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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Alabama
Research Site
Birmingham, Alabama, United States
United States, California
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Los Angeles, California, United States
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Orange, California, United States
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San Diego, California, United States
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Stockton, California, United States
United States, Colorado
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Colarado Springs, Colorado, United States
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Denver, Colorado, United States
United States, Connecticut
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Waterbury, Connecticut, United States
United States, Florida
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Kissimmee, Florida, United States
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Tampa, Florida, United States
United States, Georgia
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Stockbridge, Georgia, United States
United States, Illinois
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Normal, Illinois, United States
United States, Maryland
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Baltimore, Maryland, United States
United States, Minnesota
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Rochester, Minnesota, United States
United States, Missouri
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St Louis, Missouri, United States
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St. Louis, Missouri, United States
United States, Nebraska
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Bellevue, Nebraska, United States
United States, New Jersey
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Summit, New Jersey, United States
United States, New York
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Rochester, New York, United States
United States, North Carolina
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Winston-Salem, North Carolina, United States
United States, Ohio
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Cincinnati, Ohio, United States
United States, Oklahoma
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Oklahoma City, Oklahoma, United States
United States, Pennsylvania
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Blue Bell, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
United States, Rhode Island
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Warwick, Rhode Island, United States
United States, Texas
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Boerne, Texas, United States
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San Antonio, Texas, United States
United States, Washington
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Seattle, Washington, United States
Argentina
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Tucumán, Pcia. de Tucumán, Argentina
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Caba, Argentina
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Ciudad de Buenos Aires, Argentina
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Santa Fe, Argentina
Brazil
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Salvador, BA, Brazil
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Porto Alegre, Brasil, Brazil
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Juiz de Fora, Minas Gerais, Brazil
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Curitiba, PR, Brazil
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Rio de Janeiro, RJ, Brazil
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Porto Alegre, RS, Brazil
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Florianópolis, Santa Catarina, Brazil
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Sao Paulo, SP, Brazil
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São Paulo, SP, Brazil
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Santo André, São Paulo, Brazil
Bulgaria
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Pleven, Bulgaria
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Ruse, Bulgaria
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Sofia, Bulgaria
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Troyan, Bulgaria
Canada, Ontario
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Brampton, Ontario, Canada
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Toronto, Ontario, Canada
Canada, Quebec
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La Malbaie, Quebec, Canada
Canada
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Quebec, Canada
Colombia
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Bogota, Cundinamarca, Colombia
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Bogotá, Cundinamarca, Colombia
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Bogota, Colombia
Mexico
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Mexico, D.f., Mexico
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Guadalajara, Jalisco, Mexico
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Zapopan, Jalisco, Mexico
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Morelia, Michoacan, Mexico
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Monterrey, Nuevo Leon, Mexico
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Villahermosa, Tabasco, Mexico
Peru
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San Borja, Lima, Peru
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San Isidro, Lima, Peru
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Surco, Lima, Peru
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Lima, Peru
Poland
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Białystok, Poland
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Bydgoszcz, Poland
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Lublin, Poland
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Ostrów Wielkopolski, Poland
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Pila, Poland
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Poznań, Poland
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Tarnów, Poland
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Warszawa, Poland
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Łódź, Poland
Russian Federation
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Barnaul, Russia, Russian Federation
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Ekaterinburg, Russia, Russian Federation
Research Site
Barnaul, Russian Federation
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Chelyabinsk, Russian Federation
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Ekaterinburg, Russian Federation
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Kazan, Russian Federation
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Moscow, Russian Federation
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Novosibirsk, Russian Federation
Research Site
Saint Petersburg, Russian Federation
Research Site
Saint-Petersburg, Russian Federation
Research Site
St-Petersburg, Russian Federation
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 August 27, 2014