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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02054130
First Posted: February 4, 2014
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Amgen
Information provided by (Responsible Party):
MedImmune LLC
  Purpose
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.

Condition Intervention Phase
Asthma Drug: Placebo Drug: MEDI9929 - Low Dose IP Drug: MEDI9929 - Medium Dose IP Drug: MEDI9929 - High Dose IP Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Rate of asthma exacerbations [ Time Frame: Week 52 ]
    Annualized asthma exacerbation rate (AER)


Secondary Outcome Measures:
  • Change from baseline in pre-bronchodilator FEV1 and FVC [ Time Frame: Week 52 ]
    Measured by pre-bronchodilator FEV1 and FVC.

  • Change from baseline in post-bronchodilator FEV1 and FVC [ Time Frame: Week 52 ]
    Measured by post-bronchodilator FEV1 and FVC.

  • Change from baseline in overall symptom score measured by the Asthma Daily Diary (ACQ-6) [ Time Frame: Week 52 ]
    Measured by the Asthma Daily Diary (ACQ-6)

  • Rate of severe asthma exacerbations [ Time Frame: Week 52 ]
    Annualized severe AER.

  • Time to first asthma exacerbation/severe asthma exacerbation [ Time Frame: Week 52 ]
    Time to first asthma exacerbation/severe asthma exacerbation.

  • Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ[S] +12) and European Quality of Life (EQ-5D-5L) [ Time Frame: Week 52 ]
    AQLQ[S] +12 and EQ-5D-5L

  • Numper of Participants with treatment-emergent adverse events and treatment-emergent serious adverse events [ Time Frame: Week 0 (Day 1) - Week 64 ]
    Number of Participants with treatment-emergent adverse events and treatment-emergent serious adverse events

  • Number of participants with positive antibodies to MEDI9929 [ Time Frame: Week 0 (Day 1) - Week 64 ]
    Number of participants with positive antibodies to MEDI9929

  • Proportion of subjects with one or more asthma exacerbations/severe asthma exacerbations [ Time Frame: Week 52 ]
    Proportion of subjects with one or more asthma exacerbations/severe asthma exacerbations


Enrollment: 584
Actual Study Start Date: December 13, 2013
Study Completion Date: March 1, 2017
Primary Completion Date: December 12, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo Comparator
Drug: Placebo
Placebo
Other Name: Subcutaneous repeating dose
Experimental: MEDI9929 - Low Dose
MEDI9929 (Investigational Product)
Drug: MEDI9929 - Low Dose IP
Subcutaneous repeating dose
Experimental: MEDI9929 - Medium Dose
MEDI9929 (Investigational Product)
Drug: MEDI9929 - Medium Dose IP
Subcutaneous repeating dose
Experimental: MEDI9929 - High Dose
MEDI9929 (Investigational Product)
Drug: MEDI9929 - High Dose IP
Subcutaneous repeating dose

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054130


  Show 107 Study Locations
Sponsors and Collaborators
MedImmune LLC
Amgen
Investigators
Study Director: MedImmune LLC MedImmune LLC
  More Information

Additional Information:
Publications:
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02054130     History of Changes
Other Study ID Numbers: CD-RI-MEDI9929-1146
2013-003269-33 ( EudraCT Number )
First Submitted: December 4, 2013
First Posted: February 4, 2014
Last Update Posted: October 12, 2017
Last Verified: October 2017

Keywords provided by MedImmune LLC:
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases