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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01238861
First received: November 9, 2010
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

The primary objective of the study is to evaluate the effect of multiple-dose subcutaneous administrations of MEDI-563 on adults with uncontrolled asthma.


Condition Intervention Phase
Asthma
Drug: MEDI-563
Drug: 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 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Evaluate the effect of multiple-dose subcutaneous administrations of MEDI-563 [ Time Frame: 12-15 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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.


Enrollment: 609
Study Start Date: December 2010
Estimated Study Completion Date: January 2014
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEDI-563 - Arm A Drug: MEDI-563
Subcutaneous repeating dose
Experimental: MEDI-563 - Arm B Drug: MEDI-563
Subcutaneous repeating dose
Experimental: MEDI-563 - Arm C Drug: MEDI-563
Subcutaneous repeating dose
Placebo Comparator: Placebo Drug: Placebo
Subcutaneous repeating dose

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01238861

  Show 83 Study Locations
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Donald Raible, MD MedImmune LLC
  More Information

Additional Information:
No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01238861     History of Changes
Other Study ID Numbers: MI-CP220, 2010-020126-17
Study First Received: November 9, 2010
Last Updated: January 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by MedImmune LLC:
Asthma

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