Safety and Efficacy of Multiple Doses of Canakinumab (ACZ885) in Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT ID: NCT00581945

Last Updated: 2011-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2010-05-31

Brief Summary

Was to evaluate the safety, tolerability and efficacy of multiple doses of canakinumab (ACZ885) vs. placebo when administered via intravenous infusion (IV), on pulmonary function in patients with COPD

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Canakinumab

Participants received an initial dose of 1 mg/kg canakinumab (ACZ885) via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.

Group Type: EXPERIMENTAL

Canakinumab

Intervention Type: DRUG

The dose of canakinumab (ACZ885) administered was individualized, based on the subject's weight pre-dose, and was administered via intravenous infusion.

Placebo

Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo to ACZ885 administered via intravenous infusion.

Interventions

Canakinumab

The dose of canakinumab (ACZ885) administered was individualized, based on the subject's weight pre-dose, and was administered via intravenous infusion.

Intervention Type: DRUG

Placebo

Matching placebo to ACZ885 administered via intravenous infusion.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male and/or female subjects from 40-80 years (inclusive) of age
• Subjects have a clinical diagnosis of COPD
• Smokers or Ex-smokers with a smoking history of at least 20 pack years
• Post-bronchodilator forced expiratory volume in 1 second (FEV1 ) at screening ≤ 50% of the predicted normal value
• Post-bronchodilator FEV1/FVC ratio < 70%
• History of at least one treated exacerbation during the 24 months year prior to screening or C-Reactive Protein (CRP) ≥3.47 mg/L,
• Subjects should have no concomitant other lung disease or significant concomitant medical conditions that would affect the subjects' safety when participating in the study, or that would be expected to impact on the results of the study
• Female subjects must have been surgically sterilized at least 6 months prior to screening or must be using two forms of contraception, or postmenopausal women
• Able to provide written informed consent prior to study participation.
• Able to communicate well with the investigator and comply with the requirements of the study.

Exclusion Criteria

• COPD exacerbation(s) requiring treatment within 4 weeks prior to first dosing
• History of lung reduction surgery
• Any undiagnosed nodule on chest x-ray
• Presence of certain medical conditions as specified by the protocol
• Subjects requiring oral or parenteral corticosteroids equivalent to > 10 mg/day or > 20 mg every other day of prednisone or prednisolone
• Documented homozygous alpha-1 antitrypsin deficiency.
• Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
• Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
• A past medical history of clinically significant electrocardiogram (ECG) abnormalities or a family history of a prolonged QT-interval syndrome.
• A known hypersensitivity to drugs similar to the study drug.
• History of immunocompromise, including a positive HIV test result.
• A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
• History of drug or alcohol abuse within the 12 months prior to screening or evidence of such abuse as indicated by the laboratory assays conducted during screening.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Novartis

Principal Investigators

NOVARTIS

Role: PRINCIPAL_INVESTIGATOR

Novartis investigator site

Locations

Novartis Investigator Site

Anaheim, California, United States

Novartis Investigator Site

Los Angeles, California, United States

Novartis Investigator Site

Panama City, Florida, United States

Novartis Investigator Site

Marietta, Georgia, United States

Novartis Investigator Site

Baltimore, Maryland, United States

Novartis Investigator Site

Livonia, Michigan, United States

Novartis Investigator Site

Minneapolis, Minnesota, United States

Novartis Investigator Site

Omaha, Nebraska, United States

Novartis Investigator Site

Buffalo, New York, United States

Novartis Investigator Site

Spartanburg, South Carolina, United States

Novartis Investigator Site

Richmond, Virginia, United States

Countries

United States

Other Identifiers

CACZ885B2204

Identifier Type: -

Identifier Source: org_study_id