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    Summary
    EudraCT Number:2008-003780-38
    Sponsor's Protocol Code Number:P05575
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-23
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2008-003780-38
    A.3Full title of the trial
    A 2-Year, Dose Range-Finding, Adaptive-Design Study of the Effects of SCH 527123 in
    Subjects With Moderate to Severe COPD
    A.4.1Sponsor's protocol code numberP05575
    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 SponsorSchering-Plough Research Institute
    B.1.3.4CountryUnited States
    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 nameSCH 527123
    D.3.2Product code SCH 527123
    D.3.4Pharmaceutical form Capsule*
    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.3.8INN - Proposed INNSCH 527123
    D.3.9.1CAS number 862464-58-2
    D.3.9.3Other descriptive nameCXCR2 antagonist
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 2
    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 nameSCH 527123
    D.3.2Product code SCH 527123
    D.3.4Pharmaceutical form Capsule*
    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.3.8INN - Proposed INNSCH 527123
    D.3.9.1CAS number 862464-58-2
    D.3.9.3Other descriptive nameCXCR2 antagonist
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 placeboCapsule*
    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
    COPD
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10009033
    E.1.2Term Chronic obstructive pulmonary disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to assess the efficacy of 3 dose levels (10 mg, 30 mg, and 50 mg) of SCH 527123 compared with placebo in subjects with moderate to severe COPD, based on changes from Baseline in post-bronchodilator forced expiratory volume in one second (FEV1).
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate the safety and tolerability of SCH 527123 in subjects with COPD, as well as its effect on other lung function measures, specifically exacerbations, symptoms, activity measures, health-related quality of life, and markers of inflammation.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. A subject must be >40 to ≤75 years of age, of either sex, and of any race.
    2. A subject must have a diagnosis of COPD based on the American Thoracic Society/European Respiratory Society (ATS/ERS)/Global Initiative for Chronic Obstructive Lung Disease (GOLD) current guidelines, or have had symptoms consistent with COPD for ≥2 years prior to the baseline visit (Visit 2, Day 1).
    3. A subject must have clinically stable COPD, indicated by no exacerbation and no change in COPD treatment within 6 weeks before Screening and no such change or exacerbation between Screening and Randomization.
    4. A subject must have a history of sputum production most days of the week within the last 3 months prior to Screening.
    5. At Screening, in subjects at sites performing sputum induction, post-bronchodilator FEV1 must be ≥1000 mL.
    6. At Screening, a subject’s post-bronchodilator FEV1 must be ≥30% to ≤70% of the predicted value.
    7. At Screening, a subject’s ratio of post-bronchodilator FEV1 to forced vital capacity (FVC) must be ≤70%.
    8. A subject must be either an ex-smoker with at least 6 months of smoking cessation, or a current smoker, and must have a smoking history of ≥10 pack-years (ie, 10 pack-year history is equal to smoking 1 pack of cigarettes per day for 10 years or 2 packs per day for 5 years).
    Subjects will be counseled on the risks of smoking and available smoking cessation programs prior to enrollment.
    9. If a subject had used inhaled corticosteroids (ICS) during the 6 weeks prior to Screening, the subject must have kept to a stable, low or medium daily dosage of ICS, alone or in combination with a long-acting β-agonist (LABA) or a long-acting muscarinic agonist (LAMA), within the 6 weeks prior to Screening and between Screening and Randomization, and must agree to continue at this dosage during the first 26 weeks (6 months) of the Treatment Period unless directed by the investigator. A low or medium daily ICS dosage is defined in the protocol.
    10. A female subject of child-bearing potential must agree to use a medically acceptable, highly effective method of birth control (ie, failure rate ≤1% per year when used consistently and correctly) prior to Screening, and agree to continue using it while in the study (Screening and Treatment Periods) if she is heterosexually active. Medically acceptable, highly effective forms of birth control are hormonal implants, oral contraceptives, hormonal patches, medically acceptable prescribed intrauterine devices (IUDs), and monogamous relationship with a male partner who has had a vasectomy.
    A female subject who is not of childbearing potential must have a medical record of being surgically sterile (eg, hysterectomy, tubal ligation), or be postmenopausal. Absence of menses for at least 1 year will indicate that a female subject is postmenopausal.
