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    Summary
    EudraCT Number:2009-012444-16
    Sponsor's Protocol Code Number:39758979ASH2001
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-08-04
    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 ConcernedLatvia - SAM
    A.2EudraCT number2009-012444-16
    A.3Full title of the trial
    A Double-Blind, Randomized, Placebo-Controlled, Parallel Group Exploratory Study of the Safety and Efficacy of JNJ-39758979 in the Treatment of Adults with Persistent Asthma
    A.4.1Sponsor's protocol code number39758979ASH2001
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameJNJ-39758979-AAC-100 mg
    D.3.2Product code JNJ-39758979
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1046447-90-8
    D.3.9.2Current sponsor codeJNJ-39758979-AAC
    D.3.9.3Other descriptive name4-[(3R)-3-amino-1-pyrrolidinyl]-6-(1 methylethyl)-2-pyrimidinamine dihydrochloride
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 No
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    JNJ-39756979 is being developed for the treatment of asthma.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •To evaluate the safety and efficacy (in terms of improvement in pre-bronchodilator FEV1) of once daily oral administration of JNJ-39758979 in the treatment of adults with persistent asthma as defined by Global Initiative for Asthma (GINA) guidelines.
    E.2.2Secondary objectives of the trial
    •To evaluate the efficacy of JNJ-39758979 in terms of changes in:

    -FVC
    -FEF25-75
    -FEV1/FVC
    -Asthma Daily Diary data [AM and PM peak expiratory flow rates (PEFR), extent of albuterol/salbutamol use, presence of nocturnal awakenings, asthma symptom score]
    -Worsening of asthma

    •To explore the relationship between pharmacokinetics and pharmacodynamic measurements.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sputum Induction Substudy (at selected sites if technically feasible):

