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 Crohn’s Disease

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 Crohn's Disease ; MedDRA version: 9.1 Level: LLT Classification code 10013099 Term: Disease Crohns PRIMARY OUTCOME: Main Objective: Co‐Primary Objective for the Induction Phase ; ; • To determine the effect of MLN0002 induction treatment on clinical remission at 6 weeks (primary); ; • To determine the effect of MLN0002 induction treatment on enhanced clinical response at 6 weeks (co‐primary); ; Primary Objective for the Maintenance Phase ; ; • To determine the effect of MLN0002 maintenance treatment on clinical remission at 52 weeks; ; ; ; ; ; ; Primary end point(s): Co‐Primary Endpoint for the Induction Phase; ; • Proportion of patients in clinical remission at Week 6 (primary); ; • Proportion of patients with enhanced clinical response at Week 6 (co‐primary); ; ; 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 enhanced clinical response at 6 weeks; ; • To determine the effect of MLN0002 induction treatment on serum C‐reactive protein (CRP) levels at 6 weeks in patients with elevated CRP levels at baseline; ; ; ; Secondary Objectives for the Maintenance Phase; ; • To determine the effect of MLN0002 maintenance treatment on enhanced clinical response at 52 weeks; ; • To determine the effect of MLN0002 maintenance treatment on corticosteroid‐free remission at 52 weeks; ; • To determine the effect of MLN0002 maintenance treatment on durability of clinical remission over 52 weeks; ; ; ; ; INCLUSION CRITERIA: 1.Age 18‐80. 2.Male/female patient voluntarily able to give consent 3.Female patients must:be post‐menopausal for =1year before screening visit,OR be surgically sterile,OR(of childbearing potential)agree to practice 2 effective methods of contraception,at the same time,from time of signing informed consent form through to 6months after last dose of study drug,OR agree to completely abstain from heterosexual contact.Male patients,even if surgically sterilized, must agree to practice effective barrier contraception during entire study treatment period and through 6months after last dose of study drug,OR agree to completely abstain from heterosexual contact. 4.Diagnosis of Crohn’s disease established at least 3 months prior to enrollment by clinical & endoscopic evidence & corroborated by histopathology report.Cases of Crohn’s disease established =6 months prior to enrollment for which a histopathology report is not available will be considered.5. Moderate to sever