Asthma MedDRA version: 8.1 Level: PT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Name: CAT-354
Product Code: CAT-354
Pharmaceutical Form: Solution for injection
INN or Proposed INN: N/A
CAS Number: 1044515-88-9
Current Sponsor code: CAT-354
Other descriptive name: N/A
Conc
Sponsors
MedImmune Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female subjects. 2) Age 18 to 65 years at the time of screening. 3) Subjects must have a body mass index (BMI) between 18 and 40 kg/m2. 4) Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations. 5) Physician-diagnosed moderate-to-severe, persistent asthma requiring treatment with appropriate asthma controller medication. 6) Shows FEV1 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. 7) Pre-bronchodilator FEV1 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 the screening visit, subjects should have one or more of the following: i) Daytime asthma symptoms = 2days/week ii) Nighttime awakening = 1 night/week iii) Salbutamol use = 2 days/week 9) An ACQ score = 1.5 at Visits 1 and 3 10) At least one occurrence of asthma exacerbation in the past year that required an unscheduled medical encounter. 11) 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 2 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. 12) 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. 13) Otherwise healthy by medical history and physical examination for that age group. 14) A chest x-ray or CT scan within the previous 12 months before entering the study with no findings suggestive of acute or chronic respiratory pathology other than asthma. 15) Ability and willingness to complete the follow-up period until Study Day 169 as required by the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Known history of allergy or reaction to any component of the investigational product formulation. 2) Acute illness other than asthma at the start of the study. 3) History of an active infection within 4 weeks prior to screening, or evidence of clinically significant active infection, including ongoing chronic infection. 4) 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. 5) 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. 6) Receipt of immunoglobulin or blood products within 30 days before randomization into the study. 7) 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. 8) History of any known immunodeficiency disorder 9) A positive hepatitis B surface antigen, or hepatitis C virus antibody, as determined by medical history and/or subject’s verbal report 10) A positive human immunodeficiency virus test or is taking antiretroviral medications, as determined by medical history and/or subject’s verbal report. 11) A live or attenuated vaccination received within 4 weeks prior to screening 12) Previous medical history, or evidence, of an intercurrent illness that may compromise the safety of the subject in the study. 13) History of clinically significant abnormality on electrocardiogram (ECG) in the opinion of the investigator. 14) Lactation (women) 15) History of treatment for alcohol or drug abuse within the past year. 16) History suggestive of chronic obstructive pulmonary disease (COPD) and of cigarette smoking = 10 pack-years. 17) Evidence of any systemic disease on physical examination. 18) 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. 19) Known exposure to inhaled occupational agents or fumes. 20) 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. 21) Individuals who are legally institutionalized 22) Employees of the clinical study site or any other individuals involved with the conduct of the study, or family members of such individuals.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the effect of three SC treatment regimens of CAT-354 on asthma control at Study Day 92 versus placebo in adults with uncontrolled, moderate-to-severe, persistent asthma. ;Secondary Objective: 1) Evaluate the effect on the safety profile in this subject population; 2) Evaluate the effect on the time to asthma control through Study Days 92 and 169; 3) Evaluate the effect on the proportion of subjects achieving a change from baseline in ACQ score consistent with well controlled and partly controlled asthma 4) Evaluate the effect on the time to first asthma exacerbation 5) Evaluate the effect on asthma exacerbation rates and severity (hospitalizations) 6) Evaluate the effect on the variability of airflow obstruction using the parameters of forced expiratory volume within 1 second (FEV1) and peak expiratory flow (PEF) 7) Evaluate the effect on a subject’s requirement for concomitant controller or rescue medications and daily asthma symptoms 8) Evaluate the effect on the patient reported outcomes including health-related quality of life using the AQLQ(S) and the patient global impression of change 9) PK and immunogenicity of SC CAT-354. ;Primary end point(s): The primary endpoint is the change from baseline in the mean ACQ score at Study Day 92. | — |
Countries
Bulgaria, Germany, United Kingdom
Outcome results
None listed