A Study of the Safety and Efficacy of Etrolizumab in Patients with Moderately to Severely Active Crohn’s Disease

This is a multicenter, Phase III, double-blind, placebo-controlled study evaluating the safety and efficacy of etrolizumab during induction and maintenance treatment of moderate to severely active Crohn's disease (CD) in patients who are anti-tumor necrosis factor (TNF) naive (TNF-naive) and in patients who are refractory or intolerant of tumor necrosis factor inhibitors.

Inflammatory Bowel Disease - Crohn's Disease, Inflammatory Bowel Disease
Karlee Ausk, MD
Allison Everett

Inclusion Criteria:

  • 18-80 years of age (inclusive)
  • Moderately to severely active Crohn's disease as determined by the Crohn's Disease Activity Index (CDAI), patient reported outcomes and endoscopically defined disease activity in the ileum and/or colon
  • Intolerance, loss of response or failure to respond to corticosteroids (CS) or, immunosuppressants (IS), or TNF inhibitors within the previous 5 years
  • Use of effective contraception as defined by the protocol

Exclusion Criteria:

  • A history of, or current conditions affecting the digestive tract, such as ulcerative colitis, indeterminant colitis, fistulizing disease, abdominal or perianal abscess, adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowel syndrome
  • Planned surgery for CD
  • Ileostomy or colostomy
  • Has received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, and efilizumab, as stated in the protocol)
  • Chronic hepatitis B or C infection, HIV, active or latent tuberculosis (patients with prior history of BCG vaccination must pass protocol-defined screening criteria)

Allison Everett