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

Study identifier:MI-CP186

ClinicalTrials.gov identifier:NCT00768079

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenously Administered MEDI-563, A Humanized Anti-interleukin-5 Receptor Alpha Monoclonal Antibody, on Asthma Control Following Acute Exacerbations in Adults

Medical condition

asthma

Phase

Phase 2

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

110

Study type

Interventional

Age

18 Years - 60 Years

Date

Study Start Date: 02 Feb 2009

Primary Completion Date: 17 Dec 2010

Study Completion Date: 10 Mar 2011

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2020 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- 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.

Exclusion Criteria

- 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)
- Asthma exacerbation due to acute inhalational exposure.

No locations available

Arms	Assigned Interventions
Placebo Comparator: Placebo A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.	Other: Placebo A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.
Experimental: Benralizumab 0.3 mg/kg A single dose of benralizumab (MEDI-563) 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion over at least 30 minutes on Day 0.	Biological/Vaccine: Benralizumab A single dose of benralizumab (MEDI-563) 0.3 or 1 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0. Other Name: MEDI-563
Experimental: Benralizumab 1.0 mg/kg A single dose of benralizumab (MEDI-563) 1.0 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0.	Biological/Vaccine: Benralizumab A single dose of benralizumab (MEDI-563) 0.3 or 1 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0. Other Name: MEDI-563

Documents available

MEDI-563_CP-186_Protocol_Redacted_16Dec2014
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Joseph M. Parker

MedImmune LLC