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    Summary
    EudraCT Number:2019-003830-17
    Sponsor's Protocol Code Number:ACH228-110
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-06-23
    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 number2019-003830-17
    A.3Full title of the trial
    A Phase 2 Open-Label Proof of Concept Study to Assess the Efficacy, Safety, and Pharmacokinetics of the Oral Factor D (FD) Inhibitor ACH-0145228 in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients as Monotherapy and with an Approved C5 Inhibitor as Background Therapy
    Studio di prova di concetto in aperto di fase 2 volto a valutare l’efficacia,
    la sicurezza e la farmacocinetica dell’inibitore orale del fattore D ACH-0145228
    somministrato in monoterapia e in associazione a un inibitore di C5 approvato
    come terapia di base a pazienti affetti da emoglobinuria parossistica notturna
    (EPN)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the Oral Factor D (fD) Inhibitor ACH-0145228 in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients as Monotherapy and with background use of an Approved C5 Inhibitor
    Studio dell’inibitore orale del fattore D ACH-0145228 somministrato in
    monoterapia e in associazione a un inibitore di C5 approvato come terapia di base a pazienti affetti da EPN
    A.4.1Sponsor's protocol code numberACH228-110
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04170023
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1241-2441
    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 SponsorAchillion Pharmaceuticals, Inc., a wholly owned subsidiary of Alexion Pharmaceuticals 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 supportAchillion Pharmaceuticals, Inc. a wholly owned subsidiary of Alexion Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlexion Europe SAS
    B.5.2Functional name of contact pointEuropean Clinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address103-105 Rue Anatole France
    B.5.3.2Town/ cityLevallois-Perret
    B.5.3.3Post code92300
    B.5.3.4CountryFrance
    B.5.4Telephone number+33147100615
    B.5.5Fax number+33147100611
    B.5.6E-mailclinicaltrials.eu@alexion.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 nameALXN2050
    D.3.2Product code ACH-0145228
    D.3.4Pharmaceutical form Capsule
    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 INNN/A
    D.3.9.1CAS number 2086178-00-7
    D.3.9.2Current sponsor codeALXN2050
    D.3.9.3Other descriptive nameACH-0145228
    D.3.9.4EV Substance CodeSUB204167
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameALXN2050
    D.3.2Product code ACH-0145228
    D.3.4Pharmaceutical form Capsule
    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 INNN/A
    D.3.9.1CAS number 2086178-00-7
    D.3.9.2Current sponsor codeALXN2050
    D.3.9.3Other descriptive nameACH-0145228
    D.3.9.4EV Substance CodeSUB204167
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Paroxysmal Nocturnal Hemoglobinuria (PNH)
    Emoglobinuria Parossistica Notturna (EPN)
    E.1.1.1Medical condition in easily understood language
    Paroxysmal Nocturnal Hemoglobinuria (PNH)
    Emoglobinuria Parossistica Notturna (EPN)
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10034042
    E.1.2Term Paroxysmal nocturnal haemoglobinuria
    E.1.2System Organ Class 10038359 - Renal and urinary 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 efficacy of ACH-0145228 based on improvement hemoglobin (Hgb) relative to baseline at Week 12 of treatment
    Valutare l’efficacia di ACH-0145228 sulla base del miglioramento dei livelli di emoglobina (Hb) rispetto al basale alla Settimana 12 del trattamento
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of ACH-0145228 based on reduction in transfusion requirements
    • To evaluate the efficacy of ACH-0145228 on lactate dehydrogenase (LDH) relative to baseline at Week 12 of treatment
    • To assess laboratory markers of hemolysis and other markers relevant in patients with paroxysmal nocturnal hemoglobinuria (PNH)
    • To evaluate the safety and tolerability of 12 weeks of treatment with ACH-0145228 with or without the use of background therapy with an approved C5 inhibitor, based on treatment-emergent adverse events, (TEAEs), serious adverse events (SAEs), and events leading to discontinuation of study medication
    •Valutare l’efficacia di ACH-0145228 sulla base della riduzione del fabbisogno trasfusionale
    • Valutare l’efficacia di ACH-0145228 sulla base della lattato deidrogenasi (LDH) rispetto al basale alla Settimana 12 del trattamento
    • Valutare i marcatori di laboratorio dell’emolisi e altri marcatori pertinenti nei pazienti affetti da emoglobinuria parossistica notturna (EPN)
    •Valutare la sicurezza e la tollerabilità di 12 settimane di trattamento con ACH-0145228 con o senza l’uso di terapia di base con un inibitore di C5 approvato, sulla base di eventi avversi emergenti dal trattamento (TEAE), eventi avversi seri (SAE) ed eventi che portano all’interruzione del farmaco dello studio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female greater than or equal to 18 years of age, female subjects of child-bearing potential

    For newly identified PNH patients must meet one of the following conditions:
    1. PNH patients not currently receiving an approved C5 inhibitor must have:
    - PNH Type III erythrocyte and/or granulocyte clone size ≥10% with adequate reticulocytosis (absolute reticulocyte count ≥100×10⁹/L).
