Phase 2
N=606
Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT01238861 ↗Enrolled (actual)
606
Serious AEs
10.4%
Results posted
Nov 2016
Primary outcome: Primary: Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants — 0.57; 0.65; 0.37; 0.34 AER events/person-year — p=0.781
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Benralizumab 2 mg (Biological); Benralizumab 20 mg (Biological); Benralizumab 100 mg (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MedImmune LLC
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants |
0.57; 0.65; 0.37; 0.34 | 0.781 |
| SECONDARY Dose Response in EOS+ Participants |
— | — |
| SECONDARY Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ss) |
34.7; 182; 869 | — |
| SECONDARY Dose-Normalized Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ssD) |
17.3; 9.10; 8.69 | — |
| SECONDARY Percentage of Participants With Anti-Drug Antibodies (ADA) to Benralizumab in Eosinophilic Phenotype (EOS+) Participants |
3.8; 42.0; 30.9; 25.6 | — |
| SECONDARY Change From Baseline in Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 52 |
2.7479; 2.6479; 2.4750; 2.5346; 2.4742; 2.6381 | 0.125 |
| SECONDARY Change From Baseline in Mean Total Nasal Symptoms Score (TNSS) at Week 52 |
4.3; 4.8; 5.3; 4.4; -0.4; -0.8 | — |
| SECONDARY Change From Baseline in Mean Asthma Symptom Diary Score at Week 51-52 |
1.58; 1.65; 1.60; 1.60; -0.37; -0.56 | 0.131 |
| SECONDARY Change From Baseline in Rescue Medication Use at Week 51-52 |
3.09; 3.57; 3.82; 3.16; 4.07; 4.71 | 0.642 |
| SECONDARY Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52 |
2.033; 1.978; 2.080; 2.012; 0.0098; 0.1631 | 0.014 sig |
| SECONDARY Change From Baseline in Mean Forced Vital Capacity (FVC) at Week 52 |
3.282; 3.069; 3.285; 3.110; 3.043; 3.126 | 0.384 |
| SECONDARY Change From Baseline in Peak Expiratory Flow (PEF) at Week 52 |
319.3; 325.5; 323.1; 323.8; 13.0; 29.0 | — |
| SECONDARY Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Score at Week 52 |
3.72; 3.72; 3.79; 3.72; 0.9634; 1.2612 | 0.069 |
| SECONDARY Change From Baseline in European Quality of Life - 5 Dimensions (EQ-5D) Health State Evaluation at Week 52 |
0.7629; 0.7418; 0.7877; 0.7679; 0.0853; 0.0822 | 0.510 |
| SECONDARY Change From Baseline in EQ-5D Visual Analog Scale (VAS) at Week 52 |
65.0798; 65.4937; 64.3378; 64.6250; 12.8041; 12.5517 | 0.871 |
| SECONDARY Change From Baseline in Percentage of Nocturnal Awakening-Free Nights at Week 51-52 |
52.05; 45.07; 51.57; 50.92; 19.7595; 27.1749 | 0.550 |
| SECONDARY Change From Baseline in Mean Fraction Exhaled Nitric Oxide (FeNO) at Week 52 |
26.88; 39.52; 40.79; 26.68; 1.2523; -3.2222 | 0.896 |
Summary
The primary objective of the study is to evaluate the effect of multiple-dose subcutaneous administrations of MEDI-563 on adults with uncontrolled asthma.
Eligibility Criteria
Inclusion Criteria
- Age 18 through 75 years at the time of screening
- Adequate contraception from screening through end of trial
- Weight of more than (>) 45 kilogram (kg) but less than or equal to ( 100 pound [lb] but =) 10 pack-years or smoking within 12 months prior to screening.
- Known exposure to inhaled occupational agents or fumes with an established diagnosis of occupational asthma
- History of cancer, except for basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy >=12 months prior to screening or other malignancies treated with apparent success with curative therapy >=5 years prior to screening
- Stable dose of allergy vaccination regimen for less than 30 days prior to screening
- Subjects unable to demonstrate acceptable inhaler and peak flow meter techniques.
Data sourced from ClinicalTrials.gov (NCT01238861). 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.