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    Summary
    EudraCT Number:2009-017942-30
    Sponsor's Protocol Code Number:0914M0622
    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:2010-04-06
    Trial 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 number2009-017942-30
    A.3Full title of the trial
    An open-label safety study of S-888711 in adult subjects with relapsed persistent or chronic immune thrombocytopenia with or without prior splenectomy
    A.4.1Sponsor's protocol code number0914M0622
    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 SponsorShionogi USA, Inc.
    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 nameS-888711
    D.3.2Product code S-888711
    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.3.8INN - Proposed INN(E)-3-[2,6-Dichloro-4-[4-[3-[(S)-1-hexyloxyethyl]-2-methoxyphenyl]-thiazol-2-ylcarbamoyl]-phenyl]-2-methylacrylic acid
    D.3.9.1CAS number 1110766-97-6
    D.3.9.2Current sponsor codeS-888711
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsed persistent or chronic immune thrombocytopenia with or without prior splenectomy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10066667
    E.1.2Term Chronic thrombocytopenia
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10063129
    E.1.2Term Persisting thrombocytopenia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the long-term safety of S-888711
    E.2.2Secondary objectives of the trial
    - Assess dose requirements for long-term platelet response
    - Assess durability of platelet response
    - Evaluate bleeding events by World Health Organization (WHO) bleeding criteria
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects who previously participated in the Phase 2 ITP Study 0913M0621 and who either completed treatment or discontinued treatment due to a platelet count > 400, 000/µL and must also meet all inclusion criteria listed below, including platelet counts < 50,000/μL to be eligible for study participation:

    1. A signed and dated written informed consent obtained prior to the performance of
    Screening procedures.
    2. Males and females ≥ 18 years of age prior to Screening.
    3. All subjects must agree to use exclusively progestin-based and/or barrier method
    contraception if engaging in sexual intercourse. Female subjects of child-bearing
    potential must not be breast-feeding and must use a reliable, exclusively progestin-based and/or barrier method for at least 7 days prior to the first dose of study drug and continuing throughout the study until 6 weeks after the last dosing, except if surgically sterilized or have been post-menopausal for at least 12 months. Hormone based contraceptives (e.g., pills, patch, shots, implants) that are not exclusively progestin-based are prohibited. Male subjects should either remain abstinent or use a condom during the time interval between taking the first dose and 6 weeks following the last dose.
    4. Diagnosis of ITP by American Society of Hematology criteria for at least 12 weeks prior to Screening.
    5. Subjects > 60 years of age must have had a diagnostic bone marrow aspiration showing normal or increased numbers of megakaryocytes.
    6. Relapsed persistent or chronic ITP status, with or without prior splenectomy (exception: in Hungary only splenectomized subjects will be enrolled), after having failed at least 1 prior ITP therapy (excluding TPO) and have a platelet count < 30,000/μL if not taking medications or < 50,000/μL despite concomitant steroids or other ITP therapies, such as danazol or immunosuppressive drugs.
    7. Subjects receiving chronic maintenance steroid therapy must have received a stable dose (same milligram amount ± 10%) for at least 2 weeks prior to Screening.
    8. Prothrombin time (PT) and activated partial thromboplastin time (APTT) within 20% of the upper limit of normal at Screening.
    9. Subjects receiving stable dosages of cyclosporine A, mycophenolate mofetil,
    azathioprine, or danazol are allowed. The dosages of all these medications must be stable for at least 4 weeks prior to Visit 1 (Day 1).
    E.4Principal exclusion criteria
    A subject will not be eligible for study participation if he/she meets any of exclusion criteria, or will be discontinued at the discretion of the investigator if he/she develops one or more of the following exclusion criterion during the study.

    1. History of inherited or acquired, clinically important hemorrhagic clotting disorder.
    2. Females who are pregnant or lactating, or are receiving other hormone/chemical
    contraceptives that are not exclusively progestin-based.
    3. History of alcohol/drug abuse or dependence within 1 year of initial Screening Visit.
    4. Use of the following drugs or treatment prior to Day 1:
    • Within 1 week – Rho(D) immune globulin or intravenous immunoglobulin (IVIG) except if administered as rescue medication;
    • Within 2 weeks - platelet transfusions or plasmapheresis treatment.
    • Within 4 weeks - use of anti-platelet or anti-coagulant drugs;
    • Within 8 weeks – rituximab;
    • Within 12 weeks – alemtuzumab, multi-drug systemic chemotherapy, stem cell therapy;
    5. History of clinically significant (in the opinion of the investigator) cardiovascular or
    thromboembolic disease within 26 weeks prior to initial Screening Visit.
    6. Splenectomy within 4 weeks prior to Initial Screening Visit.
    7. Laboratory abnormalities:
    • Hemoglobin < 10.0 g/dL for men or women, not clearly related to ITP;
    • Absolute neutrophil count < 1000/mm3;
    • Abnormal peripheral blood smear with evidence of fibrosis confirmed by bone
    marrow biopsy;
    • Total bilirubin > 1.5 x upper limit of normal;
    • Alanine aminotransferase (ALT) > 1.5 x upper limit of normal;
    • Aspartate aminotransferase (AST) > 1.5 x upper limit of normal;
    • Creatinine > 1.5 x upper limit of normal;
    • Human immunodeficiency virus positive;
    • Hepatitis A IgM antibody positive, hepatitis B surface antigen or hepatitis C antibody positive
    8. Exposure to previous approved TPO mimetics/agonists eltrombopag within 2 weeks or romiplostim within 4 weeks prior to dosing.
    9. Subjects unresponsive, defined as the inability to attain adequate platelet count despite optimal dosing of previous TPO mimetics/agonists (e.g., eltrombopag, romiplostim, E5501 [AKR-501] or LGD-4665), based on investigator’s discretion.
    10. Exposure to an investigative medication, other than S-888711, within 4 weeks prior to the initial Screening Visit.
    E.5 End points
    E.5.1Primary end point(s)
    • Safety will be assessed by monitoring clinical laboratory evaluations (including hematology, blood biochemistry, urinalysis, blood smears), vital signs, physical examinations, electrocardiograms, and World Health Organization (WHO) bleeding assessments.
    • Treatment-emergent AEs and serious adverse events (SAEs) will be collected and tabulated.
    • Frequency distribution of S-888711 doses subjects receive over time
    • Duration of response from baseline to various timepoints, as the proportion of the cumulative time spent with a platelet count of ≥ 50,000/µL; and
    • Incidence and severity of bleeding associated with ITP.
    • The proportion of subjects who achieve a platelet count of ≥ 50,000/µL at various time intervals;
    • Change from baseline at various time intervals in platelet counts.
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    Provided in the Protocol.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    A legally authorised representative can sign the informed consent form on behalf of the person in the study.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 27
    F.4.2.2In the whole clinical trial 60
    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)
    Provided in the Protocol.
    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 Decision2010-06-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-05
    P. End of Trial
    P.End of Trial StatusCompleted
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