    - Anemia (Hgb <10.5 g/dL).
    - LDH ≥1.5× upper limit of normal (ULN).
    - Platelet count ≥30,000/µL without the need for platelet transfusions.
    - Absolute neutrophil count (ANC) ≥750/ µL.

    2. PNH patients with a sub-optimal response to background therapy with an approved C5 inhibitor must have:
    - Stable background regimen of an approved C5 inhibitor (at least 24 weeks for eculizumab, or at least 2 doses for ravulizumab), without change in dose or interval for at least the past 8 weeks.
    - Anemia (Hgb <10 g/dL).
    - Adequate reticulocytosis (absolute reticulocyte count ≥100×109/L).
    Platelet count ≥30,000/µL without the need for platelet transfusions.
    - Absolute neutrophil count (ANC) ≥750/ µL.
    Maschio o femmina di età pari o superiore a 18 anni, soggetti di sesso femminile in etá fertile.

    I pazienti con EPN recentemente identificati devono soddisfare una delle seguenti condizioni:
    1. I pazienti con EPN che attualmente non assumono un inibitore di C5 approvato devono avere:
    - Dimensione del clone EPN di eritrociti e/o granulociti di tipo III ≥10% con adeguata reticolocitosi (conta assoluta dei reticolociti ≥ 100×109/l)
    - Anemia (Hb < 10,5 g/dl)
    - LDH ≥ 1,5 volte il limite superiore alla norma (ULN)
    - Conta piastrinica ≥ 30.000/μl senza necessità di trasfusioni di piastrine
    - Conta assoluta dei neutrofili (ANC) ≥ 750/ μl

    2. I pazienti con EPN che ricevono la terapia di base devono avere:
    - Regime di base stabile (almeno 24 settimane per eculizumab o almeno 2 dosi per ravulizumab), senza variazioni di dose o intervallo almeno per le 8 settimane precedenti
    - Anemia (Hb < 10 g/dl)
    - Reticolocitosi adeguata (conta assoluta dei reticolociti ≥ 100×109/l)
    - Conta piastrinica ≥ 30.000/μl senza necessità di trasfusioni di piastrine
    - Conta assoluta dei neutrofili (ANC) ≥ 750/ μl
    E.4Principal exclusion criteria
    - Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 and/or are on dialysis.
    - History of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant ([HSCT] unless HSCT engraftment has failed).
    - History of dosing with an investigational agent other than danicopan within 30 days or 5 half-lives of the investigational agent prior to ACH 0145228 administration, whichever is greater.
    - New patients in the monotherapy group with a history of dosing with eculizumab at any dose or interval within the past 75 days before study medication administration or 300 days for ravulizumab.
    - Known or suspected complement deficiency.
    - Contraindication to one or more of the required vaccinations that may be used in the study.
    - History of seizure disorder unless seizure free without the use of antiepileptic medications for the past 5 years prior to screening.
    - Velocità di filtrazione glomerulare stimata (eGFR) < 30 ml/min/1,73 m2 e/o sono in dialisi.
    - Anamnesi di trapianto di organo maggiore (ad es. cuore, polmone, rene, fegato) o trapianto di cellule staminali emopoietiche/midollo osseo (HSCT) (a meno che l’innesto di HSCT non sia andato a buon fine).
