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Double-blind, Multiple Dose Study of Tezepelumab (AMG 157) in Adults With Mild Atopic Asthma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 157 in Subjects With Mild Atopic Asthma

NCT01405963•Amgen

View on ClinicalTrials.gov

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 157), as well as the safety, tolerability, immunogenicity, and pharmacokinetics of multiple doses of tezepelumab in adults with mild atopic asthma.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

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

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

Locations (5)

Research Site

Calgary, Alberta, Canada

Research Site

Vancouver, British Columbia, Canada

Research Site

Hamilton, Ontario, Canada

Research Site

Sainte-Foy, Quebec, Canada

Research Site

Saskatoon, Saskatchewan, Canada

Key Dates

Start Date

October 31, 2011

Primary Completion Date

April 5, 2013

Completion Date

April 5, 2013

Last Updated

October 17, 2022

Enrollment

ACTUAL participants

Conditions

Asthma

Interventions

Placebo

DRUG

Tezepelumab

BIOLOGICAL

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

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Asthma ExacerbationsBiomarkers / Blood+1 more

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RECRUITINGPHASE2

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

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Asthma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 17, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma