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    Summary
    EudraCT Number:2015-002685-23
    Sponsor's Protocol Code Number:ICT-107-301
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-06-01
    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 number2015-002685-23
    A.3Full title of the trial
    A Phase III randomized double-blind, controlled study of ICT-107 with maintenance temozolomide (TMZ) in newly diagnosed glioblastoma following resection and concomitant TMZ chemoradiotherapy.
    Estudio de fase III, aleatorizado, controlado y doble ciego de ICT-107 más tratamiento de mantenimiento con temozolomida (TMZ) en pacientes con glioblastoma recién diagnosticado, tras la resección del tumor y quimiorradioterapia con TMZ
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase III (main) study of medicinal product, code ICT-107, along with standard anti-tumour therapy, temozolomide (TMZ), in patients who have newly diagnosed glioblastoma (brain tumour), after surgery along with TMZ and radiation therapy
    Estudio de fase III (principal) de producto medicinal en investigación, de código ICT-107, con tratamiento estándar antitumoral, temozolomida (TMZ), en pacientes que tienen glioblastoma (tumor cerebral) recién diagnosticado, después de cirugía con TMZ y radioterapia.
    A.3.2Name or abbreviated title of the trial where available
    STING (Study of Immunotherapy in Newly Diagnosed Glioblastoma)
    STING (Estudio de inmunoterapia en el glioblastoma de reciente diagnóstico)
    A.4.1Sponsor's protocol code numberICT-107-301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02546102
    A.5.4Other Identifiers
    Name:IND numberNumber:BB-IND-12272
    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 SponsorImmunoCellular Therapeutics, Ltd.
    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 supportImmunoCellular Therapeutics, Ltd
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImmunoCellular Therapeutics, Ltd
    B.5.2Functional name of contact pointImmunoCellular Clinical Trials
    B.5.3 Address:
    B.5.3.1Street Address23622 Calabasas Road, Suite 300
    B.5.3.2Town/ cityCalabasas
    B.5.3.3Post code91302
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1818246 2300
    B.5.5Fax number+1818224 5287
    B.5.6E-mailclintrials@imuc.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/3/14/1247
    D.3 Description of the IMP
    D.3.1Product nameAutologous peripheral blood differentiated adult dendritic cells
    D.3.2Product code ICT-107
    D.3.4Pharmaceutical form Dispersion for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAutologous peripheral blood differentiated adult dendritic cells
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeICT-107
    D.3.9.3Other descriptive nameAutologous peripheral blood differentiated adult dendritic cells
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboDispersion for injection
    D.8.4Route of administration of the placeboIntradermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of newly diagnosed glioblastoma.
    Tratamiento de glioblastoma recién diagnosticado
    E.1.1.1Medical condition in easily understood language
    Treatment of brain tumours that have been newly diagnosed
    Tratamiento de tumores cerebrales que han sido recién diagnosticados
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10018337
    E.1.2Term Glioblastoma multiforme
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 overall survival (OS) of subjects treated with ICT-107 and standard of care (radiotherapy (RT)and Temozolomide (TMZ)) vs. placebo control and standard of care (RT and TMZ)
    Determinar la Supervivencia Global (SG) de los pacientes tratados con ICT-107 más el tratamiento de referencia (radioterapia (RT) y (TMZ)) frente a los que reciben un control con placebo más el tratamiento de referencia (RT y TMZ).
    E.2.2Secondary objectives of the trial
    To determine the OS of subjects with unmethylated MGMT tumours treated with ICT-107 and standard of care vs. control and standard of care.
    To determine the OS of subjects with methylated MGMT tumours treated with ICT-107 and standard of care vs. control and standard of care.
    To evaluate progression-free survival (PFS) of subjects treated with ICT-107 and standard of care vs. control and standard of care.
    To determine the overall safey of ICT-107 vs. control.
