Clinical trial NCT01966549: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pulmonary Disease, Chronic Obstructive
Moderate to Severe Chronic Obstructive Pulmonary Disease
CNTO 6785
Placebo
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2013-10-21
Enrollment: 187
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in prebronchodilator (before taking an inhaled bronchodilator) Forced Expiratory Volume in 1 second (FEV1) at Week 16
timeFrame: Baseline (Week 0), Week 16
Secondary outcomes:
measure: Change from baseline in postbronchodilator (after taking an inhaled bronchodilator) Forced Expiratory Volume in 1 second (FEV1) at Week 16
timeFrame: Baseline (Week 0), Week 16
measure: Change from baseline in weekly average number of occasions in a day that rescue medication is used at Week 16
timeFrame: Baseline (Week 0), Week 16
measure: Change from baseline in EXAcerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms™ (E-RS™) at Week 16
timeFrame: Baseline (Week 0), Week 16
measure: 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)
timeFrame: Baseline (Week 0), Week 16
Other outcomes:
Locations:
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
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
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.