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

NCT00768079 | Completed Phase 2 Results

• 1 other identifier: MI-CP186
• Study Type: interventional
• Target: 110
• Locations: 2 countries
• Sites: 11

Brief Summary

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.

Conditions

Asthma

Keywords

Benralizumab; MEDI-563; Asthma

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Asthma Exacerbations at Week 12

  Percentage of participants who required urgent healthcare visit for treatment of acute asthma exacerbation were reported. As per protocol, asthma exacerbation (relapse/de novo) was defined as either 1) increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) that did not resolve within 2 hours after use of rescue albuterol or corticosteroids and required an unscheduled medical visit or 2) during scheduled study visit, participant had acute worsening of asthma symptoms and a reduction of greater than or equal to (\>=) 20 percent (%) in Peak Expiratory Flow (PEF) or Forced Expiratory Volume in 1 Second (FEV1), which in the opinion of the investigator required treatment with systemic corticosteroids. Asthma exacerbations were analyzed in a non-adjudicated manner (by investigator), which were then adjudicated in a blinded fashion by the sponsor medical monitor prior to database lock to determine whether the reported exacerbation met the protocol definition.

  Week 12

Secondary Outcomes (18)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

  Day 0 to Day 84

• Percentage of Participants With Asthma Exacerbations at Week 4 and Week 24

  Weeks 4 and 24

• Asthma Control Questionnaire (ACQ) Scores

  Days 0, 7, 42, and 84

• Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites

  Days 0, 7, 42, and 84

• Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home

  Day 1 to Day 84

Study Arms (3)

Placebo

PLACEBO COMPARATOR

A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.

Other: Placebo

Benralizumab 0.3 mg/kg

EXPERIMENTAL

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: Benralizumab

Benralizumab 1.0 mg/kg

EXPERIMENTAL

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: Benralizumab

Interventions

Placebo OTHER

A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.

Placebo

Benralizumab BIOLOGICAL

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.

Also known as: MEDI-563

Benralizumab 0.3 mg/kg; Benralizumab 1.0 mg/kg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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)

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (11)

Research Site

Tampa, Florida, 33613, United States

Location

Research Site

Springfield, Massachusetts, 01199, United States

Location

Research Site

Detroit, Michigan, 48202, United States

Location

Research Site

East Meadow, New York, 11554, United States

Location

Research Site

New Hyde Park, New York, 11040, United States

Location

Research Site

Stony Brook, New York, 11794-8350, United States

Location

Research Site

Greenville, North Carolina, 27834, United States

Location

Research Site

Cleveland, Ohio, 44109, United States

Location

Research Site

Providence, Rhode Island, 2903, United States

Location

Research Site

Edmonton, Alberta, T6G 2R3, Canada

Location

Research Site

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Related Publications (1)

• Nowak RM, Parker JM, Silverman RA, Rowe BH, Smithline H, Khan F, Fiening JP, Kim K, Molfino NA. A randomized trial of benralizumab, an antiinterleukin 5 receptor alpha monoclonal antibody, after acute asthma. Am J Emerg Med. 2015 Jan;33(1):14-20. doi: 10.1016/j.ajem.2014.09.036. Epub 2014 Oct 5.

  PMID: 25445859 DERIVED

Related Links

• MEDI-563\_CP-186\_Protocol\_Redacted\_16Dec2014

MeSH Terms

Conditions

Asthma

Interventions

benralizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Joseph M. Parker, Director, Clinical Development
• Organization: MedImmune, LLC

information.center@astrazeneca.com

+1 301-398-4095

Study Officials

• Joseph M. Parker, M.D.

  MedImmune LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2008
• First Posted: October 7, 2008
• Study Start: February 2, 2009
• Primary Completion: December 17, 2010
• Study Completion: March 10, 2011
• Last Updated: November 18, 2020
• Results First Posted: October 12, 2020

Record last verified: 2020-10

Locations

US (9); CA (2)