A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors

  • Ulcerative Colitis
Trial Status:

Active, not recruiting

This trial runs in
Countries
  • Brazil
  • Canada
  • Czechia
  • Denmark
  • Germany
  • Hungary
  • India
  • Israel
  • Italy
  • Mexico
  • Poland
  • Slovakia
  • South Africa
  • Ukraine
  • United States
Trial Identifier:

NCT02165215 2013-004280-31 GA29102

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial 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.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT02165215 , GA29102 , 2013-004280-31 Trial Identifier
      Etrolizumab, Placebo Treatments
      Colitis, Ulcerative Condition
      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

      Eligibility Criteria

      All Gender
      ≥ 18 Years & ≤ 80 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • 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
      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
      • 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)

      For the latest version of this information please go to www.forpatients.roche.com

       

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