Crohn's Disease study: Vedolizumab IV
Official title A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)
ClinicalTrials.gov ID: NCT04779320
What this study is testing
What is Vedolizumab IV?
This is an investigational medicine being studied to treat moderate to severe Crohn's disease in children and teenagers. It is designed to reduce inflammation and pain in the digestive system.
Also referred to as Entyvio, Kyntheles, 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
- The study wants to see if the drug can bring patients into remission, meaning their symptoms improve or disappear and an endoscopy shows no inflammation.
- Who it's for
- Children and teenagers who have moderate to severe Crohn's disease.
- What's involved
- Participants receive three infusions of vedolizumab over six weeks. If they respond, they then get either a high or low dose every eight weeks, keeping the same dose each time.
- Time commitment
- The study lasts about a year, with initial infusions over six weeks and then regular visits every eight weeks for ongoing treatment.
- Phase 3: a large, late-stage study
- Time commitment: about 6 weeks
- This is a blinded 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
- Main
- The participants has moderately to severely active CD, unresponsive or intolerant to their current standard of care (SOC).
- The participants weigh ≥10 kg at the time of screening and enrollment into the study.
- Participants with Crohn's disease (CD) diagnosed at least 1 month before screening.
- Participants who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids...
You likely can't join if
- Participants who have received either (1) an investigational biologic (other than those listed in Exclusion Criterion #1) within 60 days or 5...
- Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major...
- The participants had a clinically significant infection (eg, pneumonia, pyelonephritis, coronavirus disease 2019 [COVID-19]) within 30 days prior to...
- The participants has received any live vaccinations within 30 days prior to first dose.
- Participants who currently require surgical intervention or are anticipated to require surgical intervention for CD during this study.
- Participants who have had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, known fixed stenosis of the...
See the full eligibility criteria
- Main
- The participants has moderately to severely active CD, unresponsive or intolerant to their current standard of care (SOC).
- The participants weigh ≥10 kg at the time of screening and enrollment into the study.
- Participants with Crohn's disease (CD) diagnosed at least 1 month before screening. Participants with moderately to severely active CD defined by a Pediatric Crohn's Disease Activity Index (PCDAI) \>30 and an simple...
- Participants who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (eg, azathioprine (AZA), 6-mercaptopurine (6-MP), methotrexate...
- Participants with extensive colitis or pancolitis of \>8 years' duration or left-sided colitis of \>12 years' duration must have documented evidence of a negative surveillance colonoscopy within 12 months before...
- Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines. Main
- Participants who have received either (1) an investigational biologic (other than those listed in Exclusion Criterion #1) within 60 days or 5 half-lives before screening (whichever is longer)
- Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders including stroke, multiple sclerosis, brain...
- The participants had a clinically significant infection (eg, pneumonia, pyelonephritis, coronavirus disease 2019 [COVID-19]) within 30 days prior to first dose of study drug.
- The participants has received any live vaccinations within 30 days prior to first dose.
- Participants who currently require surgical intervention or are anticipated to require surgical intervention for CD during this study.
- Participants who have had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, known fixed stenosis of the intestine, short bowel syndrome, or \>3 small intestine resections.
- Participants with a current diagnosis of indeterminate colitis.
- Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease.
- Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR
- A TB skin test reaction ≥5 mm.
- Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb).
- Participants with chronic hepatitis C virus (HCV) (ie, positive HCV antibody [HCVAb] and HCV RNA).
- The participants has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation).
- The participant has evidence of dysplasia or history of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
- Participants with positive stool studies for ova and/or parasites or stool culture at screening visit.
- Participants with positive Clostridioides difficile (C difficile) stool test at screening visit. Other inclusion/exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Atlanta, Georgia, United States
- Park Ridge, Illinois, United States
- Minneapolis, Minnesota, United States
- Morristown, New Jersey, United States
- New Hyde Park, New York, United States
- Stony Brook, New York, United States
- Houston, Texas, United States
- Roanoke, Virginia, United States
- South Brisbane, Queensland, Australia
- Zagreb, City of Zagreb, Croatia
- Split, Croatia
- Athens, Attica, Greece
- Athens, Greece
- Thessaloniki, Greece
- Miskolc, Borsod-Abauj Zemplen county, Hungary
- Szeged, Csongrád megye, Hungary
- Rome, Lazio, Italy
- Kurume-Shi, Hukuoka, Japan
- Kumamoto, Kumamoto, Japan
- Bunkyo-Ku, Tokyo, Japan
+ 8 more site(s).
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, but confirm specifics with the study team.
How long does this study last?
The study runs about 6 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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?
This study is enrolling now at Atlanta, Georgia, United States; Park Ridge, Illinois, United States; Minneapolis, Minnesota, United States; Morristown, New Jersey, United States; New Hyde Park, New York, United States; Stony Brook, New York, United States and 22 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.