Overview

This trial is active, not recruiting.

Condition asthma
Treatments placebo, medi9929 - low dose ip, medi9929 - medium dose ip, medi9929 - high dose ip
Phase phase 2
Sponsor MedImmune LLC
Collaborator Amgen
Start date December 2013
End date December 2016
Trial size 552 participants
Trial identifier NCT02054130, 2013-003269-33, CD-RI-MEDI9929-1146

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
Placebo Comparator
placebo Subcutaneous repeating dose
Placebo
(Experimental)
MEDI9929 (Investigational Product)
medi9929 - low dose ip
Subcutaneous repeating dose
(Experimental)
MEDI9929 (Investigational Product)
medi9929 - medium dose ip
Subcutaneous repeating dose
(Experimental)
MEDI9929 (Investigational Product)
medi9929 - high dose ip
Subcutaneous repeating dose

Primary Outcomes

Measure
Rate of asthma exacerbations
time frame: Week 52

Secondary Outcomes

Measure
Change from baseline in pre-bronchodilator FEV1 and FVC
time frame: Week 52
Change from baseline in post-bronchodilator FEV1 and FVC
time frame: Week 52
Change from baseline in overall symptom score measured by the Asthma Daily Diary (ACQ-6)
time frame: Week 52
Rate of severe asthma exacerbations
time frame: Week 52
Time to first asthma exacerbation/severe asthma exacerbation
time frame: Week 52
Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ[S] +12) and European Quality of Life (EQ-5D-5L)
time frame: Week 52
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 positive antibodies to MEDI9929
time frame: Week 0 (Day 1) - Week 64
Proportion of subjects with one or more asthma exacerbations/severe asthma exacerbations
time frame: Week 52

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by MedImmune LLC.