Phase 2
N=101
A Study to Evaluate the Effectiveness of MEDI-563 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT01227278 ↗Enrolled (actual)
101
Serious AEs
22.8%
Results posted
Oct 2016
Primary outcome: Primary: Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) — 0.92; 0.95 AECOPD events/person-year — p=0.941
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Other); Benralizumab 100 mg (Biological)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- MedImmune LLC
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) |
0.92; 0.95 | 0.941 |
| SECONDARY Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) |
41; 45; 9; 14 | — |
| SECONDARY Number of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) |
5; 2 | — |
| SECONDARY Percentage of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) |
11.9; 5.0 | — |
| SECONDARY Annual Incidence Rate of Hospitalization Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) |
0.11; 0.05 | — |
| SECONDARY Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Domain Scores at Day 393 |
48.04; 51.75; -4.43; -5.51; 64.59; 67.18 | — |
| SECONDARY Percentage of Participants With Improvement in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total Score |
59.5; 54.1; 38.1; 40.5; 21.4; 24.3 | — |
| SECONDARY Change From Baseline in Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) Domain Scores at Day 393 |
4.97; 4.74; -0.08; 0.09; 4.38; 3.96 | — |
| SECONDARY Percentage of Participants With a 0.5-Point Improvement in Chronic Respiratory Questionnaire Self-administered Standardized Format (CRQ-SAS) Domain Scores at Day 393 |
28.6; 32.4; 35.7; 35.1; 35.7; 27.0 | — |
| SECONDARY Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Scores at Day 393 |
2.8; 2.9; -0.1; -0.5 | — |
Summary
To evaluate the effect of the drug in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) in Adults.
Eligibility Criteria
Inclusion Criteria
- Subjects aged 40-85 years at the time of Screening
- Written informed consent obtained from the subject prior to performing any protocol related procedures
- Documented history of 1 or more Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
- Current smoker or ex-smoker with a tobacco history of greater than or equal to (>=) 10 pack-years
- Adequate contraception from screening through end of trial
- Able to read and write.
Exclusion Criteria
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
- Pregnant, breastfeeding, or lactating women
- Known history of allergy or reaction to any component of the investigational product formulation
- History of anaphylaxis to any other biologic therapy
- Donation or transfusion of blood, plasma or platelets within the past 3 months prior to Screening
- Other significant pulmonary disease which in the opinion of the investigator or medical monitor, might compromise the interpretation of the study
- Fever greater than (>) 37.0 degree Centigrade (98.6 degree Fahrenheit) at Screening
- Receipt of any novel investigational medicinal product within 3 months before the first dose of investigational product in this study and through the end of the study
- Seropositive for hepatitis A, hepatitis B surface antigen, hepatitis C, or human immunodeficiency virus 1or 2 (HIV-1 or HIV 2)
- History of alcohol or drug abuse within the past year that required treatment that the investigator felt or medical monitor felt would compromise the study data interpretation
- Past or current malignancy within the past 5 years except adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than 1 year prior to Screening
- Subjects participating in, or scheduled for, an intensive COPD rehabilitation program (subjects who are in the maintenance phase of a rehabilitation program are eligible to take part)
- Current diagnosis of asthma according to Global Initiative for Asthma guidelines
- Previous treatment with MEDI-563.
Data sourced from ClinicalTrials.gov (NCT01227278). 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.