A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)

Main Inclusion Criteria:

1. The participants has moderately to severely active CD, unresponsive or intolerant totheir current standard of care (SOC).

2. The participants weigh ≥10 kg at the time of screening and enrollment into thestudy.

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'sDisease Activity Index (PCDAI) >30 and an simple endoscopic score for Crohn'sDisease (SES-CD) >6 (or an SES-CD ≥4 if disease is confined to terminal ileum) atscreening endoscopy.

4. Participants who have failed, lost response to, or been intolerant to treatment withat least 1 of the following agents: corticosteroids, immunomodulators (eg,azathioprine (AZA), 6-mercaptopurine (6-MP), methotrexate [MTX]), and/or tumornecrosis factor (TNF)-α antagonist therapy (eg, infliximab, adalimumab). Thisincludes participants who are dependent on corticosteroids or exclusive or partialenteral nutrition to control symptoms and who are experiencing worsening of diseasein the moderate-to-severe range when attempting to wean off corticosteroids ordiscontinue exclusive enteral nutrition.

5. Participants with extensive colitis or pancolitis of >8 years' duration orleft-sided colitis of >12 years' duration must have documented evidence of anegative surveillance colonoscopy within 12 months before screening.

6. Participants with vaccinations that are up-to-date based on the countrywide acceptedschedule of childhood vaccines.

Main Exclusion Criteria:

1. Participants who have received either (1) an investigational biologic (other thanthose listed in Exclusion Criterion #1) within 60 days or 5 half-lives beforescreening (whichever is longer); or (2) an approved biologic or biosimilar agentwithin 2 weeks before the first dose of study drug or at any time during thescreening period.

2. Participants with active cerebral/meningeal disease, signs/symptoms or history ofprogressive multifocal leukoencephalopathy (PML) or any other major neurologicaldisorders including stroke, multiple sclerosis, brain tumor or neurodegenerativedisease.

3. The participants had a clinically significant infection (eg, pneumonia,pyelonephritis, coronavirus disease 2019 [COVID-19]) within 30 days prior to firstdose of study drug.

4. The participants has received any live vaccinations within 30 days prior to firstdose.

5. Participants who currently require surgical intervention or are anticipated torequire 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, shortbowel syndrome, or >3 small intestine resections.

7. Participants with a current diagnosis of indeterminate colitis.

8. Participants with clinical features suggesting monogenic very early-onsetinflammatory bowel disease.

9. Active or latent tuberculosis (TB), as evidenced by a diagnostic TB test performedwithin 30 days of screening or during the screening Period that is positive, definedas:

• 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) orhepatitis 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, theparticipant would be considered eligible if the absence of HBV DNA is confirmed byHBV DNA polymerase chain reaction reflex testing performed in the centrallaboratory.

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 beconsidered 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 asuccessfully treated non-metastatic cutaneous squamous cell or basal cell carcinomaor localized carcinoma in situ of the cervix.

14. Participants with positive stool studies for ova and/or parasites or stool cultureat screening visit.

15. Participants with positive Clostridioides difficile (C difficile) stool test atscreening visit.

Other inclusion/exclusion criteria may apply.