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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO6785OPD2001 | Other Identifier | Janssen Research & Development, LLC | |
| 2012-003607-36 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CNTO 6785 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CNTO 6785 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Week 0), Week 16 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brno | Czechia | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28753067 | Derived | 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. |
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| Placebo | Drug | 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. |
|
| 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. | Baseline (Week 0), Week 16 |
| 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. | 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) | 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. | Baseline (Week 0), Week 16 |
| Jindřichův Hradec |
| Czechia |
| Karlovy Vary | Czechia |
| Mělník | Czechia |
| Prague | Czechia |
| Praha 5 - Radotin | Czechia |
| Strakonice | Czechia |
| Berlin | Germany |
| Dresden | Germany |
| Frankfurt | Germany |
| Großhansdorf | Germany |
| Hanover | Germany |
| Koblenz | Germany |
| Magdeburg | Germany |
| Rüdersdorf | Germany |
| Balassagyarmat | Hungary |
| Budapest | Hungary |
| Farkasgyepü | Hungary |
| Komárom | Hungary |
| Létavértes | Hungary |
| Mohács | Hungary |
| Nagykanizsa | Hungary |
| Zalaegerszeg-P Zva N/A | Hungary |
| Batu Caves | Malaysia |
| Kota Bharu | Malaysia |
| Kuala Lumpur | Malaysia |
| Krakow | Poland |
| Lodz | Poland |
| Poznan | Poland |
| Wroclaw | Poland |
| Barnaul | Russia |
| Kemerovo | Russia |
| Novosibirsk | Russia |
| Saint Petersberg | Russia |
| Saint Petersburg | Russia |
| Saint-Petersberg | Russia |
| Saratov | Russia |
| Yaroslavl | Russia |
| Yekaterinburg | Russia |
| Seoul | South Korea |
| Suwon | South Korea |
| Wŏnju | South Korea |
| New Taipei City | Taiwan |
| Taipei | Taiwan |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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