Phase 2
Completed N=147
Safety and Efficacy of Multiple Doses of Canakinumab (ACZ885) in Chronic Obstructive Pulmonary Disease (COPD) Patients
Source: ClinicalTrials.gov NCT00581945 ↗Enrolled (actual)
147
Serious AEs
25.2%
Results posted
Jun 2011
Primary outcomePrimary: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) — -0.027; -0.006; -0.044; -0.033 Liters
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) |
-0.027; -0.006; -0.044; -0.033 | — |
| PRIMARY Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted |
-0.2; 0.3; -1.0; -0.7 | — |
| PRIMARY Change From Baseline in Forced Vital Capacity (FVC) |
-0.010; -0.061; -0.039; -0.065 | — |
| PRIMARY Change From Baseline in Slow Vital Capacity (SVC) |
-0.029; -0.019; -0.062; -0.017 | — |
| PRIMARY Change From Baseline in Forced Expiratory Flow 25% to 75% |
-0.022; -0.002; -0.024; -0.012 | — |
| SECONDARY Number of Participants Who Experienced Serious Adverse Events or Discontinued Due to Adverse Events |
23; 14; 1; 0; 4; 4 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT00581945). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.