Evaluation of Efficacy and Safety of MEDI2070 in Subjects With Active, Moderate to Severe Crohn's Disease

This is a four-part Phase 2b study comprised of a 16-week, double-blind, placebo-controlled,
Induction Period, a 12-week double-blind, placebo-controlled, Maintenance Period, a 24-week,
Open-label Period and a post-treatment 28 week observational safety follow-up period designed
to evaluate the short-term efficacy and the short- and long term safety of MEDI2070 in
subjects with moderate to severe, active CD who have failed or are intolerant to anti-TNFα
therapy as determined by the Investigator.

Inclusion Criteria:

- Diagnosis of ileal, ileo-colonic, or colonic Crohn's Disease (CD) for > 3 months prior
to screening - Men or women age 18 - 80 years at the time of screening - Moderate to
severely active CD, as defined by Crohn's Disease Activity Index (CDAI) AND endoscopic
demonstration of inflammation - Stable dose of medications for Crohn's disease therapy
-Prior treatment failure or intolerance with at least one Anti Tumor Necrosis
Factor-Alpha Therapy (anti-TNF α) agent. -Effective contraception from screening, and
for 36 weeks after the last dose of investigational product -No known history of
active tuberculosis (TB) & negative assessment for TB/latent TB

Exclusion Criteria:

- Severe underlying immunosuppression

- Severe gastrointestinal complications; e.g., short bowel syndromes, obstructing
strictures, recent or planned bowel surgery, Ileostomy and/or colostomy, recent bowel
perforation

- Significant infections at screening; Infected abscess, positive for Clostridium
difficile, recent infectious hospitalization,

- Recent treatment with approved or investigational biologic therapy for Crohn's disease

- Recent or planned live attenuated vaccine

- History of cancer, except for basal cell carcinoma or CIS of the cervix with apparent
cure ≥ 12 months before screening

- Pregnancy/breast feeding

- Drug abuse