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    The EU Clinical Trials Register currently displays   36086   clinical trials with a EudraCT protocol, of which   5931   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2008-004119-36
    Sponsor's Protocol Code Number:P05109
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-12-01
    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 ConcernedGermany - BfArM
    A.2EudraCT number2008-004119-36
    A.3Full title of the trial
    Proof-of-Concept and Dose Range-Finding Study of SCH 527123 in Subjects with Severe Asthma
    A.4.1Sponsor's protocol code numberP05109
    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.3.9.2Current sponsor codeSCH 527123
    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 86264-58-2
    D.3.9.2Current sponsor codeSCH 527123
    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
    Severe Asthma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    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
    The primary objective of this study is to assess the effect of SCH 527123 on severe asthma exacerbations in subjects with severe asthma.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to assess the safety and tolerability of SCH 527123 in subjects with severe asthma.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must have severe asthma, as defined by the following Inclusion/Exclusion criteria, be at least 18 to ≤70 years of age, of either sex, and any race.
    2. Subject must demonstrate a ≥12% and ≥200 mL improvement in post-bronchodilator FEV1 at Screening or have a history of FEV1 reversibility or a positive methacholine challenge <8 mg/mL within the 5 years prior to Screening. If the subject does not have a history of FEV1 reversibility or a positive methacholine challenge, and the subject fails the reversibility test at Screening, the reversibility test may be repeated up to two additional times.
    3. Subject must have had at least two severe asthma exacerbations in the year prior to Screening (defined as asthma exacerbations requiring an addition or an increase in systemic corticosteroids, or hospitalization, or emergency room [ER] visit for asthma). Subject-reported history of asthma exacerbations obtained by the investigator will be considered acceptable.
    4. Subject must be receiving ≥1000 µg/day of beclomethasone dipropionate(BDP) or equivalent for at least 3 months prior to Screening (and have been on a stable dose for at least 6 weeks prior to Screening).
    5. Subject must be a nonsmoker or previous smoker with a cumulative smoking history of ≤20 pack-years (pack-year = 20 cigarettes smoked daily for 1 year). Previous smokers may not have smoked within 1 year prior to Screening.
    6. Subject must be on a stable asthma regimen for at least 6 weeks prior to Screening and agree to remain on this stable asthma regimen throughout the study.
    7. Pre-bronchodilator FEV1 must be ≥40% to ≤90% of predicted FEV1 at Screening.
    8. Subject must be willing to give written informed consent to participate in the study.
    9. Subject must be capable of complying with the dosing regimen, adhere to the visit schedule, and participate in all treatment procedures, including sputum induction (at applicable study centers).
    10. A female subject of childbearing potential must have a negative serum pregnancy test (hCG) at Screening and must be using a medically acceptable, highly effective, adequate form 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, treatment, and follow-up periods) if she is heterosexually active. Medically acceptable, highly effective forms of birth control are hormonal implants and patches, oral contraceptives, 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 at least 1 year postmenopausal. Absence of menses for at least 1 year will indicate that a female is postmenopausal. A female subject should be encouraged to continue using a highly effective method of birth control for 30 days following the end of treatment.
    11. A female subject of childbearing 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 and patches, oral contraceptives, and medically acceptable prescribed IUDs.
    E.4Principal exclusion criteria
    1. Subject who has been diagnosed with COPD or any other clinically relevant lung disease, other than asthma (eg, cystic fibrosis, pulmonary fibrosis, bronchiectasis) that, in the opinion of the investigator, precludes the subject from participating in the study.
    2. Subject who has had an upper or lower respiratory tract infection within 6 weeks prior to Screening. 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 examination.)
    3. Subject requiring a change in asthma medication prior to randomization.
    4. Subject who has received any treatment listed in Table 4 of the protocol more recently than the indicated washout period prior to Screening.
    5. Subject who fails to enter at least 7 complete days of diary data into the electronic diary (eDiary) during the Screening Period.
    6. Subject with allergy/sensitivity to the study drug or its excipients.
    7. Subject with a PBN count <3.0 x 10^9/L at Screening. Note: if a subject's PBN count is <3.0 x 10^9/L at the Screening Visit, at the investigator's discretion, the PBN count may be repeated up to 2 additional times.
    8. Subject who had an asthma exacerbation, as determined by the investigator, within 6 weeks prior to or during the Screening Period.
    9. Subject with a post-bronchodilator FEV1<1L before sputum induction (only at centers participating in sputum induction).
    10. Woman who is breast-feeding, pregnant, or intends to become pregnant during the study.
    11. Subject requiring mechanical ventilation for a respiratory event within 6 months prior to Screening.
    12. A subject, who, in the opinion of the investigator, has relevant medical conditions (eg, hematologic, cardiovascular, renal, hepatic, neurologic, metabolic, or rheumatologic) or who is using medication that may interfere with the effect of the study medication.
    13. Subject with clinically significant infectious diseases (eg, human immunodeficiency virus [HIV], hepatitis B or C).
    14. Subject who has used any investigational drug within 30 days (or 5 halflives, whichever is greater) of Screening.
    15. Subject who is participating in any other clinical study (excluding observational studies).
    16. Subject who is part of the staff personnel directly involved with this study.
    17. Subject who is a family member of the staff personnel directly involved with this study.
    18. Subject who is has a reversed awake/asleep schedule (eg, night shift worker).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the time to first severe asthma exacerbation and will be analyzed using the log-rank test; 95% confidence intervals and p-values will be provided for pairwise comparison.
    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 concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA63
    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 years1
    E.8.9.1In the Member State concerned months7
    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 months7
    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 state100
    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)
    A follow-up visit will occur approximately one week after the subject completes treatment, unless the subject participates in the 18-month safety extension study (ie, only subjects who do not wish to continue in the 18-month safety extension study will be included in the follow-up phase of this study).
    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 Decision2009-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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