Ulcerative colitis or Crohn's Disease
Conditions
Interventions
Eligible patients will be randomized (1:1:1 ratio) to receive either sc infusion of TEV-48574 (dose A), TEV-48574 (dose B) or matching placebo once every 2 weeks in a double-blind fashion.
Sponsors
Medical Information
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Diagnosis of UC or CD for >= 3 months -Patient with moderate to severe active UC or CD a note: Additional criteria apply
Exclusion criteria
Exclusion criteria: -Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis. -Patient has colonic dysplasia or neoplasia, toxic megacolon, primary sclerosing cholangitis, known non-passable colonic stricture, presence of colonic or small bowel stoma, presence of non-passable colonic or small bowel obstruction or resection preventing the endoscopy procedure, or fulminant colitis. a note: Additional criteria apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with moderate to severe UC who show clinical remission as defined by the Mayo score at week 14 Number of patients with moderate to severe CD who show an endoscopic response as defined by the Endoscopic Score for Crohn's Disease at Week 14 | — |
Countries
Bulgaria, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Japan, Poland, Slovakia, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactInformation Medical
Teva UK Limited
Outcome results
None listed