    Determinar la SG de los pacientes con tumores que expresan el gen MGMT no metilado tratados con ICT-107 más el tratamiento de referencia frente a los que reciben un control más el tratamiento de referencia.
    Determinar la SG de los pacientes con tumores que expresan el gen MGMT metilado tratados con ICT-107 más el tratamiento de referencia frente a los que reciben un control más el tratamiento de referencia.
    Evaluar la supervivencia sin progresión (SSP) de los pacientes tratados con ICT-107 más el tratamiento de referencia frente a los que reciben un control más el tratamiento de referencia.
    Determinar la seguridad global de ICT-107 frente al control.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Screening Inclusion Criteria:
    ? Confirmed Initial Diagnosis of glioblastoma, including unmutated iso-citrate dehydrogenase (IDH)
    ? Glioblastoma tissue available for MGMT methylation testing by central lab.
    ? > 18 years of age
    ? Access to blood for HLA phenotyping
    ? WHO performance score 0-2
    ? Subjects must understand and sign the screening informed consent

    Main study inclusions
    1. Subjects must understand and sign the study specific informed consent
    2. Subjects must be in primary remission
    3. Subjects should have < 1 cm3 disease by MRI within the previous 4 weeks as defined by iRANO (by central read)
    4. Subjects must be HLA-A2 positive by central lab
    5. Subjects must have adequate renal, hepatic and bone marrow function based on screening laboratory assessments. Baseline hematologic studies and chemistry and coagulation profiles must meet the following criteria:
    a. Hemoglobin (Hgb) > 8 g/dL
    b. Absolute Neutrophil Count (ANC) > 1000/mm3
    c. Platelet count > 100,000/mm3
    d. Blood Urea Nitrogen (BUN) < 30 mg/dL
    e. Creatinine < 2 mg/dL
    f. Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) < 2 x upper limit of normal (ULN)
    g. Prothrombin Time (PT) and activated partial thromboplastin time (PTT) ? 1.6x unless therapeutically warranted
    6. Subjects must use effective contraceptive methods during the study and for three months following the last dose of study product, if of reproductive age and still retain fertility potential.
    7. Subjects must have at least one positive DTH skin response (more than 5 mm) to test item challenge prior to randomization.
    Criterios de inclusión para la selección:
    ? Diagnóstico inicial de glioblastoma confirmado, incluido el subtipo sin mutación de la isocitrato deshidrogenasa (IDH).
    ? Muestra de tejido del glioblastoma disponible para evaluar la metilación del gen MGMT en el laboratorio central.
    ? 18 años de edad como mínimo. ? Posibilidad de obtener una muestra de sangre para el fenotipado del HLA.
    ? Puntuación del estado funcional según la escala ECOG (OMS) entre 0 y 2.
    ? Los pacientes deben comprender y firmar el consentimiento informado para la selección.
    Diagnóstico y criterios principales de elegibilidad: Criterios de inclusión:
    1. Los pacientes deben comprender y firmar el consentimiento informado específico para el estudio.
    2. Los pacientes deben encontrarse en estado de remisión primaria.
    3. Los pacientes deben presentar un tumor de < 1 cm3 en el análisis mediante RM efectuado en las 4 semanas previas. En el momento de confirmación de la elegibilidad (antes de la aleatorización), una enfermedad residual > 1 cm3 es aceptable siempre que el volumen tumoral total presente un aumento ?25 % desde la RM anterior (evaluado centralmente).
    4. Los pacientes deben presentar el antígeno HLA-A2 según la evaluación del laboratorio central.
    5. Teniendo en cuenta los resultados de las pruebas analíticas realizadas en la selección, los pacientes deben presentar una funcionalidad renal, hepática y de la médula ósea satisfactoria. En el momento basal, las pruebas hematológicas, bioquímicas y de coagulación deben cumplir los criterios siguientes: a. Hemoglobina (Hb) >8 g/dl b. Recuento absoluto de neutrófilos (RAN) >1000/mm3 c. Recuento de plaquetas >100.000/mm3 d. Urea en sangre <30 mg/dl e. Creatinina <2 mg/dl f. Valores de fosfatasa alcalina (ALP), aspartato-aminotransferasa (AST) y alanina-aminotransferasa (ALT) < 2 veces el límite superior de normalidad (LSN). g. Valores de tiempo de protrombina (TP) y tiempo parcial de tromboplastina (TPT) activada ?1,6 veces el LSN excepto si está justificado terapéuticamente.
