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    The EU Clinical Trials Register currently displays   44237   clinical trials with a EudraCT protocol, of which   7338   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2019-000208-13
    Sponsor's Protocol Code Number:ACE-536-B-THAL-004
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2020-10-07
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-000208-13
    A.3Full title of the trial
    A phase 2a study to evaluate the safety and pharmacokinetics of Luspatercept (ACE-536) in paediatric subjects who require regular red blood cell transfusions due to beta thalassemia
    Studio di fase 2A per valutare la sicurezza e la farmacocinetica di Luspatercept (ACE-536) in soggetti pediatrici che richiedono regolari trasfusioni di globuli rossi a causa della beta (ß) talassemia.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 2a study to evaluate the safety and pharmacokinetics of Luspatercept (ACE-536) in paediatric subjects who required regular red blood cell transfusions due to beta thalassemia
    Studio di fase 2A per valutare la sicurezza e la farmacocinetica di Luspatercept (ACE-536) in soggetti pediatrici che richiedono regolari trasfusioni di globuli rossi a causa della beta (ß) talassemia.
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberACE-536-B-THAL-004
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/130/2019
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCELGENE CORPORATION
    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 supportCelgene corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD
    B.5.2Functional name of contact pointPPD Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressRua Leopoldo, Couto de Magalhaes jr, 758 6°
    B.5.3.2Town/ citySao Paulo
    B.5.3.3Post code04542-000
    B.5.3.4CountryBrazil
    B.5.4Telephone number00551145044700
    B.5.5Fax number00551145044000
    B.5.6E-mailClaudia.Mazara@ppdi.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/3/14/1300
    D.3 Description of the IMP
    D.3.1Product nameLuspatercept
    D.3.2Product code [ACE-536]
    D.3.4Pharmaceutical form Lyophilisate 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 INNLUSPATERCEPT
    D.3.9.1CAS number 1373715-00-4
    D.3.9.2Current sponsor codeACE-536
    D.3.9.3Other descriptive nameLuspatercept
    D.3.9.4EV Substance CodeSUB189400
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number87
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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/3/14/1300
    D.3 Description of the IMP
    D.3.1Product nameLuspatercept
    D.3.2Product code [ACE-536]
    D.3.4Pharmaceutical form Lyophilisate 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 INNLUSPATERCEPT
    D.3.9.1CAS number 1373715-00-4
    D.3.9.2Current sponsor codeACE-536
    D.3.9.3Other descriptive nameLuspatercept
    D.3.9.4EV Substance CodeSUB189400
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number37
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Beta-Thalassemia
    Beta-Talassemia
    E.1.1.1Medical condition in easily understood language
    Beta thalassemia is a blood disorder that reduces the production of hemoglobin (iron-containing protein in red blood cells that carries oxygen to cells throughout the body).
    Beta thalassemia è na malattia del sangue che riduce la produzione di emoglobina (proteina contenente ferro nei globuli rossi che trasporta ossigeno alle cellule attraverso il corpo)
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10054660
    E.1.2Term Thalassemia beta
    E.1.2System Organ Class 100000004850
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10054660
    E.1.2Term Thalassemia beta
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is:
    - To determine the recommended dose (RD) of luspatercept that is safe and tolerable in pediatric subjects with transfusion-dependent (TD) ß-thalassemia
    - To examine the pharmacokinetic (PK) profile of luspatercept in pediatric subjects with TD ß-thalassemia
    Obiettivi primari:
    - Determinare la dose raccomandata (recommended dose, RD) di luspatercept che sia sicura e tollerabile in soggetti pediatrici affetti da ß-talassemia trasfusione dipendente (TD)
    - Esaminare il profilo di farmacocinetica (PK) di luspatercept in soggetti pediatrici affetti da ß-talassemia TD
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate:
    - The mean change in red blood cell (RBC) transfusion burden
    - The hemoglobin levels over the course of the study
    - The immunogenicity of luspatercept
    - Safety of luspatercept in pediatric subjects
    Valutare:
    - La variazione media nel carico da trasfusione di RBC
    - I livelli di emoglobina nel corso dello studio
    - L’immunogenicità di luspatercept
    -La sicurezza di luspatercept in soggetti pediatrici
    Un elenco completo degli obiettivi e degli endpoint è disponibile nella Sezione 2 del protocollo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    6 months to < 18 years of age at the time of signing the informed consent form (ICF)/informed assent form (IAF).
    Documented diagnosis of ß-thalassemia or Hemoglobin E/ß-thalassemia
    Regularly transfused, defined as: >= 4 RBC transfusions in the 24 weeks prior to enrollment with no transfusion-free period >= 42 days during that period.
    Note: For the purpose of the study, transfusions administered over 2 or 3 consecutive days are considered as part of a single transfusion event.
    Karnofsky (age >=16 years) or Lansky (age < 16 years) performance status score >= 50 at screening
    Il soggetto deve avere da 6 mesi a < 18 anni di età al momento della firma del modulo di consenso informato (ICF)/modulo di assenso informato(IAF)
    Il soggetto deve presentare una diagnosi documentata di ß-talassemia o emoglobina E/ß-talassemia.
    Il soggetto deve essere sottoposto a trasfusioni regolari, definite come: >= 4 trasfusioni di RBC nelle 24 settimane precedenti l’arruolamento e nessun periodo libero da trasfusione >= 42 giorni in quell’arco di tempo.
    Nota: per l'obiettivo dello studio, le trasfusioni somministrate nell'arco di 2 o 3 giorni consecutivi sono considerate come parte di un singolo evento di trasfusione.
    Il soggetto ha un punteggio dello stato di validità di Karnofsky (età >= 16 anni) o di Lansky (età < 16 anni) >= 50 allo screening.
    E.4Principal exclusion criteria
    Subject has a diagnosis of Hemoglobin S/ß-thalassemia or alpha (a)-thalassemia (eg, Hemoglobin H); ß-thalassemia combined with a-thalassemia is allowed.
    Subject has chronic anticoagulant therapy <= 28 days prior to enrollment
    Subject has used an erythropoiesis-stimulating agent (ESA) <= 24 weeks prior to enrollment.
    Subject use of iron chelation therapy, if initiated <= 8 weeks prior to enrollment (allowed if initiated > 8 weeks before or during treatment).
    Subject use of hydroxyurea treatment <= 24 weeks prior to enrollment.
    Subject use of chronic systemic glucocorticoids <= 12 weeks prior to enrollment
    Subject use of cytotoxic agents, immunosuppressants <= 28 days prior to enrollment
    Subject has treatment with another investigational drug or device <= 28 days prior to enrollment
    Il soggetto presenta una diagnosi di emoglobina S/ß-talassemia o alfa (a)-talassemia (ad es. emoglobina H); è consentita la diagnosi di ß-talassemia combinata con a-talassemia.
    Il soggetto è in trattamento con una terapia anticoagulante cronica da <= 28 giorni prima dell'arruolamento (le terapie anticoagulanti utilizzate per la profilassi per interventi chirurgici o procedure ad alto rischio, nonché l’eparina a basso peso molecolare [LMW] per trombosi venosa superficiale [TVS] e l’aspirina cronica sono concesse).
    Il soggetto ha utilizzato un agente stimolante l'eritropoiesi (ESA) <= 24 settimane prima dell'arruolamento.
    Il soggetto è in trattamento con terapia ferrochelante (iron chelation therapy, ICT), se avviata <= 8 settimane prima dell’arruolamento (consentita se avviata > 8 settimane prima, o durante il trattamento).
    Il soggetto è in trattamento con idrossiurea da <= 24 settimane prima dell'arruolamento.
    Il soggetto fa uso di glucocorticoidi per via sistemica cronica da <= 12 settimane prima dell'arruolamento (è consentita la terapia sostitutiva fisiologica per insufficienza surrenale). È consentito un trattamento di un solo giorno con glucocorticoidi (ad es., per la prevenzione o il trattamento di reazioni alla trasfusione).
    Il soggetto fa uso di agenti citotossici, immunosoppressivi da <= 28 giorni prima dell'arruolamento (ovvero, globulina anti-timociti [ATG] o ciclosporina).
    Il soggetto è in trattamento con un altro farmaco o dispositivo sperimentale da <= 28 giorni prima dell’arruolamento.
    E.5 End points
    E.5.1Primary end point(s)
    Determination of the Recommended Dose
    Development of a PK model that describes the PK exposure data of luspatercept and associated variability
    Determinare la dose raccomandata
    Sviluppo di un modello PK che descrive i dati di esposizione PK di luspatercept e la varibilità associata
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cycle 1 Day 1 through Cycle 1 Day 22
    Cycle 1 Day 1 through EOT following the Treatment Period
    - Ciclo 1 Giorno 1 fino a Ciclo 1 giorno 22
    - ciclo 1 giorno 1 fino alla fine dello studio che segue il periodo di trattamento
    E.5.2Secondary end point(s)
    To evaluate the change in RBC transfusion burden
    To evaluate the change in hemoglobin levels over the course of the study
    Safety
    Frequency of antidrug antibodies and its effect on safety
    Exposure-response relationships for measures of activities and toxicity
    - To evaluate the change in RBC transfusion burden
    - To evaluate the change in hemoglobin levels over the course of the study
    - Safety
    - Frequency of antidrug antibodies and its effect on safety
    - Exposure-response relationships for measures of activities and toxicity
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks prior to enrollment; 12 weeks of the Treatment Period through to EOT
    Cycle 1 Day 1 through 12 weeks post-last dose
    Cycle 1 Day 1 through 12 weeks post-last dose; if positive, every 24 weeks for up to 2 years from Cycle 1 Day 1 or until negative or stabilized
    Cycle 1 Day 1 through EOT following the Treatment Period
    - 12 weeks prior to enrollment; 12 weeks of the Treatment Period through to EOT
    - Cycle 1 Day 1 through 12 weeks post-last dose
    - Cycle 1 Day 1 through 12 weeks post-last dose; if positive, every 24 weeks for up to 2 years from Cycle 1 Day 1 or until negative or stabilized
    - Cycle 1 Day 1 through EOT following the Treatment Period
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Dose-ascending Design
    Dose-ascending Design
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    aperto
    open
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Thailand
    Turkey
    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
    The End of Trial is defined as either the date of the last visit of the last subject to complete the Long-Term Treatment and Follow-up Period, or the date of receipt of the last data point from the last subject that is required for primary and/or secondary analysis, as prespecified in the protocol, whichever is the later date. Celgene may end the trial when all key endpoints and objectives of the study have been analyzed.
    La Fine della sperimentazione è definita come la data dell’ultima visita dell’ultimo soggetto per completare il Periodo di trattamento a lungo termine e follow-up, oppure la data di ricezione degli ultimi dati dell’ultimo soggetto necessari per l’analisi primaria, l’analisi secondaria e/o l’analisi esplorativa, come specificato in precedenza nel protocollo, a seconda di quale si verifichi più tardi.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    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 Yes
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 12
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 24
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 12
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Minors
    Minori
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 38
    F.4.2.2In the whole clinical trial 48
    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)
    Subjects completing Cycle 4 (last dose) of the Treatment Period and benefiting from the study treatment, at the discretion of the Investigator, will be transitioned to the Longterm Treatment Period to continue dosing with luspatercept for up to a maximum of 5 years from their Cycle 1 Day 1 or when the drug is approved for pediatric patients (whichever comes first). After the trial, subjects will be treated according to normal standard of care.
    I soggetti che completano il Ciclo 4 (ultima dose) del Periodo di trattamento e traggono beneficio dal trattamento, a discrezione dello sperimentatore, saranno trasferiti al Periodo di trattamento a lungo termine per continuare il dosaggio con luspatercept per un periodo di max 5 anni dal Giorno 1 del Ciclo 1 o fino a quando il farmaco non viene approvato per pazienti pediatrici (a seconda di quale evento si verifichi per primo). A fine studio i soggetti saranno tratti secondo terapia standard.
    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 Decision2019-08-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-24
    P. End of Trial
    P.End of Trial StatusRestarted
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