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    Summary
    EudraCT Number:2020-000848-57
    Sponsor's Protocol Code Number:GCT3013-03
    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:2022-10-06
    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 number2020-000848-57
    A.3Full title of the trial
    A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3 X CD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter’s Syndrome
    Estudio abierto de fase Ib/II para evaluar la seguridad y la eficacia de epcoritamab (GEN3013; DuoBody®-CD3 × CD20) en pacientes con leucemia linfocítica crónica recidivante/refractaria y síndrome de Richter
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy Study of Epcoritamab in Subjects with Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter’s Syndrome
    Estudio de la seguridad y la eficacia de epcoritamab en sujetos con leucemia linfocítica crónica recidivante/refractaria y síndrome de Richter
    A.4.1Sponsor's protocol code numberGCT3013-03
    A.5.4Other Identifiers
    Name:IND NumberNumber:135659
    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 SponsorGenmab A/S
    B.1.3.4CountryDenmark
    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 supportGenmab A/S
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportGenmab US, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenmab A/S
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressKalvebod Brygge 43
    B.5.3.2Town/ cityCopenhagen V
    B.5.3.3Post code1560
    B.5.3.4CountryDenmark
    B.5.6E-mailregulatory@genmab.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 nameEpcoritamab
    D.3.2Product code GEN3013
    D.3.4Pharmaceutical form Concentrate and solvent for solution for injection
    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 INNepcoritamab
    D.3.9.1CAS number 2134641-34-0
    D.3.9.2Current sponsor codeGEN3013
    D.3.9.3Other descriptive nameGEN3013
    D.3.9.4EV Substance CodeSUB190479
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNepcoritamab
    D.3.9.1CAS number 2134641-34-0
    D.3.9.3Other descriptive nameGEN3013
    D.3.9.4EV Substance CodeSUB190479
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Lymphocytic Leukemia
    Leucemia Linfocítica Crónica
    E.1.1.1Medical condition in easily understood language
    Chronic Lymphocytic Leukemia
    Leucemia Linfocítica Crónica
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10008976
    E.1.2Term Chronic lymphocytic leukemia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Identify the RP2D and the MTD of epcoritamab
    • Evaluate the safety and tolerability of epcoritamab
    • Identificar la DRF2 y la DMT de epcoritamab
    • Evaluar la seguridad y la tolerabilidad de epcoritamab
    E.2.2Secondary objectives of the trial
    • Characterize the pharmacokinetic properties of epcoritamab
    • To evaluate pharmacodynamic markers linked to efficacy and mechanism of action of epcoritamab
    • Evaluate immunogenicity of epcoritamab
    • Assess the preliminary anti-tumor activity of epcoritamab
    • Caracterizar las propiedades farmacocinéticas de epcoritamab
    • Evaluar los marcadores farmacodinámicos asociados a la eficacia y mecanismo de acción de epcoritamab
    • Evaluar la inmunogenicidad de epcoritamab
    • Evaluar la actividad antitumoral preliminar de epcoritamab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All Subjects
    • Subject must sign an ICF, prior to any screening procedures
    • Must be at least 18 years of age
    • ECOG performance status score of 0,1 or 2
    • Evidence of CD20 positivity at screening
    • Has acceptable laboratory parameters
    • Subject must have availability of fresh bone marrow material at screening
    • A woman with reproductive potential must agree to use adequate contraception during the trial, and for 12 months after the last administration of epcoritamab.
    • A woman of childbearing potential must have a negative serum (beta-hCG) pregnancy test at screening and a negative serum or urine pregnancy test before treatment administration on Day 1 of every cycle.
    • A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire trial, until 12 months after last treatment.
    • A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control.

    Inclusion Criteria Specific to the R/R CLL Cohort
    • Must have active CLL disease that needs treatment
    •R/R CLL after receiving at least 2 prior lines of systemic antineoplastic therapy
    • Has measurable disease with at least one of the following criteria:
    a. ≥5 × 109/L (5,000/μL) B lymphocytes in peripheral blood
    b. Presence of measurable lymphadenopathy and/or organomegaly
    • Must take prophylaxis for TLS

    Inclusion Criteria Specific to the Richter’s Syndrome Cohort
    • Must have a clinical history of CLL/SLL with biopsy-proven transformation toward aggressive lymphoma (ie, DLBCL subtype).
    • Deemed as ineligible for chemoimmunotherapy at investigator’s discretion or refuse to receive intensive chemotherapy.
    • Must have measurable disease
    Todos los sujetos:
    • El sujeto debe firmar un DCI antes de que se lleve a cabo cualquier procedimiento de selección
    • Tener al menos 18 años de edad
    • Puntuación del estado general ECOG de 0, 1 o 2.
    • Evidencia de positividad para CD20 en la selección.
    • Tiene parámetros analíticos aceptables
    • El sujeto debe tener disponible una muestra de médula ósea reciente en la selección
    • Una mujer en edad fértil debe aceptar el uso de métodos anticonceptivos adecuados durante el ensayo y durante los 12 meses después de la última administración de epcoritamab.
    • Una mujer en edad fértil debe presentar una prueba del embarazo en suero (β-hCG) negativa en la selección y una prueba del embarazo en suero o en orina negativa antes de la administración del tratamiento el día 1 del ciclo 1.
    • La mujer debe comprometerse a no donar óvulos con fines de reproducción asistida durante todo el ensayo, hasta 12 meses después del último tratamiento.
    • Un hombre sexualmente activo con una mujer en edad fértil que no se haya sometido a una vasectomía debe aceptar el uso de un método anticonceptivo de barrera.

