A Phase 2a Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Adults With Asthma

NCT00783289 | Completed Phase 2 Results

• 1 other identifier: MI-CP197
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 6

Brief Summary

The primary objective of this study is to evaluate the safety and tolerability of escalating multiple subcutaneous (SC) doses of MEDI-563 in adult subjects with asthma.

Conditions

Asthma

Keywords

Asthma; Benralizumab; MEDI-563

Outcome Measures

Primary Outcomes (1)

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

  An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Day 161 that were absent before treatment or that worsened relative to pre-treatment state.

  Day 0 to Day 161

Secondary Outcomes (5)

• Time to Reach Maximum Observed Serum Concentration (Tmax) for Benralizumab

  Day 0, 1, 7, 28, 35, 56, 84, 112, and 161

• Maximum Observed Serum Concentration (Cmax) for Benralizumab

  Day 0, 1, 7, 28, 35, 56, 84, 112, and 161

• Area Under the Curve From Time 0 to Infinity (AUC [0-infinity]) for Benralizumab

  Day 0, 1, 7, 28, 35, 56, 84, 112, and 161

• Terminal Phase Elimination Half-Life (t1/2) for Benralizumab

  Day 0, 1, 7, 28, 35, 56, 84, 112, and 161

• Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Benralizumab at Any Visit

  Day 0, 28, 56, 84, 112, and 161

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.

Other: Placebo

Benralizumab 25 mg

EXPERIMENTAL

Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.

Biological: Benralizumab 25 mg

Benralizumab 100 mg

EXPERIMENTAL

Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.

Biological: Benralizumab 100 mg

Benralizumab 200 mg

EXPERIMENTAL

Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.

Biological: Benralizumab 200 mg

Interventions

Placebo OTHER

Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.

Placebo

Benralizumab 25 mg BIOLOGICAL

Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.

Also known as: MEDI-563

Benralizumab 25 mg

Benralizumab 100 mg BIOLOGICAL

Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.

Also known as: MEDI-563

Benralizumab 100 mg

Benralizumab 200 mg BIOLOGICAL

Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.

Also known as: MEDI-563

Benralizumab 200 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects
• Age 18 through 80 years at screening
• Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
• Previously documented diagnosis of asthma of more than or equal to (\>=) 1 year duration, based on episodic symptoms of airflow obstruction; post-bronchodilator reversibility of airflow obstruction \>=12 percent (%) (at screening or documented within 1 year prior to randomization); or proof of a positive response to a methacholine challenge (documented within 1 year prior to randomization) as represented by a provoking concentration of methacholine to cause a 20% fall in forced expiratory volume in 1 second (FEV1); (PC20) less than (\<) 8 milligram per milliliter (mg/mL)
• Weight of \>=45 kilogram (kg) but less than or equal to (\<=) 135 kg (\>=100 pounds \[lb\] but \<=300 lb)
• Able to produce spirometry readings that meet American Thoracic Society (ATS)/European Respiratory Society (ERS) standards
• Screening pre-bronchodilator FEV1 \>=60%
• Women of childbearing potential, unless surgically sterile (including tubal ligation) and/or at least 2 years post-menopausal, must use 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) for 14 days prior to the first dose of the investigational product on Study Day 0, and must agree to continue using such precautions through Study Day 161. Cessation of birth control after this point should be discussed with a responsible physician
• Men, unless surgically sterile, must likewise use 2 effective methods of birth control (for example, condom with spermicide) and must agree to continue using such contraceptive precautions through End of Study/Study Day 161
• Ability to complete the study period, including follow-up period until Study Day 161 as required by protocol

You may not qualify if:

• Previously received benralizumab (MEDI-563)
• History of allergy or reaction to any component of the investigational product formulation
• History of allergy or reaction to any other marketed or experimental monoclonal antibody therapies, intravenous gammaglobulin (IVIG), or blood products
• Receipt of any investigational drug therapy within 30 days prior to randomization into the study or any biologic(s) within 5 half-lives of the agent prior to randomization into the study
• Treatment with an oral or systemic burst of corticosteroids within 4 weeks prior to randomization into the study
• Use of any chronic systemic immunosuppressive drugs, including oral corticosteroids within 4 weeks prior to randomization into the study
• Current use of any oral or ophthalmic beta-adrenergic antagonist (for example, propranolol), must have been stopped 2 weeks prior to randomization into the study
• Current allergy vaccination (immunotherapy)
• History of anaphylaxis
• Lung disease other than persistent asthma (for example, chronic bronchitis, cystic fibrosis, chronic obstructive pulmonary disease \[COPD\], tuberculosis \[TB\])
• Acute illnesses or evidence of significant active infection, such as fever \>=38.0 degrees Celsius \[C\] (\>=100.5 degrees Fahrenheit \[F\]) at screening and up through time of the first dose of the investigational product
• History of ingestion of untreated water in a location known to be infected with parasites, resulting in acute or chronic diarrhea; or an untreated parasitic infection within 1 month of randomization
• Pregnancy (women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to administration of the investigational product)
• Lactating woman
• Infection with human immunodeficiency virus (HIV)-1, HIV-2, or hepatitis A, B, or C virus

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (6)

Research Site

Encinitas, California, United States

Location

Research Site

Los Angeles, California, United States

Location

Research Site

Colorado Springs, Colorado, United States

Location

Research Site

Wheaton, Maryland, United States

Location

Allergy Associates Research Center

Portland, Oregon, 97213, United States

Location

Research Site

Upland, Pennsylvania, United States

Location

Related Links

• Attachments tab: MI-CP197 Redacted Protocol\_22\_Jul\_2015

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: Rene van der Merwe, MBChB/Senior Director, Clinical Development
• Organization: MedImmune, LLC.

vandermerwer@medimmune.com

301-398-0000

Study Officials

• David Gossage, 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 30, 2008
• First Posted: October 31, 2008
• Study Start: November 14, 2008
• Primary Completion: November 17, 2009
• Study Completion: November 17, 2009
• Last Updated: December 27, 2019
• Results First Posted: December 27, 2019

Record last verified: 2019-12

Locations

US (6)