A Study to Evaluate the Effectiveness and Safety of MEDI-528 in Adults

This study has been completed.
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
First received: August 28, 2009
Last updated: August 5, 2013
Last verified: August 2013

To study the safety and effectiveness of multiple-doses of MEDI-528 on asthma control in adults with uncontrolled, moderate-to-severe, persistent asthma.

Condition Intervention Phase
Biological: MEDI-528
Other: 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, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous MEDI-528 in Adults With Uncontrolled Asthma

Resource links provided by NLM:

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Asthma Control Questionnaire (ACQ) score [ Time Frame: Day 92 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate safety and tolerability of MEDI-528 on asthma exacerbations, asthma control, pulmonary function, and health-related quality of life; and PK and IM of MEDI-528. [ Time Frame: Day 323 ] [ Designated as safety issue: Yes ]

Enrollment: 329
Study Start Date: December 2009
Study Completion Date: January 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Investigational product-MEDI-528
Biological: MEDI-528
30 mg; Study Days 1, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, 155, and 169.
Experimental: 2
Investigational Product MEDI-528
Biological: MEDI-528
100 mg; Study Days 1, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, 155, and 169.
Experimental: 3
Investigational product-MEDI-528
Biological: MEDI-528
300 mg; Study Days 1, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, 155, and 169.
Experimental: 4
Other: Placebo
0 mg; Study Days 1, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, 155, and 169.

Detailed Description:

The primary objective of this study is to evaluate the effect of multiple-dose subcutaneous (SC) administration of MEDI-528 on asthma control in adults with uncontrolled, moderate-to-severe, persistent asthma.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria

Subjects must meet all of the following criteria:

  1. Male or female
  2. Age 18 through 65 years at the time of screening
  3. Written informed consent and any locally required authorization (eg, HIPAA in the USA, EU Data Privacy Directive in the EU, obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
  4. Female subjects of childbearing potential who are sexually active with non-sterilized male partner must use adequate contraception from screening through the end of the study. An acceptable method of contraception is defined as one that has no higher than a 1% failure rate. In this study, where medications and devices containing hormones are included, the recommended methods of contraception are described in Table 4.2.1-1. Sustained abstinence is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception

    1. Non-sterilized males who are sexually active with a female of child-bearing potential must use adequate contraception from screening through the end of the study
    2. Females or female partners not of childbearing potential must have been surgically sterilized (eg, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or postmenopausal (defined as at least 1 year since last regular menses)
    3. Sterilized males must be at least 1-year post vasectomy and have obtained documentation of the absence of sperm in the ejaculate
  5. Weight ≥ 45 kg but ≤ 120 kg (ie, ≥ 100 lb but ≤ 265 lb) and body mass index (BMI) between 18 and 35 kg/m2
  6. Physician-diagnosed asthma by medical chart
  7. Currently taking ICS or is a candidate to receive ICS per Expert Panel Report (EPR)-3 (National Heart, Lung, and Blood Institute, 2007)
  8. Pre-bronchodilator forced expiratory volume in 1 second (FEV1) value ≥ 40% at Day -28 and Day 1
  9. A post-bronchodilator increase in FEV1 and/or FVC ≥ 12% and ≥ 200 mL at Day -28 OR meeting any one of the following criteria:

    1. Proof of post-bronchodilator reversibility of airflow obstruction ≥ 12% documented within 36 months prior to randomization or proof of a positive response [PC20 ≤ 8 mg/mL (ATS, 2000)] to a methacholine challenge documented within 36 months prior to randomization; OR
    2. Proof of partial reversibility of ≥ 8% to < 12% improvement in post-bronchodilator FEV1 on Day -28 and achievement of ≥ 12% reversibility at a second time between Day -27 and Day -15; OR
    3. If a) and b) are not met and all other inclusion/exclusion criteria are met, subjects with a FEV1 of ≥ 1.5 L and ≥ 60% on Day -14 will be eligible to undergo a methacholine challenge. If the subject achieves a positive response to this methacholine challenge (PC20 ≤ 8 mg/mL), then this criterion is met
  10. Uncontrolled asthma consistent with EPR-3. In the 28 days before screening, subjects should have a history of one or more of the following:

