Asthma
Conditions
Keywords
Asthma, Allergy, IL-13, IL-4, IL-4R
Brief summary
A Multi-center, Randomized, Placebo, Multi-Dose study to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12.
Interventions
BIOLOGICALAMG 317 75 mg
75 mg SC weekly injection
BIOLOGICALAMG 317 150 mg
150 mg SC once weekly injection
BIOLOGICALAMG 317 300 mg
300 mg weekly SC injection
BIOLOGICALPlacebo
Placebo SC once weekly injection
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Males or females 18 to 65 years of age at the time of screening * Baseline percent of predicted FEV1 ≥ 50% to ≤ 80% at screening * At least 12% reversibility over baseline FEV1 with beta agonist inhalation, which can be demonstrated in the office or documented by medical record within the past 12 months * Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone or equivalent. Stable ICS dose for ≥ 30 days before screening and dose expected to remain stable during treatment with investigational agent. Must have used ICS for at least the last 3 consecutive months before screening * If receiving allergen immunotherapy, a stable dose for \> 3 months before screening and anticipated to remain stable for the duration of the study * Positive to skin prick or RAST * Ongoing asthma symptoms with ACQ score at screening and baseline ≥ 1.5 points * Nonsmoker or ex-smoker with \< 10 pack-years (eg, 1 pack per day for 10 years) who stopped ≥ 1 year ago
Exclusion criteria
* Acute asthma exacerbation requiring emergency room (ER) treatment or hospitalization within 3 months * History of endotracheal intubation for asthma-related exacerbation within 3 years of screening * Respiratory illness within 4 weeks of screening * History of chronic obstructive pulmonary disease (COPD) or other chronic pulmonary condition other than asthma * Received long-acting beta agonist, theophylline, inhaled anticholinergics, oral beta 2 agonists, or cromolyn therapeutics within 1 week of first run-in visit. * Leukotriene antagonists within 2 weeks before first run-in visit * Oral or parenteral corticosteroids within 6 weeks before first run-in visit * Live/attenuated vaccinations within 4 weeks of screening or during the study * Any uncontrolled, clinically significant systemic disease (eg, chronic renal failure, uncontrolled hypertension, liver disease)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12. | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline PEFR during week 12 (morning/evening, diurnal and inter-day variation) | 12 weeks |
| Change in pre and post bronchodilator FEV1 at week 12 from baseline | 12 weeks |
| Number of asthma symptom-free days | 16 weeks |
| Change from baseline in frequency of rescue beta agonist use during week 12 | 12 weeks |
| Safety endpoints: number of asthma exacerbations, antibodies, adverse events, and change in ECG, labs and vital signs | 16 weeks |
| Change in AQLQ score at week 12 from baseline | 12 weeks |
| Change from baseline in daily asthma symptoms during week 12 | 12 weeks |
Outcome results
None listed