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    Summary
    EudraCT Number:2021-001387-20
    Sponsor's Protocol Code Number:ELA026-CP002
    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:2021-08-05
    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 number2021-001387-20
    A.3Full title of the trial
    A Phase 1b, Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Multiple Doses of ELA026 in Adults and Adolescents with Secondary Hemophagocytic Lymphohistiocytosis (sHLH).
    Estudio fase 1b, abierto, multicéntrico, de un solo grupo para evaluar la seguridad, la eficacia y la farmacocinética de dosis múltiples de ELA026 en adultos y adolescentes con linfohistiocitosis hemofagocítica secundaria (LHHs).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-label Phase 1b study to evaluate safety and efficacy of ELA026 in Adults and Adolescents participants with sHLH.
    Estudio en fase 1b, abierto para evaluar la seguridad y eficacia de ELA026 en adultos y adolescentes participantes con LHHs.
    A.4.1Sponsor's protocol code numberELA026-CP002
    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 SponsorElectra Therapeutics, Inc.
    B.1.3.4CountryUnited States
    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 supportElectra Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationElectra Therapeutics, Inc.
    B.5.2Functional name of contact pointMichelle A. Carpenter
    B.5.3 Address:
    B.5.3.1Street Address681 Gateway Blvd., 3rd Floor
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post codeCA 94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number001415990 1441
    B.5.6E-mailmichelle@star-therapeutics.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 nameELA026
    D.3.2Product code ELA026
    D.3.4Pharmaceutical form Solution for 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 INNNone
    D.3.9.1CAS number None
    D.3.9.2Current sponsor codeELA026
    D.3.9.3Other descriptive nameELA026
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    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
    sHLH is a rare and life-threatening inflammatory syndrome characterized by dysregulated immune function. The disease is associated with a massive systemic inflammatory response for which patients require immediate and aggressive treatment with intensive care. Clinically, patients present with fever, hepatomegaly, pancytopenia, splenomegaly, hypotension, and coagulopathy.

    It is difficult to assess the true epidemiology of HLH due to the rarity of the condition.
    La LHHs es un síndrome raro inflamatorio potencialmente mortal caracterizado por una función inmunitaria desregulada. La enfermedad está asociada a una respuesta inflamatoria sistémica masiva por la que los pacientes precisan de tratamiento inmediato y radical con cuidados intensivos. Clínicamente, los pacientes presentan fiebre, hepatomegalia, pancitopenia, esplenomegalia, hipotensión y coagulopatía.

    Es difícil evaluar la verdadera epidemiología de LHHs debido a la rareza de la condición.
    E.1.1.1Medical condition in easily understood language
    Dysregulated Immune Function
    Función Inmunitaria Desregulada
    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 20.0
    E.1.2Level SOC
    E.1.2Classification code 10021428
    E.1.2Term Immune system disorders
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10058092
    E.1.2Term Multi-organ disorder
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To determine the safety of ELA026 administered IV and SC to adolescent and adult participants with sHLH.

    • To identify the RP3D and schedule for ELA026.
    • Determinar la seguridad de ELA026 administrado por vía intravenosa y subcutánea en participantes adolescentes y adultos con LHHs.

    • Identificar la dosis recomendada para la fase 3 (DRF3) y programar la administración de ELA026.
    E.2.2Secondary objectives of the trial
    • To characterize the pharmacokinetic (PK) profile of ELA026 administered IV and SC to adolescent and adult participants with sHLH.

    • To determine the efficacy of ELA026 administered IV and SC to adolescent and adult participants with sHLH.

    • To characterize the pharmacodynamic (PD) effect of ELA026 administered IV and SC to adolescent and adult participants with sHLH.

    • To assess the immunogenicity of ELA026 administered IV and SC to adolescent and adult participants with sHLH.
    • Caracterizar el perfil de farmacocinética (FC) de ELA026 administrado por vía intravenosa y subcutánea en participantes adolescentes y adultos con LHHs.

    • Determinar la eficacia de ELA026 administrado por vía intravenosa y subcutánea en participantes adolescentes y adultos con LHHs.

    • Caracterizar el efecto de la farmacodinámica (FD) de ELA026 administrado por vía intravenosa y subcutánea en participantes adolescentes y adultos con LHHs.

