Study of Tralokinumab in Severe Asthma

Study of Tralokinumab in Severe Asthma

This is a randomized, double-blind, parallel group, placebo-controlled study designed to
evaluate the efficacy and safety of a fixed 300 mg dose of tralokinumab administered
subcutaneously in subjects with uncontrolled asthma despite the use of regular asthma controller inhaled medication and having a history of asthma exacerbations.Approximately 5% to 10% of asthma patients have severe asthma, many of whom may be
inadequately controlled by inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA)
in combination with additional controller therapies. These patients are at risk of asthma exacerbations, have a large medical need, and represent the greatest economic burden.Tralokinumab is a human recombinant monoclonal antibody (MAb) of the immunoglobulin
G4 subclass that specifically binds human IL-13, blocking interactions with the IL-13
receptor. Tralokinumab is in development for the treatment of severe asthma. A phase 2a
study (MI-CP199) provided evidence of improvement of lung function (forced expiratory
volume in 1 second (FEV1)), following the addition of subcutaneous (SC) tralokinumab to
standard asthma controller medications. Doses of 300 and 600 mg every 2 weeks of
tralokinumab both resulted in comparable effects in FEV1 that were greater than that observed
with a 150 mg dose (Piper et al 2013). Since low pre-bronchodilator (BD) FEV1 has been
identified as a strong independent predictor of subsequent asthma exacerbations, it is plausible
that the addition of tralokinumab will reduce the rate of asthma exacerbations in this
population (Reddel et al 2009).The Primary objective of this study is to evaluate the effect of tralokinumab 300mg administered every 2 weeks compared with placebo on the annualised asthma exacerbation rate in two populations.Approximately 770 subjects ages 12-75 years old will be randomized globally. Subjects will receive either tralokinumab 300 mg, or placebo every 2 weeks via subcutaneous injection at the study site, over a 52-week treatment period.

Participant Eligibility

Below are listed the main Inclusion and Exclusion criteria for this study:

Main Inclusion Criteria
• Ages 12-75
• You have to be currently using an inhaled steroid/long acting bronchodilator daily. Examples are QVAR, Symbicort, Pulmicort, Flexhaler, Advair, Flovent, Dulera
• You need to be on a second drug, as well. Usually something like singulair
• Morning pre-bronchodilator FEV1 of

Contact

Mary Bausch-Jurken, PhD
(414) 266-6165

Additional Study Details

Full Study Title
D2210C00008 – A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting â2-Agonist

Study ID: CHW 15/51

ClinicalTrials.gov Link:

Accepts Healthy Volunteers?
No

Principal Investigator(s)
John Routes, MD

Study Sites
Children’s Hospital of Wisconsin