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Pulmonary Disease, Chronic ObstructivePhase 2NCT01966549

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

A Phase 2 study testing CNTO 6785 in people with Pulmonary Disease, Chronic Obstructive, run by Janssen Research & Development, LLC at 44 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
CNTO 6785
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
187 participants
Where
44 sitesin 8 countries
Study dates
Nov 2013to Sep 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

44 sites in 8 countries.

44 sites in 8 countries

Russia9 sites

  • Study site

    Barnaul

  • Study site

    Kemerovo

  • Study site

    Novosibirsk

  • Study site

    Saint Petersberg

  • Study site

    Saint Petersburg

  • Study site

    Saint-Petersberg

  • Study site

    Saratov

  • Study site

    Yaroslavl

  • Study site

    Yekaterinburg

Other trials in Russia

Germany8 sites

  • Study site

    Berlin

  • Study site

    Dresden

  • Study site

    Frankfurt

  • Study site

    Großhansdorf

  • Study site

    Hanover

  • Study site

    Koblenz

  • Study site

    Magdeburg

  • Study site

    Rüdersdorf

Other trials in Germany

Hungary8 sites

  • Study site

    Balassagyarmat

  • Study site

    Budapest

  • Study site

    Farkasgyepü

  • Study site

    Komárom

  • Study site

    Létavértes

  • Study site

    Mohács

  • Study site

    Nagykanizsa

  • Study site

    Zalaegerszeg-P Zva N/A

Other trials in Hungary

Czechia7 sites

  • Study site

    Brno

  • Study site

    Jindřichův Hradec

  • Study site

    Karlovy Vary

  • Study site

    Mělník

  • Study site

    Prague

  • Study site

    Praha 5 - Radotin

  • Study site

    Strakonice

Other trials in Czechia

Poland4 sites

  • Study site

    Krakow

  • Study site

    Lodz

  • Study site

    Poznan

  • Study site

    Wroclaw

Other trials in Poland

Malaysia3 sites

  • Study site

    Batu Caves

  • Study site

    Kota Bharu

  • Study site

    Kuala Lumpur

Other trials in Malaysia

South Korea3 sites

  • Study site

    Seoul

  • Study site

    Suwon

  • Study site

    Wŏnju

Other trials in South Korea

Taiwan2 sites

  • Study site

    New Taipei City

  • Study site

    Taipei

Other trials in Taiwan

About this study

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

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.

Read the 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.

Being tested
CNTO 6785, Placebo
Keywords
Pulmonary Disease, Chronic Obstructive, Moderate to Severe Chronic Obstructive Pulmonary Disease, CNTO 6785, Placebo
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CNTO 6785Drug

    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.

  • PlaceboDrug

    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.

Study groups in NCT01966549
Study groupRoleWhat they receive
CNTO 6785ExperimentalNot described
Receives: Drug: CNTO 6785
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline (Week 0), Week 16

Secondary outcomes (4)

  1. 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.

    Measured: Baseline (Week 0), Week 16

  2. 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.

    Measured: Baseline (Week 0), Week 16

  3. 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.

    Measured: Baseline (Week 0), Week 16

  4. 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.

    Measured: Baseline (Week 0), Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
187 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01966549
Sponsor's protocol ID
CR102318
Other IDs
CNTO6785OPD2001, 2012-003607-36
Status last verified
Jun 2016
First submitted
17 Oct 2013
Last updated
8 Jun 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28753067

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CNTO 6785 in people with Pulmonary Disease, Chronic Obstructive, run by Janssen Research & Development, LLC at 44 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in Russia, Germany, Hungary, Czechia, Poland and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01966549, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2016.

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