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    Summary
    EudraCT Number:2019-004469-41
    Sponsor's Protocol Code Number:PN-943-03
    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:2021-06-15
    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 number2019-004469-41
    A.3Full title of the trial
    A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects with Moderate to Severe Active Ulcerative Colitis
    Studio di Fase 2, randomizzato, in doppio cieco, controllato verso placebo, a gruppi paralleli, multicentrico per valutare la sicurezza e l’efficacia di PN-943 orale in soggetti con colite ulcerosa attiva da moderata a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to investigate the safety and efficacy of PN-943 in patients with
    moderate or severe Ulcerative Colitis (a long-term condition where the
    colon and rectum become inflamed)
    Uno studio per indagare la sicurezza e l'efficacia di PN-943 in pazienti con Colite ulcerosa moderata o grave (una condizione a lungo termine in cui il colon e il retto si infiammano)
    A.3.2Name or abbreviated title of the trial where available
    PN-943-03
    PN-943-03
    A.4.1Sponsor's protocol code numberPN-943-03
    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 SponsorProtagonist Therapeutics, 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 supportProtagonist Therapeutics, Inc
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationProtagonist Therapeutics, Inc.
    B.5.2Functional name of contact pointClinical-Regulatory Info Group
    B.5.3 Address:
    B.5.3.1Street Address7707, Gateway Blvd, ste 140
    B.5.3.2Town/ cityNewark
    B.5.3.3Post codeCA 94560-1160
    B.5.3.4CountryUnited States
    B.5.4Telephone number0015104740170
    B.5.5Fax number0015103283232
    B.5.6E-mailclinregpn943@ptgx-inc.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 namePN-943
    D.3.2Product code [PN-943]
    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 INNACETATO DI AMMONIO
    D.3.9.2Current sponsor codePN-943
    D.3.9.3Other descriptive namePN-943
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number150
    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 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 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 namePN-943
    D.3.2Product code [PN-943]
    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 INNACETATO DI AMMONIO
    D.3.9.2Current sponsor codePN-943
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number300
    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 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 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
    D.8 Placebo: 2
    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
    Ulcerative colitis (US) is a chronic relapsing inflammatory bowel disease of the large intestine characterized by bloody diarrhoea, abdominal cramps and fatigue. UC is characterized by inflammation and ulceration of mainly the mucosal and occasionally submucosal intestinal layers.
    La colite ulcerosa (US) è ¿¿una malattia infiammatoria cronica recidivante dell'intestino crasso caratterizzata da diarrea sanguinolenta, crampi addominali e affaticamento. L'UC è caratterizzata da infiammazione e ulcerazione principalmente degli strati intestinali della mucosa e occasionalmente sottomucosi.
    E.1.1.1Medical condition in easily understood language
    English Ulcerative colitis is a long-term condition where the large intestine
    (colon) and rectum become inflamed. Small ulcers can develop on the
    colon's lining, and can bleed and produce pus.
    La colite ulcerosa è una condizione a lungo termine in cui l'intestino crasso,colon e retto si infiammano.Piccole ulcere possono svilupparsi sul rivestimento del colon e può sanguinare e produrre pus.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate safety, tolerability and efficacy of PN-943 treatment in subjects with moderate to severe active ulcerative colitis compared to placebo.
    valutare la sicurezza, la tollerabilità e l’efficacia del trattamento con PN-943 in soggetti con colite ulcerosa attiva da moderata a grave rispetto al placebo.
    E.2.2Secondary objectives of the trial
    Evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and biomarker responses to PN-943 in subjects with moderate to severe active ulcerative colitis.
    valutare la farmacocinetica (PK), la farmacodinamica (PD) e la risposta dei biomarcatori a PN-943 in soggetti con colite ulcerosa attiva da moderata a grave.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part 1 Inclusion Criteria:
    1. Male and female subjects age 18 (or the minimum country specific age of consent if >18) to 75 years.
    2. Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
    3. Diagnosis of UC for = 8 weeks prior to screening supported by appropriate documentation of biopsy results consistent with UC, in the opinion of the investigator; if UC has been present for > 10 years, a total colonoscopy with biopsy must have been performed within 2 years of screening to rule out dysplasia. Subjects must be up-to-date on colorectal cancer surveillance per local standards and guidelines. The colorectal cancer screening may be performed during screening colonoscopy.