    Criterios de inclusión específicos para cohorte con LLC R/R:
    • Deben tener LLC activa que necesite tratamiento.
    • LLC R/R después de recibir al menos 2 líneas previas de tratamiento antineoplásico sistémico.
    • Tener enfermedad medible con al menos uno de los siguientes criterios:
    a. ≥5 × 109/l (5000/μl) linfocitos B en sangre periférica
    b. Presencia de linfadenopatía medible y/u organomegalia
    • Debe tomar profilaxis para el SLT

    Criterios de inclusión específicos para cohorte con Síndrome de Ritcher:
    • Deben tener antecedentes clínicos de LLC/LLP con transformación de LMDLB en biopsia.
    • Considerados como no aptos para la quimioinmunoterapia a discreción del investigador o negarse a recibir quimioterapia intensiva.
    • Deben presentar enfermedad medible
    E.4Principal exclusion criteria
    All Subjects
    • Subject received prior treatment with a CD3 × CD20 bispecific antibody.
    • Subject received any prior allogeneic HSCT or solid organ transplantation
    • Subject received treatment with an anti-cancer agent, eg:
    a. Small molecules such as BTK inhibitor, BCL2 inhibitor, or PI3K inhibitor within 5 half-lives prior to the first dose of epcoritamab; or
    b. Anti-CD20 mAb or chemotherapy within 2 weeks prior to the first dose of epcoritamab;
    or
    c. Radio-conjugated or toxin conjugated antibody or CAR-T cell therapy within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of epcoritamab
    d. Subject received treatment with an investigational drug, within 4 weeks or 5 half-lives, whichever is shorter prior to the first dose of epcoritamab.
    • Subject has autoimmune disease or other diseases that require permanent or high-dose immunosuppressive therapy.
    • Subject has clinically significant cardiac disease
    • Subject received vaccination with live vaccines within 28 days prior to the first dose of epcoritamab
    • Subject has known central nervous system (CNS) involvement at screening.
    • Has had major surgery within 4 weeks prior to enrollment.
    • Known medical history or ongoing hepatitis C infection that has not been cured.
    • Known history of seropositivity for HIV infection. Note: HIV testing is required at screening only if required per local health authorities or institutional standards.
    • Subject is a woman who is pregnant or breast-feeding, or who is planning to become pregnant while enrolled in this trial or within 12 months after the last dose of epcoritamab.
    • Subject is a man who plans to father a child while enrolled in this trial or within 12 months after the last dose of epcoritamab.
    • Subject has uncontrolled intercurrent illness, such as ongoing or active infection requiring intravenous antibiotics treatment at the time of enrollment or within the previous 2 weeks prior to the first dose of epcoritamab.

    Exclusion Criteria Specific to the R/R CLL Cohort:
    • Any history of RS or evidence indicating a potential Richter’s transformation.
    • Subject is unable to tolerate uric acid reducing medications.