    A female subject should be encouraged to continue using a highly effective method of birth control 30 days following the end of treatment.
    11. A female subject of child-bearing potential who is not currently sexually active must agree to use a highly effective method of contraception should she become heterosexually active while participating in the study.
    12. A heterosexually active male subject must agree to use an adequate form of contraception for the duration of the study and agree to have sexual relations only with those women using a highly effective birth control method. A highly effective method of birth control is defined as that which results in a low failure rate (ie, less than 1% per year when used consistently and correctly), such as hormonal implants, injectables, combined oral contraceptives, hormonal patches, or hormonal intrauterine devices (IUD).
    13. A subject must be capable of complying with the dosing regimen and visit schedules.
    14. A subject must be willing not to begin any pulmonary rehabilitation program during the first 26 weeks (6 months) of the study.
    15. A subject must be willing to give written informed consent to participate in the studyA subject must be willing to give written informed consent to participate in
    the study. Subjects must be willing to give written informed consent for pharmacogenomic testing. Subjects who are unwilling to sign the informed consent for pharmacogenomic testing may be included in the trial, however, pharmacogenomic samples must not be obtained.
    E.4Principal exclusion criteria
    1. Subject who has been diagnosed with asthma or other clinically relevant lung disease (other than COPD) that, in the opinion of the investigator, precludes the subject from participating in the study (eg, sarcoidosis, tuberculosis, pulmonary fibrosis, severe bronchiectasis, or lung cancer).
    2.Subject with clinically significant chest X-ray or computed tomography (CT) findings (eg, mass) inconsistent with stable COPD.
    3. Subject who has undergone lobectomy, pneumonectomy, lung volume reduction (including bronchoscopic lung volume reduction) or any lung surgery other than biopsy.
    4. Subject who has had a respiratory tract infection within 6 weeks prior to the Screening Visit (Visit 1) and/or between Visit 1 and Visit 2 (Baseline/Randomization Visit).
    5. Subject with acute, non-respiratory infection(s) at Screening should be excluded until resolution of the infection(s), as determined by the investigator. (The investigator should carefully look for signs and symptoms of any infections by taking a detailed history and physical exam.)
    6. Subject with >20% and ≥200 mL improvement at Screening in post bronchodilator FEV1.
    7. Subject in need of supplemental oxygen therapy for >12 hours per day.
    8. Subject who is breast-feeding, pregnant, or intends to become pregnant during the study.
    9. Subjects who decide to discontinue smoking before Randomization are ineligible to participate. Subjects will be counseled on the risks of smoking and available smoking cessation programs prior to enrollment. However, once enrolled, if a subject elects to discontinue smoking, or reduces cigarette consumption, he/she will be allowed to complete the study.
    10. Subject who is using medication that may interfere with the effect of the study medication (including but not limited to those treatments in Table 4 in the protocol, Medications Prohibited During the Study), or who has a clinically relevant medical condition that may interfere with the study procedures or evaluation, or any condition that is determined by the principal investigator to be significant. Specific examples include (but are not limited to): any history of significant cardiac disease, unstable or severe peripheral artery disease, hematologic or neurologic disease, stroke, hepatitis, abnormal renal or hepatic function tests, severe rheumatoid arthritis, known human immunodeficiency virus (HIV) diagnosis, chronic infections, significant prolongation of corrected QT (ie, QT adjusted for heart rate by Fridericia [QTcF] or Bazett [QTcB] method) >500 msec, uncontrolled or newly diagnosed (within 2 months of study entry) diabetes, insulin-dependent diabetes mellitus, or known alpha-1 antitrypsin deficiency.
    11. Subject with an ANC of <3 x 10^9/L at the Visit 1 (Screening Visit).
    12. Subject who has received any treatment listed in the protocol, Table 2 in the protocol, more recently than the indicated washout period prior to Screening.
    13. Subject who is part of the staff personnel directly involved with this study.
    14. Subject who is a family member of the investigational study staff.
    15. Subject who is currently using illicit drugs or abusing alcohol.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is defined as post-bronchodilator FEV1 during the first
    26 weeks (6 months) of treatment (Period 1).
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA65
    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
    Last Subject Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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.1.3Elderly (>=65 years) Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 500
    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)
    Normal treatment of COPD
    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 Decision2009-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-11-11
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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