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

Study identifier:CD-RI-MEDI9929-1146

ClinicalTrials.gov identifier:NCT02054130

EudraCT identifier:2013-003269-33

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

asthma

Phase

Phase 2

Healthy volunteers

Study drug

Placebo, MEDI9929 70 mg, MEDI9929 210 mg, MEDI9929 280 mg

Sex

All

Actual Enrollment

584

Study type

Interventional

Age

18 Years - 75 Years

Date

Study Start Date: 13 Dec 2013

Primary Completion Date: 12 Dec 2016

Study Completion Date: 01 Mar 2017

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2018 by MedImmune, LLC

Collaborators

Amgen Inc.

Inclusion and exclusion criteria

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.

No locations available

Arms	Assigned Interventions
Placebo Comparator: Placebo Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.	Drug: Placebo Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Experimental: MEDI9929 70 mg Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.	Drug: MEDI9929 70 mg Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
Experimental: MEDI9929 210 mg Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.	Drug: MEDI9929 210 mg Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
Experimental: MEDI9929 280 mg Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.	Drug: MEDI9929 280 mg Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.

Documents available

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Click here to find results for studies related to marketed products.
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CD-RI-MEDI9929-1146_Protocol_Synopsis_Amendment_3_Redacted_04.03.17
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CD-RI-MEDI9929-1146_Protocol_Synopsis_Redacted_06.23.17
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Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

MedImmune LLC

MedImmune, LLC