A Study to Evaluate the Effectiveness and Safety of MEDI-528 in Adults
NCT ID: NCT00968669
Last Updated: 2014-06-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
329 participants
INTERVENTIONAL
2009-12-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MEDI528 30 mg
MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI528 30 mg
MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI528 100 mg
MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI528 100 mg
MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI528 300 mg
MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI528 300 mg
MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Placebo
Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
Placebo
Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
Interventions
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MEDI528 30 mg
MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI528 100 mg
MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
MEDI528 300 mg
MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
Placebo
Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
Eligibility Criteria
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Inclusion 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 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. 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 and body mass index (BMI) between 18 and 35 kg/m2
6. Physician-diagnosed asthma by medical chart
7. Currently taking inhaled corticosteroids (ICS) or is a candidate to receive ICS per Expert Panel Report (EPR)-3
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 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
Exclusion Criteria
* Daytime asthma symptoms ≥ 2 days/week
* Nighttime awakening ≥ 1 night/week
* Albuterol/salbutamol use ≥ 2 days/week
11. An Asthma Control Questionnaire (ACQ) score ≥ 1.5 at Day -28 and at Day 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.
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) 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) 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 electrocardiogram (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
18 Years
65 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Chad Oh, M.D.
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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Research Site
Pell City, Alabama, United States
Research Site
Los Angeles, California, United States
Research Site
Sacramento, California, United States
Research Site
San Diego, California, United States
Research Site
Centennial, Colorado, United States
Research Site
Colarado Springs, Colorado, United States
Research Site
Thornton, Colorado, United States
Research Site
Waterbury, Connecticut, United States
Research Site
Kissimmee, Florida, United States
Research Site
Normal, Illinois, United States
Research Site
Overland Park, Kansas, United States
Research Site
Louisville, Kentucky, United States
Research Site
Baltimore, Maryland, United States
Research Site
Silver Spring, Maryland, United States
Research Site
North Dartmouth, Massachusetts, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
Omaha, Nebraska, United States
Research Site
Mount Laurel, New Jersey, United States
Research Site
Sylvania, Ohio, United States
Research Site
Medford, Oregon, United States
Research Site
Lincoln, Rhode Island, United States
Research Site
Greenville, South Carolina, United States
Research Site
El Paso, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Buenos Aire, Buenos Aires F.D., Argentina
Research Site
Ciudad Autonoma Bs As, Buenos Aires F.D., Argentina
Research Site
Rosario, Santa Fe Province, Argentina
Research Site
San Miguel de Tucumán, Tucumán Province, Argentina
Research Site
Buenos Aires, , Argentina
Research Site
Ciudad de Buenos Aire, , Argentina
Research Site
Porto Alegre, Rio Grande do Sul, Brazil
Research Site
Porto Alegre, Rio Grande do Sul, Brazil
Research Site
Florianópolis, Santa Catarina, Brazil
Research Site
Santo André, , Brazil
Research Site
São Paulo, , Brazil
Research Site
Calgary, Alberta, Canada
Research Site
Edmonton, Alberta, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
Mississauga, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Bogota DC, Cundinamarca, Colombia
Research Site
Bogota, Cundinamarca, Colombia
Research Site
Bogotá D.C., Cundinamarca, Colombia
Research Site
San Francisco de Dos Ríos, Provincia de San José, Costa Rica
Research Site
Panama City, , Panama
Research Site
Lima, Lima Province, Peru
Research Site
Lima, Lima Province, Peru
Research Site
Lima, Lima Province, Peru
Research Site
Jesus Maria, Lima region, Peru
Research Site
Lipa City, Batangas, Philippines
Research Site
Iloilo City, Iloilo, Philippines
Research Site
Quezon City, National Capital Region, Philippines
Research Site
Kaohsiung City, , Taiwan
Research Site
Taoyuan District, , Taiwan
Countries
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References
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Oh CK, Leigh R, McLaurin KK, Kim K, Hultquist M, Molfino NA. A randomized, controlled trial to evaluate the effect of an anti-interleukin-9 monoclonal antibody in adults with uncontrolled asthma. Respir Res. 2013 Sep 19;14(1):93. doi: 10.1186/1465-9921-14-93.
Lloyd CM, Hessel EM. Functions of T cells in asthma: more than just T(H)2 cells. Nat Rev Immunol. 2010 Dec;10(12):838-48. doi: 10.1038/nri2870. Epub 2010 Nov 9.
Other Identifiers
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MI-CP198
Identifier Type: -
Identifier Source: org_study_id
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