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Study to Evaluate the Efficacy and Safety of MEDI9929 (AMG 157) in Adult Subjects With Inadequately Controlled, Severe Asthma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study to Evaluate the Efficacy and Safety of MEDI9929 (AMG 157) in Adult Subjects With Inadequately Controlled, Severe Asthma

A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI9929 in Adult Subjects With Inadequately Controlled, Severe Asthma

NCT02054130•MedImmune LLC

View on ClinicalTrials.gov

Summary

The primary objective of the study is to evaluate the effect of 3 dose levels of MEDI9929 (AMG 157) on asthma exacerbations in adult subjects with inadequately controlled, severe asthma.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age 18 through 75
•Body mass index (BMI) between 18-40 kg/m2 and weight greater than or equal 40 kg
•Documented physician-diagnosed asthma - Subjects must have received a physician-prescribed asthma controller regimen with medium- or high-dose inhaled corticosteroids (ICS) plus long acting β2 agonist (LABA) -If on asthma controller medications in addition to ICS plus LABA, the dose of the other asthma controller medications (leukotriene receptor inhibitors, theophylline, secondary ICS, long-acting anti-muscarinics (LAMA), cromones, or maintenance oral prednisone or equivalent up to a maximum of 10 mg daily or 20 mg every other day for the maintenance treatment of asthma) must be stable. -Subjects must have a documented history of at least 2 asthma exacerbation events OR at least 1 severe asthma exacerbation resulting in hospitalization within the 12 months prior to first study visit.

Exclusion Criteria

•Diagnosis of vocal cord dysfunction, reactive airways dysfunction syndrome, hyperventilation and panic attacks, or other mimics of asthma.
•Current smokers or subjects with a smoking history of ≥ 10 pack years
•Former smokers with \< 10 pack years must have stopped for at least 1 year to be eligible.
•Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of subject safety or study results (eg, chronic obstructive pulmonary disease, cystic fibrosis, pulmonary fibrosis, bronchiectasis, allergic bronchopulmonary aspergillosis, Churg-Strauss syndrome).
•Evidence of active liver disease.
•History of Cancer, except for basal cell carcinoma or insitu carcinoma of the cervix treated with apparent success with curative therapy or other malignancies are eligible provided that curative therapy was completed -Known history of active tuberculosis (TB)
•History of anaphylaxis to any biologic therapy
•Positive medical history for hepatitis B or C
•Subject with human immunodeficiency virus (HIV) or subject taking antiretroviral medications, as determined by medical history and/or subject's verbal report.

Locations (107)

Research Site

Los Angeles, California, United States

Research Site

Los Angeles, California, United States

Research Site

Miami, Florida, United States

Research Site

Oviedo, Florida, United States

Research Site

Savannah, Georgia, United States

Research Site

Peoria, Illinois, United States

Research Site

Baltimore, Maryland, United States

Research Site

Rochester, Minnesota, United States

Research Site

New York, New York, United States

Research Site

New York, New York, United States

Key Dates

Start Date

December 13, 2013

Primary Completion Date

December 12, 2016

Completion Date

March 1, 2017

Last Updated

December 4, 2018

Enrollment

584

ACTUAL participants

Conditions

Asthma

Interventions

Placebo

DRUG

MEDI9929 70 mg

DRUG

MEDI9929 210 mg

DRUG

MEDI9929 280 mg

DRUG

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

NCT07219173

Asthma

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RECRUITING

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

NCT02327897

Asthma

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RECRUITINGNA

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

NCT07486401

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: December 4, 2018Data 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.

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Study to Evaluate the Efficacy and Safety of MEDI9929 (AMG 157) in Adult Subjects With Inadequately Controlled, Severe Asthma

Inclusion Criteria

Exclusion Criteria

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)

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

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

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