Study identifier:D2211C00001
ClinicalTrials.gov identifier:NCT01482884
EudraCT identifier:N/A
CTIS identifier:N/A
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
ulcerative colitis
Phase 2
No
tralokinumab, placebo
All
147
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Mar 2016 by AstraZeneca
AstraZeneca
MedImmune Ltd
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: 1 tralokinumab (CAT-354) sc injection | Drug: tralokinumab 2 sc injections of every 2 weeks for 12 weeks. |
Placebo Comparator: 2 placebo sc injection | Drug: placebo 2 sc injections of every 2 weeks for 12 weeks. |