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    Summary
    EudraCT Number:2009-014842-28
    Sponsor's Protocol Code Number:SM101-201-itp-09
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-02
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2009-014842-28
    A.3Full title of the trial
    A Randomised, Multi-centre, Double-Blind, Placebo-Controlled, Single/Multiple Dose Escalation Phase Ib/IIa Clinical Trial to Investigate the Safety and Efficacy of Recombinant Human Soluble Fc-gamma Receptor IIb (SM101) for Intravenous Application in the Treatment of Patients with Chronic Adult Primary Immune Thrombocytopenia (ITP).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the safety and effectiveness of the study drug(SM101) versus placebo( dummy treatment)in adult patients with chronic Primary Immune Thrombocytopenia(ITP)
    A.4.1Sponsor's protocol code numberSM101-201-itp-09
    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 SponsorSuppreMol GmbH
    B.1.3.4CountryGermany
    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 supportSuppreMol GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSuppremol GmbH
    B.5.2Functional name of contact pointSascha Tillmanns - Medical Director
    B.5.3 Address:
    B.5.3.1Street AddressAm Klopferspitz 19a
    B.5.3.2Town/ cityMartinsried
    B.5.3.3Post code82152
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 89 309050 6825
    B.5.5Fax number+49 89 309050 6868
    B.5.6E-mailTillmanns@suppremol.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/07/462
    D.3 Description of the IMP
    D.3.1Product nameSM101 20mg/mL
    D.3.2Product code SM101
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSM101
    D.3.9.2Current sponsor codeSM101
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/07/462
    D.3 Description of the IMP
    D.3.1Product nameSM101 5mg/mL
    D.3.2Product code SM101
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSM101
    D.3.9.2Current sponsor codeSM101
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary Immune Thrombocytopenia
    E.1.1.1Medical condition in easily understood language
    autoimmune disease in which platelets (a type of blood cell involved in
    clotting) are destroyed, leading to bruising.
    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 15.1
    E.1.2Level PT
    E.1.2Classification code 10021245
    E.1.2Term Idiopathic thrombocytopenic purpura
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and tolerability of i.v. administered SM101 at various dose levels in a single/multiple dosing manner in subjects with chronic ITP
    E.2.2Secondary objectives of the trial
    •To evaluate the efficacy of SM101 following single and multiple
    intravenous dosing in the treatment of subjects with chronic ITP
    •To evaluate an appropriate SM101 dose for the additional dose
    escalation included in the extension part and for future clinical trials
    with SM101
    •To evaluate various immunology parameters during and after SM101
    treatment
    •To evaluate pharmacokinetic (PK) parameters of i.v. administered
    SM101
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject has provided written informed consent prior to any study-related procedure
    2. Male or female subjects aged 18 to 75, with or without splenectomy
    3. Diagnosis of persistent or chronic adult Primary Immune thrombocytopenia (ITP) based on subject’s history, physical examination, blood count and blood film examination according to the international consensus report guidelines with at least 3 months ITP history
    4. Subjects > 60 years of age at the timepoint of ITP diagnosis must have had a documented history of chronic ITP with a bone marrow report to confirm the diagnosis
    5. Subject has previously received at least one ITP therapy
    6. All other previously completed ITP treatment must achieve at least 5time their terminal half-life prior to first administration of IMP
    7. Concurrent ITP corticosteroid dose, if any, has been stable for 4 weeks preceding the first dose of IMP, and is intended to remain stable during the IMP treatment period
    8. Platelet count less than 30,000/μL from at least 2 measurements within 4 weeks prior to first investigational medicinal product (IMP) administration. The second measurement should not be older than 1 week. Both measurements should be at least 1 week apart.
    9. Patients with a body weight ≤ 100kg
    10. Adequate liver and kidney function (as detailed in the protocol)
    11. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1, with a life expectancy of at least 6 months
    12. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 1 week prior to first IMP administration
    13. Both WOCBP and men must use a medically acceptable method of contraception (Appendix III) prior to inclusion and throughout the study
    E.4Principal exclusion criteria
    1. Female subjects who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period
    2. Secondary thrombocytopenia caused by: previously diagnosed or possible high risk of conditions that may be associated with autoimmune thrombocytopenia, liver diseases, drugs, bone marrow diseases, recent transfusions, inherited thrombocytopenia, etc.
