An Efficacy And Safety of CNTO 6785 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

A Randomized, Placebo-controlled, Double-blind, Multi-center, Phase 2 Study to Assess the Efficacy and Safety of CNTO 6785 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003607-36-CZ

Enrollment

170

Registered

2013-07-15

Start date

2013-09-25

Completion date

Unknown

Last updated

2016-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease MedDRA version: 16.1 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: CNTO6785 Product Code: CNTO6785 Pharmaceutical Form: Lyophilisate for solution for infusion INN or Proposed INN: CNTO 6785 Current Sponsor code: CNTO 6785 Concentration unit: mg millig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Be male or female and =40 years and =75 years of age. • Have moderate to severe chronic obstructive pulmonary disease (COPD, Grade II or Grade III according to the GOLD Guidelines • Have persistent COPD symptoms that required repeated (>1) ‘as needed’ use of a short-acting rescue medication within 4 weeks prior to Study Visit 1. • Have a diagnosis of chronic bronchitis (defined as sputum production on most days for at least 12 weeks per year for at least 2 successive years) reported by the subject at Study Visit 1. • Be able to meet at least 1 of the following 2 criteria: have had at least 2 COPD exacerbations requiring antibiotics and/or systemic corticosteroids in the past 2 years; or be able to spontaneously produce an adequate sputum sample at Study Visit 1 or Study Visit 2. • Be a current or ex-smoker who has a smoking history of at least 10 pack years (10 pack years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.) at Study Visit 1. • Have been treated with stable dose of LABA and/or long-acting anticholinergic bronchodilators alone or in combination with ICS for at least 4 weeks prior to Study Visit 1. • Have a percent-predicted post-BD FEV1 =40% and 500 mL at Study Visit 1. Participants in the bronchoscopy substudy must have a post-BD FEV1 >800 mL at Study Visit 1 and Study Visit 2 • No active, old, or latent tuberculosis (TB), and no close contact with active TB patients within 3 months prior to Study visit 1. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 102 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 68

Exclusion criteria

Exclusion criteria: • Has a body mass index (BMI) >32.0 kg/m2. • Has another pulmonary disease, eg, asthma, clinically significant bronchiectasis, cystic fibrosis, sarcoidosis, interstitial lung disorder, moderate or severe sleep apnea, or pulmonary hypertension at Study Visit 1. • Has a history of granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to Study Visit 1. • Has ever experienced life-threatening COPD (eg, intensive care unit [ICU] admission, intubation, non-invasive ventilation). • Has had a lung lobectomy, lung cancer surgery, lung volume reduction, or a lung transplant. • Has had any of the following respiratory tract conditions within the specified time intervals: pneumonia (as confirmed by chest x-ray findings and treated with antibiotics) within 1 year prior to Study Visit 1; COPD exacerbation that required systemic steroids and/or antibiotics or required hospitalization and was not associated with pneumonia within 6 weeks prior to Study Visit 1; upper or lower respiratory tract infection (including common cold or sinusitis) that was not associated with either pneumonia or COPD exacerbation within 4 weeks prior to Study Visit 1.

Design outcomes

Primary

Measure	Time frame
Main Objective: The change from baseline in pre-bronchodilator FEV1 at Week 16;Secondary Objective: • Baseline change in post-bronchodilator FEV1 at Wk16 • Baseline change from baseline in weekly average number of occasions in a day that rescue medication is used at Wk16 • Baseline change in E-RS at Wk16 • Baseline change in total score of the SGRQ-C at Wk16. • Baseline change in 1' and major 2' endpoints at all visits, up to 24wks • Baseline change in other spirometry assessments (PEFR, pre- and post-BD FVC, FEF25-75%, FEV1/FVC ratio) up to 24wks • Baseline change in weekly average daytime/night-time symptoms, and weekly average number of occasions in a day that rescue medication is used, up to 24wks • Baseline change in weekly average daytime/night-time domiciliary peak flow measurements, up to 24wks • Number and time to, protocol defined moderate or severe COPD exacerbations, up to 24wks • Number, intensity and duration of COPD exacerbation events as reported through EXACT PRO, up to 24wks • PGIC and proportion of patients in each response category, up to 24wks;Primary end point(s): The change from baseline in pre-bronchodilator FEV1 ;Timepoint(s) of evaluation of this end point: At Week 16	—

