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    Summary
    EudraCT Number:2020-004162-18
    Sponsor's Protocol Code Number:PDY16894
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-02-11
    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 - PEI
    A.2EudraCT number2020-004162-18
    A.3Full title of the trial
    A multicenter, Phase 2a, open-label, non-randomized study evaluating the efficacy, safety, and tolerability of BIVV020 in adults with persistent/chronic immune thrombocytopenia (ITP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2a study evaluating BIVV020 in adults with persistent/chronic immune thrombocytopenia (ITP)
    A.4.1Sponsor's protocol code numberPDY16894
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1253-2343
    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 SponsorSanofi-Aventis Recherche & Développement
    B.1.3.4CountryFrance
    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 supportSanofi-Aventis Recherche & Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-Aventis Deutschland GmbH
    B.5.2Functional name of contact point
    B.5.3.4CountryGermany
    B.5.6E-mailmedinfo.de@sanofi.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.3.2Product code BIVV020
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBIVV020
    D.3.9.2Current sponsor codeBIVV020
    D.3.9.3Other descriptive nameBIVV020
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    immune thrombocytopenia (ITP)
    E.1.1.1Medical condition in easily understood language
    Blood and lymphatic diseases
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10083842
    E.1.2Term Immune thrombocytopenia
    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 effect of BIVV020 on the durability of platelet
    E.2.2Secondary objectives of the trial
    • To assess the safety and tolerability of BIVV020
    • To assess the pharmacokinetics of BIVV020
    • To assess the response rate of treatment with BIVV020
    • To assess the time to response
    • To assess the effect of treatment with BIVV020 on the requirement for rescue ITP therapy
    • To assess the immunogenicity of BIVV020
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male and female participants ≥18 years of age at the time of signing the
    informed consent
    - Confirmed diagnosis of primary ITP; for participants who previously
    received sutimlimab in study TDR16218 (NCT03275454), a response to
    sutimlimab must have been obtained, as defined by platelet count ≥30 ×
    10^9/L on 2 visits at least 7 days apart
    - For participants who have not previously received sutimlimab:
    persistent/chronic ITP (ITP lasting for ≥6 months) and all the following conditions:
    a) Platelet count ≤30 × 10^9/L on 2 occasions at least 5 days apart during
    the Screening Period;
    b) Lack of an adequate platelet count response (as defined by
    maintenance of sustained platelet count ≥30 × 109/L in the absence of bleeding) to at least 2 ITP treatments, 1 of which was a thrombopoietin receptor agonist. Other ITP treatments include: IVIg, anti-D immunoglobulin, corticosteroids, splenectomy, rituximab, cyclophosphamide, azathioprine, danazol, cyclosporin A, mycophenolate mofetil, or fostamatinib.
    c) If receiving weekly thrombopoietin receptor agonist dosing, the last
    dose must have been administered ≥7 days before the first dose of
    BIVV020. If receiving daily thrombopoietin receptor agonist dosing, the
    last dose must have been administered ≥24 hours before the first dose of
    BIVV020
    d) If applicable, concurrent administration of ITP medications (eg.
    corticosteroids, IVIg, azathioprine, danazol, cyclosporin A, mycophenolate
    mofetil, or thrombopoietin receptor agonists) is acceptable provided the
    patient has been on a stable dose for at least 1 month.
    e) If previously dosed with rituximab, the last dose of rituximab must have
    been administered at least 12 weeks before the first dose of BIVV020
    - Documented vaccinations against encapsulated bacterial pathogens
    (Neisseria meningitidis, including serogroup B where available,
    Haemophilus influenzae, and Streptococcus pneumoniae) within 5 years
    of enrollment
    - Contraceptive use for women of childbearing potential and men who are
    sexually active with a female partner of childbearing potential
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    - Clinically significant medical history or ongoing chronic illness that
    would jeopardize the safety of the participant or compromise the quality of
    the data derived from his/her participation in the study
    - Clinical diagnosis of SLE
    - Clinically relevant infection within the month prior to enrollment
    - History of venous or arterial thrombosis within the year prior to
    enrollment
    - Secondary ITP from any cause including lymphoma, chronic
    lymphocytic leukemia, and drug-induced thrombocytopenia
    - Positive hepatitis B surface antigen (HBsAg) or active HCV
    infection
    - HIV infection
    - Pregnant or lactating women
    - Hemoglobin level <10 g/dL
    E.5 End points
    E.5.1Primary end point(s)
    -Proportion of participants with a durable platelet Response.
    Durable platelet response is defined for naïve participants as the proportion
    of participants with a platelet count ≥50 × 109/L at ≥50% of scheduled visits,
    or for participants with baseline platelet count <15 × 109/L, a ≥20 × 109/L
    increase in platelet count from baseline at ≥50% of scheduled visits, without
    receiving rescue ITP therapy, as assessed from Week 3 to Week 24.
    Durable platelet response is defined for participants who previously received
    sutimlimab as maintenance of platelet count ≥30 × 109/L at ≥50% of
    scheduled visits, without receiving rescue ITP therapy, as assessed from
    Week 3 to Week 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 3 to Week 24
    E.5.2Secondary end point(s)
    1) Number of participants with treatment emergent adverse Events
    2) Plasma concentrations of BIVV020
    3) Response rate of treatment with BIVV020:Response rate at Weeks 24 and 52, defined as a platelet count ≥50 × 109/L
    and a greater than 2-fold increase from baseline, measured on 2 occasions
    at least 7 days apart, with the absence of bleeding (bleeding is defined as
    bleeding with a score ≥2 on the WHO bleeding scale), and the lack of combination ITP therapy during this period.
    4)Time to first platelet Response:
    Time from baseline to first platelet response, defined as greater than or
    equal to each of the following values: 50 × 109/L and 100 × 109/L (confirmed by 2 measurements at least 7 days apart)
    5) Proportion of patients who did not require
    rescue therapy for an acute episode of
    thrombocytopenia after Week 3
    6) Number of participants with incidence and titer (if relevant) of anti-BIVV020 antibodies
    E.5.2.1Timepoint(s) of evaluation of this end point
    1)Week 52
    2)Week 52
    3)Weeks 24 and 52
    4)Baseline to Week 52
    5)From Week 3 to Week 52
    6)Week 24, Week 52
    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 Yes
    E.6.6Pharmacokinetic Yes
    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 No
    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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Austria
    Belgium
    Germany
    Netherlands
    Spain
    United Kingdom
    Czechia
    E.8.7Trial has a data monitoring committee No
    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
    LSLV
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days28
    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: 9
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 9
    F.4.2.2In the whole clinical trial 12
    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 Decision2021-02-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-02-07
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