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Summary

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

Description

Summary

This Phase III, randomized, double-blind, parallel-grouped, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab in maintenance of remission in participants with moderately to severely active UC who are naive to TNF inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment.

Official Title

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

Keywords

Colitis, Ulcerative Colitis Ulcer

Eligibility

You can join if…

Open to people ages 18–80

  • Moderately to severely active UC as determined by an MCS of 6-12 with an endoscopic subscore greater than or equal to (>=) 2 as determined by the central reading procedure (endoscopy to be performed 4-16 days prior to Day 1), a rectal bleeding subscore >=1, and a stool frequency subscore >= 1 during the screening period (prior to Day 1)
  • Evidence of UC extending a minimum of 20 centimeters (cm) from the anal verge as determined by baseline endoscopy (flexible sigmoidoscopy or colonoscopy) performed during screening, 4-16 days prior to Day 1
  • Naive to treatment with any anti-TNF therapy
  • Participants must have had an inadequate response, loss of response, or intolerance to 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
  • 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
  • Have received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, and efalizumab) as stated in the protocol
  • Prior treatment with anti-adhesion molecules (such as mucosal addressin cell adhesion molecule [MAdCAM-1])
  • Chronic hepatitis B or C infection, human immunodeficiency virus (HIV), or tuberculosis (active or latent)

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
  • Ventura Clinical Trials accepting new patients
    Ventura, California, 93003, United States
  • Facey Medical Group withdrawn
    Mission Hills, California, 91345, United States
  • Gastrointestinal Bioscience terminated
    Los Angeles, California, 90067, United States
  • Santa Monica Research Institute terminated
    Santa Monica, California, 90404, United States
  • University of California, Irvine Medical Center accepting new patients
    Orange, California, 92868, United States
  • Therapeutic Research Institute of Orange County withdrawn
    Laguna Hills, California, 92653, 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
NCT02165215
Phase
Phase 3
Study Type
Interventional
Last Updated
December 5, 2017
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