Conditions: Ulcerative Colitis
Keywords: tralokinumab inflammatory bowel disease moderate to severe ulcerative colitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 147
Healthy volunteers: no

Brief summary:
The study is designed to evaluate the clinical efficacy and safety of tralokinumab as compared to placebo. Investigational product will be administered as subcutaneous injection. All patients will continue background therapy for ulcerative colitis as per local standards of care in addition to investigational product.

Detailed description:
A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis

Arms:
arm 1: tralokinumab (CAT-354) sc injection arm 2: placebo sc injection

Interventions: intervention 1: tralokinumab intervention 2: placebo
Intervention descriptions: intervention 1: 2 sc injections of every 2 weeks for 12 weeks. intervention 2: 2 sc injections of every 2 weeks for 12 weeks.

Protocol document: