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



Status:Active, not recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:2/14/2019
Start Date:May 21, 2014
End Date:December 26, 2020

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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 Have Been Previously Exposed to TNF Inhibitors

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 have been
previously exposed to TNF inhibitors.


Inclusion Criteria:

- Moderately to severely active UC as determined by the Mayo Clinic Score assessment
(MCS)

- 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

- Treatment within 5 years prior to screening with one or two induction regimines that
contain TNF inhibitors (including TNF inhibitor biosimilars)

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

- Any prior treatment with anti-adhesion molecules (e.g. anti-MAdCAM-1)

- 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
We found this trial at
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1720 2nd Ave S
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Chapel Hill, North Carolina 27599
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4800 Belfort Rd # 2
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