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

Completed · Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

This Phase III, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with moderately to severely active ulcerative colitis (UC) who have been previously exposed to TNF inhibitors.

Key facts

Study ID

NCT02100696

Run by

Hoffmann-La Roche

People needed

609

Starts

2014-05-21

Expected to finish

2020-04-16

Last updated by the study team

2021-08-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of UC established at least 3 months prior to Day 1
• Moderately to severely active UC as determined by the Mayo Clinic Score (MCS) assessment
• Treatment within 5 years prior to screening with one or two induction regimens that contain TNF inhibitors (including TNF inhibitor biosimilars)
• 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

You may not qualify if…

• A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, suspicion of ischemic colitis, radiation colitis, or microscopic 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)
• Any prior treatment with anti-adhesion molecules (e.g. anti-MAdCAM-1)
• Any prior treatment with rituximab
• Any treatment with tofacitinib during screening
• Congenital or acquired immune deficiency, chronic hepatitis B or C infection, human immunodeficiency virus (HIV) positive, or history of tuberculosis (active or latent)
• Evidence of or treatment for Clostridium difficile or clinically significant cytomegalovirus (CMV) colitis within 60 days prior to Day 1
• Evidence of or treatment for other intestinal pathogens within 30 days prior to Day 1
• History of recurrent opportunistic infections and/or severe disseminated viral infections
• History of organ transplant
• Any major episode of infection requiring treatment with intravenous (IV) antibiotics within 8 weeks prior to screening or oral antibiotics within 4 weeks prior to screening
• Received a live attenuated vaccine within 4 weeks prior to Day 1

Where it is running

• University of California San Diego Medical Center — La Jolla, California, United States
• Clinical Applications Laboratories, Inc. — San Diego, California, United States
• Precision Research Institute, LLC — San Diego, California, United States
• University of California at San Francisco — San Francisco, California, United States
• Rocky Mountain Gastroenterology Associates — Denver, Colorado, United States
• Rocky Mountain Gastroenterology Associates, P.L.L.C.; Gastroenterology — Lakewood, Colorado, United States
• FQL Research, LLC — Miramar, Florida, United States
• Center For Digestive Health — Orlando, Florida, United States
• Internal Medicine Specialists — Orlando, Florida, United States
• Shafran Gastroenterology Center — Winter Park, Florida, United States
• Gastroenterology Associates of Central Georgia — Macon, Georgia, United States
• Gastrointestinal Specialists of Georgia, PC — Marietta, Georgia, United States
• Atlanta Gastroenterology Specialists, PC — Suwanee, Georgia, United States
• Northwestern University Feinberg School Of Medicine — Chicago, Illinois, United States
• Southwest Gastroenterology — Oak Lawn, Illinois, United States
• Cotton-O'Neil Clinical Research Center, Digestive Health — Topeka, Kansas, United States
• Gastroenterology Associates, LLC — Baton Rouge, Louisiana, United States
• Louisiana Research Center, LLC — Shreveport, Louisiana, United States
• Massachusetts General Hospital; Crohn's & Colitis Center — Boston, Massachusetts, United States
• University of Michigan; Michigan Institute for Clinical and Health Research (MICHR) — Ann Arbor, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Center for Digestive Health — Troy, Michigan, United States
• Kansas City Research Institute, LLC — Kansas City, Missouri, United States
• Clinica Peruano Americana S.A. — Great Neck, New York, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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