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

October 30, 2008
August 20, 2012
November 2008
November 2009   (final data collection date for primary outcome measure)
Summarizing AEs and SAEs. [ Time Frame: End of Study (Study Day 161). ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00783289 on ClinicalTrials.gov Archive Site
To assess the PK and IM of MEDI-563 [ Time Frame: End of Study (Study Day 161) ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Phase 2a Study to Evaluate the Safety and Tolerability of MEDI-563 in Adults With Asthma
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Asthma
  • Biological: MEDI-563
    25,50-mg MEDI-563 injections
  • Other: Placebo
    Placebo SC injections
  • Experimental: 1
    MEDI-563
    Intervention: Biological: MEDI-563
  • Placebo Comparator: 2
    Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
December 2009
November 2009   (final data collection date for primary outcome measure)

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).
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00783289
MI-CP197
No
MedImmune LLC
MedImmune LLC
Not Provided
Study Director: David Gossage, M.D. MedImmune LLC
MedImmune LLC
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP