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    Summary
    EudraCT Number:2019-000884-26
    Sponsor's Protocol Code Number:TP0003
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-02-28
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2019-000884-26
    A.3Full title of the trial
    A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
    Estudio de fase 3, multicéntrico, en doble ciego, aleatorizado y controlado con placebo, para evaluar la eficacia, seguridad y tolerabilidad de rozanolixizumab en adultos con trombocitopenia inmune primaria persistente o crónica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)
    Estudio para evaluar la eficacia, seguridad y tolerabilidad de rozanolixizumab en adultos con trombocitopenia inmune primaria (ITP) crónica o persistente
    A.3.2Name or abbreviated title of the trial where available
    myOpportunITy1
    A.4.1Sponsor's protocol code numberTP0003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04200456
    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 SRL
    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.5.6E-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 Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2131
    D.3 Description of the IMP
    D.3.1Product nameRozanolixizumab
    D.3.2Product code UCB7665
    D.3.4Pharmaceutical form 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 INNROZANOLIXIZUMAB
    D.3.9.1CAS number 1584645-37-3
    D.3.9.2Current sponsor codeUCB7665
    D.3.9.4EV Substance CodeSUB187374
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboSubcutaneous 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
    Trombocitopenia Inmune Primaria
    E.1.1.1Medical condition in easily understood language
    Primary immune thrombocytopenia is a autoimmune disease which is characterized by an isolated low platelet count (thrombocytopenia) and the absence of other causes of thrombocytopenia.
    La trombocitopenia inmune primaria es una enfermedad autoinmune que se caracteriza por un recuento bajo de plaquetas aisladas (trombocitopenia) y la ausencia de otras causas de trombocitopenia
    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
    Demonstrate the clinical efficacy of rozanolixizumab in maintenance treatment in study participants with primary immune thrombocytopenia (ITP)
    Demostrar la eficacia clínica de rozanolixizumab en el tratamiento de mantenimiento de los pacientes del estudio con trombocitopenia inmune primaria
    E.2.2Secondary objectives of the trial
    Assess the safety and tolerability of rozanolixizumab
    Evaluar la seguridad y tolerabilidad de rozanolixizumab
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Study participants who have consented can participate in the pharmacogenomics sub-study.
    Los pacientes del estudio que hayan dado su consentimiento podrán participar en el sub-estudio de farmacogenómica
    E.3Principal inclusion criteria
    -Study participant must be ≥18 years of age at the time of the Screening Visit
    -Study participant has a diagnosis of persistent (>3 months duration) or chronic (>12 months duration) primary immune thrombocytopenia (ITP) at the Screening Visit
    -Study participant has documented intolerance or insufficient response to one or more appropriate courses of standard of care ITP medication prior to Screening
    -Study participants must have prior history of a response to a previous ITP therapy
    -If taking allowed immunosuppressive drugs, study participant must be on stable doses during defined time periods prior to Baseline (Day 1)
    -Study participant has a documented history of low platelet count (<30x10^9/L) prior to Screening
    -Study participant has a platelet count measurement at Screening and at Baseline (Day 1) with an average of the two <30x10^9/L and no single count may be >35x10^9/L (using local laboratories)
    -Study participant has a current or history of a peripheral blood smear consistent with ITP
    -Study participants may be male or female:
    a. A male participant must agree to use contraception during the Treatment Period and for at least 3 months after the final dose of study treatment and refrain from donating sperm during this period
    b. A female participant is eligible to participate if she is not pregnant as confirmed by a negative serum pregnancy test or not planning to get pregnant during the participation in the study, not breastfeeding, and at least one of the following conditions applies:
    Not a woman of childbearing potential (WOCBP)
    OR
    A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 3 months after the dose of study treatment
    - El participante del estudio debe tener >/=18 años en el momento de la visita de selección.
    - El participante del el estudio tiene un diagnóstico de trombocitopenia inmunitaria primaria (TIP) persistente (>3 meses) o crónica (>12 meses) en la visita de selección.
    - El participante del estudio tiene una intolerancia documentada o una respuesta insuficiente a uno o más ciclos adecuados de medicación para la TIP de tratamiento estándar antes de la selección.
    - Los participantes del estudio deben tener antecedentes de respuesta a un tratamiento previo para la TIP.
    - Si se toman fármacos inmunosupresores permitidos, el participante del estudio debe recibir dosis estables durante periodos de tiempo definidos antes del inicio (día 1).
    - El participante del estudio tiene antecedentes documentados de recuento plaquetario bajo (<30x10^9/l) antes de la selección.
    - El participante del estudio tiene una medición de recuento plaquetario en la selección y al inicio (día 1) con un promedio de las dos <30x10^9/l y ningún recuento único puede ser >35x10^9/l (utilizando los laboratorios locales).
    - El participante del estudio tiene un frotis de sangre periférica compatible con TIP o antecedentes de ello.
