Phase 2
N=550
Study to Evaluate the Efficacy and Safety of MEDI9929 (AMG 157) in Adult Subjects With Inadequately Controlled, Severe Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT02054130 ↗Enrolled (actual)
550
Serious AEs
12.0%
Results posted
Dec 2018
Primary outcome: Primary: Annualized Asthma Exacerbation Rate (AER) Through Week 52 — 0.72; 0.27; 0.20; 0.23 events per person-year — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); MEDI9929 70 mg (Drug); MEDI9929 210 mg (Drug); MEDI9929 280 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MedImmune LLC
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annualized Asthma Exacerbation Rate (AER) Through Week 52 |
0.72; 0.27; 0.20; 0.23 | <0.001 sig |
| SECONDARY Reduction in AER on Subpopulations at Week 52 |
0.78; 0.29; 0.26; 0.21; 0.65; 0.25 | — |
| SECONDARY Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Week 52 |
0.071; 0.200; 0.210; 0.245; 0.068; 0.244 | — |
| SECONDARY Change From Baseline in FEV1 on Subpopulations at Week 52 |
-0.045; 0.118; 0.125; 0.160; -0.072; -0.030 | — |
| SECONDARY Change From Baseline in Post-bronchodilator (Post-BD) FEV1 and FVC at Week 52 |
-0.064; 0.117; 0.099; 0.128; -0.092; 0.088 | — |
| SECONDARY Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52 |
-0.57; -0.62; -0.78; -0.72; -0.49; -0.60 | — |
| SECONDARY Change From Baseline in Asthma Symptoms Measured by Asthma Daily Diary at Week 52 |
-0.483; -0.657; -0.669; -0.680; -0.493; -0.598 | — |
| SECONDARY Change From Baseline in Asthma Symptoms Measured by Asthma Control Questionnaire (ACQ-6) Score at Week 52 |
-0.89; -1.24; -1.17; -1.19 | — |
| SECONDARY Rate of Severe Asthma Exacerbation Through Week 52 |
0.14; 0.04; 0.02; 0.03 | — |
| SECONDARY Time to First Asthma Exacerbation Through Week 52 |
NA; NA; NA; NA | — |
| SECONDARY Time to First Severe Asthma Exacerbation Through Week 52 |
NA; NA; NA; NA | — |
| SECONDARY Number of Participants With at Least One Asthma Exacerbations Through Week 52 |
43; 30; 21; 25 | — |
| SECONDARY Number of Participants With at Least One Severe Asthma Exacerbations Through Week 52 |
9; 5; 3; 4 | — |
| SECONDARY Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ [S]) Overall Score at Week 52 |
1.04; 1.19; 0.93; 1.13 | — |
| SECONDARY Change From Baseline in European Quality of Life-5 Dimensions 5 Level Version (EQ-5D-5L) Health State Evaluation at Week 52 |
0.1051; 0.0752; 0.0729; 0.0395; 13.8; 14.0 | — |
| SECONDARY Total Amount of Study Drug Exposure |
877.0; 2493.9; 6574.9 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) |
91; 93; 90; 89; 18; 17 | — |
| SECONDARY Number of Participants With TEAEs Related to Vital Sign Parameters |
0; 1; 0; 0; 1; 2 | — |
| SECONDARY Number of Participants With TEAEs Related to Clinical Laboratory Evaluation |
0; 0; 0; 1; 0; 1 | — |
| SECONDARY Number of Participants With TEAEs Related to Electrocardiogram Evaluations |
1; 0; 2; 0; 0; 1 | — |
| SECONDARY Mean Serum Concentrations of MEDI9929 |
3933.6; 10733.1; 39722.7; 6215.8; 16625.4; 63223.7 | — |
| SECONDARY Number of Participants With Positive Antibodies to MEDI9929 |
7; 1; 2; 2; 13; 6 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT02054130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.