    • Daytime asthma symptoms ≥ 2 days/week
    • Nighttime awakening ≥ 1 night/week
    • Albuterol/salbutamol use ≥ 2 days/week
  11. An ACQ score ≥ 1.5 at Day -28 and at Day 1 (ACQ is described in Section Subject may be re-screened one additional time if they met this criterion at Day -28 but failed to meet it at Day 1 (procedure described in Section 4.6.1)
  12. At least one asthma exacerbation in the 12 months before screening that required intake of systemic corticosteroids after an unscheduled medical encounter or as agreed with a physician based on an asthma action plan that defines when oral steroids can be taken by the subject
  13. Ability and willingness to complete the follow-up period through Day 323 as required by the protocol.

Exclusion Criteria

Any of the following would exclude the subject from participation in the study:

  1. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
  2. Concurrent enrollment in another clinical study
  3. Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
  4. Known history of allergy or reaction to any component of the investigational product formulation
  5. History of anaphylaxis to other biologic therapy
  6. Lung disease other than asthma (eg, chronic obstructive pulmonary disease [COPD], cystic fibrosis)
  7. Severe depression as measured by a depression score > 15 on the Hospital Anxiety and Depression Scale (HADS; see Appendix 7) at either Day-28 or Day 1.
  8. History of suicidal behavior in the previous 3 years as measured by the Columbia Suicide Severity Rating Scale (C-SSRS; see Appendix 8 [Baseline C-SSRS]) at Day -28.
  9. Acute illness other than asthma at the screening and randomization visits
  10. History of an active infection within 28 days before and during the screening period, or evidence of clinically significant active infection, including ongoing chronic infection
  11. History of ingestion of untreated water in a location known to be infected with parasites, resulting in acute or chronic diarrhea; history of recent travel to areas where parasite infestations are endemic within 6 months before screening; or a diagnosis of parasitic infection within 6 months before screening
  12. Use of immunosuppressive medication (except oral prednisone up to a dose of 20 mg every other day or equivalent [eg, 10 mg a day or 5 mg twice a day] and inhaled and topical corticosteroids) within 28 days before randomization
  13. Receipt of immunoglobulin or blood products within 28 days before randomization
  14. Plans to donate blood during the entire study period
  15. Donated blood or has had a blood transfusion within 28 days before screening
  16. Receipt of any non-biological study drugs or interventional therapy (including surgical procedures) within 28 days of the first dose of investigational product in this study
  17. Receipt of any biologicals including MEDI-528 within 5 half-lives before the first dose of investigational product in this study
  18. History of any known immunodeficiency disorder
  19. A positive hepatitis B surface antigen, or hepatitis C virus antibody, as determined by medical history and/or subject's verbal report
  20. A positive human immunodeficiency virus test or is taking antiretroviral medications, as determined by medical history and/or subject's verbal report
  21. A live attenuated vaccination received within 28 days before screening
  22. History of clinically significant abnormality on ECG in the opinion of the investigator
  23. Breastfeeding or lactating
  24. History of treatment for alcohol or drug abuse within the past year
  25. History suggestive of COPD or of tobacco smoking ≥ 10 pack-years
  26. Evidence of any uncontrolled systemic disease upon physical examination
  27. History of cancer, apart from basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy ≥ 1 year before Day 1 or other malignancies treated with apparent success with curative therapy ≥ 5 years before screening
  28. Any noninfectious disease involving multiple organs (eg, cystic fibrosis, systemic lupus erythematosus, hemophilia, multiple sclerosis, etc.) that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
  29. Individuals who are legally institutionalized
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968669

