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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42567   clinical trials with a EudraCT protocol, of which   7008   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-004572-30
    Sponsor's Protocol Code Number:GS-US-406-1840
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-04-26
    Trial results View 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 ConcernedFrance - ANSM
    A.2EudraCT number2015-004572-30
    A.3Full title of the trial
    A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Tolerability of Entospletinib, a Selective SYK Inhibitor, in Combination with Systemic Corticosteroids as First-Line Therapy in Subjects with Chronic Graft Versus Host Disease (cGVHD)
    Etude de phase II, randomisée, en double aveugle testant l'efficacité et la tolérance de l'Entospletinb, un inhibiteur spécifique de SYK et des corticoïdes, contre placebo en association avec des corticoïdes, en traitement de première ligne de patients atteints de GVH chronique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study for Efficacy and Tolerability of Entospletinib in Combination with Corticosteroids as First-Line Therapy in (cGVHD)
    Etude de l'efficacité et de la tolérance de l'Entospletinb, et des corticoïdes, en première ligne de traitement de GVH chronique
    A.4.1Sponsor's protocol code numberGS-US-406-1840
    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 SponsorGilead Sciences, 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 supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd.
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park, Abington
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.5Fax number+441223897284
    B.5.6E-mailclinical.trials@gilead.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.3.2Product code GS-9973
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEntospletinib
    D.3.9.3Other descriptive nameENTOSPLETINIB
    D.3.9.4EV Substance CodeSUB178740
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Graft Versus Host Disease (cGVHD)
    GVH chronique
    E.1.1.1Medical condition in easily understood language
    Chronic Graft Versus Host Disease (cGVHD) is a disease observed in transplant recipients.
    GVH chronique est une maladie observé chez les greffes d'organes
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10066261
    E.1.2Term Chronic graft versus host disease
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of ENTO on the best overall response rate (BORR) as assessed by the NIH cGVHD Activity Assessment (NCAA) by 24 weeks in the setting of add-on to systemic corticosteroids as part of first-line therapy for cGVHD
    Évaluer l'effet de l'ENTO sur le meilleur taux de réponse globale (MTRG) selon les critères d'évaluation de l'activité de la GVH chronique définis par le NIH (critères NCAA) à 24 semaines, en tant que traitement de première ligne de la GVH chronique, adjuvant aux corticostéroïdes systémiques
    E.2.2Secondary objectives of the trial
    The key secondary objectives are:
    - To evaluate the effect of ENTO on the skin domain of the Lee Symptom Scale (LSS) at 24 weeks
    - To evaluate the effect of ENTO on the mouth domain of the LSS at 24 weeks
    - To evaluate the effect of ENTO on the eyes domain of the LSS at 24 weeks
    - To evaluate the effect of ENTO on the total score of the LSS at 24 weeks
    Objectifs secondaires clés :
    - Évaluer l'effet de l'ENTO à l'aide du score pour le domaine cutané de l'échelle des symptômes de Lee (LSS) à 24 semaines (annexe 6 du protocole en anglais)
    - Évaluer l'effet de l'ENTO à l'aide du score pour le domaine buccal de l'échelle LSS à 24 semaines
    - Évaluer l'effet de l'ENTO à l'aide du score pour le domaine oculaire de l'échelle LSS à 24 semaines
    - Évaluer l'effet de l'ENTO en utilisant le score total de l'échelle LSS à 24 semaines
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
    2) 18-75 years of age, inclusive at Screening
    3) Newly diagnosed cGVHD defined by:
    a) At least 100 days after receiving any allogeneic hematopoietic stem cell transplant
    AND
    b) Receiving new course of systemic corticosteroids (1.0 mg/kg/day or prednisone equivalent) as first-line therapy for cGVHD within 10 days of screening
    AND
    c) Moderate to severe cGVHD as assessed by NCDSC with at least three organ systems involved OR one organ system with a score of 2 OR lung organ score = 1
    4) Subjects who have undergone transplantation for benign indications are eligible for the study. Complete remission is required for subjects who have undergone transplantations for hematologic malignancies.
    5) Have either a normal ECG or one with abnormalities that are considered clinically insignificant by the investigator in consultation with the Sponsor
    6) A negative serum pregnancy test is required for female subjects (unless permanently sterile or greater than two years post-menopausal)
    7) A female subject is eligible to enter the study if it is confirmed that she is:
    a) Not pregnant or nursing
    b) Of non-childbearing potential (i.e., women who have had a hysterectomy, have had both ovaries removed or medically documented ovarian failure, or are postmenopausal women > 54 years of age with cessation (for more than or equal to 12 months) of previously occurring menses), or
    c) Of childbearing potential and agrees to utilize a highly effective protocol-specified contraceptive method or be non-heterosexually active or practice sexual abstinence from Screening throughout the duration of study treatment and for 30 days following the last study drug dose
    d) Female subjects who utilize a hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing
    8) Male subjects of childbearing potential who engage in heterosexual intercourse must agree to
    use protocol specified method(s) of contraception.
