Vedolizumab Subcutaneous Long-Term Open-Label Extension Study

The drug being tested in this study is called vedolizumab subcutaneous (vedolizumab SC).
Vedolizumab SC is being tested to assess its long-term safety and effectiveness in treating
participants with UC or CD. This study will look at the long-term side effects and
response/remission of UC and CD in participants who received vedolizumab SC in a prior
vedolizumab SC study.

The study will enroll up to 692 patients. All participants enrolled in this study will have
previously participated in the MLN0002SC-3027 or MLN0002SC-3031 study. Participants who
completed the Maintenance Period (Week 52) in their previous study, or who did not achieve a
clinical response at Week 6 but who did achieve a clinical response at Week 14 after having
received a third vedolizumab IV infusion at Week 6 in their previous study, will receive
open-label vedolizumab SC 108 mg, once every 2 weeks (Q2W). Participants who withdrew early
from the Maintenance Period of their previous study due to disease worsening or need for
rescue medications will receive open-label vedolizumab SC 108 mg, once every week (QW).
Participants who experience treatment failure (disease worsening or need for rescue
medications while in the current study will be dose escalated to vedolizumab SC 108 mg QW.

This multi-center trial will be conducted worldwide. Participation in this vedolizumab SC
study will continue until vedolizumab SC becomes commercially available, the participant
withdraws from the study, or the sponsor decides to close the study. Participants will make
multiple visits to the clinic, plus a final visit 18 weeks after last dose of study drug for
a follow-up assessment. Participants will also participate in a long-term safety follow-up,
by phone, at 6 months after the last dose of study drug.

Inclusion Criteria:

1. Prior participation in Study MLN0002SC-3027 or MLN0002SC-3031, and, in the opinion of
the investigator, tolerated the study drug well. Early withdrawal from Study MLN0002SC-3027
or MLN0002SC-3031 must have been due to treatment failure during the Maintenance Period.

Exclusion Criteria:

1. Surgical intervention for IBD during or after participation in Study MLN0002SC-3027 or
MLN0002SC-3031, or at any time during this study.

2. Chronic or severe infection, or, any new, unstable, or uncontrolled cardiovascular,
pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological,
coagulation, immunological, endocrine/metabolic, neurologic, oncologic, or other
medical disorder developed during or after participation in a prior vedolizumab study
that, in the opinion of the investigator, would confound the study results or
compromise participant safety.

3. Withdrawal from Study MLN0002SC-3027 or MLN0002SC-3031 due to a study-drug related
adverse event (AE).