    6. Los pacientes deben utilizar métodos anticonceptivos eficaces durante el estudio y en los tres meses posteriores a la última dosis del producto del estudio si están en edad reproductiva y todavía conservan su fecundidad.
    7. Los pacientes deben presentar al menos una respuesta cutánea de hipersensibilidad tardía (superior a los 5 mm) en una vacuna del tétanos y la difteria antes de la aleatorización.
    E.4Principal exclusion criteria
    1. Subjects receiving investigational study drug for any indication or immunological-based treatment for any reason (Filgrastim may be used for prevention of severe neutropenia).
    2. Subjects with glioblastoma mutated IDH by Immunohistochemistry (IHC)
    3. Subjects with concurrent conditions that would jeopardize the safety of the subject or compliance with the protocol.
    4. Subjects with a history of chronic or acute hepatitis C or B infection.
    5. Subjects require or are likely to require more than a 2-week course of corticosteroids for intercurrent illness. Subjects must have completed the course of corticosteroids at the time of apheresis to meet eligibility.
    6. Subjects have any acute infection that requires specific therapy. Acute therapy must have been completed within seven days prior to study enrollment.
    7. Subjects with active malignancy diagnosed in the past 3 years (excepting in situ tumors)
    8. Subjects known to be pregnant or nursing.
    9. See Section 8.12.1 for excluded therapies
    1. Pacientes que se encuentran en tratamiento con un medicamento en investigación para cualquier indicación o en un tratamiento inmunológico por cualquier motivo (se admite la administración de Filgrastim para prevenir la neutropenia grave).
    2. Pacientes con glioblastoma que expresa una mutación de la IDH según los resultados de las pruebas inmunohistoquímicas.
    3. Los pacientes con patologías concurrentes que podrían comprometer su seguridad y el cumplimiento del protocolo.
    4. Pacientes con antecedentes de hepatitis aguda o crónica de tipo C o infección por el virus de la hepatitis B.
    5. Pacientes que precisan o es bastante probable que precisen recibir más de un curso de corticosteroides de 2 semanas de duración para el tratamiento de una enfermedad intercurrente. Los pacientes deberán haber concluido el ciclo de tratamiento con corticosteroides en el momento de la aféresis para cumplir los requisitos de elegibilidad.
    6. Pacientes con alguna infección aguda que precisa un tratamiento específico. El tratamiento de corta duración debe haber concluido siete días antes de la inclusión del paciente en el estudio.
    7. Pacientes con otra neoplasia maligna activa diagnosticada en los últimos tres años (excepto en el caso de los tumores localizados).
    8. Pacientes embarazadas o en periodo de lactancia materna.
    9. Véanse los tratamientos excluidos en el Apartado 8.12.1.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is overall survival (OS), which will be analyzed after 282 deaths have been observed, of subjects treated with ICT-107 and standard of care (RT and TMZ) vs. placebo control and standard of care (RT and TMZ)
    El criterio principal de valoración es la supervivencia global (SG), que se analizará después de que se hayan observado 282 muertes, de pacientes tratados con ICT-107 y tratamiento de referencia (RT y TMZ) frente a control de placebo y tratamiento de referencia (RT y TMZ).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint is overall survival (OS), which will be analyzed after 282 deaths have been observed
    El criterio principal de valoración es la supervivencia global (SG), que se analizará después de que se hayan observado 282 muertes.
