Study to Evaluate the Safety and Efficacy of CAT-354

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00873860
• Other study ID #: MI-CP199
• Secondary ID: 2008-007844-33
• Status: Completed
• Phase: Phase 2
• First received: April 1, 2009
• Last updated: August 29, 2012
• Start date: June 2009
• Est. completion date: August 2010

Study information

• Verified date: August 2012
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
Bulgaria	Research Site	Burgas
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Rousse
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Stara Zagora
Bulgaria	Research Site	Varna
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Frankfurt/Main
Germany	Research Site	Lich
Germany	Research Site	Mainz
Poland	Research Site	Gdansk
Poland	Research Site	Lodz
Poland	Research Site	Skalskie
Poland	Research Site	Warsazawa
Poland	Research Site	Warszawa
Poland	Research Site	Wroclaw
Poland	Research Site	Zabrze
Romania	Research Site	Arad
Romania	Research Site	Arad
Romania	Research Site	Bucharest
Romania	Research Site	Bucharest
Romania	Research Site	Bucharest
Romania	Research Site	Cluj-Napoca
Romania	Research Site	Deva
Romania	Research Site	Timisoara Timis
United Kingdom	Research Site	Cambridge
United Kingdom	Research Site	Leicester
United Kingdom	Research Site	Wythenshawe	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Countries where clinical trial is conducted

Bulgaria,  Germany,  Poland,  Romania,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To study the effect of CAT-354 on asthma control against placebo		Study Day 92	No
Secondary	To study the effect of CAT-354 on the safety profile in this patient population.		Study Day 92 and 169	Yes
Secondary	To study the effect of CAT-354 on the time to asthma control.		Study Days 92 & 169	No
Secondary	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		Study Days 92 and 169	No
Secondary	To study the effect of SC CAT-354 on the time to first asthma exacerbation.		Study Day 92 and 169	No
Secondary	To study the effect of SC CAT-354 on asthma exacerbation rates and severity (hospitalizations)		Study Day 92 and 169	No
Secondary	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)		Study Day 92 and 169	No
Secondary	To study the effect of SC CAT-354 on a subject's requirement for concomitant asthma controller or rescue medications		Study Day 92 and 169	No
Secondary	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		Study Day 92 and 169	No
Secondary	To determine the pharmacokinetics and immunogenicity of SC CAT-354.		Study Day 92 and 169	No

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