Long Term Safety of MLN0002 in Patients With Ulcerative Colitis and Crohn's Disease

• Adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
• Vital signs, standard laboratory tests, physical examinations, and signs and symptoms of progressive multifocal leukoencephalopathy (PML) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
• Assessment for human anti-human antibodies (HAHA) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

• PK assessments will include but are not limited to MLN0002 trough concentration on a limited number of study visits. [ Time Frame: pre-dose day 1, days 43, 99, 155, 267 ] [ Designated as safety issue: No ]
• PD evaluation on a limited number of study visits will include measurement of the saturation of receptors by MLN0002. [ Time Frame: pre-dose day 1, days 43, 99, 155, 267 ] [ Designated as safety issue: No ]

This is an open-label study to determine the long term safety of MLN0002 in patients with Crohn's disease and ulcerative colitis. Approximately 80 patients at centers in North America and Europe will participate in this study. The treatment and observation period is expected to last approximately 21 months.

• Ulcerative Colitis
• Crohn's Disease

• Drug: vedolizumab (MLN0002)
  Patients with no prior exposure to MLN0002 will receive 6 mg/kg of MLN0002 administered intravenously on Days 1, 15 and 43. After that patients will receive 6 mg/kg every 8 weeks for up to 78 weeks, followed by 90 day observation period for post-treatment assessments of safety.
  Other Name: MLN0002
• Drug: vedolizumab (MLN0002)
  Patients rolling over from a previous MLN0002 study will follow the same dosing and follow-up schedule as Arm 1, however they will receive of a dose of 2 mg/kg.
  Other Name: MLN0002

• Experimental: 1
  Patients with no previous exposure to MLN0002 will receive the drug at a dose of 6 mg/kg
  Intervention: Drug: vedolizumab (MLN0002)
• Experimental: 2
  Patients rolling over from a previous MLN0002 study will receive MLN0002 a dose of 2 mg/kg
  Intervention: Drug: vedolizumab (MLN0002)

Inclusion Criteria:

• Confirmed and active UC or CD

  • CDAI Score of 220 - 450
  • Partial Mayo 2 - 7
• Subject should be appropriate candidate for biologic therapy per guidelines
• Up-to-date on cancer screening
• No severe systemic disease
• Agree to comply with study procedures including contraception

Exclusion Criteria:

• Low lymphocyte counts
• History of imaging abnormalities, MS, brain tumor or other neurological illness
• Active or recent serious infections
• Recent treatment with biologic (ie Remicade) or investigational drug
• Impending surgery