Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis

Study identifier:D2211C00001

ClinicalTrials.gov identifier:NCT01482884

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

ulcerative colitis

Phase

Phase 2

Healthy volunteers

No

Study drug

tralokinumab, placebo

Sex

All

Actual Enrollment

147

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Mar 2012
Primary Completion Date: 01 Mar 2013
Study Completion Date: 01 Jun 2013

Study design

Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

MedImmune Ltd

Inclusion and exclusion criteria