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    Summary
    EudraCT Number:2017-003583-12
    Sponsor's Protocol Code Number:CA224-047
    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:2018-03-14
    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 number2017-003583-12
    A.3Full title of the trial
    A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined with Nivolumab versus Nivolumab in Participants with Previously Untreated Metastatic or Unresectable Melanoma
    Estudio fase 2/3, aleatorizado, doble ciego de Relatlimab (BMS-986016) combinado con nivolumab frente a nivolumab en monoterapia en pacientes con Melanoma metastásico o irresectable no tratado previamente.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Relatlimab plus Nivolumab Versus Nivolumab Alone in Participants with Advanced Melanoma
    Un estudio de Relatlimab combinado con nivolumab frente a nivolumab en monoterapia en pacientes con Melanoma metastásico o irresectable no tratado previamente
    A.4.1Sponsor's protocol code numberCA224-047
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1201-4386
    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 SponsorBristol-Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointHead of the GCT-SU
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance, Avenue de Finlande, 4
    B.5.3.2Town/ cityBraine l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.4Telephone number(+) 900 150 160
    B.5.6E-mailclinical.trials@bms.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 nameRelatlimab/ Nivolumab 1:3 Fixed Dose Combination
    D.3.2Product code BMS-986213
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNIVOLUMAB
    D.3.9.1CAS number 946414-94-4
    D.3.9.2Current sponsor codeBMS-936558
    D.3.9.3Other descriptive nameMDX-1106, ONO-4538
    D.3.9.4EV Substance CodeSUB32944
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRelatlimab
    D.3.9.2Current sponsor codeBMS-986016
    D.3.9.3Other descriptive nameanti-LAG-3
    D.3.9.4EV Substance CodeSUB168199
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Opdivo (100 mg/10 ml)
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameNIVOLUMAB
    D.3.2Product code BMS-936558
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNIVOLUMAB
    D.3.9.1CAS number 946414-94-4
    D.3.9.2Current sponsor codeBMS-936558
    D.3.9.3Other descriptive nameMDX-1106, ONO-4538
    D.3.9.4EV Substance CodeSUB32944
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Previously Untreated Metastatic or Unresectable Melanoma
    Melanoma metastásico o irresectable no tratado previamente
    E.1.1.1Medical condition in easily understood language
    Advanced Melanoma
    Melanoma avanzado
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10053571
    E.1.2Term Melanoma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027481
    E.1.2Term Metastatic melanoma
    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
    Phase 3 portion of the trial
    - To compare progression-free survival (PFS) of BMS-986213 to nivolumab monotherapy in participants with previously untreated, unresectable or metastatic melanoma.

    Phase 2 portion of the trial
    - To compare the overall-response rate (ORR) of BMS-986213 to nivolumab monotherapy in participants with unresectable or metastatic melanoma.
