Overview
Study to Evaluate the Safety and Efficacy of CAT-354
Status:
Completed
Completed
Trial end date:
0000-00-00
0000-00-00
Target enrollment:
194
194
Participant gender:
Both
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 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
MedImmune LLCLast 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.