Summary

for people ages 18-80 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Melvin Heyman

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 have been previously exposed to 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 Have Been Previously Exposed to TNF Inhibitors

Keywords

Ulcerative Colitis Colitis Ulcer Colitis, Ulcerative Etrozulimab

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)
  • 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, 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
  • Treatment within 5 years prior to screening with one or two induction regimines that contain TNF inhibitors (including TNF inhibitor biosimilars)

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
  • Any prior treatment with anti-adhesion molecules (e.g. anti-MAdCAM-1)
  • 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

  • University of California at San Francisco in progress, not accepting new patients
    San Francisco California 94115 United States
  • Uni. of California at San Francisco; Dept Pediatric, Div. of Gastroenterology, Hepatology & Nutri accepting new patients
    San Francisco California 94158 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