A Study of the Efficacy and Safety of Etrolizumab in Ulcerative Colitis Participants Who Are Refractory to or Intolerant of Tumor Necrosis Factor (TNF) Inhibitors

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

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
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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Edward Loftus, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Edward Loftus, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

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