    • Evaluar la inmunogenicidad de ELA026 administrado por vía intravenosa y subcutánea en participantes adolescentes y adultos con LHHs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age
    1. ≥12 years at the time of HLH diagnosis.
    Type of Participant and Disease Characteristics
    1. Treatment naive
    OR
    2. Relapsed or refractory HLH defined as:
    a. Participant has failed to respond to 2 weeks of non-etoposide, non-steroid therapy with a less than 50% decrease in serum ferritin, OR
    b. Participant has received 4 doses of etoposide with a less than 50% decrease in serum ferritin 72 hours after last dose, OR
    c. On a case-by-case basis as determined by the Medical Monitor
    3. Participant is hospitalized with an HLH confirmed diagnosis based on fulfilling 5 out of 8 HLH-2004 criteria below (Henter, Horne, et al., 2007):
    Clinical Criteria
    1. Fever ≥38.5C
    2. Splenomegaly
    Laboratory Criteria
    1. Cytopenia (affecting ≥2 of 3 lineages in the peripheral blood):
    Haemoglobin (<90 g/L), Platelet (<100 x 10*9/L), Neutrophil (<1.0 x 10*9/L).
    2. Hypertriglyceridemia and/or hypofibrinogenemia:
    Fasting triglycerides ≥1.0 mmol/L or ≥3SD of the normal value for age, fibrinogen ≤1.5 g/L or 3SD.
    Histopathologic Criteria
    1. Hemophagocytosis in bone marrow or spleen or lymph nodes or liver.
    2. Low or absent natural killer (NK)-cell activity (according to local laboratory reference).
    3. Ferritin ≥500 microgram/L
    4. Elevated soluble CD25 (e.g., soluble IL-2 receptor).
    Sex and Contraception
    1. Male or female
    Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    2.Female participants must be either of non-reproductive potential (ie., post-menopausal by history with no menses for ≥1 year; or have a history of hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or, if of childbearing potential, must have a negative pregnancy test in serum prior to trial entry and must be willing to practice at least one of the following highly effective methods of birth control (<1% failure rate per year) at least from 28 days prior to study drug initiation to 30 days after the last dose of study drug.
    3. Male must be willing to use a condom during penile-vaginal intercourse with female partners of child-bearing potential, throughout the study and up to 60 days after the last dose.
    Informed Consent
    1. Participant or legally authorized representative(s) (LAR) capable of giving signed informed consent.
    2. Minor participants must be capable of giving written assent as appropriate per the applicable age.
    Para ser elegibles para participar en este estudio, los sujetos deben cumplir todo lo siguiente:

    Edad
    1. ≥ 12 años en el momento del diagnóstico LHH.

    Tipo de participante y características de la enfermedad
    1. Tratamiento naïve
    O
    2. Recaída de la LHH o LHH refractario definido como:
    a. Sujeto que no ha respondido a 2 semanas de tratamiento con tociluzumab, anakinra, o terapia biológica con una disminución inferior del 50% de la ferritina en suero, O
    b. Sujeto que ha recibido 4 dosis de etopósido con una disminución inferior al 50% de la ferritina en suero 72 horas después de la última dosis, O
    c. O determinado caso por caso por el Monitor Médico
    3. Sujeto hospitalizado con un diagnóstico confirmado de LHH basado en el cumplimiento de 5 de los 8 criterios de LHH-2004 descritos abajo (Henter, Horne, et al., 2007):

    Criterios clínicos
    1. Fiebre ≥ 38,5 ºC
    2. Esplenomegalia

    Criterios de laboratorio
    1. Citopenia (afectando ≥ 2 de 3 linajes de la sangre periférica): Hemoglobina (<90 g/L), Plaquetas (<100 x 10*9/L), Neutrofilos (<1.0 x 10*9/L)
    2. Hipertrigliceridemia y/o hipofibrinogenemia: Triglicéridos rápidos ≥1.0 mmol/L or ≥3 límite superior del valor normal de la edad, fibrinogeno ≤1.5 g/L or 3 límite superior del valor normal

    Criterios histopatológicos
    1. Hemofagocitosis en médula ósea, bazo, nódulos linfáticos o hígado
    2. Ausencia o baja actividad de las células natural killer (NK) (de acuerdo al laboratorio de referencia)
    3. Ferritina ≥500 microgramo/L
    4. Valor elevado del CD25 soluble (ej: receptor IL-2 soluble)

    Sexo y Contracepción
    1. Hombre o Mujer
    La contracepción usada por hombres o mujeres debería ser consistente con las regulaciones locales con respecto a los métodos anticonceptivos para aquellos que participan en ensayos clínicos.
    2. Las mujeres participantes deben ser potencialmente no fértiles (ej: postmenopáusicas con ninguna historia de menstruación durante ≥ 1 año; tener antecedents de histerectomia, una ligadura de trompas bilateral, u ooferoctomía bilateral) o, si son mujeres potencialmente fértiles, deben terner una prueba de embarazo en suero negativo antes de la entrada en el ensayo y debe estar dispuesta a practicar uno de los siguientes métodos anticonceptivos (<1% ratio de fallo por año) al menos durante 28 días antes del comienzo del fármaco del estudio y 30 días después de la última dosis del fármaco del estudio:
    a. Verdadera abstinencia, cuando esto está en línea con el estilo de vida preferido y habitual del sujeto, desde las relaciones sexuales con un miembro del sexo opuesto
    b. Relaciones sexuales con un hombre vasectomizado
    c. Contraceptivos hormonales femeninos (oral, parenteral, intravaginal, implantable o transdérmico) durante al menos 3 meses consecutivos antes de la administración de intervención del estudio (cuando no esté clínicamente contraindicado como en los cánceres de mama, ovario y endometrio)
    d. Uso de un dispositivo contraceptivo intrauterino
    3. El hombre debe estar dispuesto a usar condón en las relaciones sexuales pene-vaginales con mujeres fértiles durante todo el estudio y hasta 60 días después de la última dosis.

    Consentimiento Informado
    1. El participante o el representante legalmente autorizado (RLA) debe ser capaz de dar un consentimiento informado firmado que incluya el cumplimiento de los requisitos y restricciones listados en el Consentimiento Informado (CI) y en este protocolo.
    2. Los participantes menores de edad deben ser capaces de dar su consentimiento por escrito según corresponda a la edad aplicable (según las leyes locales).
    E.4Principal exclusion criteria
    Medical Conditions
    1. Known or previous treatment for primary HLH.
    2. Any other significant concurrent, uncontrolled medical condition that in the opinion of the Investigator contraindicates participation in this study.
    Prior/Concurrent Therapy
    1. Hemapoietic Stem Cell Transplant (HSCT) within 100 days of the first dose of ELA026.
    2. Treatment with CAR T-Cell therapy within 3 months of the first dose of ELA026.
    3. Ongoing administration of any investigational treatment or treatment for HLH (excluding dexamethasone) within 14 days prior to Screening or 5 drug half-lives, whichever is shorter.
    4. Live or attenuated vaccine received within 6 weeks or bacille Calmette-Guerin (BCG) vaccine within 12 weeks prior to Screening.
    Los participantes deben ser excluidos de participar en este estudio si cumple cualquiera de los siguientes criterios:

    Condiciones Médicas
    1. Conocida o tratamiento previo para la LHH primaria
    2. Cualquier otra condición médica significativa concurrente, incontrolada que en opinión del investigador contraindique la participación en este estudio.

    Terapia Previa/Concomitante
    1. Trasplante hemopoiético de células madre (TSH) dentro de los 100 días de la primera dosis de ELA026.
    2. Tratamiento con terapia de células T y CAR dentro de los 3 meses posteriores a la primera dosis de ELA026.
    3. Administración de cualquier tratamiento en investigación (excluyendo la dexametasona) dentro de los 14 días anteriores a la Selección o 5 vidas medias del fármaco, lo que sea más corto.
    4. Vacunas vivas o atenuadas recibidas en las 6 semanas previas a la Visita de Selección o vacuna de Calmette-Guerin (BCG) con bacilo en las 12 semanas previas a la Visita de Selección.

    Otros
    1. Historia de hipersensibilidad o alergia a la dexametasona.
    2. Historia de hipersensibilidad o alergia a cualquier componente del ELA026.
    3. Lactancia actual
    4. No querer o no poder cumplir con las instrucciones de tratamien
    E.5 End points
    E.5.1Primary end point(s)
    • Incidence of adverse events (AEs) including dose-limiting toxicities (DLTs), serious adverse events (SAEs), deaths, AEs leading to withdrawal from study.

    • Safety, efficacy, PD.
    • Incidencia de acontecimientos adversos (AA), entre los que se incluyen las toxicidades limitantes de la dosis (TLD), los acontecimientos adversos graves (AAG), las muertes y los AA que causan la retirada del estudio.

    • Seguridad, eficacia, FD.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluated on an ongoing basis.
    Evaluado de forma continua.
    E.5.2Secondary end point(s)
    • Best response by week 4 defined as either complete response (CR) modified complete response (mCR) or partial response (PR) evaluated by objective clinical and laboratory parameters.

    • Plasma concentrations and PK parameters of ELA026.

    • Change from baseline in monocytes and T lymphocytes.

    • Incidence of Anti-drug antibodies (ADAs) to ELA026.
    • Mejor respuesta a las 4 semanas, definida como respuesta completa (RC), respuesta completa modificada (RCM) o respuesta parcial (RP) evaluado por parámetros clínicos y de laboratorio objetivos.

    • Concentraciones plasmáticas y parámetros de FC de ELA026.

    • Cambio en los monocitos respecto al valor inicial y linfocitos T.

    • Anticuerpos contra el fármaco (ADA) de ELA026.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After the given period is completed.
    Después de que se complete el período dado.
    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 Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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) 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 Last Subject
    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 months2
    E.8.9.1In the Member State concerned days7
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 5
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 19
    F.1.3Elderly (>=65 years) No
    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 24
    F.4.2.2In the whole clinical trial 24
    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)
    There will be no additional intervention following the end of the study.
    No habrá ninguna intervención adicional una vez finalizado el estudio.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-08
    P. End of Trial
    P.End of Trial StatusOngoing
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