EUCTR2013-004280-31-CZActive, not recruitingPhase 1
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
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- F. Hoffmann-La Roche Ltd
- Enrollment
- 350
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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)
- •Naive to treatment with TNF inhibitor therapy
- •An inadequate response, loss of response, or intolerance to prior corticosteroid and/or immunosuppressant treatment
- •Background regimen for UC may include oral 5-ASA, oral corticosteroids, budesonide therapy, probiotics, AZA, 6-MP, or MTX if doses have been stable during the screening period
- •Use of highly effective contraception as defined by the protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 339
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
Exclusion Criteria
- •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)
- •Chronic hepatitis B or C infection, HIV, or tuberculosis (active or latent).
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