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    Summary
    EudraCT Number:2021-002039-40
    Sponsor's Protocol Code Number:CLNP023L12201
    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:2021-11-03
    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 number2021-002039-40
    A.3Full title of the trial
    An open-label, multi-center, phase 2 basket study to assess efficacy, safety and pharmacokinetics of iptacopan (LNP023) in participants with autoimmune benign hematological disorders
    Estudio basket de fase 2, multicéntrico y abierto para evaluar la
    eficacia, la seguridad y la farmacocinética de iptacopán (LNP023) en
    participantes con trastornos hematológicos autoinmunes benignos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Basket study to assess efficacy, safety and PK of iptacopan (LNP023) in autoimmune benign hematological disorders
    Estudio basket para evaluar la eficacia, la seguridad y la PK de
    iptacopán (LNP023) en trastornos hematológicos autoinmunes
    benignos
    A.4.1Sponsor's protocol code numberCLNP023L12201
    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 SponsorNovartis Farmacéutica, S.A.
    B.1.3.4CountrySpain
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointTrial Monitoring Organization (TMo)
    B.5.3 Address:
    B.5.3.1Street AddressGran Via de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number+34900353036
    B.5.5Fax number+34932479903
    B.5.6E-maileecc.novartis@novartis.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 nameiptacopan
    D.3.2Product code LNP023
    D.3.4Pharmaceutical form Capsule, hard
    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 INNiptacopan
    D.3.9.2Current sponsor codeLNP023
    D.3.9.3Other descriptive name LNP023 HYDROCHLORIDE SALT
    D.3.9.4EV Substance CodeSUB180361
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Immune thrombocytopenia (ITP)
    Cold agglutinin disease (CAD)
    Trombocitopenia inmune (TPI) primaria
    Enfermedad de aglutininas frías (CAD) primaria
    E.1.1.1Medical condition in easily understood language
    Immune thrombocytopenia (ITP)
    Cold agglutinin disease (CAD)
    Trombocitopenia inmune (TPI) primaria
    Enfermedad de aglutininas frías (CAD) 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 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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10068863
    E.1.2Term Cold agglutinin disease
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Cohort 1: To assess the ability of iptacopan to induce a clinically meaningful increase in platelet count in participants with primary ITP

    Cohort 2: To assess the ability of iptacopan to induce a clinically meaningful increase in hemoglobin levels in participants with primary CAD
    Cohorte 1: evaluar la capacidad de iptacopán de inducir un incremento clínicamente significativo en el recuento de plaquetas en participantes con PTI primaria.

    Cohorte 2: evaluar la capacidad de iptacopán de inducir un aumento clínicamente significativo en los niveles de hemoglobina en participantes con CAD primaria.
    E.2.2Secondary objectives of the trial
    •To assess the time to first response
    •To assess the duration of response during Part A
    •To assess the magnitude of response during Part A
    •To assess the need for rescue therapy during Part A
    •Cohort 2: To assess the effect of iptacopan on relevant disease biomarkers (BM) not covered in the primary objective during Part A
    •To assess the safety and tolerability of iptacopan in participants with benign hematological disorders
    •To assess the pharmacokinetics of iptacopan
    •Evaluar el tiempo hasta la primera respuesta.
    • Evaluar la duración de la respuesta durante la parte A.
    • Evaluar la magnitud de la respuesta durante la parte A.
    • Evaluar la necesidad de tratamiento de rescate durante la parte A.
    • Cohorte 2: evaluar el efecto de iptacopán en los biomarcadores
    (BM) pertinentes de la enfermedad que no estén cubiertos en el
    objetivo principal durante la parte A.
    • Evaluar la seguridad y la tolerabilidad de iptacopán en participantes
    con trastornos hematológicos benignos.
    •Evaluar la farmacocinética de iptacopán.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All Cohorts: Written informed consent; Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infections is required and vaccination against Haemophilus influenzae infection is recommended prior to the start of treatment.

    Cohort 1 specific inclusion criteria: Participants with a diagnosis of primary ITP; Participants must have received at least 1 prior line of ITP-directed therapy; Sustained thrombocytopenia

    Cohort 2 specific inclusion criteria: Participants with a diagnosis of primary CAD; Participants must have received at least 1 prior line of CAD-directed therapy; Laboratory evidence of ongoing hemolysis; Sustained anemia
    Todas las cohortes: Consentimiento informado; vacuna contra infecciones por Neisseria meningitidis y Streptococcus pneumoniae es obligatoria y la vacuna contra la infección por Haemophilus influenzae está recomendada antes del inicio del tratamiento.

    Cohorte 1: Participantes con un diagnóstico de PTI primaria; Participantes que hayan recibido al menos una línea de tratamiento previo dirigido a la PTI; Trombocitopenia sostenida.

