Chronic Obstructive Pulmonary DiseasePhase 1/2NCT00581945

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

A Phase 1/2 study testing Canakinumab in people with Chronic Obstructive Pulmonary Disease, run by Novartis at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: Canakinumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 147 participants
Where: 11 sitesUnited States
Study dates: Jan 2007to May 2010
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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,

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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.

Who cannot join

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.

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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 locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Novartis Investigator Site
Anaheim, California, 92801
Novartis Investigator Site
Baltimore, Maryland, 21224
Novartis Investigator Site
Buffalo, New York, 14215
Novartis Investigator Site
Livonia, Michigan, 48152
Novartis Investigator Site
Los Angeles, California, 90095
Novartis Investigator Site
Marietta, Georgia, 300060
Novartis Investigator Site
Minneapolis, Minnesota, 55402
Novartis Investigator Site
Omaha, Nebraska, 68198-5885
Novartis Investigator Site
Panama City, Florida, 32405
Novartis Investigator Site
Richmond, Virginia, 23225
Novartis Investigator Site
Spartanburg, South Carolina, 29303

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About this study

Official title: A Randomized, Double-blind, Placebo Controlled, Exploratory Study to Assess the Safety and Efficacy of Multiple Doses of ACZ885 in Chronic Obstructive Pulmonary Disease (COPD) Patients

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: Canakinumab, Placebo
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00581945
Study group	Role	What they receive
Canakinumab	Experimental	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. Receives: Drug: Canakinumab
Placebo	Placebo comparator	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. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 was measured by spirometry performed at approximately the same time of day on each visit to avoid diurnal variation. All spirometry calibrations and evaluations followed the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. A positive change from baseline in FEV1 indicates improvement in lung function.
Measured: Baseline, Week 25 and Week 45
Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted
The FEV1 percent predicted expresses FEV1 as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function.
Measured: Baseline, Week 25 and Week 45
Change From Baseline in Forced Vital Capacity (FVC)
Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed by spirometry. A positive change from baseline in FVC indicates improvement in lung function.
Measured: Baseline, Week 25 and Week 45
Change From Baseline in Slow Vital Capacity (SVC)
Vital Capacity is the amount of air that can be forcibly exhaled from the lungs after a full inhalation. Slow Vital Capacity (SVC) test is performed by having the patient slowly and completely blow out all of the air from their lungs. A positive change from baseline in SVC indicates improvement in lung function.
Measured: Baseline, Week 25 and Week 45
Change From Baseline in Forced Expiratory Flow 25% to 75%
The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry. A positive change from baseline in FEF indicates improvement in lung function.
Measured: Baseline, Week 25 and Week 45

Secondary outcomes (1)

Number of Participants Who Experienced Serious Adverse Events or Discontinued Due to Adverse Events
Safety was assessed by the number of participants with serious adverse events and/or adverse events leading to study discontinuation. A summary of adverse events is presented with this outcome, additional details are provided in the Adverse Events section.
Measured: Adverse events were collected during the 45 week treatment period and the 12 week follow-up period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007May 2010

First posted28 Dec 2007 (estimated)
Study startJan 2007
Primary completionMay 2010
Study completionMay 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 147 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00581945
Sponsor's protocol ID: CACZ885B2204
Status last verified: Jun 2011
First submitted: 21 Dec 2007
Last updated: 30 Jun 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo Controlled, Exploratory Study to Assess the Safety and Efficacy of Multiple Doses of ACZ885 in Chronic Obstructive Pulmonary Disease (COPD) Patients
ClinicalTrials.gov ID: NCT00581945
Acronym / sponsor ID: CACZ885B2204
Conditions: Chronic Obstructive Pulmonary Disease
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 147 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Jan 2007
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 28 Dec 2007 (estimated)
Results: Posted 27 Jun 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Canakinumab	Experimental	Drug: CanakinumabParticipants 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.
Placebo	Placebo comparator	Drug: PlaceboParticipants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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%

