A Study of the Efficacy and Safety of Etrolizumab in Ulcerative Colitis Participants Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors

  • Ulcerative Colitis
Trial Status:

Active, not recruiting

This trial runs in
Countries
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Korea, Republic of
  • Lithuania
  • Mexico
  • Netherlands
  • Poland
  • Romania
  • Spain
  • Switzerland
  • United Kingdom
  • United States
Trial Identifier:

NCT02100696 2013-004278-88 GA28950

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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, 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.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT02100696 , GA28950 , 2013-004278-88 Trial Identifier
      Etrozulimab, Placebo Treatments
      Ulcerative Colitis Condition
      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

      Eligibility Criteria

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

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

       

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