    - Los participantes del estudio pueden ser hombres o mujeres:
    a. un participante de sexo masculino debe aceptar utilizar métodos anticonceptivos durante el periodo de tratamiento y durante al menos 3 meses después de la dosis final del tratamiento del estudio y abstenerse de donar esperma durante este periodo;
    b. una participante de sexo femenino es apta para participar si no está embarazada según lo confirmado por una prueba de embarazo en suero negativa o no tiene previsto quedarse embarazada durante la participación en el estudio, no está en periodo de lactancia y se aplica al menos una de las siguientes condiciones:
    no ser una mujer con capacidad de concebir
    O BIEN
    ser una mujer con capacidad de concebir que acepte seguir las indicaciones sobre métodos anticonceptivos durante el periodo del tratamiento y durante al menos 3 meses después de la dosis del tratamiento del estudio.
    E.4Principal exclusion criteria
    -Participant has a history of arterial or venous thromboembolism (eg, stroke, transient ischemic attach, myocardial infarction, deep vein thrombosis or pulmonary embolism) within the 6 months prior to randomization or requires anticoagulant treatment
    -Study participant has clinically significant bleeding that warrants immediate platelet adjustment (eg, menorrhagia with significant drop in hemoglobin)
    -Study participant has a known hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs (and/or an investigational device) as stated in this protocol
    -Study participant has evidence of a secondary cause of immune thrombocytopenia from the past medical history (eg, bacterial or viral infection, past medical history of leukemia, lymphoma, common variable immunodeficiency, systemic lupus erythematosus, autoimmune thyroid disease) or to drug treatments (eg, heparin, quinine, antimicrobials, anticonvulsants) or participant has a multiple immune cytopenia, eg, Evan’s syndrome
    -Study participant has a clinically relevant active infection (eg, sepsis, pneumonia, or abscess) in the opinion of the investigator, or had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to the dose of IMP
    -Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent tuberculosis infection (LTBI), or current/history of nontuberculous mycobacterial infection (NTMBI)
    -Study participant has a history of a major organ transplant or hematopoietic stem cell/marrow transplant
    -Study participant has experienced intracranial bleed in the last 6 months prior to the Screening Visit
    -Study participant has a history of coagulopathy disorders other than ITP
    -Study participant has a Karnofsky Performance Status rating <60% at the Screening Visit
    -Study participant with current or medical history of immunoglobulin A (IgA) deficiency, or a measurement of IgA <50 mg/dL at the Screening Visit
    -Study participant has undergone a splenectomy in the 2 years prior to the Baseline Visit
    - El participante tiene antecedentes de tromboembolia arterial o venosa (p. ej., accidente cerebrovascular, accidente isquémico transitorio, infarto de miocardio, trombosis venosa profunda o embolia pulmonar) en los 6 meses anteriores a la aleatorización o necesita tratamiento anticoagulante.
    - El participante del estudio tiene hemorragia clínicamente significativa que justifica el ajuste plaquetario inmediato (p. ej., menorragia con disminución significativa de la hemoglobina).
    - El participante del estudio tiene una hipersensibilidad conocida a cualquier componente del producto en investigación (PEI) o a fármacos comparativos (o un dispositivo en investigación) tal y como se indica en este protocolo.
    - El participante del estudio tiene evidencias de una causa secundaria de trombocitopenia inmunitaria de acuerdo a los últimos antecedentes médicos (p. ej., infección bacteriana o vírica, antecedentes médicos de leucemia, linfoma, inmunodeficiencia variable común, lupus eritematoso diseminado, enfermedad tiroidea autoinmunitaria) o es inmune a tratamientos farmacológicos (p. ej., heparina, quinina, antibióticos, anticonvulsivos) o el participante tiene citopenia inmunitaria múltiple, p. ej., síndrome de Evan.
    - El participante del estudio tiene una infección activa clínicamente relevante (p. ej., sepsis, neumonía o absceso) en opinión del investigador o tuvo una infección grave (que provocó la su hospitalización o requirió tratamiento antibiótico parenteral) en las 6 semanas anteriores a la administración del PEI.
    - El participante del estudio presenta una infección conocida por tuberculosis (TB), un riesgo elevado de contraer infección por TB o bien presenta infección por tuberculosis latente (ITBL) o padece actualmente infección por micobacterias no tuberculosas (IMBNT) o tiene antecedentes de ello.
    - El participante del estudio tiene antecedentes de trasplante de órganos importantes o de trasplante de células madre hematopoyéticas/médula ósea.
    - El participante del estudio ha experimentado hemorragia intracraneal en los 6 meses anteriores a la visita de selección.
    - El participante del estudio tiene antecedentes de trastornos de coagulopatía distintos de TIP.
    - El participante del estudio tiene una puntuación del estado funcional en la escala de Karnofsky <60 % en la visita de selección.
