A Study Evaluating the Effects of Lebrikizumab on Airway Eosinophilic Inflammation in Participants With Uncontrolled Asthma
Status: | Completed |
---|---|
Conditions: | Asthma |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 5/20/2017 |
Start Date: | November 30, 2014 |
End Date: | October 13, 2016 |
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
This Phase II, randomized, double-blind, placebo-controlled, multicenter study will evaluate
the effects of lebrikizumab on airway eosinophilic inflammation in participants with
uncontrolled asthma who are using inhaled corticosteroid (ICS) treatment and a second
controller medication. Enrolled participants will undergo a 3-week screening period during
which assessments, including a bronchoscopy procedure, will be made. Participants will
subsequently be randomized to receive lebrikizumab or placebo by subcutaneous (SC) injection
on Day 1, Day 8, Week 4, and Week 8. Participants 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.
the effects of lebrikizumab on airway eosinophilic inflammation in participants with
uncontrolled asthma who are using inhaled corticosteroid (ICS) treatment and a second
controller medication. Enrolled participants will undergo a 3-week screening period during
which assessments, including a bronchoscopy procedure, will be made. Participants will
subsequently be randomized to receive lebrikizumab or placebo by subcutaneous (SC) injection
on Day 1, Day 8, Week 4, and Week 8. Participants 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.
Inclusion Criteria:
- Asthma diagnosis for greater than or equal to (>/=) 12 months prior to Visit 1
- Bronchodilator response demonstrated within the 12 months before Visit 1 or at Visit
1, 2, or 3 of screening
- Pre-bronchodilator FEV1 of 40 percent (%) - 80% predicted at both Visits 2 and 3
- On ICS therapy at a total daily dose of 500-2000 mcg of fluticasone propionate dry
powder inhaler (DPI) or equivalent for >/= 6 months prior to Visit 1, with no changes
within 4 weeks prior to Visit 1, and no anticipated changes throughout the study
- On an eligible second controller medication (long-acting Beta-agonist [LABA),
leukotriene receptor antagonist [LTRA], long-acting muscarinic antagonists [LAMAs] or
theophylline) for 6 months prior to Visit 1, with no changes within 4 weeks prior to
Visit 1, and no anticipated changes throughout the study
- Uncontrolled asthma at Visit 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 (prior to Visit 3) that confirms the absence
of other clinically significant lung disease
- Demonstrated adherence with controller medication during the screening period
Exclusion Criteria:
- Maintenance oral corticosteroid therapy, defined as daily alternate-day oral
corticosteroid maintenance therapy within 3 months prior to Visit 1
- Treatment with systemic corticosteroids within 4 weeks prior to Visit 1 or during the
screening period for any reason, including an acute exacerbation event
- Any infection requiring hospital, intravenous (IV) or intramuscular (IM) antibiotic
treatment or any respiratory infection within 4 weeks prior to Visit 1 or during
screening. Any infection requiring oral antibiotic treatment with 2 weeks prior to
Visit 1 or during screening, or any parasitic infection within 6 months prior to
Visit 1 or during screening
- Active tuberculosis requiring treatment within 12 months prior to Visit 1
- Known immunodeficiency, including, but not limited to, human immunodeficiency virus
(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 medical disease that is uncontrolled despite treatment, that
is likely, in the opinion of the investigator, to impact the participant's ability to
participate in the study, or to impact the study assessments
- History of alcohol or drug abuse that would impair or risk the participant's full
participation in the study, in the opinion of the investigator
- Current smoker or history of smoking (greater than [>] 10 pack-years), or
unwillingness to abstain from smoking for the duration of the study
- Past and/or current use of any anti-interleukin (IL)-13 or 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 Visit 1 (whichever is longer) or during screening
- Use of other investigational therapy within 4 weeks or 5 drug half-lives prior to
Visit 1 (whichever is longer) or during screening
- Initiation of or increase in allergen immunotherapy within 3 months prior to Visit 1
or during screening
- Body mass index >38 kilograms per square meter (kg/m^2)
- Body weight <40 kilograms (kg)
- History of bronchial thermoplasty
We found this trial at
17
sites
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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1192 East Newport Center Drive
Deerfield Beach, Florida 33442
Deerfield Beach, Florida 33442
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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2315 Stockton Boulevard
Sacramento, California 95817
Sacramento, California 95817
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University of Arizona The University of Arizona is a premier, public research university. Established in...
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Winston-Salem, North Carolina 27157
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