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Study Complete
Sponsor ID
20101183

Double-blind, Multiple Dose Study of Tezepelumab (AMG 157) in Adults with Mild Atopic Asthma

Sponsor ID
20101183
Clinicaltrials.gov ID
NCT01405963
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The purpose of this study is to assess the late and early asthmatic response after an allergen inhalation challenge in adults with mild atopic asthma after receiving multiple doses of tezepelumab (AMG 157), as well as the safety, tolerability, immunogenicity, and pharmacokinetics of multiple doses of tezepelumab in adults with mild atopic asthma.

Additional Study Details

Phase
Phase 1
Product
AMG 157
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
31
Additional Study Details

Protocol Summary

Primary Outcome Measures

Evaluate late asthmatic response, as measured by area under the curve (AUC) in the forced expiratory volume (FEV1) in 1 sec btwn 3 & 7 hrs after an allergen inhalation challenge in mild atopic asthmatic subjects

Timeframe: 14 weeks

Evaluate late asthmatic response, as measured by the max percentage fall in the forced expiratory volume (FEV1) in 1 sec btwn 3 & 7 hrs after an allergen inhalation challenge in mild atopic asthmatic subjects

Timeframe: 14 weeks

Secondary Outcome Measures

Evaluate early asthmatic response, as measured by area under the curve (AUC) in forced expiratory volume (FEV1) in 1 sec btwn 0 & 2 hrs after an allergen inhalation challenge in mild atopic asthmatic subjects

Timeframe: 14 weeks

Evaluate early asthmatic response, as measured by the max percentage fall in forced expiratory volume (FEV1) in 1 sec btwn 0 & 2 hrs after an allergen inhalation challenge in mild atopic asthmatic subjects

Timeframe: 14 weeks

Measure the area under the plasma concentration curve versus time of AMG 157 after multiple dose administration in subjects with mild atopic asthma

Timeframe: 26 weeks

Examine the number of adverse events per subject, after multiple dose administration of AMG 157 in subjects with mild atopic asthma

Timeframe: 26 weeks

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Hamilton, ON, Canada, L8N 3Z5
Status
Recruiting
Location
Research Site
Sainte-Foy, QC, Canada, G1V 4G5
Status
Recruiting
Location
Research Site
Saskatoon, SK, Canada, S7N 0W8
Status
Recruiting
Location
Research Site
Vancouver, BC, Canada, V5Z 1M9
Status
Recruiting
Location
Research Site
Calgary, AB, Canada, T2N 4Z6
Status
Recruiting
Study Info
Age
18 - 60 Years
Condition
  • Asthma
    • Sex
    All
    Trial Dates
    Oct 2011 - Apr 2013
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Male or female subjects with history of mild atopic asthma between 18 and 60 years-of-age - Body mass index (BMI) between 18 and 35 kg/m^2 - Normal or clinically acceptable physical examination (PE), clinical laboratory values, and electrocardiogram (ECG); clinically acceptable PE includes history of mild atopic asthma - Used only inhaled short-acting β2-agonists infrequently to treat asthma - No current exposure to allergens to which subject experiences asthmatic responses - No other lung disease, exacerbations of asthma or lower respiratory tract infections for at least 6 weeks prior to screening - Positive skin prick test to common aeroallergens at screening - Additional inclusion criteria apply
    Exclusion Criteria:
    - History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion; - History or current medical conditions that are contraindicated for methacholine challenge, such as myocardial infarction or stroke within previous 3 months, known cardiac disease, uncontrolled hypertension and aortic or cerebral aneurysm - Evidence of active or suspected bacterial, viral, fungal or parasitic infections within past 6 weeks - Subject has know type I/II diabetes - History of residential exposure to tuberculosis or has a positive purified protein derivative (PPD) or QuantiFERON test within 4 weeks before randomization - Subject who has history of malignancy of any type within 5 years prior to enrollment - Subjects tested positive for drugs/alcohol or nicotine use at screening - Subjects tested positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C - Additional exclusion criteria apply