Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-003329-26
    Sponsor's Protocol Code Number:OSCO-P2101
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-08-08
    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 ConcernedGreece - EOF
    A.2EudraCT number2018-003329-26
    A.3Full title of the trial
    A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study to Evaluate the Efficacy and Safety of Oral SKI-O-703, SYK Inhibitor, in Patients with Persistent and Chronic Immune Thrombocytopenia (ITP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of oral SKI-O-703 in persistent and chronic immune thrombocytopenia
    A.4.1Sponsor's protocol code numberOSCO-P2101
    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 SponsorOscotec Inc.
    B.1.3.4CountryKorea, Republic of
    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 supportOscotec Inc.
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOscotec Inc.
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressKorea Bio Park, Building A, 9th Floor, 700 Daewangpangyo ro, Bundang gu
    B.5.3.2Town/ citySeongnam si, Gyeonggi do
    B.5.3.3Post code13488
    B.5.3.4CountryKorea, Republic of
    B.5.4Telephone number820316287661
    B.5.5Fax number820316287668
    B.5.6E-mailclinical-oct@oscotec.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 nameCevidoplenib
    D.3.2Product code SKI-O-703
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    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 INNCevidoplenib
    D.3.9.1CAS number 2043659-93-2
    D.3.9.2Current sponsor codeSKI-O-703
    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) 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 No
    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
    Persistent and Chronic Immune Thrombocytopenia (ITP)
    E.1.1.1Medical condition in easily understood language
    Immune thrombocytopenia despite prior therapy
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level LLT
    E.1.2Classification code 10066667
    E.1.2Term Chronic thrombocytopenia
    E.1.2System Organ Class 100000004851
    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 on the primary endpoint (platelet response) of select (200 mg BID and 400 mg BID) doses of SKI-O-703 compared to placebo in patients with persistent and chronic ITP, with a platelet count <30,000/μL on 2 occasions at least 7 days apart with the confirmatory count on the first day of treatment.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy on the secondary endpoints of select (200 mg BID and 400 mg BID) doses of SKI-O-703 compared to placebo in patients with persistent and chronic ITP
    To investigate the PK profile of SKI-O-592 (the free base of SKI-O-703) and its metabolites (M2 and M4) in patients with persistent and chronic ITP
    To evaluate the effects of SKI-O-703 on PD biomarkers in patients with persistent and chronic ITP
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able to provide written informed consent and agreeable to the schedule of assessments
    2. Male or female subjects, aged 18 years or older
    3. Diagnosis of primary ITP (persistent or chronic) made according to the American Society of Hematology 2011 evidence-based guideline
    4. Failed to respond or relapsed after at least 1 prior therapy, with a platelet count of <30,000/μL on 2 occasions at least 7 days apart with the confirmatory count on the first day of treatment. Response to such prior therapy is defined as platelet count of ≥30,000/µL and >2 times increase from baseline in the absence of bleeding. Failure to respond and relapse to such prior therapy are defined as failure to achieve and/or failure to maintain response on a tolerable regiment of prior therapy.
    5. Adequate hematologic, hepatic, and renal function (absolute neutrophil count ≥ 1.5 X 109/L, hemoglobin [Hgb] ≥ 10.0 g/dL, aspartate aminotransferase [AST] and alanine aminotransferase [ALT] ≤ 2.0 x ULN, bilirubin <1.5 x ULN, albumin ≥ 3 g/dL, estimated glomerular filtration rate [eGFR] ≥40 mL/min/1.73m2, and creatinine ≤ 1.5 x ULN)
    6. ECOG performance status of 0, 1, or 2
    7. Both male and female subjects must agree to take the following steps to reduce the potential for transmission of genetic material containing the investigational product
    a. Both male and female subjects, the subject and their partners of childbearing potential must agree to use 2 of the following medically acceptable methods of contraception from the time of randomization, during the study, and for 6 months following discontinuation of study drug, of which:
    o One must be a highly reliable method of contraception, such as:
     An intrauterine device or intrauterine system implanted for at least 30 days prior to Day 1
     Surgical sterilization of one of the partners for at least 6 months prior to the date of informed consent (assuming this will be the only partner for the whole duration of the clinical trial)
     Consistent and correct use of hormonal contraceptives (hormonal implants, injectables, contraception pills, transdermal patches, or contraceptive rings) for at least 30 days prior to Day 1
    o One supplementary barrier method, such as:
     Male or female condom always with spermicide (a spermicidal foam/gel/film/cream)
     Diaphragm or cervical/vault caps always with spermicide (a spermicidal foam/gel/film/cream)
     Double-barrier methods (which means a barrier method used by both partners at the same time), even when used with spermicide, are not considered to be highly reliable contraception methods, and as such, may not be the only forms of contraception used
    One of the other listed highly reliable methods must be used in conjunction with a barrier method.
    b. Female subjects must agree not to breastfeed starting from the time of Screening, throughout the study, and until after 6 months following the last dose of study drug.
    c. Male subjects must agree not to donate sperm starting from the time of randomization, throughout the study, and until after 6 months following the last dose of study drug
    d. For subjects and partners considered not of childbearing potential, the following conditions apply:
    a. Menopausal females must have experienced their last period more than 12 months prior to the date of informed consent to be classified as not of childbearing potential.
    b. Male and female subjects are in a situation of abstinence from heterosexual intercourse from Screening until after 6 months following the last dose of study drug when this is in line with the preferred lifestyle of the subject (eg, homosexual women and men or a member of a religious order such as nuns and priests).
