Study to Evaluate the Safety and Efficacy of CAT-354

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MedImmune

Status and phase

Completed
Phase 2

Conditions

Asthma

Treatments

Biological: CAT-354 300 mg
Biological: CAT-354 600 mg
Other: Placebo
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

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

Trial contacts and locations

57

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Data sourced from clinicaltrials.gov

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