A Study to Evaluate the Effectiveness and Safety of CNTO6785 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

NCT ID: NCT01966549

Last Updated: 2016-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 187 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-09-30

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CNTO 6785

Group Type: EXPERIMENTAL

CNTO 6785

Intervention Type: 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.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

CNTO 6785

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

Placebo

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Brno, , Czechia

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

Countries

Czechia; Germany; Hungary; Malaysia; Poland; Russia; South Korea; Taiwan

References

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.

Reference Type: DERIVED

PMID: 28753067 (View on PubMed)

Other Identifiers

CNTO6785OPD2001

Identifier Type: OTHER

Identifier Source: secondary_id

2012-003607-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR102318

Identifier Type: -

Identifier Source: org_study_id