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.