    1) Capacité à comprendre et à signer un formulaire de consentement éclairé, qui doit être obtenu avant toute procédures liées à l'étude.
    2) Avoir entre 18 et 75 ans au moment de la sélection
    3) GVH chronique diagnostiquée récemment :
    a) au moins 100 jours après l’allogreffe de cellules souches hématopoïétiques ;
    ET
    b) ayant nécessité un nouveau traitement par corticostéroïdes systémiques (1,0 mg/kg/jour ou l'équivalent pour la prednisone) comme traitement de première ligne de la GVH chronique dans les 10 jours précédant la sélection ;
    ET
    c)évaluée comme étant modérée ou sévère tel que défini par les critères NCDSC, touchant au moins trois systèmes d'organes OU un seul système d'organes avec un score de 2 OU seulement les poumons avec un score de 1
    4) Nécessité d'être en rémission totale pour les patients qui ont reçu une greffe pour traiter une affection hématologique maligne
    5) Avoir un ECG normal ou un ECG présentant des anomalies qui sont considérées comme non significatives sur le plan clinique par l'investigateur en consultation avec le promoteur
    6 ) Un test de grossesse sérique négatif est requis pour les patientes de sexe féminin ( sauf si stérilisées ou ménopausées depuis plus de deux ans)
    7) Un patient de sexe féminin est admissible à participer à l'étude si elle est confirmée qu'elle est :
    a) Non enceinte ou qu'elle n'allaite pas
    b ) n'est pas en âge de procréer (par exemple, les femmes qui ont subi une hystérectomie , ont eu deux ablation des ovaires ou insuffisance ovarienne médicalement documentés, ou bien les femmes ménopausées > 54 ansavec l'arrêt (pour plus de ou égal à 12 mois ) de menstrues survenus précédemment ) , ou
    c ) en âge de procréer et accepte d'utiliser une méthode contraceptive telle que décrite dans le protocole spécifiée très efficace ou qui ont des relations hétérosexuelles ou pratiquer l'abstinence sexuelle pendant toute la durée du traitement à l'étude et pendant 30 jours après la dernière prise du médicament à l'étude
    d) les patients de sexe féminins qui utilisent un contraceptif hormonal comme l'une des méthodes de contraception doivent avoir utilisé la même méthode contraceptive depuis au moins trois mois avant la prise de la dose
    8 ) les patients de sexe masculin et féminin en âge de procréer qui ont des relations hétérosexuelles doivent accepter l’utilisation d’une ou de plusieurs méthodes de contraception telles que mentionnées dans le protocole

    E.4Principal exclusion criteria
    1) Uncontrolled infection within 4 weeks of Screening
    2) History of the following therapies in the post-transplant period:
    a) B cell depleting biologic agents
    b) CD19 CAR-T cells based therapies
    c) BTK/SYK/JAK/PI3K inhibitors
    d) Phototherapy-unless administered for aGVHD
    3) Treatment of cGVHD with anti-thymocyte globulins (ATG), or campath within 60 days of Screening visit unless used for treatment of acute GVHD
    4) Severe organ dysfunction manifest during Screening period:
    a) Requiring supplemental oxygen at more than 2L/min
    b) Uncontrolled arrhythmia or heart failure
    c) Creatinine clearance (Cockroft-Gault) < 30 mL/min
    5) Known hypersensitivity to the Investigational Medicinal Product (IMP), the metabolites, or formulation excipient.
    6) Laboratory abnormalities including:
    a) Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen or hepatitis C antibody positive (Subjects with positive HCV antibody and without detectable HCV RNA are permitted to enrol)
    b) Aspartate aminotrasferase (AST)/Alanine aminotransferase (ALT) ≥ 2 X upper limit of normal (ULN) unless deemed to be secondary to Liver GVHD
    c) Total bilirubin ≥ 2 X ULN unless deemed to be secondary to Liver GVHD
    7) Positive serum pregnancy test (for female subjects)
    8) Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements
    9) Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial
    10) Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance or subject safety
    11) Subjects receiving ongoing therapy with any of the medications from the following drug class: mTOR inhibitor, any cell depleting antibody, phototherapy, BTK agents, JAK inhibitors, strong and moderate CYP3A/2C9 inducers, strong CYP2C9 inhibitors, herbal/natural supplements
    1) Infection non contrôlée dans les 4 semaines précédant la sélection
    2) Prise des traitements suivants au cours de la période post-greffe :
    a) Agents biologiques causant la déplétion en lymphocytes B
    b) Traitements basés sur les cellules CD19 CAR-T
    c) Inhibiteurs de BTK, SYK, JAK ou PI3K
    d) Photothérapie (sauf pour traiter une GVH aiguë)
    3) Traitement de la GVH chronique à base de globulines anti-thymocyte (ATG) ou de Campath pris au cours des 60 jours précédant la visite de sélection (sauf pour traiter une GVH aiguë)
    4) Dysfonction sévère d'un organe qui se manifeste pendant la période de sélection :
    a) Oxygénothérapie nécessaire à plus de 2 l/min
    b) Arythmie ou insuffisance cardiaque non contrôlée
    c) Clairance de la créatinine (calculée à l'aide de la méthode Cockroft-Gault) < 30 mL/min
    5) Hypersensibilité connue à l'un des composants du medicament, les métabolites, la formulation de l’excipient.
    6) Les anomalies dans les résultats au niveau des analyses du laboratoire, y compris:
    a) virus de l'immunodéficience humaine (VIH) anticorps, l'antigène de surface de l'hépatite B ou le VIH anticorps de l'hépatite C (sujets positifs avec anticorps anti-VHC positif et sans ARN du VHC détectable sont autorisés à participer)
    b) de l'aspartate aminotransférase (AST) / alanine aminotransférase (ALAT) ≥ 2 x la limite supérieure de la normale (LSN) à moins que cela soit dû à la GVH secondaire du foie
    c) bilirubine totale ≥ 2 x LSN à moins d'une GVH secondaire du foie
    7) test de grossesse sérique positif (pour les sujets de sexe féminin)
    8) Toute autre condition clinique ou traitement antérieur qui, de l'avis de l'investigateur, ne soit pas apte à participer àl'étude ou incapable de se conformer aux exigences de la posologie
    9) La participation à tout autre essai clinique sans l'approbation préalable du promoteur est interdite tout en participant à cet essai
    10) antécédents d’abus de médicaments et d’alcoolisme qui, selon l’investigateur, peut empêcher le respect des activités de l’étude
    11) sujets recevant un traitement en cours avec l'un des médicaments de la classe des médicaments suivants: inhibiteur de mTOR, une cellule dépletant l’anticorps, la photothérapie, les agents BTK, les inhibiteurs de JAK, puissants et modérés CYP3A / 2C9 inducteurs, inhibiteurs du CYP2C9 forts, les suppléments à base de plantes / produits naturels
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is BORR as assessed by the NCAA by 24 weeks in the setting of add-on to systemic corticosteroids as part of first-line therapy for cGVHD
    Le critère d'évaluation principal est le MTRG à 24 semaines, évalué selon les critères NCAA, lorsque l'ENTO est administré en tant que traitement de première ligne de la GVH chronique, en tant qu’adjuvant aux corticostéroïdes systémiques
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    24 semaines
    E.5.2Secondary end point(s)
    The key secondary endpoints are:
    - Change from Baseline in the skin domain of the LSS at 24 weeks
    - Change from Baseline in the mouth domain of the LSS at 24 weeks
    - Change from Baseline in the eyes domain of the LSS at 24 weeks
    - Change from Baseline in the total score of the LSS at 24 weeks
    Les critères d'évaluation secondaires clés sont les suivants :
    • Changement à 24 semaines par comparaison à la visite de référence du score pour le domaine cutané de l'échelle LSS
    - Changement à 24 semaines par comparaison à la visite de référence du score pour le domaine buccal de l'échelle LSS
    - Changement à 24 semaines par comparaison à la visite de référence du score pour le domaine occulaire de l'échelle LSS
    - Changement à 24 semaines par comparaison à la visite de référence du score total de l'échelle LSS
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks
    24 semaines
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Canada
    France
    Germany
    Korea, Republic of
    Spain
    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
    Dernière Visite du Dernier Patient
    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 days17
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days27
    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: 95
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 49
    F.4.2.2In the whole clinical trial 100
    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 patient has completed/terminated their study participation, long term care of the participant will remain the responsibility of their primary treating physicians.
    Après que le patient aie completé/terminé sa participation à l'étude, les soins de longue durée des patients resteront de la responsabilité de leur médecin traitant.
    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 Decision2016-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-12-14
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