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Treatment of moderate to severe Crohn's disease in children and teenagers with vedolizumab

A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

Phase 3 Interventional Takeda · NCT04779320

This study is testing if a new medication called vedolizumab can help children and teenagers with moderate to severe Crohn's disease feel better and reduce inflammation in their digestive system.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment120 (estimated)
Ages2 Years to 17 Years
SexAll
SponsorTakeda Industry-sponsored
Drugs / interventionsinfliximab, adalimumab, methotrexate, Vedolizumab
Locations96 sites (Phoenix, Arizona and 95 other locations)
Trial IDNCT04779320 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of vedolizumab, a medication that reduces inflammation in the digestive system, in children and teenagers suffering from moderate to severe Crohn's disease. Participants will receive three initial infusions of the drug over six weeks, followed by maintenance doses every eight weeks for those who respond positively. The study aims to determine if these treatments can lead to remission, defined as an improvement in symptoms and no signs of inflammation during endoscopy. Approximately 120 patients will be enrolled, focusing on those who have not responded to standard therapies.

Who should consider this trial

Good fit: Ideal candidates are children and teenagers aged 10 kg or more with moderate to severe Crohn's disease who have not responded to or are intolerant to current standard therapies.

Not a fit: Patients who have not been diagnosed with Crohn's disease or those who have not failed previous treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for pediatric patients with Crohn's disease by achieving remission.

How similar studies have performed: Other studies have shown success with vedolizumab in adult populations, but this specific application in pediatric patients is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Main Inclusion Criteria:

1. The participants has moderately to severely active CD, unresponsive or intolerant to their current standard of care (SOC).
2. The participants weigh ≥10 kg at the time of screening and enrollment into the study.
3. 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 endoscopic score for Crohn's Disease (SES-CD) \>6 (or an SES-CD ≥4 if disease is confined to terminal ileum) at screening endoscopy.
4. 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 \[MTX\]), and/or tumor necrosis factor (TNF)-α antagonist therapy (eg, infliximab, adalimumab). This includes participants who are dependent on corticosteroids or exclusive or partial enteral nutrition to control symptoms and who are experiencing worsening of disease in the moderate-to-severe range when attempting to wean off corticosteroids or discontinue exclusive enteral nutrition.
5. 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 screening.
6. Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines.

Main Exclusion Criteria:

1. 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); or (2) an approved biologic or biosimilar agent within 2 weeks before the first dose of study drug or at any time during the screening period.
2. 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 tumor or neurodegenerative disease.
3. 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.
4. The participants has received any live vaccinations within 30 days prior to first dose.
5. Participants who currently require surgical intervention or are anticipated to require surgical intervention for CD during this study.
6. 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.
7. Participants with a current diagnosis of indeterminate colitis.
8. Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease.
9. Active or latent tuberculosis (TB), as evidenced by a diagnostic TB test performed within 30 days of screening or during the screening Period that is positive, defined as:

   * Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR
   * A TB skin test reaction ≥5 mm.
10. Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune participants(i.e., hepatitis B surface antigen \[HBsAg\]-negative and hepatitis B antibody-positive) may, however, be included.

    Note: If a participant tests negative for HBsAg, but positive for HBcAb, the participant would be considered eligible if the absence of HBV DNA is confirmed by HBV DNA polymerase chain reaction reflex testing performed in the central laboratory.
11. Participants with chronic hepatitis C virus (HCV) (ie, positive HCV antibody \[HCVAb\] and HCV RNA).

    Note: Participants who are HCVAb-positive without evidence of HCV RNA may be considered eligible (spontaneous viral clearance or previously treated and cured \[defined as no evidence of HCV RNA at least 12 weeks before baseline\]).
12. The participants has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus \[HIV\] infection, organ transplantation).
13. 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.
14. Participants with positive stool studies for ova and/or parasites or stool culture at screening visit.
15. Participants with positive Clostridioides difficile (C difficile) stool test at screening visit.

Other inclusion/exclusion criteria may apply.

Where this trial is running

Phoenix, Arizona and 95 other locations

+46 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Crohn's DiseaseDrug Therapy
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.