A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumour Necrosis Factor (TNF) Inhibitors

Official Title

PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAÏVE TO TNF INHIBITORS

Summary:

This is a multicentre, Phase III, randomized, double-blind, double-dummy, parallel-group study to evaluate the safety, efficacy, and tolerability of etrolizumab compared with infliximab in treating participants with moderate to severe ulcerative colitis (UC) who are naive to tumour necrosis factor (TNF) inhibitors. Participants will be randomized in a 1:1 ratio to receive either etrolizumab 105 (milligrams) by subcutaneous (SC) injection [SC] every 4 weeks [Q4W]) + placebo (intravenous [IV] infusion at Weeks 0, 2, and 6, then every 8 weeks) or infliximab 5 milligrams/kilogram (mg/kg) IV at Weeks 0, 2, and 6, then every 8 weeks) + placebo (SC Q4W). Time on treatment is 54 weeks.

Trial Description

Primary Outcome:

  • Percentage of Participants with both Clinical Response at Week 10 and Clinical Remission at Week 54
Secondary Outcome:
  • Percentage of Participants Achieving Clinical Remission, Defined as MCS
  • Percentage of Participants Achieving Clinical Remission, Defined as MCS
  • Percentage of Participants Achieving Clinical Remission at both Week 10 and Week 54, Defined as MCS
  • Percentage of Participants with Improvement from Baseline in Endoscopic Appearance of the Mucosa at Week 10
  • Percentage of Participants with Improvement from Baseline in Endoscopic Appearance of the Mucosa at Week 54
  • Percentage of Participants with Improvement from Baseline in Endoscopic Appearance of the Mucosa at both Week 10 and Week 54
  • Percentage of Participants Achieving Clinical Response, Defined as MCS with >/=3-point Decrease and 30% Reduction from Baseline as well as >/=1-point Decrease in Rectal Bleeding Subscore or an Absolute Rectal Bleeding Score of 0 or 1
  • Percentage of Participants with Endoscopic Remission at Week 54
  • Percentage of Participants Achieving Clinical Response at both Weeks 10 and 54, Defined as MCS with >/=3-point Decrease and 30% Reduction from Baseline, and >/=1-point Decrease in Rectal Bleeding Subscore or an Absolute Rectal Bleeding Score of 0 or 1
  • Percentage of Participants that Achieve Clinical Remission Corticosteroid-Free at Week 54 (off Corticosteroid for at Least 24 Weeks Prior to Week 54)
  • Percentage of participants with Adverse Events
  • Pharmacokinetic: Etrolizumab Serum Concentration
  • Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Weeks 10,30 and 54
  • Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) to Etrolizumab or Infliximab

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society