Evaluation of Efficacy and Safety of Tralokinumab in Patients With Active, Moderate-to-severe Ulcerative Colitis

Phase 2 Completed 147 enrolled AstraZeneca MedImmune LLC · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2012-03
Primary completion: 2013-03
Completion: 2013-06

Outcome

Missed primary endpoint

registry Tralokinumab vs Placebo; p = 0.4062; Risk Difference (RD) 4.8 (95% CI -13.0 to 22.5) NCT01482884 ↗

paper Add-on therapy with tralokinumab did not significantly improve clinical response. PMID 25304132 ↗

Publications

Results Danese S, Rudzinski J, Brandt W, Dupas JL, Peyrin-Biroulet L, Bouhnik Y, Kleczkowski D, Uebel P, Lukas M, Knutsson M, Erlandsson F, Hansen MB, Keshav S. Tralokinumab for moderate-to-severe UC: a randomised, double-blind, placebo-controlled, phase IIa study. Gut. 2015 Feb;64(2):243-9. doi: 10.1136/gutjnl-2014-308004. Epub 2014 Oct 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tralokinumab	Monoclonal antibody	300 mg	Subcutaneous