Study to Evaluate the Safety and Efficacy of CAT-354

MedImmune

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Biological: CAT-354 300 mg; Other: Placebo; Biological: CAT-354 600 mg; Biological: CAT-354 150 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00873860

MI-CP199

2008-007844-33 (EudraCT Number)

Details and patient eligibility

About

This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel-arm study to evaluate the efficacy and safety of 3 subcutaneous (SC) treatment regimens of CAT-354 in adult subjects with uncontrolled, moderate-to-severe, persistent asthma.

Full description

Study MI-CP199, a Phase 2a, randomized, double-blind, placebo-controlled, parallel-arm, multicenter study will evaluate the effect of 3 SC treatment regimens of CAT-354 on asthma control in adults with uncontrolled, moderate-to-severe, persistent asthma.

Enrollment: 357 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 kilogram per square meter (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 forced expiratory volume in 1 second (FEV1) reversibility postbronchodilator of greater than or equal to (>=)12 percent and >=200 milliliter (mL) or have shown such values in a previous test within the last year, or have a positive airway hyperresponsiveness (AHR) test result in the last year
• Pre-bronchodilator FEV 1 value >=40 percent of individual predicted value at Visits 1 and 3
• Uncontrolled asthma consistent with Expert Panel Report (EPR)-3. In the 2 to 4 weeks preceding Screening, subjects should have a history of 1 or more of the following: Daytime asthma symptoms >=2 days/week, Nighttime awakening >=1 night/week, Salbutamol use >=2 days/week
• An Asthma control questionnaire (ACQ) score >=1.5 at Visits 1 and 3
• At least 1 occurrence of asthma exacerbation in the past year that required an unscheduled medical encounter
• Men, unless surgically sterile, must likewise practice 2 effective methods of birth control (condom with spermicide) and must use such precautions from Day 1 through Study Day 169
• Otherwise healthy by medical history and physical examination for that age group
• A chest x-ray or computed tomography (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 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 milligram/day (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
• 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 less than or equal to (<=)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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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357 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.

Treatment:

Other: Placebo

CAT-354 150 mg

Experimental group

Description:

CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.

Treatment:

Biological: CAT-354 150 mg

CAT-354 300 mg

Experimental group

Description:

CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.

Treatment:

Biological: CAT-354 300 mg

CAT-354 600 mg

Experimental group

Description:

CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.

Treatment:

Biological: CAT-354 600 mg