Clinical Trials

Main Inclusion Criteria:

For Treatment Cohort:

1. The participant should have completed Study MLN0002-3024 or Study MLN0002-3025 and
achieved corticosteroid-free clinical response at Week 54 (and has tapered off of
steroids, as applicable, at least 12 weeks before Week 54) as defined by a reduction
of partial Mayo score of ≥2 points and ≥25% from baseline for participants with UC, or
by a decrease of pediatric Crohn's disease activity index (PCDAI) of ≥15 points for
participants with CD.

2. A male participant who is sexually active with a female partner of childbearing
potential agrees to use barrier method of contraception (e.g., condom with or without
spermicide) from signing of informed consent throughout the duration of the study and
for 18 weeks after last dose. The female partner of a male participant should also be
advised to use a highly effective method of contraception.

3. A female participant of childbearing potential who is sexually active with a
nonsterilized male partner agrees to use a highly effective method of contraception
from signing of informed consent throughout the duration of the study and 18 weeks
after the last dose.

For Observational Cohort:

1. The participant has received at least 1 dose of vedolizumab during Study MLN0002-3024 or
Study MLN0002-3025 and early terminated OR completed the Week 54 visit of Study
MLN0002-3024 or Study MLN0002-3025 but was not eligible to enroll in the treatment cohort
of this study.

Main Exclusion Criteria:

For Treatment Cohort only:

1. The participant currently requires major surgical intervention for UC or CD (e.g.,
bowel resection), or is anticipated to require major surgical intervention for UC or
CD during the study.

2. The participant has developed any new unstable or uncontrolled cardiovascular, heart
failure moderate to severe (New York Class Association III or IV), pulmonary, hepatic,
renal, gastrointestinal (GI), genitourinary, hematological, coagulation,
immunological, endocrine/metabolic, neurological, or other medical disorder that, in
the opinion of the investigator, would confound the study results or compromise
participant safety.

3. The participant has other serious comorbidities that will limit their ability to
complete the study.

4. The participant is unable to comply with all study assessments.

5. The participant has hypersensitivity or allergies to any of the vedolizumab
excipients.

6. The participant is lactating or pregnant.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 7/7/23. Questions regarding updates should be directed to the study team contact.