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United States, Alabama
Research Site
Pell City, Alabama, United States, 35128
United States, California
Research Site
Los Angeles, California, United States, 90025
Research Site
Sacramento, California, United States, 95819
Research Site
San Diego, California, United States, 92123
United States, Colorado
Research Site
Centennial, Colorado, United States, 80112
Research Site
Colarado Springs, Colorado, United States, 80907
Research Site
Thornton, Colorado, United States, 80233
United States, Connecticut
Research Site
Waterbury, Connecticut, United States, 06708
United States, Florida
Research Site
Kissimmee, Florida, United States, 34741
United States, Illinois
Research Site
Normal, Illinois, United States, 61761
United States, Kansas
Research Site
Overland Park, Kansas, United States, 66210
United States, Kentucky
Research Site
Louisville, Kentucky, United States, 40215
United States, Maryland
Research Site
Baltimore, Maryland, United States, 21236
Research Site
Silver Spring, Maryland, United States, 20902
United States, Massachusetts
Research Site
N. Dartmouth, Massachusetts, United States, 02747
United States, Minnesota
Research Site
Minneapolis, Minnesota, United States, 55402
United States, Nebraska
Research Site
Omaha, Nebraska, United States, 68131
United States, New Jersey
Research Site
Mt. Laurel, New Jersey, United States, 08054
United States, Ohio
Research Site
Sylvania, Ohio, United States, 43560
United States, Oregon
Research Site
Medford, Oregon, United States, 97504
United States, Rhode Island
Research Site
Lincoln, Rhode Island, United States, 02865
United States, South Carolina
Research Site
Greenville, South Carolina, United States, 29607
United States, Texas
Research Site
El Paso, Texas, United States, 79903
Research Site
San Antonio, Texas, United States, 78229
Research Site
Buenos Aire, Caba, Argentina, 1425
Research Site
Buenos Aires, Ciudad de Buenos Aires, Argentina, 1405
Research Site
Rosario, Santa Fe, Argentina, 2000
Research Site
San Miguel de Tucuman, Tucuman, Argentina, T4000IAR
Research Site
Buenos Aires, Argentina, C1424BSF
Research Site
Ciudad de Buenos Aire, Argentina, 1425
Research Site
Porto Alegre, RS, Brazil, 90610-000
Research Site
Porto Alegre, RS, Brazil, 90020-090
Research Site
Florianopolis, Santa Catarina, Brazil, 88040-970
Research Site
Santo André, Brazil, 09060-870
Research Site
Sao Paulo, Brazil, 05403-000
Canada, Alberta
Research Site
Calgary, Alberta, Canada, T2N 4Z6
Research Site
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Research Site
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
Research Site
Mississauga, Ontario, Canada, L5A 3V4
Research Site
Ottawa, Ontario, Canada, K1Y 4G2
Canada, Quebec
Research Site
Montreal, Quebec, Canada, H2X 2P4
Research Site
Quebec City, Quebec, Canada, G1V 4M6
Research Site
Québec, Quebec, Canada
Research Site
Bogota, Cundinamarca, Colombia
Research Site
Bogota DC, Cundinamarca, Colombia
Research Site
Bogotá D.C., Cundinamarca, Colombia
Costa Rica
Research Site
San Francisco de Dos Rios, San José, Costa Rica
Research Site
Ciudad de Panama, Panama
Research Site
Jesus Maria, Lima, Peru, Lima 11
Research Site
Lima, Peru, Lima 27
Research Site
Lima, Peru, LIMA 33
Research Site
Lima, Peru
Research Site
Lipa City, Batangas, Philippines
Research Site
Iloilo City, Iloilo, Philippines, 5000
Research Site
Quezon City, Metro Manila, Philippines, 870
Research Site
Kaohsiung, Taiwan
Research Site
Taoyuan, Taiwan
Sponsors and Collaborators
MedImmune LLC
Study Director: David Gossage, M.D., MBA MedImmune LLC
  More Information

Additional Information:
No publications provided by MedImmune LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical Monitor, MedImmune, LLC
ClinicalTrials.gov Identifier: NCT00968669     History of Changes
Other Study ID Numbers: MI-CP198
Study First Received: August 28, 2009
Last Updated: August 5, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014