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

Novartis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Placebo; Drug: Canakinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00581945

CACZ885B2204

Details and patient eligibility

About

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

Enrollment: 147 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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147 participants in 2 patient groups, including a placebo group

Canakinumab

Experimental group

Description:

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.

Treatment:

Drug: Canakinumab

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo