A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis

• Status: Not yet recruiting
• Trial end date: 2024-05-30
• Target enrollment: 0
• Participant gender: All

Summary

Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe ulcerative colitis will be treated with vedolizumab.

The main aim of the study is to check if participants achieve remission after treatment with vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no or limited signs of disease.

Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive 1 of 3 doses of vedolizumab once every 8 weeks. They will receive the same dose every time.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Vedolizumab

Criteria

Inclusion Criteria:

1. Has moderately to severely active UC, unresponsive or intolerant to their current standard of care (SOC).

2. Weighs ≥10 kg at the time of screening and enrollment into the study.

3. Has moderately to severely active UC diagnosed at least 1 month before screening, defined by a modified Mayo score of 5 to 9 (sum of Mayo endoscopic subscore, stool frequency subscore, and rectal bleeding subscore) with a Mayo endoscopic subscore of ≥2 (mucosal friability indicates an endoscopic subscore of at least 2).

4. Has failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids (eg, azathioprine [AZA], 6-mercaptopurine [6-MP], methotrexate [MTX]), immunomodulators, and/or tumor necrosis factor alpha (TNF-α) antagonist therapy (eg, infliximab, adalimumab). This includes participants who are dependent on corticosteroids to control symptoms and who are experiencing worsening of disease in the moderate-to-severe range when attempting to wean off corticosteroids.

5. Has evidence of UC extending proximal to the rectum (i.e., not limited to proctitis), at a minimum.

6. Has 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.

7. Participants with vaccinations that are up-to-date based on the countrywide, accepted schedule of childhood vaccines.

Exclusion Criteria:

1. Has previous exposure to approved or investigational anti-integrins including, but not limited to natalizumab, efalizumab, etrolizumab, or Abrilumab (AMG 181), or mucosal addressin cell adhesion molecule-1 (MAdCAM-1) antagonists or rituximab.

2. Has received an investigational biologic within 60 days or 5 half-lives before screening (whichever is longer); or an approved biologic or biosimilar agent within 2 weeks before the first dose of study drug or at any time during the screening period.

3. 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 neurodegenerative disease.

4. Has had clinically significant infection (eg, pneumonia, pyelonephritis, coronavirus disease 2019 [COVID-19]) within 30 days prior to first dose of study drug.

5. Has received any live vaccinations within 30 days prior to first dose of study drug.

6. Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC during this study.

7. Has had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, or known fixed stenosis of the intestine.

8. Participants with a current diagnosis of indeterminate colitis.

9. Participants with clinical features suggesting monogenic very early onset inflammatory bowel disease.

10. Participant with 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. NOTE: If participants have received Bacillus Calmette-Guérin vaccine then a QuantiFERON TB Gold test should be performed instead of the TB skin test.

11. Has chronic hepatitis B virus (HBV) infection* or chronic hepatitis C virus infection.

• HBV immune participants (ie, being hepatitis B surface antigen negative and hepatitis B antibody positive) may be included, however.

12. Has positive stool studies for ova and/or parasites or stool culture at screening visit.

13. Has positive Clostridium difficile stool test at screening visit.