    E.4Principal exclusion criteria
    1. History of any clinically significant disease or disorder that in the opinion of the investigator or the sponsor may put the subject at risk due to study participation, impact the subject’s ability to participate in the study, or influence the study results
    2. History of current, active malignancy requiring or likely to require chemotherapeutic or surgical treatment during the study, with the exception of non-melanoma skin cancer, carcinoma in situ of the cervix, and localized prostate cancer managed by active surveillance
    3. Transfusion with blood or blood products or plasmapheresis within 2 weeks before the first administration of study drug (Day 1)
    4. PT INR > 1.5
    5. History of known inherited coagulopathy (including prothrombotic conditions such as Factor V Leiden, APC resistance, AT-III deficiency, and lupus anticoagulant), or recent arterial or deep venous thrombosis within the preceding 6 months
    6. Change in corticosteroid or immunosuppressant (azathioprine, mycophenolate mofetil, cyclosporine) dose within 2 weeks prior to Day 1 (more than 10% variation from Day 1 daily doses)
    7. Treatment with thrombopoietin (TPO) receptor agonists within 2 weeks before Day 1
    8. Treatment with rituximab or splenectomy within the 8 weeks prior to Day 1
    9. Treatment with IVIGs within 4 weeks prior to Day 1
    10. Infections requiring intravenous antibiotics or hospitalization within 3 months prior to Day 1
    11. Subject had positive test results at Screening for human immunodeficiency virus, hepatitis B surface antigen (HBsAg), or hepatitis C virus Subjects with past or resolved hepatitis B
    infection (defined as having a negative HBsAg test and a positive IgG antibody to hepatitis B core antigen [anti-HBc]) are eligible but hepatitis B virus (HBV) DNA must be obtained in these patients prior to Cycle 1, Day 1, and must demonstrate no active infection. Subjects positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA
    12. Live vaccine within 28 days prior to Day 1 or plan to receive one during the study
    13. History or presence of any gastrointestinal, hepatic, or renal disease or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs
    14. Subject has not recovered from a recent medical/surgical procedure or trauma by Day 1 as determined by the investigator
    15. Uncontrolled hypertension (as defined by systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg)
    16. Subject had ECG findings of corrected QT interval by Fridericia formula (QTcF) > 480 msec, cardiac arrhythmias, or clinically significant cardiac or ECG abnormalities
    17. Subject have received any investigational medication within 30 days or 5 half lives prior to Day 1, whichever was longer
    18. Concomitant use of any anticoagulants and platelet aggregation inhibiting drugs including aspirin (within 14 days of planned dosing through end of follow-up)
    19. Female subject who is currently pregnant or breastfeeding
    20. Prior treatment with a SYK inhibitor
    21. Planned surgery in the time frame of the dosing period.
    E.5 End points
    E.5.1Primary end point(s)
    Patient platelet response is defined as platelet count ≥ 30,000/μL and doubling the baseline (average of 2 previous counts), at any visit during the treatment period and without the use of rescue medication
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    Subjects able to achieve 2 or more consecutive platelet counts of ≥ 30,000/μL separated by at least 5 days and without use of rescue medication
    Subjects able to achieve 2 or more consecutive platelet counts of ≥ 30,000/μL with an increase of platelet count of ≥20,000/μL from baseline separated by at least 5 days and without use of rescue medication
    Subjects able to achieve 2 or more consecutive platelet counts of ≥ 50,000/μL separated by at least 5 days and without use of rescue medication
    Subjects able to achieve 2 or more consecutive platelet counts of ≥ 100,000/μL during the treatment period, separated by at least 5 days and without use of rescue medication
    Subjects able to achieve platelet counts of ≥ 50,000/μL at 3 of the last 4 visits
    Change from baseline in the average of the last 2 platelet counts during the treatment period
    Time to first platelet response (>30,000/μL and 2 x baseline)
    Number of subjects receiving rescue medication at least once during treatment period
    Subjects with at least one Grade 2 or higher non-skin bleeding event during treatment period.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12 and Week 16
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 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 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 trial3
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    Korea, Republic of
    United States
    Poland
    Spain
    Greece
    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 years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days26
    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 days26
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    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)
    None.
    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 Decision2019-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-01-10
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 03 06:51:13 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA