A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN ADULT PATIENTS WITH MILD TO MODERATE ASTHMA

Hoffmann-La Roche0 sites313 target enrollmentJune 2014

ConditionsAsthma

Interventionsplacebo montelukast [Singulair]lebrikizumab

Drugslebrikizumab montelukast [Singulair]

Overview

Phase: Phase 3
Intervention: placebo
Conditions: Asthma
Sponsor: Hoffmann-La Roche
Enrollment: 313
Primary Endpoint: Absolute change in pre-bronchodilator forced expiratory volume in 1 second (FEV1)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This Phase III, randomized, double-blind, placebo-controlled, multicenter study will assess the efficacy and safety of lebrikizumab in adult patients with mild to moderate asthma treated with short-acting beta-agonist (SABA) therapy alone. Patients will be randomized in a 1:1:1 ratio to receive either blinded lebrikizumab or placebo treatment by subcutaneous (SC) injection (every 4 weeks for a total of 3 doses) or open-label treatment with Singulair (Montelukast; 10 mg daily). Time on study treatment will last 12 weeks.

Registry

clinicaltrials.gov

Start Date

June 2014

End Date

May 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18-75 years old at study start
•Asthma diagnosis for \>/= 12 months prior to study start
•Bronchodilator response at screening
•Pre-bronchodilator FEV1 of 60% - 85% predicted at both screening visits 2 and 3
•No other clinically significant lung disease as confirmed by chest X-ray or computed tomography (CT) scan
•Stable and symptomatic asthma during the screening period
•Use of effective contraception, as defined by the protocol, until 24 weeks after the last dose

Exclusion Criteria

•Maintenance of corticosteroid therapy, defined as daily or alternate-day oral corticosteroid maintenance therapy within 3 months prior to study start
•Treatment with systemic or inhaled corticosteroids within 4 weeks prior to study start or during the screening period for any reason, including an acute exacerbation event
•Treatment with a leukotriene receptor antagonist (LTRA), long-acting beta-agonist (LABA) long-acting muscarinic antagonist (LAMA), zileuton, roflumilast, or theophylline within 2 weeks prior to study start
•Documented prior treatment failure with Montelukast
•Treatment with intra-articular corticosteroids within 4 weeks prior to study start or during the screening period or anticipated need for intra articular corticosteroids during the course of the study
•Any infection requiring hospital, IV or IM antibiotic treatment or any respiratory infection within 4 weeks of study start. Any infection requiring oral antibiotic treatment within 2 weeks of study start, or any parasitic infection within 6 months of study start
•Clinically significant abnormality found during screening or clinically significant medical disease that is uncontrolled despite treatment that is likely, in the opinion of the investigator, to impact the patient's ability to participate in the study, or impact the study assessments
•History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease other than asthma
•History of alcohol or drug abuse that would impair or risk the patient's full participation in the study, in the opinion of the investigator
•Current or history of smoking (\> 10 pack-years), or unwillingness to abstain from smoking for the duration of the study

Arms & Interventions

Placebo

Intervention: placebo

Singulair (montelukast)

Intervention: montelukast [Singulair]

lebrikizumab

Intervention: lebrikizumab

Outcomes

Primary Outcomes

Absolute change in pre-bronchodilator forced expiratory volume in 1 second (FEV1)

Time Frame: From Baseline to Week 12

Secondary Outcomes

Relative change in morning pre-bronchodilator peak expiratory flow (PEF)(From Baseline to Week 12)
Time to treatment failure(From Baseline to Week 12)
Pharmacokinetics: Maximum serum lebrikizumab concentration after the first dose (Cmax)(Week 1)
Change in patient-reported outcome, as measured by the Standardized Asthma Quality of Life Questionnaire (AQLQ(S))(From Baseline to Week 12)
Change in asthma rescue medication use(From Baseline to Week 12)
Incidence of adverse events(Approximately 20 weeks)
Pharmacodynamics: Change in blood eosinophil count(From Baseline to Week 12)
Pharmacodynamics: Relative change in fractional exhaled nitric oxide (FeNO)(From Baseline to Week 12)