Measure

Time frame

Main Objective: The change from baseline in pre-bronchodilator FEV1 at Week 16;Secondary Objective: • Baseline change in post-bronchodilator FEV1 at Wk16 • Baseline change from baseline in weekly average number of occasions in a day that rescue medication is used at Wk16 • Baseline change in E-RS at Wk16 • Baseline change in total score of the SGRQ-C at Wk16. • Baseline change in 1' and major 2' endpoints at all visits, up to 24wks • Baseline change in other spirometry assessments (PEFR, pre- and post-BD FVC, FEF25-75%, FEV1/FVC ratio) up to 24wks • Baseline change in weekly average daytime/night-time symptoms, and weekly average number of occasions in a day that rescue medication is used, up to 24wks • Baseline change in weekly average daytime/night-time domiciliary peak flow measurements, up to 24wks • Number and time to, protocol defined moderate or severe COPD exacerbations, up to 24wks • Number, intensity and duration of COPD exacerbation events as reported through EXACT PRO, up to 24wks • PGIC and proportion of patients in each response category, up to 24wks;Primary end point(s): The change from baseline in pre-bronchodilator FEV1 ;Timepoint(s) of evaluation of this end point: At Week 16

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Secondary

Measure	Time frame
Secondary end point(s): 1.Change from baseline in post-bronchodilator FEV1 2.Transitional Dyspnea Index focal score 3.Change from baseline in rescue medication usage 4.Change from baseline in EXACT-RS 5.Change from baseline in total score of the SGRQ-C 6.Changes from baseline in primary endpoint and major secondary endpoints at all visits 7.Change from baseline in other spirometry assessments as measured in the clinic (pre- and post-BD peak expiratory flow rate (PEFR), pre- and post-BD FVC, forced expiratory flow at 25% and 75% of vital capacity (FEF25-75%), FEV1/FVC ratio 8.Change from baseline in weekly average of daytime and night-time symptoms, and weekly average rescue medication usage 9.Change from baseline in weekly average of daytime and night-time domiciliary peak flow measurements 10.Number of investigator-reported COPD exacerbations and time to first exacerbation 11.Number, intensity and duration of COPD exacerbation events as reported through EXACT PRO 12.Patient’s Global Impression of Change (PGIC) and proportion of patients in each response category ;Timepoint(s) of evaluation of this end point: 1. At Week 16 2. At Week 16 3. At Week 16 4. At Week 16 5. At Week 16 6. Up to 24 weeks 7. Up to 24 weeks 8. Up to 24 weeks 9. Up to 24 weeks 10. Up to 24 weeks 11. Up to 24 weeks 12. Up to 24 weeks	—

Measure

Time frame

Secondary end point(s): 1.Change from baseline in post-bronchodilator FEV1 2.Transitional Dyspnea Index focal score 3.Change from baseline in rescue medication usage 4.Change from baseline in EXACT-RS 5.Change from baseline in total score of the SGRQ-C 6.Changes from baseline in primary endpoint and major secondary endpoints at all visits 7.Change from baseline in other spirometry assessments as measured in the clinic (pre- and post-BD peak expiratory flow rate (PEFR), pre- and post-BD FVC, forced expiratory flow at 25% and 75% of vital capacity (FEF25-75%), FEV1/FVC ratio 8.Change from baseline in weekly average of daytime and night-time symptoms, and weekly average rescue medication usage 9.Change from baseline in weekly average of daytime and night-time domiciliary peak flow measurements 10.Number of investigator-reported COPD exacerbations and time to first exacerbation 11.Number, intensity and duration of COPD exacerbation events as reported through EXACT PRO 12.Patient’s Global Impression of Change (PGIC) and proportion of patients in each response category ;Timepoint(s) of evaluation of this end point: 1. At Week 16 2. At Week 16 3. At Week 16 4. At Week 16 5. At Week 16 6. Up to 24 weeks 7. Up to 24 weeks 8. Up to 24 weeks 9. Up to 24 weeks 10. Up to 24 weeks 11. Up to 24 weeks 12. Up to 24 weeks

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Countries

China, Czech Republic, Germany, Hungary, Korea, Republic of, Malaysia, Russian Federation, Taiwan, United Kingdom

Contacts

Public ContactClinical Registry Group

Janseen-Cilag International NV

ClinicalTrialsEU@its.jnj.com+3171524 21 66

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026