A Study to Evaluate the Effectiveness and Safety of CNTO6785 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
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
3 other identifiers
interventional
187
8 countries
44
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2013
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2013
CompletedFirst Posted
Study publicly available on registry
October 21, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedJune 8, 2016
June 1, 2016
1.8 years
October 17, 2013
June 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline (Week 0), Week 16
Secondary Outcomes (4)
Change from baseline in postbronchodilator (after taking an inhaled bronchodilator) Forced Expiratory Volume in 1 second (FEV1) at Week 16
Baseline (Week 0), Week 16
Change from baseline in weekly average number of occasions in a day that rescue medication is used at Week 16
Baseline (Week 0), Week 16
Change from baseline in EXAcerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms™ (E-RS™) at Week 16
Baseline (Week 0), Week 16
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)
Baseline (Week 0), Week 16
Study Arms (2)
CNTO 6785
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Unknown Facility
Brno, Czechia
Unknown Facility
Jindřichův Hradec, Czechia
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Karlovy Vary, Czechia
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Mělník, Czechia
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Prague, Czechia
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Praha 5 - Radotin, Czechia
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Strakonice, Czechia
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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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Hanover, Germany
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Koblenz, Germany
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Magdeburg, Germany
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Rüdersdorf, Germany
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Balassagyarmat, Hungary
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Budapest, Hungary
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Farkasgyepü, Hungary
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Komárom, Hungary
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Létavértes, Hungary
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Mohács, Hungary
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Nagykanizsa, Hungary
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Zalaegerszeg-P Zva N/A, Hungary
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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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Wroclaw, Poland
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Barnaul, Russia
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Kemerovo, Russia
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Novosibirsk, Russia
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Saint Petersberg, Russia
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Saint Petersburg, Russia
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Saint-Petersberg, Russia
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Saratov, Russia
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Yaroslavl, Russia
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Yekaterinburg, Russia
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Seoul, South Korea
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Suwon, South Korea
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Wŏnju, South Korea
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New Taipei City, Taiwan
Unknown Facility
Taipei, Taiwan
Related Publications (1)
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.
PMID: 28753067DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2013
First Posted
October 21, 2013
Study Start
November 1, 2013
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
June 8, 2016
Record last verified: 2016-06