A Phase 2 Study to Evaluate the Safety and Efficacy of Intravenously Administered Benralizumab (MEDI-563).

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

The study will evaluate the effect of two intravenous dose regimens of benralizumab (MEDI-563) on the proportion of adult subjects with asthma exacerbations who required an urgent healthcare visit for treatment of an acute asthma exacerbation.

Key facts

Study ID: NCT00768079
Run by: MedImmune LLC
People needed: 110
Starts: 2009-02-02
Expected to finish: 2011-03-10
Last updated by the study team: 2020-11-18

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female subjects aged 18 to 60 years at the time of the administration of investigational product
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization (applies to covered entities in the US only) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
Physician-diagnosed asthma with a duration of greater than or equal to (>=) 2 years by medical chart or subject report
Had an asthma exacerbation requiring urgent care in the year prior to screening
Meets National Heart, Lung, and Blood Institute (NHLBI) for persistent asthma in the 3 months prior to the current urgent healthcare visit
Current asthma exacerbation that must have lasted >= 2 hours prior to arrival to the urgent healthcare setting
Requires at least 2 treatments of inhaled bronchodilators for the current asthma exacerbation in the urgent healthcare setting or within the emergency medical system (EMS) for >= 1 hour
Shows an FEV1 or PEF of not more than 70 percent (%) predicted after 1 hour of treatment of the current asthma exacerbation
Women of child-bearing potential, unless surgically sterile (including tubal ligation) and/or at least 2 years post-menopausal, must have used 2 effective methods of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, abstinence, use of a condom with spermicide by the sexual partner, or sterile sexual partner) from screening through the end of the study (Day 84; Cessation of birth control after this point should be discussed with a responsible physician)
Men, unless surgically sterile, must likewise practice 2 effective methods of birth control (condom with spermicide or abstinence) and must use such precautions from Day 0 through Day 84
Otherwise healthy by medical history and physical examination
A chest x-ray that is normal for an asthmatic population and excludes alternative diagnosis per the investigation
Ability to complete the follow-up period until Day 168 as required by protocol
The investigator has determined that the subject is clinically stable and the FEV1, is >= 30% predicted prior to receiving investigational product on Day 0.

You may not qualify if…

Known history of allergy or reaction to any component of the investigational product formulation
Acute illness other than asthma at the start of the study
Fever more than (>) 38.6 degrees Celsius (C) (>101.5 degrees Fahrenheit [F])
Current acute asthma attack is due to aspirin-induced asthma
Current asthma episode is an anaphylactoid/anaphylactic reaction presenting with acute bronchospasm
Evidence of clinically significant non-respiratory active infection, including ongoing chronic infection
History or current prolonged diarrhea, abdominal pain, and/or blood and mucus in stools or have minor symptoms and have exposure to stream or lake water, been exposed to someone who has a parasitic infection (like a family member), or study subject has traveled outside the United States of America (USA) and/or Canada within the last year
Use of immunosuppressive medication (except oral prednisone and inhaled and topical corticosteroids) within 30 days before randomization into the study
Have received Xolair within 6 months before randomization into the study
Receipt of immunoglobulin or blood products within 30 days before randomization into the study
Receipt of any investigational drug therapy within 6 months before the first dose of investigational product in this study through Day 168
History of primary immunodeficiency
Previous medical history, or evidence, of an intercurrent illness that may compromise the safety of the subject in the study
History of clinically significant abnormality on ECG in the opinion of the investigator
Pregnancy (must have a negative serum pregnancy test prior to the first dose of investigational product)
Breastfeeding or lactating woman
History of treatment for alcohol or drug abuse within the past year
Diagnosis of chronic obstructive pulmonary disease (COPD) by a healthcare professional
Evidence of any clinically significant systemic disease on physical examination
History of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy >1 year prior to entry or other malignancies treated with apparent success with curative therapy >5 years prior to entry
Known exposure to inhaled occupational agents or fumes with an established diagnosis of occupational asthma
Any condition (that is, impending ventilatory failure or hemodynamic compromise) that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of study results
Any employee of the clinical study site who is involved with the conduct of the study
History of cigarette smoking >20 pack years
Previously received benralizumab (MEDI-563)

Where it is running

Research Site — Tampa, Florida, United States
Research Site — Springfield, Massachusetts, United States
Research Site — Detroit, Michigan, United States
Research Site — East Meadow, New York, United States
Research Site — New Hyde Park, New York, United States
Research Site — Stony Brook, New York, United States
Research Site — Greenville, North Carolina, United States
Research Site — Cleveland, Ohio, United States
Research Site — Providence, Rhode Island, United States
Research Site — Edmonton, Alberta, Canada
Research Site — Halifax, Nova Scotia, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.