Status:
COMPLETED
Double-blind, Multiple Dose Study of Tezepelumab (AMG 157) in Adults With Mild Atopic Asthma
Lead Sponsor:
Amgen
Conditions:
Asthma
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 31 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2013
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01405963
Start Date
October 31 2011
End Date
April 5 2013
Last Update
October 17 2022
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Calgary, Alberta, Canada, T2N 4Z6
2
Research Site
Vancouver, British Columbia, Canada, V5Z 1M9
3
Research Site
Hamilton, Ontario, Canada, L8N 3Z5
4
Research Site
Sainte-Foy, Quebec, Canada, G1V 4G5