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CanakinumabThe dose of canakinumab (ACZ885) administered was individualized, based on the subject's weight pre-dose, and was administered via intravenous infusion.	Drug	Canakinumab
PlaceboMatching placebo to ACZ885 administered via intravenous infusion.	Drug	Placebo

Primary outcome

Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline, Week 25 and Week 45
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 was measured by spirometry performed at approximately the same time of day on each visit to avoid diurnal variation. All spirometry calibrations and evaluations followed the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. A positive change from baseline in FEV1 indicates improvement in lung function.
Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted
Time frame: Baseline, Week 25 and Week 45
The FEV1 percent predicted expresses FEV1 as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function.
Change From Baseline in Forced Vital Capacity (FVC)
Time frame: Baseline, Week 25 and Week 45
Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed by spirometry. A positive change from baseline in FVC indicates improvement in lung function.
Change From Baseline in Slow Vital Capacity (SVC)
Time frame: Baseline, Week 25 and Week 45
Vital Capacity is the amount of air that can be forcibly exhaled from the lungs after a full inhalation. Slow Vital Capacity (SVC) test is performed by having the patient slowly and completely blow out all of the air from their lungs. A positive change from baseline in SVC indicates improvement in lung function.
Change From Baseline in Forced Expiratory Flow 25% to 75%
Time frame: Baseline, Week 25 and Week 45
The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry. A positive change from baseline in FEF indicates improvement in lung function.

1 secondary outcome

Number of Participants Who Experienced Serious Adverse Events or Discontinued Due to Adverse Events
Time frame: Adverse events were collected during the 45 week treatment period and the 12 week follow-up period.

Results and safety

Results posted to the registry on 27 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Canakinumab	74	65
Placebo	73	63

Primary outcome: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)

Time frame: Baseline, Week 25 and Week 45. Mean (Standard Deviation). Unit: Liters

Measure	Canakinumab n = 74	Placebo n = 73
Change from Baseline at Week 25	-0.027 (0.1725)	-0.006 (0.2545)
Change from Baseline at Week 45	-0.044 (0.1542)	-0.033 (0.2512)

Population analysed: The safety population consisted of all randomized patients who received at least one dose of the study drug.

Primary outcome: Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted

Time frame: Baseline, Week 25 and Week 45. Mean (Standard Deviation). Unit: Percent of predicted

Measure	Canakinumab n = 74	Placebo n = 73
Change from Baseline at Week 25	-0.2 (6.42)	0.3 (8.86)
Change from Baseline at Week 45	-1.0 (5.35)	-0.7 (8.49)

Population analysed: Safety population

Primary outcome: Change From Baseline in Forced Vital Capacity (FVC)

Time frame: Baseline, Week 25 and Week 45. Mean (Standard Deviation). Unit: liters

Measure	Canakinumab n = 74	Placebo n = 73
Change from Baseline at Week 25	-0.010 (0.3720)	-0.061 (0.4856)
Change from Baseline at Week 45	-0.039 (0.3122)	-0.065 (0.5170)

Population analysed: Safety population

Primary outcome: Change From Baseline in Slow Vital Capacity (SVC)

Time frame: Baseline, Week 25 and Week 45. Mean (Standard Deviation). Unit: liters

Measure	Canakinumab n = 74	Placebo n = 73
Change from Baseline at Week 25	-0.029 (0.3746)	-0.019 (0.5082)
Change from Baseline at Week 45	-0.062 (0.3727)	-0.017 (0.5379)

Population analysed: Safety population

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected over the 45-week treatment period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Canakinumab	23 of 74 (31.1%)	59 of 74 (79.7%)	Not reported
Placebo	14 of 73 (19.2%)	51 of 73 (69.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

NOVARTIS principal investigator

Novartis investigator site

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Canakinumab in people with Chronic Obstructive Pulmonary Disease, run by Novartis at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) (time frame: Baseline, Week 25 and Week 45). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00581945.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2011.