Study to Evaluate the Safety and Efficacy of CAT-354
Condition: Asthma
MeSH terms: Asthma
Intervention: Placebo; CAT-354 150 mg; CAT-354 300 mg; CAT-354 600 mg
Intervention description: Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.; CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.; CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.; CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 357.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: CAT-354; Tralokinumab; Asthma

Summary:

      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.
    

Eligibility 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 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.