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
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- STATUS
- Recruiting
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- sponsor
- Hoffmann-La Roche
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:- 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
Details
| Condition | Ulcerative Colitis |
|---|---|
| Clinical Study Identifier | TX153770 |
| Sponsor | Hoffmann-La Roche |
| Last Modified on | 25 March 2021 |
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