    3. Subjects with confirmed HIV, hepatitis B or C infection.
    4. Subjects with other acute infections within 4 weeks preceding the first dose of investigational medicinal product (IMP)
    5. Subject received intravenous immunoglobulins (IVIGs) or anti-D antibody treatment within 4 weeks preceding the first dose of IMP
    6. Subject received rituximab or any other B-cell depleting agent within 24 months preceding the first dose of IMP
    7. Subject receives concomitant ITP medication other than corticosteroids, except rescue medication during the clinical trial
    8. Splenectomy within 4 weeks prior to screening
    9. Subject received or is planning to receive a haematopoietic stem cell transplantation during the clinical trial
    10. Any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with all study procedures
    11. Known hypersensitivity to any recombinant E. coli-derived product or IMP excipients (Tween, Mannitol)
    12. Subjects participating in a concurrent clinical trial or treated with another investigational drug within 4 weeks or 5 terminal half-lives of the drug (whichever is longer) preceding the first dose of IMP
    13. History of or current alcohol or drug abuse
    14. Any condition which in the judgment of the investigator would place the subject at undue risk or interfere with the results of the study
    15. Subjects with an active malignancy
    16. Subjects with active, serious, life-threatening disease with a life expectancy of less than 6 months
    17. Subject was previously treated with SM101 or corresponding placebo
    E.5 End points
    E.5.1Primary end point(s)
    Safety based on incidence, severity, causality and seriousness of adverse events and laboratory results. Adverse events will be graded using the NCI CTCAE, v 3.0
    E.5.1.1Timepoint(s) of evaluation of this end point
    Interim analyses will be performed after the escalation part of the study,
    after all extension part patients have completed 3 months follow up and
    at the end of the study.
    E.5.2Secondary end point(s)
    Efficacy
    • Proportion of subjects with a platelet count ≥ 50,000/μL at day 22 (-0,5h), 29, 50, 78, 106, 134, 162 and 190.
    • Proportion of subjects with a platelet count ≥ 30,000/μL and at least twice the baseline amount (defined at screening study day -7) at day 22 (-0,5h), 29, 50, 78, 106, 134, 162 and 190.
    • Mean cumulative duration of a platelet count ≥ 50,000/μL until end of study
    • Mean cumulative duration of a platelet count ≥ 30,000/μL and at least twice the baseline amount (defined at screening study day -7) until end of study
    • Mean time to reach first platelet count of ≥ 50,000/μL, calculated from baseline at day 1
    • Mean time to reach first platelet count of ≥ 30,000/μL and at least twice the baseline amount calculated from baseline at day 1.
    • Proportion of subjects requiring rescue medication until end of study
    • Total number of days with rescue medication intake until end of study
    • Proportion of subjects with dose reduction of concomitant ITP corticosteroid medication
    • Mean percentage reduction of concomitant ITP corticosteroid medication at end of study
    • Proportion of subjects with WHO bleeding events grade 2 (mild blood loss) or higher until end of study
    • Total number of WHO bleeding events grade 2 (mild blood loss) or higher until end of study
    • Change of Immunological marker profile and IMP PK parameters
    • Proportion of patients with a reduction of autoantibodies against platelet glycoproteins Ib/IX or IIb/IIIa (if any) from baseline (day -7) to day 29, 106 and 190.
    E.5.2.1Timepoint(s) of evaluation of this end point
    See timepoints listed in E.5.2
    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 No
    E.6.10Pharmacogenetic Yes
    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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 EEA6
    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
    Germany
    Poland
    Russian Federation
    Ukraine
    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
    The end of the trial is defined as the last visit of the last subject
    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.1.2.1Number of subjects for this age range: 48
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 21
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 49
    F.4.2.2In the whole clinical trial 69
    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)
    Experience with SM101 is limited due to the early phase of development; subjects will not be offered any additional doses of study drug after completion of the study. Subjects will be treated with other standard therapies and medical care at the discretion of their physician.
    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 Decision2010-01-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-29
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