    - Anamnesi di somministrazione di un agente sperimentale diverso da danicopan entro 30 giorni o 5 emivite dell’agente sperimentale prima della somministrazione di ACH-0145228, a seconda di quale dei due periodi abbia durata maggiore
    - Nuovi pazienti nel gruppo trattato in monoterapia con un’anamnesi di somministrazione di eculizumab a qualsiasi dose o intervallo negli ultimi 75 giorni prima della somministrazione del farmaco dello studio o 300 giorni per ravulizumab.
    - Deficit di complemento, noto o sospetto.
    - Controindicazioni a una o più delle vaccinazioni che possono essere utilizzate nello studio.
    - Anamnesi di disturbo convulsivo, a meno che non sia libero da crisi convulsive senza l’uso di farmaci antiepilettici negli ultimi 5 anni prima dello screening.
    E.5 End points
    E.5.1Primary end point(s)
    Change in Hgb relative to baseline at Week 12
    Variazione del livello di Hb rispetto al basale alla Settimana 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    at Week 12
    Settimana 12
    E.5.2Secondary end point(s)
    1.Transfusion requirements: Change in transfusion requirements during the treatment compared to 12 weeks of historical transfusion requirements
    2. Lactate dehydrogenase (LDH): Change in LDH relative to baseline at Week 12
    3. Reticulocyte count: Change from baseline in absolute reticulocyte count
    4. Direct Bilirubin: Change from baseline in direct bilirubin
    5. Total Bilirubin: Change from baseline total bilirubin
    6. PNH red blood cell (RBC) clone size: Change from baseline in PNH red blood cell (RBC) clone size
    7. C3 complement protein (C3) fragment deposition on PNH RBCs: Change from baseline in C3 complement protein (C3) fragment deposition on PNH RBCs at week 12
    8. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]: Number of TEAEs recorded
    9. Incidence of Serious Adverse events [Safety and Tolerability]: Number of SAEs recorded
    10. Incidence of adverse events leading to discontinuation [Safety and Tolerability]: Number of events leading to discontinuation of study medication recorded
    1. Requisiti trasfusionali: variazione del fabbisogno trasfusionale durante il trattamento rispetto a 12 settimane di dati storici del fabbisogno trasfusionale
    2. Lattato Deidrogenasi (LDH): Variazione del livello di LDH rispetto al basale alla Settimana 12
    3. Conta reticolocitaria: variazione rispetto al basale della conta assoluta dei reticolociti
    4. Bilirubina diretta: variazione rispetto al basale della bilirubina diretta
    5. Bilirubina totale: variazione rispetto al basale della bilirubina totale
    6. Dimensione del clone EPN dei globuli rossi (RBC): variazione rispetto al basale della dimensione del clone EPN dei globuli rossi (RBC)
    7. Deposizione di frammenti C3 della proteina del complemento (C3) sui globuli rossi EPN: variazione rispetto al basale della deposizione di frammenti C3 della proteina del complemento (C3) sui globuli rossi EPN alla settimana 12
    8. Incidenza di Eventi Avversi Emergenti dal Trattamento [Sicurezza e Tollerabilitá]: numero di TEAEs registrati
    9. Incidenza di Eventi Avversi Seri [Sicurezza e Tollerabilitá]: numero di SAE registrati
    10. Incidenza di Eventi Avversi che portano all’interruzione del farmaco dello studio [Sicurezza e Tollerabilitá]: numero di Eventi Avversi che portano all’interruzione del farmaco dello studio regstrati
    E.5.2.1Timepoint(s) of evaluation of this end point
    at Week 12
    Settimana 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response 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
    Effect on biomarkers
    Effetto sui biomarcatori
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    Italy
    Korea, Republic of
    New Zealand
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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 the study is defined as the date of the last visit of the last patient remaining in the study.
    La data di conclusione della sperimentazione é definita come l'ultima visita dell'ultimo paziente rimasto in studio
    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 months5
    E.8.9.1In the Member State concerned days9
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days9
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 26
    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)
    The Sponsor currently does not intend to provide any treatment or care after the subjects have ended the participation in the trial. However the Sponsor considers to review of the decision before the global end of the trial.
    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 Decision2021-10-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-13
    P. End of Trial
    P.End of Trial StatusOngoing
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