Study to Evaluate the Efficacy and Safety of MEDI9929 (AMG 157) in Adult Subjects With Inadequately Controlled, Severe Asthma
Status and phase
Completed
Phase 2
Conditions
Asthma
Treatments
Drug: Placebo
Drug: MEDI9929 70 mg
Drug: MEDI9929 280 mg
Drug: MEDI9929 210 mg
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
584 patients
Sex
All
Ages
18 to 75 years old
Volunteers
No Healthy Volunteers
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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
584 participants in 4 patient groups, including a placebo group
Placebo
Placebo Comparator group
Description:
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Treatment:
Drug: Placebo
MEDI9929 70 mg
Experimental group
Description:
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.
Treatment:
Drug: MEDI9929 70 mg
MEDI9929 210 mg
Experimental group
Description:
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.
Treatment:
Drug: MEDI9929 210 mg
MEDI9929 280 mg
Experimental group
Description:
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Treatment:
Drug: MEDI9929 280 mg
Trial contacts and locations
107
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Data sourced from clinicaltrials.gov
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