Study to Evaluate the Safety and Efficacy of CAT-354

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 194
• Participant gender: Both

Summary

This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel-arm study to evaluate the efficacy and safety of three subcutaneous (SC) treatment regimens of CAT-354 in adult subjects with uncontrolled, moderate-to-severe, persistent asthma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MedImmune LLC
• Last Updated: 2012-08-29

Criteria

Inclusion Criteria:

• Male or female subjects.

• Age 18 to 65 years at the time of screening.

• Subjects must have a body mass index (BMI) between 18 and 40 kg/m 2.

• Written informed consent obtained from the subject prior to performing any protocol related procedures, including screening evaluations.

• Physician-diagnosed moderate-to-severe, persistent asthma requiring treatment with appropriate asthma controller medication.

• Shows FEV 1 reversibility postbronchodilator of ≥12% and ≥200 mL or have shown such values in a previous test within the last year, or have a positive AHR test result in the last year.

• Pre-bronchodilator FEV 1 value ≥40% of individual predicted value at Visits 1 and 3 8) Uncontrolled asthma consistent with Expert Panel Report (EPR)-3. In the 2 to 4 weeks preceding screening, subjects should have a history of one or more of the following:

• Daytime asthma symptoms ≥2 days/week ii) Nighttime awakening ≥1 night/week iii) Salbutamol use ≥2 days/week.

• An ACQ score ≥1.5 at Visits 1 and 3 (the ACQ is described in Section .7.10.1).

• At least one occurrence of asthma exacerbation in the past year that required an unscheduled medical encounter.

• Women of child-bearing potential, unless surgically sterile (including tubal ligation) and/or at least 2 years postmenopausal must have a negative pregnancy test prior to the first dose of investigational product, and must agree to use - effective methods of avoiding pregnancy (including oral, injectable, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, use of condom by male sexual partner); or abstinence or sterile sexual partner from screening through Study Day 169. Women of childbearing potential must continue to practice birth control during the study and for at least 2 months after completing the study.

• Men, unless surgically sterile, must likewise practice 2 effective methods of birth control (condom with spermicide) and must use such precautions from Study Day 1 through Study Day 169.

• Otherwise healthy by medical history and physical examination for that age group.

• A chest x-ray or CT scan within the previous 12 months with no findings suggestive of acute or chronic respiratory pathology other than asthma.

• Ability and willingness to complete the follow-up period until Study Day 169 as required by the protocol.

Exclusion Criteria:

• Known history of allergy or reaction to any component of the investigational product formulation.

• Acute illness other than asthma at the start of the study.

• History of an active infection within 4 weeks prior to screening, or evidence of clinically significant active infection, including ongoing chronic infection.

• History of ingestion of untreated water in a location known to be infected with parasites, resulting in acute or chronic diarrhea; or a diagnosis of parasitic infection within 6 months prior to screening.

• Use of immunosuppressive medication (except oral prednisone up to 10 mg/day and inhaled and topical corticosteroids) within 30 days before randomization into the study.

• Receipt of immunoglobulin or blood products within 30 days before randomization into the study.

• Receipt of any investigational drug therapy or use of any biologicals including omalizumab within 6 months before the first dose of investigational product in this study or within 5 half-lives of an investigational agent or biologic, whichever is longer.

• History of any known immunodeficiency disorder.

• A positive hepatitis B surface antigen, or hepatitis C virus antibody, as determined by medical history and/or subject's verbal report.

• A positive human immunodeficiency virus test or is taking antiretroviral medications, as determined by medical history and/or subject's verbal report.

• A live or attenuated vaccination received within 4 weeks prior to screening Previous medical history, or evidence, of an intercurrent illness that may compromise the safety of the subject in the study.

• History of clinically significant abnormality on electrocardiogram (ECG) in the opinion of the investigator.

• Lactation (women)

• History of treatment for alcohol or drug abuse within the past year.

• History suggestive of chronic obstructive pulmonary disease (COPD) and of cigarette smoking ≥10 pack-years.

• Evidence of any systemic disease on physical examination.

• History of cancer, apart from basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy ≤1 year prior to Study Day 1 or other malignancies treated with apparent success with curative therapy ≤5 years prior to entry.

• Known exposure to inhaled occupational agents or fumes.

• Any condition (eg, cystic fibrosis [CF] or COPD) that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of study results.

• Individuals who are legally institutionalized

• Employees of the clinical study site or any other individuals involved with the conduct of the study, or family members of such individuals.