Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01238861
First received: November 9, 2010
Last updated: September 16, 2014
Last verified: September 2014

November 9, 2010
September 16, 2014
December 2010
March 2013   (final data collection date for primary outcome measure)
Evaluate the effect of multiple-dose subcutaneous administrations of MEDI-563 [ Time Frame: 12-15 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01238861 on ClinicalTrials.gov Archive Site
Evaluate the safety and tolerability of MEDI-563 [ Time Frame: 12-15 months ] [ Designated as safety issue: Yes ]
  • To evaluate the safety and tolerability of MEDI-563.
  • To determine the optimal dose of MEDI-563 to be used in Phase 3 studies.
  • To describe the immunogenicity (IM) and pharmacokinetics (PK) of MEDI-563.
  • To assess the effect of MEDI-563 on other assessments of clinical activity (i.e, asthma control and pulmonary function).
  • To assess the effect of MEDI-563 on health-related quality of life.
Same as current
Not Provided
Not Provided
 
Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma
A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma

The primary objective of the study is to evaluate the effect of multiple-dose subcutaneous administrations of MEDI-563 on adults with uncontrolled 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
  • Drug: MEDI-563
    Subcutaneous repeating dose
  • Drug: Placebo
    Subcutaneous repeating dose
  • Experimental: MEDI-563 - Arm A
    Intervention: Drug: MEDI-563
  • Experimental: MEDI-563 - Arm B
    Intervention: Drug: MEDI-563
  • Experimental: MEDI-563 - Arm C
    Intervention: Drug: MEDI-563
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
965
August 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 through 75 years at the time of screening.
  • Adequate contraception from screening through end of trial.
  • Weight of > 45 kg but ≤ 150 kg (> 100 lb but ≤ 330 lb).
  • History of physician-diagnosed asthma for at least 12 months prior to screening.
  • Physician prescribed daily use of medium-dose or high-dose ICS plus LABA for at least 12 months prior to screening.
  • Willingness to switch to an ICS/LABA combination product.
  • Dose of other asthma controller medications must be stable for at least 30 days prior to screening.
  • At least 2 documented asthma exacerbations in the 12 months prior to screening that required use of a systemic corticosteroid burst.
  • For subjects 65 years of age or older, a chest x-ray (CXR) or chest computed tomography (CT) that is normal for an asthmatic population.
  • Ability and willingness to complete the study to Week 66, and if needed to Week 92.

Exclusion Criteria:

  • Known history of allergy or reaction to any component of the investigational product formulation.
  • History of anaphylaxis to any biologic therapy.
  • Unexplained diarrhea within 30 days prior to screening or diagnosis of helminth parasitic infestation within 6 months prior to screening.
  • Use of immunosuppressive medication within 3 months prior to screening. Chronic oral prednisone or equivalent up to 10 mg daily or 20 mg every other day for asthma is allowed.
  • Oral corticosteroid burst or short-acting systemic corticosteroid within 30 days prior to screening or during the screening/run-in period.
  • Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 30 days prior to the screening or during the screening/run-in period.
  • Receipt of immunoglobulin or blood products within 30 days prior to screening.
  • Receipt of any marketed or investigational biologic within 4 months or 5 half-lives prior to screening, whichever is longer.
  • Receipt of any investigational nonbiologic within 30 days or 5 half-lives prior to screening, whichever is longer.
  • Previously received MEDI-563.
  • Any clinically relevant abnormal findings in physical examination.
  • Past history of clinically significant cardiac disease or any electrocardiogram (ECG) abnormality.
  • Breastfeeding or lactating women.
  • History of alcohol or drug abuse within 12 months prior to screening.
  • History of any known primary immunodeficiency disorder.
  • Positive medical history for hepatitis B or C. Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to enroll.
  • A positive human immunodeficiency virus (HIV) test or subject taking antiretroviral medications.
  • History of cigarette smoking ≥ 10 pack-years or smoking within 12 months prior to screening.
  • Known exposure to inhaled occupational agents or fumes with an established diagnosis of occupational asthma.
  • History of cancer, except for basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy ≥ 12 months prior to screening or other malignancies treated with apparent success with curative therapy ≥ 5 years prior to screening.
  • Stable dose of allergy vaccination regimen for less than 30 days prior to screening.
  • Subjects unable to demonstrate acceptable inhaler and peak flow meter techniques.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   United States,   Russian Federation,   Brazil,   Bulgaria,   Canada,   Colombia,   Mexico,   Peru,   Poland
 
NCT01238861
MI-CP220, 2010-020126-17
Not Provided
MedImmune LLC
MedImmune LLC
Not Provided
Study Director: Donald Raible, MD MedImmune LLC
MedImmune LLC
September 2014

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