb, Croatia

Fakultni nemocnice v Motole, Pediatricka klinika 2

Prague, Czechia

Sotiria Thoracic Diseases Hospital, Dpt. of Gastroenterology, Building Z

Athens, Attica, Greece

Shaare Zedek Medical Center

Jerusalem, Israel

Schneider Children's Medical Center of Israel

Petah Tikva, Israel

Istituto G Gaslini Ospedale Pediatrico IRCCS

Genova, Italy

Azienda Ospedaliero Universitaria, Policlinico Gaetano Martino

Messina, Italy

AOU dell'Universita degli Studi della Campania Luigi Vanvitelli

Naples, Italy

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Rome, Italy

IRCCS Materno Infantile Burlo Garofolo

Trieste, Italy

Instytut Pomnik-/Centrum Zdrowia dziecka

Warsaw, Poland

Hospital Sant Joan de Deu

Esplugues de Llobregat, Barcelona, Spain

Hospital Universitari I Politecnic La Fe de Valencia

Valencia, Spain

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NCT06443502


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