- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01966549
A Study to Evaluate the Effectiveness and Safety of CNTO6785 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
June 6, 2016 updated by: Janssen Research & Development, LLC
A Randomized, Placebo Controlled Double-Blind, Multi-Center, Phase II Study to Assess the Efficacy and Safety of CNTO6785 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
The purpose of the study is to evaluate the effect of CNTO6785 compared with placebo in participants with moderate to severe Chronic Obstructive Pulmonary Disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a multi-center, randomized (study medication is assigned by chance), placebo-controlled (effect of the study medication will be compared with the effect of placebo [inactive substance]), double-blind (neither physician nor participant knows the treatment that the participant receives), parallel-group study (each group of participants will be treated at the same time).
This study consists of 3 phases: a screening phase (within 3 weeks prior to the start of study medication), a treatment phase (12 weeks), and a follow-up phase (12 weeks after the last administration of study medication).
Approximately 170 participants will be enrolled in this study to receive CNTO6785 or placebo in 1:1 ratio.
Safety will be evaluated by the assessment of adverse events, vital signs, 12-lead electrocardiogram, physical examination, early detection of active tuberculosis, and clinical laboratory tests which will be monitored throughout the study.
The total duration of study participation for a participant will be 30 weeks.
Study Type
Interventional
Enrollment (Actual)
187
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brno, Czech Republic
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Jindrichuv Hradec, Czech Republic
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Karlovy Vary, Czech Republic
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Melnik, Czech Republic
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Praha 5 - Radotin, Czech Republic
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Praha 8, Czech Republic
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Strakonice, Czech Republic
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Berlin, Germany
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Dresden, Germany
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Frankfurt, Germany
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Grosshansdorf, Germany
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Hannover, Germany
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Koblenz, Germany
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Magdeburg, Germany
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Ruedersdorf, Germany
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Balassagyarmat, Hungary
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Budapest, Hungary
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Farkasgyepü, Hungary
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Komarom, Hungary
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Létavértes, Hungary
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Mohacs, Hungary
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Nagykanizsa, Hungary
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Zalaegerszeg-P Zva N/A, Hungary
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Seoul, Korea, Republic of
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Suwon, Korea, Republic of
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Wonju-Si, Korea, Republic of
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Batu Caves, Malaysia
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Kota Bharu, Malaysia
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Kuala Lumpur, Malaysia
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Krakow, Poland
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Lodz, Poland
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Poznan, Poland
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Poznań, Poland
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Wroclaw, Poland
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Barnaul, Russian Federation
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Ekaterinburg, Russian Federation
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Kemerovo, Russian Federation
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Novosibirsk, Russian Federation
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Saint Petersberg, Russian Federation
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Saint-Petersberg, Russian Federation
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Saratov, Russian Federation
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St. Petersburg, Russian Federation
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Yaroslavl, Russian Federation
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New Taipei City, Taiwan
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Taipei, Taiwan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Moderate to severe Chronic Obstructive Pulmonary Disease (COPD) (Grade II or Grade III according to the GOLD Guidelines) with chronic bronchitis (sputum production on most days for at least 12 weeks per year for at least 2 successive years) at screening
- Persistent COPD symptoms that required repeated (greater than 1) 'as needed' use of a short acting rescue medication within 4 weeks prior to screening
- Had at least 2 COPD exacerbations requiring antibiotics and/or systemic corticosteroids in the past 2 years OR able to spontaneously produce an adequate sputum sample within 3 to 6 weeks prior to the start of study medication
- Be a current or ex-smoker who has a smoking history of at least 10 pack years at screening
- Meet tuberculosis(TB) screening criteria as: no history of latent or active TB, no signs or symptoms suggestive of active TB, have not had recent (within 3 months) close contact with a person with active TB, and no evidence of current, active TB or old, inactive TB
Exclusion criteria:
- Pulmonary disease, such as asthma, clinically significant bronchiectasis, cystic fibrosis, sarcoidosis, interstitial lung disorder, moderate or severe sleep apnea, or pulmonary hypertension at screening
- Has ever experienced life-threatening COPD, had a lung lobectomy, lung cancer surgery, lung volume reduction, or a lung transplant
- Requires oxygen therapy on a daily basis (greater than 12 hours/day) for chronic hypoxemia (inadequate level of oxygen in the blood) at screening
- Has received any live, attenuated viral or bacterial vaccines within 3 months prior to screening or is expected to receive any live attenuated vaccinations during the study or up to 6 months after the last administration of study medication
- Positive serology to human immunodeficiency virus 1 or 2, hepatitis B virus, or hepatitis C virus
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
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Sterile, 5 percent dextrose will be used as the placebo in this study.
Placebo will be administered by intravenous infusion on Weeks 0, 2, 4, 8 and 12.
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Experimental: CNTO 6785
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CNTO 6785 (6 mg/kg) will be administered by intravenous (into a vein) infusion on Weeks 0, 2, 4, 8 and 12. Participants who weigh more than 100 kg will receive a dose of 600 mg of CNTO 6785.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change from baseline in prebronchodilator (before taking an inhaled bronchodilator) Forced Expiratory Volume in 1 second (FEV1) at Week 16
Time Frame: Baseline (Week 0), Week 16
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FEV1 is the amount of air that can be exhaled in one second.
FEV1 will be measured by spirometry.
A positive change from baseline in FEV1 indicates improvement in lung function.
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Baseline (Week 0), Week 16
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change from baseline in postbronchodilator (after taking an inhaled bronchodilator) Forced Expiratory Volume in 1 second (FEV1) at Week 16
Time Frame: Baseline (Week 0), Week 16
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FEV1 is the amount of air that can be exhaled in one second.
FEV1 will be measured by spirometry.
A positive change from baseline in FEV1 indicates improvement in lung function.
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Baseline (Week 0), Week 16
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Change from baseline in weekly average number of occasions in a day that rescue medication is used at Week 16
Time Frame: Baseline (Week 0), Week 16
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Rescue medication is a relief medication for chronic obstructive pulmonary disease symptoms.
e.g. when patients feel breathless, chest tight, or frequent cough.
The reduction of number of the occasions indicates disease improvement with less symptoms.
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Baseline (Week 0), Week 16
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Change from baseline in EXAcerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms™ (E-RS™) at Week 16
Time Frame: Baseline (Week 0), Week 16
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E-RS is a 11-item respiratory system scoring algorithm to assess the severity of respiratory symptoms in participants with chronic obstructive pulmonary disease (COPD).
Each item has either 5 or 6 response options.
Higher score indicates more severe COPD.
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Baseline (Week 0), Week 16
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Change from baseline at Week 16 in total score of the St George's respiratory questionnaire for Chronic Obstructive Pulmonary Disease (COPD) participants (SGRQ-C)
Time Frame: Baseline (Week 0), Week 16
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SGRQ-C is a 40-item questionnaire designed to measure health impairment in participants with COPD.
SGRQ-C is divided into two components: 1) symptoms, 2) activity& impacts.
Total SGRQ-C score ranges from 0 (best) and 100 (worst).
Higher scores indicate greater health impairment.
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Baseline (Week 0), Week 16
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
October 17, 2013
First Submitted That Met QC Criteria
October 17, 2013
First Posted (Estimate)
October 21, 2013
Study Record Updates
Last Update Posted (Estimate)
June 8, 2016
Last Update Submitted That Met QC Criteria
June 6, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR102318
- CNTO6785OPD2001 (Other Identifier: Janssen Research & Development, LLC)
- 2012-003607-36 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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