Actively Recruiting
A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis
Led by Takeda · Updated on 2025-09-19
30
Participants Needed
14
Research Sites
266 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant weighs at least 10 kg at screening and first dose
- Has active chronic pouchitis with a mPDAI score of 5 or higher and an endoscopic subscore of 2 or more
- Has had at least one episode of pouchitis in the past year lasting at least 4 weeks and treated with antibiotics or other therapies, or has had inadequate response, lost response, or intolerance to antibiotic therapy
- Is aged 2 to 17 years at screening and first dose
- Has a history of proctocolectomy and ileal pouch-anal anastomosis performed at least one year before screening for ulcerative colitis, Crohn's disease, familial adenomatous polyposis, Hirschsprung's disease, or similar conditions
You will not qualify if you...
- Symptoms mainly due to irritable pouch syndrome
- Has isolated cuffitis
- Dysplasia found at screening endoscopy
- Mechanical pouch complications such as stricture or fistula
- Requires or plans surgical intervention during the study
- Has a diverting stoma
- Active infection such as sepsis, CMV, or listeriosis during screening
- Significant infection within 35 days before first dose
- Active or latent tuberculosis as indicated by recent tests
- Positive hepatitis B surface antigen or core antibody unless confirmed absence of virus
- Chronic hepatitis C virus infection
- Congenital or acquired immunodeficiency including HIV or organ transplant
- Positive stool tests for parasites or Clostridium difficile at screening
- Taking excluded medications
- History of major neurological disorders or progressive multifocal leukoencephalopathy
- Evidence of dysplasia or certain malignancies except treated nonmetastatic skin or cervical cancers
- Any unstable or uncontrolled major medical condition that could affect safety or study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
2
Children's Hospital Zagreb
Zagreb, Croatia, 10000
Actively Recruiting
3
Fakultni nemocnice v Motole, Pediatricka klinika 2
Prague, Czechia, 150 06
Actively Recruiting
4
Sotiria Thoracic Diseases Hospital, Dpt. of Gastroenterology, Building Z
Athens, Attica, Greece, 115 27
Actively Recruiting
5
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Actively Recruiting
6
Schneider Children's Medical Center of Israel
Petah Tikva, Israel, 4920235
Actively Recruiting
7
Istituto G Gaslini Ospedale Pediatrico IRCCS
Genova, Italy, 16147
Actively Recruiting
8
Azienda Ospedaliero Universitaria, Policlinico Gaetano Martino
Messina, Italy, 98124
Actively Recruiting
9
AOU dell'Universita degli Studi della Campania Luigi Vanvitelli
Naples, Italy, 80138
Actively Recruiting
10
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Rome, Italy, 00161
Actively Recruiting
11
IRCCS Materno Infantile Burlo Garofolo
Trieste, Italy, 34137
Actively Recruiting
12
Instytut Pomnik-/Centrum Zdrowia dziecka
Warsaw, Poland, 04-730
Actively Recruiting
13
Hospital Sant Joan de Deu
Esplugues de Llobregat, Barcelona, Spain, 8950
Actively Recruiting
14
Hospital Universitari I Politecnic La Fe de Valencia
Valencia, Spain, 46026
Actively Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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