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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Age 18 through 75
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 ICS plus 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, 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 HIV or subject taking antiretroviral medications, as determined by medical history and/or subject's verbal report.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator John Hagan, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

John Hagan, M.D.

Closed for enrollment

More information

Publications

In some patients with moderate-to-severe asthma, particularly those with noneosinophilic inflammation, the disease remains uncontrolled. This trial evaluated the efficacy and safety of tezepelumab (AMG 157/MEDI9929), a human monoclonal antibody specific for the epithelial-cell-derived cytokine thymic stromal lymphopoietin (TSLP), in patients whose asthma remained uncontrolled despite treatment with long-acting beta-agonists and medium-to-high doses of inhaled glucocorticoids. Read More on PubMed

Clinical Trials