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    Summary
    EudraCT Number:2015-003984-12
    Sponsor's Protocol Code Number:TP0001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-05
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-003984-12
    A.3Full title of the trial
    A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA
    Studio multicentrico, in aperto, multidose volto a valutare la sicurezza, la tollerabilit¿ e l'efficacia di UCB7665 in soggetti con trombocitopenia immune primaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test the safety of UCB7665 in patients with low levels of platelets.
    Uno studio volto a valutare la sicurezza di UCB7665 in pazienti con un basso livello di piastrine
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberTP0001
    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 SponsorUCB Biopharma SRL
    B.1.3.4CountryBelgium
    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 supportUCB Biopharma SPRL
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB Biosciences GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Str. 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number00492173481515
    B.5.5Fax number0049217381572
    B.5.6E-mailclinicaltrials@ucb.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 nameUCB7665
    D.3.2Product code [UCB7665 ]
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUCB7665
    D.3.9.1CAS number 1584645-37-3
    D.3.9.2Current sponsor codeUCB7665
    D.3.9.4EV Substance CodeSUB166282
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary immune thrombocytopenia (ITP)
    Trombocitopenia immune primaria
    E.1.1.1Medical condition in easily understood language
    Primary immune thrombocytopenia (ITP)
    Trombocitopenia immune primaria
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10043554
    E.1.2Term 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 safety and tolerability of UCB7665 administered by subcutaneous (sc) infusion in patients with immune thrombocytopenia (ITP)
    Valutare la sicurezza e la tollerabilit¿ di UCB7665 somministrato tramite sc nei soggetti con ITP.
    E.2.2Secondary objectives of the trial
    ¿ To assess the clinical efficacy of UCB7665 as measured by the change in platelet count
    ¿ To assess the pharmacodynamic (PD) effect of UCB7665 as measured by the change in total immunoglobulin G (IgG) concentration in serum
    - valutare l¿efficacia clinica di UCB7665 in base alla misurazione del cambiamento della conta piastrinica
    - valutare l¿effetto di farmacodinamica (pharmacodynamic, PD) di UCB7665 in base alla misurazione del cambiamento nelle concentrazioni di IgG totale nel siero.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Pharmacogenomics
    Version: -
    Date: 15/02/2017
    Title: Exploratory genomic substudy
    Objectives: -

    Farmacogenomica
    Versione: -
    Data: 15/02/2017
    Titolo: Sottostudio Genomico Esplorativo
    Obiettivi: -
    E.3Principal inclusion criteria
    • Subject has a diagnosis of primary immune thrombocytopenia for a minimum of 3 months prior to Screening Visit
    • Subject has a platelet count <30x10^9/L at Screening and <35x10^9/L at Baseline (Visit 2)
    • Subject has a current or history of a peripheral blood smear consistent with ITP
    • Subject has adequate peripheral venous access
    • Subject has responded to previous ITP therapy (according to the judgment of the investigator)
    - Il soggetto presenta una diagnosi di ITP primaria da almeno 3 anni prima della Visita di screening.
    - Il soggetto presenta una conta piastrinica <30x109/l allo screening e <35x109/l al basale (Visita 2).
    - Il soggetto presenta uno striscio di sangue periferico coerente con ITP.
    - Il soggetto deve avere disponibilità di un accesso venoso periferico adeguato.
    - Il soggetto ha risposto a una precedente terapia per l’ITP (in base al giudizio dello sperimentatore).
    E.4Principal exclusion criteria
    • Subject has an immunoglobulin G (IgG) level =6g/L at Screening Visit
    • Subject has a partial thromboplastin time (PTT) =1.5x upper limit of normal (ULN) or International Normalized Ratio (INR) =1.5 at Screening Visit
    • Subject has renal and/or liver impairment
    • Subject has planned an elective surgical procedure in the coming 6 months
    • Subject has evidence of a secondary cause of immune thrombocytopenia
    • Subject has a history of clinically relevant ongoing chronic infections
    • Subject has a family history of primary immunodeficiency
    • Subject has a clinically relevant active infection or has had a serious infection within 6 weeks prior to the first dose of IMP
    • Subject has a history of known inflammatory bowel disease, diverticular disease or has a history of confirmed, duodenal, gastric or esophageal ulceration in the past 6 months
    • Subject has experienced a clinically symptomatic gastrointestinal bleed (positive hemoccult tests without any signs and symptoms of gastrointestinal bleedings will not be considered as "clinically
    symptomatic") in the last 6 months prior to Screening Visit and/or has current gastritis or esophagitis and/or has a known risk for clinical
    relevant gastrointestinal bleeding beyond ITP
    • Subject has a medical history of thrombosis within the past 5 years or a history of thrombosis with unknown cause at any time or a significant
    known risk for thrombosis
    • Subject has a history of coagulopathy disorders other than ITP
    • Subject has received a live vaccination within 8 weeks prior to the Baseline Visit; or intends to have a live vaccination during the course of
    the study or within 7 weeks following the final dose of IMP
    • Subject has had prior treatment with rituximab in the 6 months prior to the Baseline
    • Subject has not completed the washout period for the immune suppressants, biologics and other therapies
    - Il soggetto presenta un livello di IgG =6 g/l alla Visita di screening.
