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    Summary
    EudraCT Number:2012-003607-36
    Sponsor's Protocol Code Number:CNTO6785OPD2001
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-08-08
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2012-003607-36
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Efficacy And Safety of CNTO 6785 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
    A.4.1Sponsor's protocol code numberCNTO6785OPD2001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen Research and Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanseen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressJanssen Biologics BV - Clinical Registry Group-Archimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+3171524 21 66
    B.5.5Fax number+3171524 21 10
    B.5.6E-mailClinicalTrialsEU@its.jnj.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCNTO6785
    D.3.2Product code CNTO6785
    D.3.4Pharmaceutical form Lyophilisate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCNTO 6785
    D.3.9.2Current sponsor codeCNTO 6785
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Obstructive Pulmonary Disease
    E.1.1.1Medical condition in easily understood language
    Respiratory disease
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10009033
    E.1.2Term Chronic obstructive pulmonary disease
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The change from baseline in pre-bronchodilator FEV1 at Week 16
    E.2.2Secondary objectives of the trial
    • 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
    E.2.3Trial contains a sub-study No
    E.3Principal 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 <80%, and a post BD FEV1/FVC <0.70 at Visit 1.
    • Have a post-BD FEV1 >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.
    E.4Principal 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.
    E.5 End points
    E.5.1Primary end point(s)
    The change from baseline in pre-bronchodilator FEV1
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 16
    E.5.2Secondary 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
    E.5.2.1Timepoint(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
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    China
    Czech Republic
    Germany
    Hungary
    Korea, Republic of
    Malaysia
    Russian Federation
    Taiwan
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 102
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 68
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state58
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 111
    F.4.2.2In the whole clinical trial 170
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    No plan for providing study agent after the subject has ended his/her participation in the trial. The study doctor will discuss future medial care options with the subject.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-09-28
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