    Cohorte 2: Paricipantes con diagnóstico de CAD primaria; Participantes que hayan recibido al menos una línea de tratamiento previo dirigido a la CAD; Evidencia analítica de hemólisis en curso; Anemia sostenida.
    E.4Principal exclusion criteria
    All cohorts:
    -Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer or longer if required by local regulations
    -Past or concomitant use of medications prohibited by the protocol; Known or suspected hereditary or acquired complement deficiency.
    -History of primary or secondary immunodeficiency, including a positive HIV test result.
    -Chronic infection with Hepatitis B or C virus.
    -History of recurrent invasive infections caused by encapsulated organisms, including Neisseria meningitidis, Streptococcus pneumoniae, or Haemophilus influenzae.
    -Presence or suspicion of any active infection within 14 days prior to first study drug administration.
    -Any medical condition deemed likely to interfere with the participant's participation in the study.
    -Any malignant disease diagnosed within the past 5 years, with the exception of localized non-melanoma skin cancer, in situ cervical cancer, or, for CAD, a low-grade lymphoproliferative disorder.
    -History of bone marrow/hematopoietic stem cell or solid organ transplantation.
    -Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of investigational drug and for 1 week after last iptacopan dose.

    Cohort 1 specific exclusion criteria:
    -Secondary ITP, as may arise in the setting of certain autoimmune disorders, immunodeficiency syndromes, infections, malignancies, and drug treatments.
    -No ITP-directed background therapy permitted, with the exception of a thrombopoietin receptor agonist or low-dose corticosteroid, as long as stable dosage for at least 4 weeks prior to baseline
    -Abnormal coagulation screening labs.

    Cohort 2 specific exclusion criteria:
    -Secondary cold agglutinin syndrome, as may arise in the setting of certain infections, autoimmune disorders, and malignancies (with the exception of a low-grade lymphoproliferative disorder).
    -No CAD-directed background therapy permitted.
    Todas las cohortes:
    -Uso de otros fármacos en investigación en el momento del reclutamiento o durante las 5 vidas medias o 30 días anteriores a la inclusión, aquel periodo que sea más largo, o durante más tiempo si así lo exige la normativa local.
    -Uso anterior o concomitante de medicación prohibida según el protocolo.
    -Déficit de complemento hereditario o adquirido o sospecha de ello.
    -Antecedentes de inmunodeficiencia primaria o secundaria, incluido un resultado positivo en la prueba de VIH.
    -Infección crónica por virus de la hepatitis B o C.
    -Antecedentes de infecciones invasivas recurrentes causadas por organismos encapsulados, como N. meningitidis, S. pneumoniae o H. influenzae.
    -Presencia o sospecha (basándose en el criterio del investigador) de cualquier infección activa en los 14 días anteriores a la primera administración del fármaco del estudio.
    -Cualquier condición médica con probabilidad de interferir en la participación del paciente en el estudio.
    -Cualquier enfermedad maligna diagnosticada durante los últimos 5 años, con la excepción del cáncer de piel no melanomatoso localizado, cáncer de cuello uterino in situ o, en caso de CAD, trastorno linfoproliferativo de bajo grado.
    -Antecedentes de trasplante de médula ósea/células madre hematopoyéticas o de órganos sólidos.
    -Mujeres en edad fértil, definidas como toda mujer fisiológicamente capaz de quedarse embarazada, salvo que esté utilizando métodos anticonceptivos eficaces durante la administración del fármaco en investigación y durante la semana posterior a la última dosis de iptacopán.
    Criterios de exclusión específicos de la cohorte 1:
    -PTI secundaria que pueda producirse en el ámbito de ciertos trastornos autoinmunes, síndromes de inmunodeficiencia, infecciones, tumores malignos y tratamientos farmacológicos.
    -No está permitido ningún tratamiento de base dirigido a la PTI, con la excepción de un agonista del receptor de trombopoyetina (AR-TPO) o corticosteroide a dosis bajas, siempre y cuando la dosis sea estable durante al menos las 4 semanas anteriores a la basal.
    -Anomalías en las pruebas analíticas de coagulación en la selección (TP/INR, TTP).
    Criterios de exclusión específicos de la cohorte 2:
    -Síndrome de aglutininas frías secundario que pueda producirse en el ámbito de ciertas infecciones, trastornos autoinmunes y tumores malignos (con la excepción de un trastorno linfoproliferativo de bajo grado).
    -No está permitido ningún tratamiento de base dirigido a la CAD.
    E.5 End points
    E.5.1Primary end point(s)
    -Cohort 1 (ITP): A clinically meaningful response, defined by a platelet count of >=50 k/µL sustained for at least 2 consecutive weeks during the main, 12-week treatment part without the use of rescue therapy
    -Cohort 2 (CAD): A clinically meaningful response, defined by a hemoglobin level increase of >=1.5 g/dL above baseline sustained for at least 2 consecutive weeks during the main, 12-week treatment part without the use of rescue therapy
    -Cohorte 1 (PTI): una respuesta clínicamente significativa, que es aquella en la que se presenta un recuento de plaquetas >=50 k/μl mantenido durante al menos 2 semanas consecutivas en la parte de tratamiento principal de 12 semanas de duración, sin uso de tratamiento de rescate.
    -Cohorte 2 (CAD): una respuesta clínicamente significativa, que es aquella en la que se presenta un aumento en el nivel de hemoglobina >=1,5 g/dl por encima del valor basal mantenido durante al menos 2 semanas consecutivas en la parte de tratamiento principal de 12 semanas de duración, sin uso de tratamiento de rescate.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 to Day 85
    Día 1 a día 85
    E.5.2Secondary end point(s)
    • Cohort 1: Time to first platelet count >=50 k/μL
    • Cohort 2: Time to first hemoglobin level >=1.5 g/dL above baseline
    • Cohort 1: Duration during which platelet count remains >=50k/μL without the use of rescue therapy
    • Cohort 2: Duration during which hemoglobin level remains >=1.5 g/dL above baseline without the use of rescue therapy
    • Cohort 1: Magnitude of platelet count increase from baseline
    • Cohort 2: Magnitude of hemoglobin increase from baseline
    • Use of rescue therapy
    • Lactate dehydrogenase (LDH), total bilirubin, reticulocyte count and haptoglobin
    • Safety parameters include vital signs, adverse events, hematology, blood chemistry, reproductive and thyroid hormones, coagulation, urinalysis and ECG evaluation.
    • Iptacopan PK parameters including but not limited to Cmax, AUCtau, AUClast, Ctrough and Tmax.
    -Cohort 2: tiempo hasta primer nivel de hemoglobina >=1,5 g/dl
    - Cohort 1: duración mantenida del recuento de plaquetas >=50 k/μl sin uso de tratamiento de rescate
    -Cohort 2: duración mantenida del nivel de hemoglobina >=1,5 g/dl sin uso de tratamiento de rescate
    -Cohort 1: Magnitud del incremento del recuento de plaquetas desde el basal
    -Cohort 2: Magnitud del incremento de hemoglobina desde el basal
    - Uso de tratamiento de rescate
    -Lactato deshidrogenasa (LDH), bilirrubina total, recuento de reticulocitos y haptoglobina
    -Parámetros de seguridad incluyen evaluación de acontecimientos adversos, exploraciones físicas, constantes vitales, ECG, hematología, bioquímica, hormonas tiroideas y reproductivas, coagulación y urinalisis.
    -Parámetros farmacocinéticos de Iptacopan incluyendo (pero no limitado a) Cmax, AUCtau, AUClast, Ctrough and Tmax.
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Platelet count, Hemoglobin levels, Number of patients who use rescue therapy: Day 1 to Day 85

