Overview

This trial is active, not recruiting.

Condition asthma
Treatments lebrikizumnab, placebo
Phase phase 2
Sponsor Hoffmann-La Roche
Start date November 2014
End date April 2017
Trial size 64 participants
Trial identifier NCT02099656, GB29260

Summary

This phase II, randomized, double-blind, placebo-controlled study will evaluate the effects of lebrikizumab on airway eosinophilic inflammation in patients with uncontrolled asthma who are using inhaled corticosteroid (ICS) treatment and a second controller medication. Enrolled patients will undergo a 3-week screening period during which assessments, including a bronchoscopy procedure, will be made. Patients will subsequently be randomized to receive lebrikizumab or placebo by subcutaneous injection (SC) on Day 1, Day 8, Week 4, and Week 8. Patients will continue their standard of care therapy throughout the study. End of treatment assessments will be taken at Week 12. Total study period, including screening and follow-up, is expected to last 23 weeks.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
lebrikizumnab
Given by SC on Day 1, Day 8, Week 4, and Week 8
(Placebo Comparator)
placebo
Given by SC on Day 1, Day 8, Week 4, and Week 8

Primary Outcomes

Measure
Relative change in the number of airway submucosal eosinophils per surface area of basal lamina (cells/mm2)
time frame: From Baseline to Week 12

Secondary Outcomes

Measure
Relative change in forced expiratory volume in 1 second (FEV1)
time frame: From Baseline to Week 12
Incidence of adverse events
time frame: Up to Week 20
Absolute change in number of airway submucosal eosinophils per surface area of basal lamina (cells/mm2)
time frame: From Baseline to Week 12
Relative change in the number of airway epithelial eosinophils per surface area of basal lamina (cells/mm2)
time frame: From Baseline to Week 12
Absolute change in the number of airway epithelial eosinophils per surface area of basal lamina (cells/mm2)
time frame: From Baseline to Week 12
Relative change in number of airway submucosal eosinophils per volume of submucosa (cells/mm3)
time frame: From Baseline to Week 12
Absolute change in number of airway submucosal eosinophils per volume of submucosa (cells/mm3)
time frame: Form Baseline to Week 12
Relative change in number of airway epithelial eosinophils per volume of epithelium (cells/mm3)
time frame: From Baseline to Week 12
Absolute change in number of airway epithelial eosinophils per volume of epithelium (cells/mm3)
time frame: From Baseline to Week 12
Changes in asthma-related biomarkers
time frame: From Baseline to Week 12
Change in lung epithelial cell gene expression
time frame: From Baseline to Week 12
Relative change in fractional exhaled nitric oxide (FeNO)
time frame: From Baseline to Week 12

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Age 18-75 years old at study start - Asthma diagnosis for >/= 12 months prior study start - Documented Bronchodilator Reversibility within past 12 months or during screening - Pre-bronchodilator FEV1 of 40% - 80% predicted at both screening visits 2 and 3 - On ICS therapy at a total daily dose of 500-2000 ug of fluticasone propionate dry powder inhaler (DPI) or equivalent for >/= 6 months prior to study start, with no changes within 4 weeks prior, and no anticipated changes throughout the study - On an eligible second controller medication (LABA, LTRA, LAMA, or theophylline) for 6 months prior to study start, with no changes within 4 weeks prior, and no anticipated changes throughout the study - Uncontrolled asthma at screening visits 1 and/or 2, and at visit 3 - Chest X-ray or computed tomography (CT) scan within 12 months prior to Visit 1 or chest X-ray during the screening period that confirms the absence of other clinically significant lung disease - Demonstrated adherence with controller medication during the screening period - Use of effective contraception, as defined by the protocol, until 24 weeks after the last dose Exclusion Criteria: - Maintenance oral corticosteroid therapy, defined as daily r alternate-day oral corticosteroid maintenance therapy within 3 months prior to study start - Treatment with systemic corticosteroids within 4 weeks prior to study start or during the screening period for any reason - Any infection requiring hospital, IV or IM antibiotic treatment or any respiratory infection within 4 weeks of study start or during screening. Any infection requiring oral antibiotic treatment with 2 weeks of study start, or any parasitic infection within 6 months of study start during screening - Active tuberculosis requiring treatment within 12 months prior to study start or during screening - Known immunodeficiency, including, but not limited to, HIV infection - History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease other than asthma - Known current malignancy or current evaluation for a potential malignancy - Unable to safely undergo elective flexible fiberoptic bronchoscopy - 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 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 - Past and/or current use of any anti IL-13 r anti IL-4/IL-13 therapy, including lebrikizumab - Use of a licensed or investigational monoclonal antibody other than anti-IL-13, or anti IL-4/IL-13, including, but not limited to, omalizumab, anti IL-5, or anti IL-17, within 6 months or 5 drug half-lives prior to Visit 1 (whichever is longer) or during screening - Use of a systemic immunomodulatory or immunosuppressive therapy within 3 months or 5 drug half-lives prior to study start (whichever is longer) or during screening - Use of other investigational therapy within 4 weeks or 5 drug half-lives rior to study start (whichever is longer) or during screening - Initiation of or increase in allergen immunotherapy within 3 months prior to study start or during screening - Body mass index > 38 kg/m2 - Body weight < 40 kg - History of bronchial thermoplasty

Additional Information

Official title A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED BRONCHOSCOPY STUDY TO EVALUATE THE EFFECTS OF LEBRIKIZUMAB ON AIRWAY EOSINOPHILIC INFLAMMATION IN PATIENTS WITH UNCONTROLLED ASTHMA ON INHALED CORTICOSTEROIDS AND A SECOND CONTROLLER MEDICATION
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.