    •Sputum induction: Sputum will be analyzed for cell counts, RNA and other biomarkers in the sputum supernatants and cell pellets which may include but are not limited to IL-8, IL-4, IL-5, IL-13, Muc5ac and IFN
    •PBMC FACS and ex-vivo challenge: PBMC will be purified and ex vivo challenge experiments will be carried out to inflammatory markers by immunochemistry and FACS analysis.
    Enrollment into the sputum induction substudy will continue until samples through Week 12 from approximately 24 subjects have been collected.
    E.3Principal inclusion criteria
    1. Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
    2. To participate in the optional pharmacogenomic component of this study, subjects (or their legally acceptable representative) must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study (where local regulations permit). Refusal to consent for this component does not exclude a subject from participation in the clinical study.
    3. Man or woman between 18 and 65 years of age, inclusive
    4. Healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening.
    5. Chest x-ray performed within the past 6 months without clinically significant abnormalities.
    6. Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, coagulation tests, or urinalysis are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities or deviations from normal as not clinically significant or as appropriate and reasonable for the population under study. This determination must be recorded in the subject's source documents and initialed by the investigator.
    7. Medically confirmed diagnosis of persistent asthma according to EPR-3 and GINA guidelines for at least six months. (See Attachment 3.)
    8. FEV1 of 55-85% predicted measured >6 hours after the most recent use of a bronchodilator at screening.
    9. Evidence of FEV1 reversibility at screening as demonstrated by an increase in FEV1 of at least 12% and 200 ml 15 to 30 minutes after administration of 4 puffs (360 mcg) of albuterol/salbutamol via a metered-dose inhaler (MDI) or 2.5 mg albuterol/salbutamol nebulized solution. Subjects suspected of being reversible but not meeting this criterion at Screening may have one repeat reversibility assessment within 7 days of the initial assessment. If a subject does not meet this reversibility criterion either at screening or at repeat assessment but has FEV1 reversibility documented within 12 months of screening, they may be included following discussion with the sponsor.
    10. Score of 1.5 or greater on the Asthma Control Questionnaire (ACQ) at screening.
    11. Short-acting beta-agonist (SABA) use ³5 times in the 2 weeks prior to screening.
    12. Based on investigator's assessment, an adequate supply of albuterol/salbutamol in a MDI for use as a quick-relief medication as needed throughout the Run-in and Treatment Periods (other SABAs are not permitted).
    13. Women must be one of the following:
    a.postmenopausal,
    b.surgically sterile.
    c.abstinent
    d.or if sexually active, be practicing an effective method of birth control which must be used consistently for 3 months prior to run-in as local regulations permit, before entry, and must agree to continue to use the same method of contraception throughout the study and for 6 months after the last dose of study drug.
    14. Male subjects must consent to utilize a medically acceptable method of contraception throughout the study and for six months after the last dose of study drug and to not donate sperm during the study and for 6 months after receiving the last dose of study drug. Medically acceptable methods of contraception that may be used by the subject and/or the partner include diaphragm with vaginal spermicide, IUD, condom and partner using vaginal spermicide, surgical sterilization (6 months post surgery), post menopausal partner (not experiencing a menstrual period for a minimum of two years) and hormonal contraceptives (which must be used consistently for 3 months prior to run-in) such as oral contraceptives, hormonal patches, progestin implants or injections, and etonogestrel/ethinyl estradiol vaginal rings (NuvaRing).
    15. Female subjects must have a negative serum pregnancy test at screening; and a negative urine pregnancy test at randomization.
    16. Are considered eligible according to the following TB screening criteria:
    a.Have no history of latent or active TB prior to screening.
    b.Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
    c.Have had no recent close contact with a person with active TB or, if there has been such contact, have been evaluated by a physician specializing in TB and do not have evidence of, or require treatment for, latent TB.
    d.Within 6 weeks prior to the first administration of study agent, have negative TB screening test results (defined as either a negative Mantoux tuberculin skin test [TST] as outlined in Attachment 8, or a negative QuantiFERON-TB Gold test as outlined in Attachment 9)
    17. Willing/able to adhere to the prohibitions and restrictions specified in this protocol.
    E.4Principal exclusion criteria
    1. History of life-threatening asthma attack requiring intubation or ICU admission, hospitalization for asthma within 5 years of screening, or emergency department (ED) treatment of asthma within one (1) month of screening.
    2. Have current signs or symptoms of liver insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive or uncontrolled in the investigator’s discretion.
    3. History of drug/alcohol abuse within 5 years
    4. Moderate or severe renal insufficiency as measured by creatinine clearance less than 50 mL/min as calculated by Cockcroft-Gault formula.
    5. Positive anti-HCV, anti-HIV test, or evidence of HBV infection (positive HBsAg and/or HBcAb test) at screening
    6. Cigarette smoking within 12 months prior to Screening or a greater than 10 pack year smoking history, as determined by medical history or subject’s verbal report.
    7. Known allergies, hypersensitivity, or intolerance to JNJ-39758979 or its excipients (refer to Section 15.1 Physical Description of Study Drug(s)
    8. Have received, or are expected to receive, any live virus, including FluMistâ, or bacterial vaccination within 1 month prior to the first administration of study agent, during the trial, or within 3 months after the last dose of study drug
    9. Use of disallowed therapies:
    a. Systemic corticosteroids within 4 weeks of Week –2 (start of run-in period)
    b. Inhaled corticosteroids (ICS) within 2 weeks of Week -2
    c. Long-acting beta agonists (LABA) within 1 week of Week –2
    d. Oral beta agonists within 1 week of Week –2
    e. Cromolyns, leukotriene inhibitors (zileuton, zafirlukast, montelukast), theophylline or inhaled anti-cholinergic agents within 1 week of Week -2
    f. Omalizumab within 130 days (5 half-lives) of Week –2
    10. Initiation or discontinuation of allergen immunotherapy within 3 months of Randomization (Stable doses of allergen immunotherapy are allowed).
    11. History of upper respiratory infection (URI) [rhinitis or sinusitis] within 2 weeks of Week –2 (Start of Run-in Period). Subjects developing a URI between Week -2 and Randomization may repeat the Run-in Period after discussion with the medical monitor.
    12. Screening or baseline (randomization) QTc (Fridericia) interval >450 msec (men) or >470 msec (women), or a history of additional risk factors for torsades de pointe (eg, heart failure, hypokalemia, family history of Long QT Syndrome)
    13. Received an investigational drug or used an investigational medical device within 30 days before the planned start of treatment or are currently enrolled in an investigational study.
    14. Pregnant or breast-feeding
    15. Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
    16. Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    •Improvement in pre-bronchodilator FEV1 as measured by percent change from baseline in pre-bronchodilator % predicted FEV1 value at Week 12
    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.8.3 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 100
    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 Decision2009-09-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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