A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease

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 receiving SC 108 mg Q2W 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.

Primary Outcome Measures

1. Number of Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment
   A TEAE was defined as an adverse event (AE) that started or worsened on or after study Day 1 (defined as day first dosed) and no more than 18 weeks after the last dose of study drug. An SAE was defined as any untoward medical occurrence that occurs at any dose and resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event such as acute liver failure, pulmonary hypertension, or confirmed or suspected transmission of an infectious agent by a medicinal product. Participant years is defined as the total exposure-time of the participants in the respective treatment group. Incidence per 100 participant years is defined as (Number of participants with events\*100/participant years). As per planned analysis, data for this outcome measure is grouped and presented per disease condition.

Secondary Outcome Measures

1. Number of Adverse Events of Special Interest (AESIs) Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment
   AESIs included hypersensitivity reactions (including injections site reactions), serious infections, malignancies, hepatotoxicity (abnormal liver function test) and progressive multifocal leukoencephalopathy (PML). Participant years is defined as the total exposure-time of the participants in the respective treatment group. Incidence per 100 participant years is defined as (Number of participants with events\*100/participant years). As per planned analysis, data for this outcome measure is grouped and presented per disease condition.
2. Number of Participants With Ulcerative Colitis Achieving Partial Mayo Scoring Clinical Response at Week 48
   Clinical response is defined as a decrease in the partial Mayo score of at least 2 points and ≥25% from baseline, with an accompanying decrease in rectal bleeding subscore of ≥1 point from baseline or absolute rectal bleeding subscore of ≤1 point. As per planned analysis, data for this outcome measure is grouped and presented for participants with ulcerative colitis.
3. Number of Participants With Crohn's Disease Achieving Clinical Response Based on Harvey-Bradshaw Index (HBI) Scores at Week 48
   Clinical response is defined as a decrease in HBI score of ≥3 points from baseline in CD participants (randomized early terminator CD participants only \[defined as randomized CD participants withdrawn from the parent study between Week 6 and Week 52\]). As per planned analysis, data for this outcome measure is grouped and presented for participants with Crohn's disease.
4. Number of Participants With Ulcerative Colitis Achieving Clinical Remission Based on Partial Mayo Score
   Clinical remission is defined as a partial Mayo score of ≤2 with no individual subscore \>1. As per planned analysis, data for this outcome measure is grouped and presented for participants with ulcerative colitis.
5. Number of Participants With Crohn's Disease Achieving Clinical Remission Based on Harvey-Bradshaw Index (HBI) Scores
   Clinical remission is defined as total HBI score of ≤4 points. As per planned analysis, data for this outcome measure is grouped and presented for participants with Crohn's disease.