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
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Lead
Hoffmann-La Roche
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | 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
