Clinical Trial Details
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NCT02100696 : A Study of the Efficacy and Safety of Etrolizumab in Ulcerative Colitis Participants Who Are Refractory to or Intolerant of Tumor Necrosis Factor (TNF) Inhibitors
PhasePhase 3
AgesMin: 18 Years Max: 80 Years
Inclusion Criteria:

- Moderately to severely active UC as determined by the Mayo Clinic Score assessment

- Intolerance, loss response or failure to respond to treatment with at least one
TNF-inhibitor within the previous 5 years

- Washout of anti-TNF therapy for at least 8 weeks preceding Day 1

- Background regimen for UC may include oral 5-aminosalicylic acid (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

- Any prior treatment with etrolizumab or other anti-integrin agents (including
natalizumab, vedolizumab, and efalizumab) and rituximab

- Chronic hepatitis B or C infection, human immunodeficiency virus (HIV) or

- Evidence of or treatment for Clostridium difficile clinically significant
cytomegalovirus (CMV) colitis within 60 days prior to Day 1
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