    E.5.2Secondary end point(s)
    To determine the OS of subjects with unmethylated MGMT tumors treated with ICT-107 and standard of care vs. control and standard of care
    ? To determine the OS of subjects with methylated MGMT tumors treated with ICT-107 and standard of care vs. control and standard of care.
    ? To evaluate progression-free survival (PFS) of subjects treated with ICT-107 and standard of care vs. control and standard of care
    ? To determine the overall safety of ICT-107 vs. control
    Determinar la SG de los pacientes con tumores que expresan el gen MGMT no metilado tratados con ICT-107 más el tratamiento de referencia frente a los que reciben un control más el tratamiento de referencia.
    Determinar la SG de los pacientes con tumores que expresan el gen MGMT metilado tratados con ICT-107 más el tratamiento de referencia frente a los que reciben un control más el tratamiento de referencia.
    Evaluar la supervivencia sin progresión (SSP) de los pacientes tratados con ICT-107 más el tratamiento de referencia frente a los que reciben un control más el tratamiento de referencia.
    Determinar la seguridad global de ICT-107 frente al control.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Final Evaluation on all endpoints at 46 months
    Secondary Endpoint:
    1 and 2: OS at 6, 9, 12 months, and every 3 months after until study completion.
    3: Progression-free-survival (PFS) is determined based on patient having disease progression (PD). If preliminary diagnosis of PD is made at any time, follow up in 2 months to confirm. In the first cycle tumour assessments take place week 3, then cycles 2, 4, 6, 8, 10, 12, 14, 16, 18, 20 and 22.
    4: - Overall safety assessed during Induction Phase on day of injection (weekly for 4 weeks), every 2 weeks during Maintenance Phase (Weeks 1 and 3 during Cycles 1 ? 11), monthly during Extended Maintenance Phase (Cycles 12 -23). Also at time of PD confirmation and End of Study visit. Additionally, at any other time an adverse event reported.
    46 meses para todos los criterios de valoración.
    Criterios secundarios de valoración:
    1 y 2: SG a los 6,9,12 meses,y cada 3 meses hasta completar estudio.
    3: SSP se determina según progresión de la enfermedad (EP). Si hay diagnóstico de EP preliminar en cualquier momento, habrá seguimiento 2 meses después para confirmar. Las evaluaciones tumorales tienen lugar en Semana 3, y en ciclos 2, 4, 6, 8, 10, 12, 14, 16, 18, 20 y 22.
    4: Seguridad Global evaluada en Fase de Inducción en el día de la inyección (una cada 4 semanas), cada 2 semanas en Fase de Mantenimiento (Semanas 1 y 3 en Ciclos 1-11), mensualmente en Fase de Mantenimiento Ampliada (Ciclos 12-23). También durante la confirmación de EP, en visita Fin de Estudio y en cualquier momento que se reporte un acontecimiento adverso.
    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 No
    E.6.7Pharmacodynamic No
    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) 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA53
    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
    Canada
    France
    Germany
    Italy
    Netherlands
    Spain
    Switzerland
    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
    LVLS
    Última Visita del Ultimo Paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 328
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 86
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 137
    F.4.2.2In the whole clinical trial 414
    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)
    After the subject has completed participation in the trial, all future care will be determined by their treating physician. After the end of study visit, subjects will be contacted by telephone every 3 months until death; date and cause of death to be documented in the subject's CRF.
    Tras haber completado su participación en el ensayo, todo el tratamiento posterior del sujeto será determinado por su médico. Después de la visita de fin de estudio, los pacientes serán contactados telefónicamente cada 3 meses hasta fallecimiento; la fecha y la causa del fallecimiento se registrarán en el CRF del paciente.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation UKCRN
    G.4.3.4Network Country United Kingdom
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation European Organisation for Research and Treatment of Cancer (EORTC)
    G.4.3.4Network Country Belgium
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Alliance Foundation Trials, LLC (AFT)
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation Canadian Brain Tumour Consortium (CBTC)
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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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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