    Exclusion Criteria Specific to the Richter’s Syndrome Cohort
    • Diagnosis of Richter's syndrome not of the DLBCL subtype such as Hodgkin’s lymphoma, prolymphocytic leukemia.
    • Subject received autologous HSCT within 3 months prior to the first dose of epcoritamab.
    • Subject received more than 1 prior line of therapy for RS.
    Todos los sujetos:
    • El sujeto recibió tratamiento previo con un anticuerpo biespecífico CD3 × CD20.
    • El sujeto recibió un trasplante alogénico de TCMH o de órganos sólidos.
    • El paciente recibió tratamiento con un medicamento antineoplásico, p. ej.:
    a. moléculas pequeñas como el inhibidor de BTK, el inhibidor de BCL2 o el inhibidor de PI3K en el plazo de 5 semividas antes de la primera dosis de epcoritamab; o
    b. anticuerpo monoclonal anti-CD20 o quimioterapia en las 2 semanas previas a la primera dosis de epcoritamab; o
    c. tratamiento con anticuerpos conjugados con radio o toxinas o linfocitos T-CAR en las 4 semanas o 5 semividas, lo que sea más corto, antes de la primera dosis de epcoritamab.
    d. El sujeto ha recibido tratamiento con un fármaco en investigación en las 4 semanas o 5 semividas previas a la primera dosis de epcoritamab, lo que sea más corto.
    • El sujeto tiene una enfermedad autoinmunitaria u otras enfermedades que requieran tratamiento inmunodepresor permanente o en dosis altas.
    • El sujeto tiene una enfermedad cardíaca clínicamente significativa
    • Se vacunó al sujeto con vacunas elaboradas con microbios vivos en los 28 días anteriores a la primera dosis de epcoritamab.
    • El sujeto tiene una afectación conocida del sistema nervioso central (SNC) en la selección.
    • Haberse sometido a una cirugía mayor en las 4 semanas anteriores a la selección.
    • Antecedentes médicos conocidos o infección por el virus de la hepatitis C en curso que no se ha curado.
    • Antecedentes conocidos de seropositividad para la infección por el VIH. Nota: la prueba del VIH se requiere en la evaluación solo si así lo exigen las autoridades sanitarias locales o las normas institucionales.
    • El sujeto es una mujer que está embarazada o en periodo de lactancia o que tiene previsto quedarse embarazada mientras esté inscrita en este ensayo o en un plazo de 12 meses después de la última dosis de epcoritamab.
    • El sujeto es un hombre que tiene previsto tener hijos mientras esté inscrito en este ensayo o en un plazo de 12 meses después de la última dosis de epcoritamab.
    • El sujeto tiene una enfermedad intercurrente no controlada, como infección activa o en curso que requiere tratamiento con antibióticos por vía intravenosa en el momento de la inscripción o en las 2 semanas previas a la primera dosis de epcoritamab.

    Criterios de exclusión específicos para cohorte con LLC R/R:
    • Cualquier antecedente de SR o evidencia que indique una posible transformación de Richter.
    • El sujeto es incapaz de tolerar los medicamentos para reducir el ácido úrico.

    Criterios de exclusión específicos para cohorte con Síndrome de Ritcher:
    • Diagnóstico de síndrome de Richter que no es del subtipo de LMDLB como linfoma de Hodgkin o leucemia prolinfocítica.
    • El sujeto recibió TCMH autólogo en los 3 meses anteriores a la primera dosis de epcoritamab.
    • El sujeto recibió más de 1 línea de tratamiento anterior para el SR.
    E.5 End points
    E.5.1Primary end point(s)
    • Incidence of DLTs
    • Incidence and severity of AEs and SAEs.
    • Incidence and severity of CRS, ICANS and TLS
    • Incidence of dose interruption, dose delay, and dose intensity
    • Incidencia de las TLD
    • Incidencia e intensidad de los acontecimientos adversos (AA) y de los acontecimientos adversos graves (AAG).
    • Incidencia e intensidad de SLC, ICANS y síndrome de lisis tumoral (SLT)
    • Incidencia de la interrupción de la dosis, retraso de la dosis e intensidad de la dosis
    E.5.1.1Timepoint(s) of evaluation of this end point
    DLT evaluation period is defined as the first 4 weeks, ie, 28 days after the first administration ofepcoritamab.
    For the other end points, please refer to protocol
    El período de evaluación de TLD se define como las primeras 4 semanas, es decir, 28 días después de la primera administración de epcoritamab.
    Para los otros puntos finales, consulte el protocolo
    E.5.2Secondary end point(s)
    • PK parameters (eg, clearance, volume of distribution and AUC0-last and AUC0-∞, Cmax, Tmax, predose values, and t½)
    • Pharmacodynamic markers in blood samples
    • Incidence of ADAs to epcoritamab
    • ORR
    • CR/CRi rate
    • DOR
    • TTR
    • PFS
    • OS
    • Parámetros farmacocinéticos(p. ej., aclaramiento, volumen de distribución y ABC0-últ. y ABC0-∞, Cmáx., Tmáx., valores antes de la dosis y t1⁄2)
    • Parámetros farmacodinámicos en las muestras de sangre
    • Incidencia de los anticuerpos antifármaco (AAF) contra epcoritamab
    • Tasa de respuesta global (TRG)
    • Tasa de remisión completa (RC) o RC con recuperación incompleta de la médula (RCi)
    • Duración de la respuesta (DR)
    • Tiempo hasta la respuesta (THR)
    • Supervivencia sin progresión (SSP)
    • Supervivencia global (SG)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to protocol
    Por favor consultar protocolo
    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 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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase 1b/2
    Fase 1b/2
    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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Australia
    Israel
    United States
    France
    Netherlands
    Spain
    Germany
    Italy
    Belgium
    Denmark
    United Kingdom
    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 Site (LVLS)
    Última visita último centro
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 76
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 66
    F.4.2.2In the whole clinical trial 96
    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)
    When a patient is no longer in the trial, further treatment is at the discretion of the patient's doctor
    Cuando un paciente ya no está en el ensayo, el tratamiento adicional queda a discreción del médico del paciente.
    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 Decision2023-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-20
    P. End of Trial
    P.End of Trial StatusOngoing
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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