A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis

INTERVENTION:

Product Name: VEDOLIZUMAB Product Code: MLN0002 Pharmaceutical Form: Powder for solution for infusion INN or Proposed

INN:

VEDOLIZUMAB CAS Number: 943609‐66‐3 Current Sponsor code: MLN0002 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300mg‐ Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use

CONDITION:

Moderate to Severe Ulcerative Colitis ; MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis

PRIMARY OUTCOME:

Main Objective: Primary Objective for the Induction Phase ; ; • To determine the effect of MLN0002 induction treatment on clinical response at 6 weeks; ; Primary Objective for the Maintenance Phase ; ; • To determine the effect of MLN0002 maintenance treatment on clinical remission at 52 weeks; ; ; ; ; ; Primary end point(s): Primary Endpoint for the Induction Phase:; ; • Proportion of patients with clinical response at Week 6; ; ; Primary Endpoint for the Maintenance Phase:; ; • Proportion of patients in clinical remission at Week 52; ; ; ; ; ; Secondary Objective: Secondary Objectives for the Induction Phase; ; • To determine the effect of MLN0002 induction treatment on clinical remission at 6 weeks; ; • To determine the effect of MLN0002 induction treatment on mucosal healing at 6 weeks; ; ; Secondary Objectives for the Maintenance Phase; ; • To determine the effect of MLN0002 maintenance treatment on durability of clinical response ; ; • To determine the effect of MLN0002 maintenance treatment on mucosal healing at 52 weeks; ; • To determine the effect of MLN0002 maintenance treatment on durability of clinical remission ; ; • To determine the effect of MLN0002 maintenance treatment on corticosteroid‐free remission at 52 weeks; ; ; ; ; ;

INCLUSION CRITERIA:

1. Age 18 to 80 2. Male or female patient who is voluntarily able to give informed consent 3. Female patients must: • be post‐menopausal for at least 1 year before the screening visit, OR • be surgically sterile, OR • (if they are of childbearing potential) agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 6 months after the last dose of study drug, OR • agree to completely abstain from heterosexual contact. Male patients, even if surgically sterilized (ie, status post‐vasectomy), must: • agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug, OR • agree to completely abstain from heterosexual contact. 4. Diagnosis of ulcerative colitis established at least 6 months prior to enrollment by clinical and endoscopic evidence and corroborated by a his