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Study to Evaluate the Safety and Efficacy of CAT-354

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00873860
First received: April 1, 2009
Last updated: August 29, 2012
Last verified: August 2012

April 1, 2009
August 29, 2012
June 2009
August 2010   (final data collection date for primary outcome measure)
To study the effect of CAT-354 on asthma control against placebo [ Time Frame: Study Day 92 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00873860 on ClinicalTrials.gov Archive Site
  • To study the effect of CAT-354 on the safety profile in this patient population. [ Time Frame: Study Day 92 and 169 ] [ Designated as safety issue: Yes ]
  • To study the effect of CAT-354 on the time to asthma control. [ Time Frame: Study Days 92 & 169 ] [ Designated as safety issue: No ]
  • To study the effect of CAT-354 on the mean percentage of subjects achieving a change from baseline ACQ score consistent with well controlled and partially controlled asthma [ Time Frame: Study Days 92 and 169 ] [ Designated as safety issue: No ]
  • To study the effect of SC CAT-354 on the time to first asthma exacerbation. [ Time Frame: Study Day 92 and 169 ] [ Designated as safety issue: No ]
  • To study the effect of SC CAT-354 on asthma exacerbation rates and severity (hospitalizations) [ Time Frame: Study Day 92 and 169 ] [ Designated as safety issue: No ]
  • To study the effect of SC CAT-354 on the variability of airflow obstruction using the parameters of forced volume within 1 second (FEV1) and peak expiratory flow (PEF) [ Time Frame: Study Day 92 and 169 ] [ Designated as safety issue: No ]
  • To study the effect of SC CAT-354 on a subject's requirement for concomitant asthma controller or rescue medications [ Time Frame: Study Day 92 and 169 ] [ Designated as safety issue: No ]
  • To study the effect of SC CAT-354 on patient reported outcomes including health-related quality of life using the Asthma Quality of Life Questionnaire with Standard Activities (AQLQ[S]) and the patient global impression of change [ Time Frame: Study Day 92 and 169 ] [ Designated as safety issue: No ]
  • To determine the pharmacokinetics and immunogenicity of SC CAT-354. [ Time Frame: Study Day 92 and 169 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate the Safety and Efficacy of CAT-354
A Phase 2a, Randomized, Double-blind, Placebo-Controlled, Parallel-Arm, Multicenter Study to Evaluate the Efficacy and Safety of CAT-354, on Asthma Control in Adults

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.

Study MI-CP199, a Phase 2a, randomized, double-blind, placebo-controlled, parallel-arm, multicenter study will evaluate the effect of three SC treatment regimens of CAT-354 on asthma control in adults with uncontrolled, moderate-to-severe, persistent asthma.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Asthma
  • Drug: CAT-354
    SC CAT-354 once every 2 weeks
  • Other: Placebo
    Placebo contains the same excipients, in the same concentration only lacking CAT-354.
  • Experimental: 1
    150 mg SC CAT-354 (n=48) or 1 mL placebo (n=16
    Interventions:
    • Drug: CAT-354
    • Other: Placebo
  • Experimental: 2
    300 mg CAT-354 (n=48) or 2 mL placebo (n=16)
    Interventions:
    • Drug: CAT-354
    • Other: Placebo
  • Experimental: 3
    600 mg CAT-354 (n=48) or 4 mL placebo (n=16)
    Interventions:
    • Drug: CAT-354
    • Other: Placebo
Piper E, Brightling C, Niven R, Oh C, Faggioni R, Poon K, She D, Kell C, May RD, Geba GP, Molfino NA. A phase II placebo-controlled study of tralokinumab in moderate-to-severe asthma. Eur Respir J. 2013 Feb;41(2):330-8. doi: 10.1183/09031936.00223411. Epub 2012 Jun 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
194
August 2010
August 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Germany,   Poland,   Romania,   United Kingdom
 
NCT00873860
MI-CP199, 2008-007844-33
No
MedImmune LLC
MedImmune LLC
Not Provided
Study Director: Edward Piper, M.D. MedImmune LLC
MedImmune LLC
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP