PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (MAINTENANCE OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - LAURE

F. Hoffmann-La Roche Ltd0 sites350 target enrollmentJuly 31, 2014

Overview

No summary available.

Registry

who.int

Start Date

July 31, 2014

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- 18\-80 years of age, inclusive.
•\- Diagnosis of UC established at least 3 months prior to Day 1 by clinical and endoscopic evidence
•\- Moderately to severely active UC as determined by the Mayo Clinic Score assessment (MCS)
•\- Evidence of UC extending a minimum of 20 cm from the anal verge as determined by baseline endoscopy
•\- Naive to treatment with any anti\-TNF therapy
•\-Patients must have an inadequate response, loss of response, or intolerance to prior corticosteroid and/or immunosuppressant treatment
•\- 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
•Are the trial subjects under 18? no

•\- 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.
•\- Have received non\-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, and efalizumab) as stated in the protocol.
•\- 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 within 60 days prior to Day 1 or other intestinal pathogens within 30 days prior to Day 1
•\- History of recurrent opportunistic infections, severe disseminated viral infections and organ transplant