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Tests treatment safety and results for Pouchitis
Official title A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis
ClinicalTrials.gov ID: NCT06443502
What this study is testing
What is Vedolizumab?
Vedolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pouchitis.
Also referred to as Entyvio, MLN0002.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- The participant weighs \>=10 kg at the time of screening and first dose.
- Has active chronic pouchitis, defined by a mPDAI score \>=5 assessed using the 3-day average of participant-reported clinical symptoms prior to the...
- \>=1 previous episodes of pouchitis within 1 year before the screening visit, with symptoms lasting for at least a total of 4 weeks, treated with...
- Have had an inadequate response with, or lost response to, or be intolerant to antibiotic therapy (ie, requiring maintenance antibiotic therapy taken...
- The participant is aged 2 to 17 years, inclusive, at the time of screening and first dose.
You likely can't join if
- The exclusion criteria are divided into 3 categories: active chronic pouchitis exclusion criteria, infectious disease exclusion criteria, and general...
- Has symptoms believed to be predominantly due to irritable pouch syndrome.
- Has isolated cuffitis.
- Is found to have dysplasia at the screening endoscopy.
- Has mechanical complications of the pouch (for example [e.g.] pouch stricture or pouch fistula).
- Currently requires or has a planned surgical intervention during the study.
See the full eligibility criteria
- The participant weighs \>=10 kg at the time of screening and first dose.
- Has active chronic pouchitis, defined by a mPDAI score \>=5 assessed using the 3-day average of participant-reported clinical symptoms prior to the screening endoscopy (that is [ie] video pouchoscopy with biopsy) or...
- \>=1 previous episodes of pouchitis within 1 year before the screening visit, with symptoms lasting for at least a total of 4 weeks, treated with \>=2 weeks of antibiotic or other prescription therapy (ie, other...
- Have had an inadequate response with, or lost response to, or be intolerant to antibiotic therapy (ie, requiring maintenance antibiotic therapy taken for \>=4 weeks immediately before the baseline endoscopy visit or not...
- The participant is aged 2 to 17 years, inclusive, at the time of screening and first dose.
- The participant has a history of proctocolectomy and ileal pouch-anal anastomosis (IPAA) as treatment for ulcerative colitis (UC), Crohn's disease (CD), familial adenomatous polyposis (FAP), or other underlying...
- The exclusion criteria are divided into 3 categories: active chronic pouchitis exclusion criteria, infectious disease exclusion criteria, and general exclusion criteria. Active Pouchitis Exclusion Criteria:
- Has symptoms believed to be predominantly due to irritable pouch syndrome.
- Has isolated cuffitis.
- Is found to have dysplasia at the screening endoscopy.
- Has mechanical complications of the pouch (for example [e.g.] pouch stricture or pouch fistula).
- Currently requires or has a planned surgical intervention during the study.
- Has a diverting stoma. Infectious Disease Exclusion Criteria:
- Has evidence of an active infection (e.g. sepsis, cytomegalovirus [CMV], or listeriosis) during screening.
- Had a clinically significant infection (e.g. pneumonia, pyelonephritis, coronavirus disease 2019 [COVID-19]) within 35 days before first dose of study drug.
- Has active or latent tuberculosis (TB), as evidenced by a diagnostic TB test performed within 3 months of screening or during the screening period that is positive, as defined by:
- A positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, or
- A TB skin test reaction \>=5 millimeter (mm). NOTE: If participant have received Bacillus Calmette-Guérin vaccine, then a QuantiFERON TB Gold test should be performed instead of the TB skin test. NOTE: Participants with...
- Has evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune participants (e.g. HBsAg negative and hepatitis B antibody positive) may, however, be...
- Has chronic hepatitis C virus (HCV) (ie, positive HCV antibody [HCVAb] and HCV Ribonucleic Acid [RNA]). NOTE: Participants who are HCVAb-positive without evidence of HCV RNA may be considered eligible (spontaneous viral...
- Has any identified congenital or acquired immunodeficiency (e.g. common variable immunodeficiency, HIV infection, organ transplantation).
- Has positive stool studies for ova and/or parasites or stool culture at screening visit.
- Has positive Clostridium difficile stool test at screening visit. General Exclusion Criteria:
- Is taking, has taken, or is required to take any excluded medications.
- Has active cerebral/meningeal disease, signs/symptoms, or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders, including stroke, multiple sclerosis, brain tumor, or...
- Has evidence of dysplasia or history of malignancy other than a successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
- Has any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, GI, genitourinary, hematologic, coagulation, immunological, endocrine/metabolic, neurologic, or other medical disorder that, in the opinion of...
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Vlaams-Brabant, Belgium
- Zagreb, Croatia
- Prague, Czechia
- Athens, Attica, Greece
- Jerusalem, Israel
- Petah Tikva, Israel
- Genova, Italy
- Messina, Italy
- Naples, Italy
- Rome, Italy
- Trieste, Italy
- Warsaw, Poland
- Esplugues de Llobregat, Barcelona, Spain
- Valencia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Vlaams-Brabant, Belgium; Zagreb, Croatia; Prague, Czechia; Athens, Attica, Greece; Jerusalem, Israel; Petah Tikva, Israel and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.