Back to resultsA Study to Evaluate the Effectiveness and Safety of CNTO6785 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CNTO 6785
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Pulmonary Disease, Chronic Obstructive, Moderate to Severe Chronic Obstructive Pulmonary Disease, CNTO 6785, Placebo
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CNTO 6785
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in prebronchodilator (before taking an inhaled bronchodilator) Forced Expiratory Volume in 1 second (FEV1) at Week 16
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.
Secondary Outcome Measures
Change from baseline in postbronchodilator (after taking an inhaled bronchodilator) Forced Expiratory Volume in 1 second (FEV1) at Week 16
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.
Change from baseline in weekly average number of occasions in a day that rescue medication is used at Week 16
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.
Change from baseline in EXAcerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms™ (E-RS™) at Week 16
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.
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)
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.
Full Information
NCT ID
NCT01966549
First Posted
October 17, 2013
Last Updated
June 6, 2016
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT01966549
Brief Title
A Study to Evaluate the Effectiveness and Safety of CNTO6785 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Pulmonary Disease, Chronic Obstructive, Moderate to Severe Chronic Obstructive Pulmonary Disease, CNTO 6785, Placebo
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
187 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CNTO 6785
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CNTO 6785
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in prebronchodilator (before taking an inhaled bronchodilator) Forced Expiratory Volume in 1 second (FEV1) at Week 16
Description
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.
Time Frame
Baseline (Week 0), Week 16
Secondary Outcome Measure Information:
Title
Change from baseline in postbronchodilator (after taking an inhaled bronchodilator) Forced Expiratory Volume in 1 second (FEV1) at Week 16
Description
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.
Time Frame
Baseline (Week 0), Week 16
Title
Change from baseline in weekly average number of occasions in a day that rescue medication is used at Week 16
Description
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.
Time Frame
Baseline (Week 0), Week 16
Title
Change from baseline in EXAcerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms™ (E-RS™) at Week 16
Description
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.
Time Frame
Baseline (Week 0), Week 16
Title
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)
Description
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.
Time Frame
Baseline (Week 0), Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Brno
Country
Czech Republic
City
Jindrichuv Hradec
Country
Czech Republic
City
Karlovy Vary
Country
Czech Republic
City
Melnik
Country
Czech Republic
City
Praha 5 - Radotin
Country
Czech Republic
City
Praha 8
Country
Czech Republic
City
Strakonice
Country
Czech Republic
City
Berlin
Country
Germany
City
Dresden
Country
Germany
City
Frankfurt
Country
Germany
City
Grosshansdorf
Country
Germany
City
Hannover
Country
Germany
City
Koblenz
Country
Germany
City
Magdeburg
Country
Germany
City
Ruedersdorf
Country
Germany
City
Balassagyarmat
Country
Hungary
City
Budapest
Country
Hungary
City
Farkasgyepü
Country
Hungary
City
Komarom
Country
Hungary
City
Létavértes
Country
Hungary
City
Mohacs
Country
Hungary
City
Nagykanizsa
Country
Hungary
City
Zalaegerszeg-P Zva N/A
Country
Hungary
City
Seoul
Country
Korea, Republic of
City
Suwon
Country
Korea, Republic of
City
Wonju-Si
Country
Korea, Republic of
City
Batu Caves
Country
Malaysia
City
Kota Bharu
Country
Malaysia
City
Kuala Lumpur
Country
Malaysia
City
Krakow
Country
Poland
City
Lodz
Country
Poland
City
Poznan
Country
Poland
City
Poznań
Country
Poland
City
Wroclaw
Country
Poland
City
Barnaul
Country
Russian Federation
City
Ekaterinburg
Country
Russian Federation
City
Kemerovo
Country
Russian Federation
City
Novosibirsk
Country
Russian Federation
City
Saint Petersberg
Country
Russian Federation
City
Saint-Petersberg
Country
Russian Federation
City
Saratov
Country
Russian Federation
City
St. Petersburg
Country
Russian Federation
City
Yaroslavl
Country
Russian Federation
City
New Taipei City
Country
Taiwan
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
28753067
Citation
Eich A, Urban V, Jutel M, Vlcek J, Shim JJ, Trofimov VI, Liam CK, Kuo PH, Hou Y, Xiao J, Branigan P, O'Brien CD. A Randomized, Placebo-Controlled Phase 2 Trial of CNTO 6785 in Chronic Obstructive Pulmonary Disease. COPD. 2017 Oct;14(5):476-483. doi: 10.1080/15412555.2017.1335697. Epub 2017 Jul 28.
Results Reference
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Learn more about this trial
A Study to Evaluate the Effectiveness and Safety of CNTO6785 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
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