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Eligibility
for people ages 18–80
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

This phase III, double blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission in participants with moderately to severely active ulcerative colitis (UC) who are refractory to or intolerant of TNF inhibitors.

Official Title

Phase III, Double Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab During Induction and Maintenance in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Refractory to or Intolerant of TNF Inhibitors

Keywords

Ulcerative Colitis

Eligibility

You can join if…

Open to people ages 18–80

  • Moderately to severely active UC as determined by the Mayo Clinic Score assessment(MCS)
  • 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

You CAN'T join if...

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

Locations

  • Uni. of California at San Francisco; Dept Pediatric, Div. of Gastroenterology, Hepatology & Nutri accepting new patients
    San Francisco, California, 94158, United States
  • Sutter Gould Medical Foundation terminated
    Modesto, California, 95355, United States
  • Sutter Institute for Medical Research terminated
    Roseville, California, 95661, United States
  • Gastrointestinal Bioscience terminated
    Los Angeles, California, 90067, United States
  • Santa Monica Research Institute terminated
    Santa Monica, California, 90404, United States
  • UCLA Medical Center withdrawn
    Los Angeles, California, 90095, United States
  • Community Clinical Trials terminated
    Orange, California, 92868, United States
  • Las Vegas Medical Research withdrawn
    Las Vegas, Nevada, 89113, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT02100696
Phase
Phase 3
Lead Scientist
Melvin Heyman
Study Type
Interventional
Last Updated
March 1, 2017
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