Overview

This trial is active, not recruiting.

Condition uncontrolled asthma
Treatments tralokinumab, placebo
Phase phase 3
Sponsor AstraZeneca
Start date June 2014
End date February 2017
Trial size 1140 participants
Trial identifier NCT02161757, D2210C00007

Summary

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 β2-Agonist

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
Tralokinumab subcutaneous injection
tralokinumab
Subcutaneous injection
(Placebo Comparator)
Placebo subcutaneous injection
placebo
Subcutaneous injection
(Experimental)
Tralokinumab subcutaneous injection
tralokinumab
Subcutaneous injection
(Placebo Comparator)
Placebo subcutaneous injection
placebo
Subcutaneous injection

Primary Outcomes

Measure
Asthma exacerbation rate reduction (AERR)
time frame: Week 0 to Week 52

Secondary Outcomes

Measure
Percent change from baseline to Week 52 in pre-dose/pre-bronchodilator forced expiratory volume in 1 second
time frame: Week 0 to Week 52
Change from baseline to Week 52 in daily asthma symptom score
time frame: Week 0 to Week 52
Change from baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older total score
time frame: Week 0 to Week 52
Change from baseline to Week 52 in Asthma Control Questionnaire-6 defined asthma control
time frame: Week 0 to Week 52
Annualised asthma exacerbation rate that is associated with an ER or urgent care visit, or a hospitalization
time frame: Week 0 to Week 52
European Quality of Life - 5 Dimension 5 Level Daily Living Questionnaire
time frame: Week 0 to Week 52
Rescue medication use
time frame: Week 0 to Week 52
Home peak expiratory flow (morning and evening)
time frame: Week 0 to Week 52
Night-time awakening due to asthma
time frame: Week 0 to Week 52
Time to first asthma exacerbation
time frame: Week 0 to Week 52
Proportion of subjects with ≥1 asthma exacerbation
time frame: Week 0 to Week 52
Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions
time frame: Week 0 to Week 52
Asthma specific resource utilization
time frame: Week 0 to Week 52
Pharmacokinetic parameters (Ctrough at steady state)
time frame: Week 0 to Week 72
Incidence rate of positive anti-drug antibodies including the characterization of their neutralizing potential
time frame: Week 0 to Week 72
Asthma exacerbation rate reduction
time frame: Week 0 to Week 52

Eligibility Criteria

Male or female participants from 12 years up to 75 years old.

Inclusion Criteria: 1. Age 12 -75 2. Documented physician-diagnosed asthma. 3. Documented treatment with ICS at a total daily dose corresponding to ≥500μg fluticasone propionate dry powder formulation equivalents) and a LABA 4. Morning pre-BD FEV1 value of ≥40 and <80% value (<90% for patients 12 to 17 years of age) of their PNV. 5. Post-BD reversibility of ≥12% and ≥200 mL in FEV1 6. ACQ-6 score ≥1.5 Exclusion Criteria: 1. Pulmonary disease other than asthma 2. History of anaphylaxis following any biologic therapy 3. Hepatitis B, C or HIV 4. Pregnant or breastfeeding 5. History of cancer 6. Current tobacco smoking or a history of tobacco smoking for ≥ 10 pack-years 7. Previous receipt of tralokinumab

Additional Information

Official title A 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 β2-Agonist
Principal investigator Reynold A Panettieri, M.D.
Description This is a randomized, double-blind, parallel group, placebo-controlled study designed to evaluate efficacy and safety of tralokinumab administered subcutaneously in subjects with uncontrolled asthma on inhaled corticosteroid plus long-acting β2-agonist and having a history of asthma exacerbations. Approximately 1140 subjects will be randomized globally. Subjects will receive tralokinumab, or placebo, administered via subcutaneous injection at the study site, over a 52-week treatment period.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.