A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-arm, Multicenter Study to Evaluate the Efficacy and Safety of CAT-354, a Fully Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), on Asthma Control in Adults with Uncontrolled, Moderate-to-severe, Persistent Asthma
- Conditions
- AsthmaMedDRA version: 8.1Level: PTClassification code 10003553Term: Asthma
- Registration Number
- EUCTR2008-007844-33-DE
- Lead Sponsor
- MedImmune Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 192
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method