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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
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.
The drug being tested in this study is called vedolizumab. This study will look at the efficacy, safety, tolerability, pharmacokinetics (PK), and immunogenicity of vedolizumab in pediatric participants with active chronic pouchitis. The study will enroll approximately 30 participants. All the participants will be enrolled in a single treatment group to receive treatment with vedolizumab based on participant's weight mentioned as follows: * Participants with body weight greater than or equal to (\>=) 30 kilogram (kg) will receive vedolizumab, high dose * Participants with body weight greater than (\>) 15 to less than (\<) 30 kg will receive vedolizumab, medium dose * Participants with body weight 10 to 15 kg will receive vedolizumab, low dose All participants will receive vedolizumab intravenous infusion at Day 1, and at Weeks 2, 6, 14, 22, and 30. Participants will also receive concomitant antibiotic treatment (ciprofloxacin, metronidazole, or other antibiotics) from Day 1 through Week 2. Participants with clinical response at the end of Part 1 maintenance at Week 34 will continue to Part 2 of the study and will receive vedolizumab intravenous infusion every 8 weeks from Week 38 through Week 78. This multi-center trial will be conducted globally. The maximum overall duration of the study is up to approximately 2 years. Participants will be followed up for 18 weeks after the last dose of the study drug for safety.
Age
2 - 17 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
November 19, 2024
Primary Completion Date
December 31, 2029
Completion Date
December 31, 2029
Last Updated
September 19, 2025
30
ESTIMATED participants
Vedolizumab
DRUG
Concomitant Antibiotic Therapy
DRUG
Lead Sponsor
Takeda
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03545386