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
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: CAT-354
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • To study the effect of CAT-354 on asthma control against placebo [ Time Frame: Study Day 92 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 194
Study Start Date: June 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
150 mg SC CAT-354 (n=48) or 1 mL placebo (n=16
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: 2
300 mg CAT-354 (n=48) or 2 mL placebo (n=16)
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: 3
600 mg CAT-354 (n=48) or 4 mL placebo (n=16)
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873860

Locations
Bulgaria
Research Site
Burgas, Bulgaria, 8000
Research Site
Plovdiv, Bulgaria, 4000
Research Site
Rousse, Bulgaria, 7000
Research Site
Sofia, Bulgaria, 1000
Research Site
Sofia, Bulgaria, 1606
Research Site
Sofia, Bulgaria, 1431
Research Site
Stara Zagora, Bulgaria, 6000
Research Site
Varna, Bulgaria, 9000
Germany
Research Site
Berlin, Germany, 10117
Research Site
Berlin, Germany, 14057
Research Site
Frankfurt/Main, Germany, 60389
Research Site
Lich, Germany, 86899
Research Site
Mainz, Germany, 55131
Poland
Research Site
Gdansk, Poland, 80-211
Research Site
Lodz, Poland, 90-153
Research Site
Skalskie, Poland, 41-940
Research Site
Warsazawa, Poland, 01-138
Research Site
Warszawa, Poland, 00-909
Research Site
Wroclaw, Poland, 54-239
Research Site
Zabrze, Poland, 41-800
Romania
Research Site
Arad, Romania, 310011
Research Site
Arad, Romania, 310085
Research Site
Bucharest, Romania, 050159
Research Site
Bucharest, Romania, 030303
Research Site
Bucharest, Romania, 050554
Research Site
Cluj-Napoca, Romania, 400371
Research Site
Deva, Romania, 050554
Research Site
Timisoara Timis, Romania, 300310
United Kingdom
Research Site
Wythenshawe, Manchester, United Kingdom, M23 9QZ
Research Site
Cambridge, United Kingdom, CB23 2TN
Research Site
Leicester, United Kingdom, LE3 9QP
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Edward Piper, M.D. MedImmune LLC
  More Information

Additional Information:
No publications provided by MedImmune LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00873860     History of Changes
Other Study ID Numbers: MI-CP199, 2008-007844-33
Study First Received: April 1, 2009
Last Updated: August 29, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by MedImmune LLC:
Interleukin
Adult

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 29, 2014