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

June 6, 2016 updated by: Janssen Research & Development, LLC

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
187

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno, Czech Republic
      • Jindrichuv Hradec, Czech Republic
      • Karlovy Vary, Czech Republic
      • Melnik, Czech Republic
      • Praha 5 - Radotin, Czech Republic
      • Praha 8, Czech Republic
      • Strakonice, Czech Republic
  • Germany
      • Berlin, Germany
      • Dresden, Germany
      • Frankfurt, Germany
      • Grosshansdorf, Germany
      • Hannover, Germany
      • Koblenz, Germany
      • Magdeburg, Germany
      • Ruedersdorf, Germany
  • Hungary
      • Balassagyarmat, Hungary
      • Budapest, Hungary
      • Farkasgyepü, Hungary
      • Komarom, Hungary
      • Létavértes, Hungary
      • Mohacs, Hungary
      • Nagykanizsa, Hungary
      • Zalaegerszeg-P Zva N/A, Hungary
  • Korea, Republic of
      • Seoul, Korea, Republic of
      • Suwon, Korea, Republic of
      • Wonju-Si, Korea, Republic of
  • Malaysia
      • Batu Caves, Malaysia
      • Kota Bharu, Malaysia
      • Kuala Lumpur, Malaysia
  • Poland
      • Krakow, Poland
      • Lodz, Poland
      • Poznan, Poland
      • Poznań, Poland
      • Wroclaw, Poland
  • Russian Federation
      • Barnaul, Russian Federation
      • Ekaterinburg, Russian Federation
      • Kemerovo, Russian Federation
      • Novosibirsk, Russian Federation
      • Saint Petersberg, Russian Federation
      • Saint-Petersberg, Russian Federation
      • Saratov, Russian Federation
      • St. Petersburg, Russian Federation
      • Yaroslavl, Russian Federation
  • Taiwan
      • New Taipei City, Taiwan
      • Taipei, Taiwan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
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.
Experimental: CNTO 6785
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in prebronchodilator (before taking an inhaled bronchodilator) Forced Expiratory Volume in 1 second (FEV1) at Week 16
Time Frame: Baseline (Week 0), 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in postbronchodilator (after taking an inhaled bronchodilator) Forced Expiratory Volume in 1 second (FEV1) at Week 16
Time Frame: Baseline (Week 0), 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
Change from baseline in weekly average number of occasions in a day that rescue medication is used at Week 16
Time Frame: Baseline (Week 0), 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
Time Frame: Baseline (Week 0), 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)
Time Frame: Baseline (Week 0), Week 16
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR102318
  • CNTO6785OPD2001 (Other Identifier: Janssen Research & Development, LLC)
  • 2012-003607-36 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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