SHS_211079 AUSK CGEN 15226

Phase III, Randomized, double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Maintenance of Remission) and Safety of Etrolizumab Compared with Placebo in Patients with Moderate to Severe Active Ulcerative Colitis Who are Naive to TNF Inhibitors

This Phase III, double blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab in maintenance of remission in patients with moderately to severely active ulcerative colitis (UC) who are naive to tumor necrosis factor (TNF) inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment.

Inclusion Criteria:

•18-80 years of age, inclusive
•Moderately to severely active UC as determined by the Mayo Clinic Score assessment (MCS)
•Naive to treatment with any anti-TNF therapy
•An inadequate response to or intolerance of prior corticosteroid and/or immunosuppressant treatment
•Background regimen for UC may include oral 5-aminosalicylate (5-ASA), oral corticosteroids, budesonide multi-matrix system (MMX), probiotics, azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX) if doses have been stable during the screening period
•Use of highly effective contraception as defined by the protocol
•Must have received a colonoscopy within the past year or be willing to undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening

Exclusion Criteria:

•A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps
•Prior or planned surgery for UC
•Past or present ileostomy or colostomy
•Have received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, and efalizumab) as stated in the protocol
•Chronic hepatitis B or C infection, HIV or tuberculosis (active or latent)
Phase III
NCT02165215
All Other
Gastrointestinal
Karlee Ausk, M.D.
Genentech
Allison Everett
  • Swedish Medical Center