    - El participante del estudio tiene actualmente una deficiencia de inmunoglobulina A (Iga) o una medición de Iga <50 mg/dl o tiene antecedentes médicos de ello en la visita de selección.
    - El participante del estudio se ha sometido a una esplenectomía en los 2 años anteriores a la visita inicial.
    E.5 End points
    E.5.1Primary end point(s)
    Durable Clinically Meaningful Platelet Response of ≥50x10^9/L during the last 12 weeks
    Respuesta plaquetaria duradera clínicamente significativa de >/= 50x10^9/L durante las últimas 12 semanas
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the last 12 weeks (Week 13 to Week 25)
    Durante las últimas 12 semanas (semana 13 a semana 25)
    E.5.2Secondary end point(s)
    1. Cumulative number of visits with Clinically Meaningful Platelet Response of ≥50x10^9/L
    2. Response defined as platelet count ≥30x10^9/L and at least a 2-fold increase of the Baseline count confirmed on at least 2 separate occasions at two adjacent nominal visits at least 7 days apart, and absence of bleeding by visit
    3. Complete Response defined as platelet count ≥100x10^9/L confirmed on at least 2 separate occasions at two adjacent nominal visits at least 7 days apart, and absence of bleeding by visit
    4. Time to Clinically Meaningful Platelet Response of ≥50x10^9/L: time from starting treatment to achievement of first response of ≥50x10^9/L
    5. Clinically Meaningful Platelet Response of ≥50x10^9/L by Day 8
    6. Time to first rescue therapy
    7. Response defined as change from Baseline at or above the defined threshold for ITP Patient Assessment Questionnaire (ITPPAQ) Symptoms Score
    8. Occurrence of treatment-emergent adverse events (TEAEs)
    9. Occurrence of TEAEs leading to withdrawal of investigational medicinal product (IMP)
    1. Número acumulado de visitas con respuesta plaquetaria clínicamente significativa ≥50x10^9/l.
    2. Respuesta definida como recuento plaquetario ≥30x10^9/l y al menos un aumento de 2 veces el recuento inicial confirmado en al menos 2 ocasiones separadas en dos visitas nominales adyacentes con al menos 7 días de diferencia y ausencia de hemorragia por visita.
    3. Respuesta completa, definida como recuento plaquetario ≥100x10^9/l confirmado en al menos 2 ocasiones separadas en dos visitas nominales adyacentes con al menos 7 días de diferencia y ausencia de hemorragia por visita.
    4. Tiempo de respuesta plaquetaría clínicamente significativa de >/= 50 x 10^9/l tiempo desde el inicio de del tratamiento hasta el logro de la primera respuesta >/= 50 x 10^9/l
    5. Respuesta plaquetaria clinicamente significativa de>/= 50 x 10^9/l en el día 8
    6. Tiempo para la primera terapia de rescate
    7. Respuesta definida como cambio desde el tiempo basal a o por encima de lo definido en el umbral de sintomas del Cuestionario de evaluación del paciente ITP (ITPPAQ)
    8. Ocurrencia de efectos adversos emergentes del tratamiento (TEAE).
    9. Ocurrencia de TEAE que lleva a una retirada del medicamento en investigación
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.; 2.; 3. and 7. From Baseline during Treatment Period (up to Week 25)
    4. Time from starting treatment to achievement of first response of ≥50x10^9/L (up to Week 25)
    5. Baseline to Day 8
    6. From Baseline to first rescue therapy (up to Week 25)
    8. and 9. From Baseline to end of Safety Follow-Up Period (up to Week 31)
    1.; 2.; 3. and 7. Desde el momento basal durante el periodo de tratamiento (hasta la semana 25)
    4. Tiempo desde que se comienza el tratamiento hasta alcanzar la primera respuesta de >/= 50x10^9/L (hasta la semana 25)
    5. Momento basal al Día 8
    6. Desde el momento basal a la primera terapia de rescate (hasta la semana 25)
    8. y 9. Desde el momento basal hasta el final del periodo de seguimiento (hasta la semana 31)
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, Immunogenicity
    Tolerabilidad, Inmunogenicidad
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Bulgaria
    Canada
    China
    Czech Republic
    France
    Georgia
    Germany
    Hong Kong
    Hungary
    Italy
    Japan
    Moldova, Republic of
    Netherlands
    Poland
    Romania
    Russian Federation
    Spain
    Taiwan
    Ukraine
    United Kingdom
    United States
    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
    last visit of the last subject (LVLS)
    Última visita del último paciente
    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 months7
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days8
    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: 69
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 105
    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)
    Eligible study participants will be given the opportunity to enroll into the open-label extension (OLE) study, TP0004.
    Los pacientes elegidos se les dará la oportunidad de entrar en el estudio abierto de extensión (OLE), TP0004
    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 Decision2020-04-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-11
    P. End of Trial
    P.End of Trial StatusOngoing
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