None listed
Conditions
Interventions
Group 1 Type of group
MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Group name:Group 4 Type of group
Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
Sponsors
ASTRAZENECA PERU S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: • Male or female • Age 18 through 65 years at the time of screening • Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations • Female subjects of childbearing potential who are sexually active with non-sterilized male partner must use adequate contraception from screening through the end of the study. An acceptable method of contraception is defined as one that has no higher than a 1% failure rate. Sustained abstinence is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception • Non-sterilized males who are sexually active with a female of child-bearing potential must use adequate contraception from screening through the end of the study • Females or female partners not of childbearing potential must have been surgically sterilized (eg, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or postmenopausal (defined as at least 1 year since last regular menses) • Sterilized males must be at least 1-year post vasectomy and have obtained documentation of the absence of sperm in the ejaculate • Weight = 45 kg but = 120 kg and body mass index (BMI) between 18 and 35 kg/m2 • Physician-diagnosed asthma by medical chart • Currently taking inhaled corticosteroids (ICS) or is a candidate to receive ICS per Expert Panel Report (EPR)-3 • Pre-bronchodilator forced expiratory volume in 1 second (FEV1) value = 40% at Day -28 and Day 1 • A post-bronchodilator increase in FEV1 and/or FVC = 12% and = 200 mL at Day -28 • Uncontrolled asthma consistent with EPR-3. In the 28 days before screening, subjects should have a history of one or more of the following:- Daytime asthma symptoms = 2 days/week- Nighttime awakening = 1 night/week- Albuterol/salbutamol use = 2 days/week • An Asthma Control Questionnaire (ACQ) score = 1.5 at Day -28 and at Day 1. • At least one asthma exacerbation in the 12 months before screening that required intake of systemic corticosteroids after an unscheduled medical encounter or as agreed with a physician based on an asthma action plan that defines when oral steroids can be taken by the subject • Ability and willingness to complete the follow-up period through Day 323 as required by the protocol.
Exclusion criteria
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 • Concurrent enrollment in another clinical study • Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals • Known history of allergy or reaction to any component of the investigational product formulation • History of anaphylaxis to other biologic therapy • Lung disease other than asthma (eg, chronic obstructive pulmonary disease [COPD], cystic fibrosis) • Severe depression as measured by a depression score > 15 on the Hospital Anxiety and Depression Scale (HADS) at either Day-28 or Day 1. • History of suicidal behavior in the previous 3 years as measured by the Columbia Suicide Severity Rating Scale (C-SSRS) at Day -28. • Acute illness other than asthma at the screening and randomization visits • History of an active infection within 28 days before and during the screening period, or evidence of clinically significant active infection, including ongoing chronic infection • History of ingestion of untreated water in a location known to be infected with parasites, resulting in acute or chronic diarrhea; history of recent travel to areas where parasite infestations are endemic within 6 months before screening; or a diagnosis of parasitic infection within 6 months before screening • Use of immunosuppressive medication (except oral prednisone up to a dose of 20 mg every other day or equivalent [eg, 10 mg a day or 5 mg twice a day] and inhaled andtopical corticosteroids) within 28 days before randomization • Receipt of immunoglobulin or blood products within 28 days before randomization • Plans to donate blood during the entire study period • Donated blood or has had a blood transfusion within 28 days before screening • Receipt of any non-biological study drugs or interventional therapy (including surgical procedures) within 28 days of the first dose of investigational product in this study • Receipt of any biologicals including MEDI-528 within 5 half-lives before the first dose of investigational product in this study • History of any known immunodeficiency disorder • A positive hepatitis B surface antigen, or hepatitis C virus antibody, as determined by medical history and/or subject´s verbal report • A positive human immunodeficiency virus test or is taking antiretroviral medications, as determined by medical history and/or subject´s verbal report • A live attenuated vaccination received within 28 days before screening • History of clinically significant abnormality on electrocardiogram (ECG) in the opinion of the investigator • Breastfeeding or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Change at Day 92 from baseline (Day 1, prior to dosing) in mean ACQ scores in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful. Measure:Change at Day 92 From Baseline in Mean Asthma Control Questionnaire (ACQ) Scores (Intent-toTreat Analysis) Timepoints:Day 92 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Weighted asthma exacerbation rate (total number of exacerbation rate in each group per total duration of participant-year follow-up in each group) between Day 1 and Day 92 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subjects asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy. Measure:Weighted Asthma Exacerbation Rate Through Day 92 (Intent-to-Treat Analysis) Timepoints:Days 1 - 92 ; Outcome name:Weighted asthma exacerbation rate (total number of exacerbation rate in each group per total duration of participant-year follow-up in each group) between Day 1 and Day 176 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subjects asthma symptoms diminished and PEF or FEV1 return to g | — |
Countries
Argentina, Brazil, Canada, Colombia, Costa Rica, Panama, Peru, Philippines, Taiwan, United States
Contacts
Public ContactEdward Ramirez
ASTRAZENECA PERU S.A.
Outcome results
None listed