    Parte de la Fase 3 del estudio
    - comparar la supervivencia libre de progresión (SLP) con BMS-986213 con respecto a la obtenida con nivolumab en monoterapia en pacientes con melanoma irresecable o metastásico no tratado previamente,
    Parte de la Fase 2 del estudio
    - comparar la Tasa de respuesta global (TRO) con BMS-986213 con la obtenida con nivolumab
    monoterapia en pacientes con melanoma irresecable o metastásico
    E.2.2Secondary objectives of the trial
    Phase 3 portion of the trial
    - To compare overall survival (OS) of BMS-986213 to nivolumab o in subjects with with previously untreated, unresectable or metastatic melanoma
    - To compare ORR of BMS-986213 to nivolumab in subjects with unresectable or metastatic melanoma

    Phase 2 portion of the trial
    Among subjects with unresectable or metastatic melanoma treated with BMS-986213 and those treated with nivolumab monotherapy:
    - To estimate the treatment effect, measured by ORR, as determined by BICR using RECISTv1.1, in subgroups based on combinations of LAG-3 expression and PDL-1 status
    - To evaluate DOR, DCR, PFS rates at pre-specified time points based on BICR assessments using RECIST v1.1 in the randomized population and in subgroups based on combinations of LAG-3 expression and PDL-1 status
    - To assess the 1- and 2-year landmark OS in the randomized population and in subgroups based on combinations of LAG-3 expression and PDL-1 status
    - To assess safety and tolerability
    Fase 3 : - comparar SG con BMS-986213 con la obtenida con nivo en monoterapia en pacien. con melanoma irresecable o metastásico no tratado previamente, - comparar la TRO con BMS-986213 con la obtenida con nivo en monote. en pacien. con melanoma irresecable o metastásico. Fase 2: Entre los pacien. con melanoma irresecable o metastásico tratados con BMS-986213 y aquellos tratados con nivo en monoter.: - Estimar el efecto del tratamiento, medido mediante la TRO, determinado por RCIE usando RECISTv1.1, en subgrupos basados en combinaciones de expresión LAG-3 y estado de PDL-1. - Evaluar tasas de DdR, TCE y tasas SLP en momentos de tiempo preespecificados de acuerdo con las evaluaciones RCIE usando RECIST v1.1 en la población aleatorizada y en subgrupos basados en la combinación de expresión de LAG-3 y estado de PDL-1. - Evaluar SG de 1 y 2 años en la población aleatorizada y en subgrupos basados en combinaciones de expresión de LAG-3 y estado de PDL-1. - Evaluar seguridad y tolerabilidad.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    See protocol Section 9.8.2.7.: Additional Research Collection
    Consultar la secdción 9.8.2.7 (Colección adicional de investigación) del protocolo
    E.3Principal inclusion criteria
    - Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the AJCC staging system
    - Participants must not have had prior systemic anticancer therapy for unresectable or metastatic melanoma
    - Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses
    - Los participantes deben tener melanoma confirmado histológicamente en estadio III (irresecable) o en estadio IV, según el sistema de estadificación del AJCC
    - Los participantes no deben haber recibido tratamiento oncológico sistémico previo para melanoma irresecable o metastásico
    - Debe facilitarse tejido tumoral de una localización irresecable o metastásico de la enfermedad para análisis de biomarcadores
    E.4Principal exclusion criteria
    - Participants must not have active brain metastases or leptomeningeal metastases
    - Participants must not have ocular melanoma
    - Participants must not have an active, known, or suspected autoimmune disease
    Metástasis cerebrales activas o metástasis leptomeníngeas

    Melanoma ocular

    Participantes con enfermedad autoinmune activa, conocida o sospechada
    E.5 End points
    E.5.1Primary end point(s)
    Primary Outcome Measures:
    1/ Progression Free Survival (PFS) Phase 3 portion of trial. Assessed by a Blinded Independent Central Review (BICR)
    2/ Overall Response Rate (ORR) Phase 2 portion of trial, assessed by a BICR
    Medidas primarias de resultados:
    1 / Supervivencia libre de progresión (SLP) Fase 3 del ensayo. Evaluada por
    una Revisión Central Independiente Enmascarada (RCIE)
    2 / Tasa de respuesta objetiva (TRO) Fase 2 del ensayo, evaluada por un
    RCIE
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time Frame:
    1/ Up to 5 years
    2/ Up to 5 years
    Periodo de tiempo:
    1 / hasta 5 años
    2 / hasta 5 año
    E.5.2Secondary end point(s)
    Secondary outcome measures:
    1/ Overall Survival (OS)
