Overview

This trial is active, not recruiting.

Condition asthma
Treatments medi-563, placebo
Phase phase 2
Sponsor MedImmune LLC
Start date December 2010
End date March 2013
Trial size 609 participants
Trial identifier NCT01238861, 2010-020126-17, MI-CP220

Summary

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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
medi-563
Subcutaneous repeating dose
(Experimental)
medi-563
Subcutaneous repeating dose
(Experimental)
medi-563
Subcutaneous repeating dose
(Placebo Comparator)
placebo
Subcutaneous repeating dose

Primary Outcomes

Measure
Evaluate the effect of multiple-dose subcutaneous administrations of MEDI-563
time frame: 12-15 months

Secondary Outcomes

Measure
Evaluate the safety and tolerability of MEDI-563
time frame: 12-15 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

Official title A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by MedImmune LLC.