    - Il soggetto presenta un tempo di tromboplastina parziale (partial thromboplastin time, PTT) =1,5x limite superiore della normalità (upper limit of normal, ULN) o un rapporto internazionale normalizzato (International Normalized Ratio, INR)=1,5 alla Visita di screening.
    - Il soggetto presenta disfunzione renale e/o epatica.
    - Il soggetto ha programmato una procedura chirurgica elettiva nei prossimi 6 mesi.
    -Il soggetto presenta evidenza di una causa secondaria della porpora trombocitopenica immune da pregressa anamnesi medica.
    -Il soggetto presenta una storia di infezioni croniche in corso clinicamente rilevanti, tra cui, ma senza limitazioni, il virus dell’immunodeficienza umana
    .-Il soggetto presenta una storia familiare di immunodeficienza primaria.
    - Il soggetto presenta un’infezione attiva clinicamente rilevante oppure presenta un’infezione grave nelle 6 settimane precedenti la prima dose
    dell’IMP
    .- Il soggetto ha una storia di nota malattia infiammatoria dell’intestino, malattia diverticolare o ha una storia di ulcera gastrica, duodenale o esofagea confermata negli ultimi 6 mesi.
    -Il soggetto ha manifestato un sanguinamento gastrointestinale clinicamente sintomatico (test del sangue occulto nelle feci positive senza segni e sintomi di sanguinamento gastrointestinale non sarà considerato come “clinicamente sintomatico”) nei 6 mesi precedenti la Visita di screening e/o presenta una gastrite o esofagite in corso e/o un rischio noto di sanguinamento gastrointestinale di rilevanza clinica oltre ITP
    - Il soggetto presenta un’anamnesi medica di trombosi negli ultimi 5 anni o una storia di trombosi con causa sconosciuta in qualsiasi momento o un rischio noto significativo di trombosi.
    -Il soggetto ha una storia di coagulopatie diverse da ITP.
    .-Il soggetto ha ricevuto un vaccino vivo nelle 8 settimane precedenti la Visita basale; oppure intende sottoporsi a un vaccino vivo durante lo studio o nelle 7 settimane successive la dose finale dell’IMP.
    -Il soggetto è stato sottoposto a pregresso trattamento con rituximab nei 6 mesi precedenti la Visita basale.
    - Il soggetto non ha completato il periodo di wash-out per gli immunosoppressori, I biologici e altre terapie.
    E.5 End points
    E.5.1Primary end point(s)
    Number of Subjects experiencing at least one Treatment Emergent Adverse Event (TEAE)
    Numero di soggetti che hanno avuto esperienza di eventi avversi successivi al trattamento (TEAE)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Visit2 (Week1) until End of Study Visit
    dalla Visita 2 (Settimana 1) fino alla Visita di Conclusione studio
    E.5.2Secondary end point(s)
    -
    -
    E.5.2.1Timepoint(s) of evaluation of this end point
    -
    -
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tollerabilit¿
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Dose differente dello stesso prodotto.
    Different dose of the same product
    E.8.2.4Number of treatment arms in the trial5
    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 EEA33
    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
    Australia
    Belgium
    Bulgaria
    Czechia
    France
    Georgia
    Germany
    Italy
    Lithuania
    Moldova, Republic of
    Poland
    Romania
    Spain
    United Kingdom
    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
    Last Subject Last Visit
    "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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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.1.2.1Number of subjects for this age range: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 53
    F.4.2.2In the whole clinical trial 66
    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)
    No post-trial medication will be provided.
    Nessun farmaco sar¿ fornito dopo la conclusion della sperimentazione.
    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 Decision2016-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-11
    P. End of Trial
    P.End of Trial StatusCompleted
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    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
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