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 Are Refractory to or Intolerant of TNF Inhibitors

  • STATUS
    Recruiting
  • sponsor
    Hoffmann-La Roche
Updated on 25 March 2021

Summary

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 Are Refractory to or Intolerant of TNF Inhibitors

Description

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 are refractory to or intolerant of TNF inhibitors.

Exclusion Criteria:
  1. 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
  2. Prior or planned surgery for UC
  3. Past or present ileostomy or colostomy
  4. Any prior treatment with etrolizumab or other anti-integrin agents (including natalizumab, vedolizumab, and efalizumab) and rituximab
  5. Chronic hepatitis B or C infection, human immunodeficiency virus (HIV) or tuberculosis
  6. Evidence of or treatment for Clostridium difficile clinically significant cytomegalovirus (CMV) colitis within 60 days prior to Day 1

Details
Clinical Study IdentifierTX153770
SponsorHoffmann-La Roche
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Moderately to severely active UC as determined by the Mayo Clinic Score assessment (MCS)
Intolerance, loss response or failure to respond to treatment with at least one TNF-inhibitor within the previous 5 years
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 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 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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