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

Pouchitis Clinical Trial

Official title: 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

Status Not yet recruiting

Clinical Trial 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.

Participants will receive up to 6 infusions of vedolizumab. 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 total. After completing treatment with vedolizumab, participants will visit their clinic for a health check at Week 34. One final health check will be scheduled 4.5 months (18 weeks) after the last vedolizumab infusion.

Participants who continue to benefit from their treatment at the end of this study will be invited to continue treatment with vedolizumab in another clinical study (Vedolizumab-3042).

Clinical Trial Description

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 along with ciprofloxacin, metronidazole, or other antibiotics 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, Weeks 2, 6, 14, 22, and 30 along with concomitant antibiotic treatment from Day 1 through Week 2.

This multi-center trial will be conducted globally. The overall duration of the study is up to 57 weeks. Participants will be followed up for 18 weeks after the last dose of the study drug for safety. ;

Related Conditions & MeSH terms

• Pouchitis

• NCT number: NCT06443502
• Study type: Interventional
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS@takeda.com
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 25, 2024
• Completion date: December 31, 2029