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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00783289
First received: October 30, 2008
Last updated: August 20, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Asthma
Biological: MEDI-563
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2a, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Tolerability of Multiple-dose Subcutaneous Administration of MEDI-563, a Humanized Anti-interleukin-5 Receptor Alpha Monoclonal Antibody, in Adults With Asthma

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Summarizing AEs and SAEs. [ Time Frame: End of Study (Study Day 161). ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the PK and IM of MEDI-563 [ Time Frame: End of Study (Study Day 161) ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: November 2008
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MEDI-563
Biological: MEDI-563
25,50-mg MEDI-563 injections
Placebo Comparator: 2
Placebo
Other: Placebo
Placebo SC injections

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects.
  • Age 18 through 80 years at screening.
  • Written informed consent and HIPAA authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
  • Previously documented diagnosis of asthma of ≥ 1 year duration, based on episodic symptoms of airflow obstruction; post-bronchodilator reversibility of airflow obstruction ≥ 12% (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) < 8 mg/mL.
  • Weight of ≥ 45 kg but ≤ 135 kg (≥ 100 lbs but ≤ 300 lbs).
  • Able to produce spirometry readings that meet 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 (eg, 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.

Exclusion Criteria:

  • Previously received 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 β-adrenergic antagonist (eg, 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 [eg, chronic bronchitis, cystic fibrosis, chronic obstructive pulmonary disease (COPD), tuberculosis (TB)].
  • Acute illnesses or evidence of significant active infection, such as fever

    ≥ 38.0°C (≥ 100.5°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 HIV-1, HIV-2, or hepatitis A, B, or C virus.
  • History of cancer, apart from basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy ≥ 1 year prior to randomization into the study.
  • History of cigarette smoking ≥ 10 pack years.
  • History of alcohol abuse or drug abuse that required treatment < 1 year prior to randomization into the study.
  • Elective surgery planned during the study period.
  • Evidence of any systemic disease or any finding upon physical examination, laboratory abnormality, CXR, or ECG that, in the opinion of the investigator or medical monitor, may compromise the safety of the subject in the study or confound the analysis of the study results.
  • Employees of the clinical study site or any other individuals involved with the conduct of the study, or first degree family members of such individuals (ie, parents, siblings, or children).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00783289

Locations
United States, California
Warren Pleskow, M.D.
Encinitas, California, United States, 92024
Allergy Research Foundation, Inc.
Los Angeles, California, United States, 90025
United States, Colorado
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, United States, 80907
United States, Maryland
Institute of Asthma and Allergy, PC
Wheaton, Maryland, United States, 20904
United States, Oregon
Allergy Associates Research Center
Portland, Oregon, United States, 97213
United States, Pennsylvania
Asthma and Allergy Research Associates
Upland, Pennsylvania, United States, 19013
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: David Gossage, M.D. MedImmune LLC
  More Information

No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00783289     History of Changes
Other Study ID Numbers: MI-CP197
Study First Received: October 30, 2008
Last Updated: August 20, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014