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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00783289
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : August 29, 2012
Information provided by (Responsible Party):
MedImmune LLC

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Biological: MEDI-563 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: 1
Biological: MEDI-563
25,50-mg MEDI-563 injections

Placebo Comparator: 2
Other: Placebo
Placebo SC injections

Primary Outcome Measures :
  1. Summarizing AEs and SAEs. [ Time Frame: End of Study (Study Day 161). ]

Secondary Outcome Measures :
  1. To assess the PK and IM of MEDI-563 [ Time Frame: End of Study (Study Day 161) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00783289

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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
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Study Director: David Gossage, M.D. MedImmune LLC

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Responsible Party: MedImmune LLC Identifier: NCT00783289     History of Changes
Other Study ID Numbers: MI-CP197
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: August 29, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Asthmatic Agents
Respiratory System Agents