    -Lactate dehydrogenase (LDH): Screening, Day 15, Day 29, Day 85, Day 113

    -Total billirubin: Screening, Day 15, Day 29, Day 85, Day 113

    -Reticulocytes count: Screening, Baseline, Day1, Day 15, Day 29, Day 85, Day 99, Day 113

    -Haptoglobin: Screening, Day 15, Day 29, Day 85, Day 113

    -Pharmacokinetic parameter: Day 15, Day 29, Day 57
    -Recuento de plaquetas, niveles de hemoglobin, número de pacientes que necesitaron tratamiento de rescate: Día 1 a día 85
    -Lactato Deshidrogenasa (LDH) en visita de selección, Dia 15, Dia 29, Dia 85, Dia 113

    -Bilirubina total en visita de selección, Dia 15, Dia 29, Dia 85, Dia 113
    -Recuento de reticulocitos en visita de selección, Dia 1, Dia 15, Dia 29, Dia 85, Dia 99 y dia 113

    -Haptoglobina en visita de selección, Dia 15, Dia 29, Dia 85, Dia 113
    -Parámetros farmacocinéticos en Dia 15, Dia 29, Dia 57
    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 Yes
    E.6.13.1Other scope of the trial description
    tolerability
    Tolerabilidad
    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 Yes
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Germany
    Italy
    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
    LVLS
    Ultima visita del ultimo paciente
    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 months10
    E.8.9.1In the Member State concerned days19
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months11
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 30
    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)
    Continuing care should be provided by the investigator and/or referring physician after the EOS visit as per local standard of care
    El investigador y/o medico de referencia deberán prestar atención continuada despues de la visita de fin de estudio, según la práctica medica habitual
    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 Decision2021-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-21
    P. End of Trial
    P.End of Trial StatusOngoing
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