    Phase 3 portion of trial. To compare BMS-986213 to nivolumab monotherapy
    2/ ORR
    Phase 3 portion of trial, assessed by a BICR
    3/ ORR
    Phase 2 portion of trial, assessed by a BICR in subgroups
    4/ Duration of Response (DOR)
    Phase 2 portion of trial. In the randomized population and in subgroups
    5/ Disease Control Rate (DCR)
    Phase 2 portion of trial. In the randomized population and in subgroups
    6/ PFS
    Phase 2 portion of trial. In the randomized population and in subgroups
    7/ OS
    Phase 2 portion of trial. In the randomized population and in subgroups
    8/ Number of Adverse Events (AEs)
    Phase 2 portion of the trial
    9/ Number of Serious Adverse Events (SAEs)
    Phase 2 portion of the trial
    10/ Number of AEs Leading to Discontinuation
    Phase 2 portion of the trial
    11/ Number of Deaths
    Phase 2 portion of the trial
    12/ Number of Laboratory Abnormalities
    Phase 2 portion of the trial
    Medidas de resultado secundarias:
    1 / Supervivencia global (SG)
    Fase 3 del estudio. Para comparar BMS-986213 con nivolumab
    monoterapia
    2 / TRO tasa respuesta objetiva
    Fase 3 del estudio, evaluada por un RCIE
    3 / TRO tasa respuesta objetiva
    Fase 2 del estudio, evaluada por un RCIE en subgrupos
    4 / Duración de la respuesta (DdR)
    Fase 2 del estudio. En la población aleatorizada y en subgrupos
    5 / Tasa de control de enfermedades (TCE)
    Fase 2 del estudio. En la población aleatorizada y en subgrupos
    6 / SLP
    Fase 2 del estudio. En la población aleatorizada y en subgrupos
    7 / SG
    Fase 2 del estudio. En la población aleatorizada y en subgrupos
    8 / Cantidad de eventos adversos (EA)
    Fase 2 del estudio
    9 / Número de eventos adversos graves (EAG)
    Fase 2 del estudio
    10 / Cantidad de eventos adversos que conducen a la interrupción
    Fase 2 del estudio
    11 / Número de muertes
    Fase 2 del estudio
    12 / Número de anomalías en el laboratorio
    Fase 2 del estudio
    E.5.2.1Timepoint(s) of evaluation of this end point
    1/ Time Frame: Up to 5 years
    2/ Time Frame: Up to 5 years
    3/ Time Frame: Up to 5 years
    4/ Time Frame: Up to 5 years
    5/ Time Frame: Up to 5 years
    6/ Time Frame: Up to 5 years
    7/ Time Frame: Up to 5 years
    8/ Time Frame: Up to 5 years
    9/ Time Frame: Up to 5 years
    10/ Time Frame: Up to 5 years
    11/ Time Frame: Up to 5 years
    12/ Time Frame: Up to 5 years
    1 / Marco de tiempo: hasta 5 años
    2 / Marco de tiempo: hasta 5 años
    3 / Marco de tiempo: hasta 5 años
    4 / Marco de tiempo: hasta 5 años
    5 / Marco de tiempo: hasta 5 años
    6 / Marco de tiempo: hasta 5 años
    7 / Marco de tiempo: hasta 5 años
    8 / Marco de tiempo: hasta 5 años
    9 / Marco de tiempo: hasta 5 años
    10 / Marco de tiempo: hasta 5 años
    11 / Marco de tiempo: hasta 5 años
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) Yes
    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) Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Chile
    Colombia
    Denmark
    Finland
    France
    Germany
    Greece
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    New Zealand
    Norway
    Poland
    Romania
    Russian Federation
    Spain
    Sweden
    Taiwan
    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
    LPLV
    LPLV
    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 months9
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days1
    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: 10
    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: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 690
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 state31
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 480
    F.4.2.2In the whole clinical trial 1000
    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)
    At the conclusion of the study, participants who continue to demonstrate clinical benefit will be eligible to receive BMS-supplied study treatment for the maximum treatment duration specified in Section 5.3. Study treatment will be provided via an extension of the study, a rollover study requiring approval by responsible health authority and ethics committee, or through another mechanism at the discretion of BMS. Please refer to Section 7.8 of the Protocol for more details.
    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 Decision2018-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-28
    P. End of Trial
    P.End of Trial StatusOngoing
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