    4. Moderate to severe active UC with an Adapted Mayo Score of 5 to 9, rectal bleeding subscore (RBS) =1, stool frequency subscore (SFS) =1, and endoscopic subscore (ESS) =2 at baseline (pre-randomization) as determined by blinded central read. ESS of =2 must be observed at =15 cm from the anal verge.
    5. Demonstrated inadequate response, loss of response, or intolerance of at least 1 of the following treatments including oral corticosteroids, immunomodulators, IL-12/23 antagonists, and/or TNFa antagonists as defined in the protocol at inclusion criterias section
    6. A female participant must be:
    a) Not of childbearing potential OR
    b) Of childbearing potential and practicing a highly effective method of contraception (failure rate of <1% when used consistently and correctly) and agrees to remain on a highly effective method while receiving study medication and until 30 days after receiving the last dose of study medication. (Appendix 6).
    7. A female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 30 days after receiving the last dose of study medication.
    8. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Day 1 prior to the first dose of study medication.
    9. Men with partners of child bearing potential must agree to use a highly effective method of contraception (failure rate of <1% when used consistently and correctly) and agree to remain on a highly effective method while receiving study medication and until 90 days after receiving last dose of study medication (Appendix 6).
    10. A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose.
    11. Subject is eligible according to the tuberculosis (TB) screening criteria as stated in the protocol (Appendix 3).
    For Inclusion criteria of Part 2, please refer to Study protocol.
    Criteri di inclusione Parte 1:
    1. Soggetti di sesso maschile e femminile di età compresa tra 18 (o l’età minima specifica per il paese per dare il consenso se > 18 anni) e 75 anni.
    2. Il soggetto comprende le procedure dello studio e acconsente a partecipare allo studio dando il proprio consenso informato scritto.
    3. Diagnosi di CU per =8 settimane prima dello screening supportata da documentazione appropriata di risultati bioptici compatibili con CU, secondo l’opinione dello sperimentatore; se la CU è presente da >10 anni, una colonscopia totale con biopsia deve essere stata effettuata entro 2 anni dallo screening per escludere displasia. I soggetti devono essere in regola con gli standard e le linee guida locali in merito alla prevenzione del tumore del colon-retto. Lo screening per il tumore del colon-retto può essere eseguito durante la colonscopia di screening.
    4. CU da moderata a grave con punteggio Mayo adattato da 5 a 9, parametro del sanguinamento rettale (RBS) =1, parametro di frequenza dell’evacuazione (SFS) =1 e parametro endoscopico (ESS) =2 al basale (prima della randomizzazione), come determinato mediante una lettura centralizzata in cieco. ESS =2 deve essere osservato a =15 cm dal margine anale.
    5. Risposta inadeguata comprovata, perdita della risposta o intolleranza ad almeno 1 dei seguenti trattamenti, compresi corticosteroidi, farmaci immunomodulanti, anti-IL-12/23 e/o anti-TNFa come definiti nel protocollo nella sezione dei criteri di inclusione.
    6. Le partecipanti di sesso femminile devono essere:
    a) Non in età fertile OPPURE
    b) In età fertile e adottare un metodo contraccettivo altamente efficace (tasso di fallimento <1% quando usato in modo costante e corretto) e accettare di continuare a usare un metodo contraccettivo altamente efficace mentre ricevono il farmaco dello studio e fino a 30 giorni dopo aver ricevuto l’ultima dose di farmaco dello studio. (Appendice 6).
    7. Le partecipanti di sesso femminile devono accettare di non donare ovuli (cellule uovo, ovociti) a scopo di riproduzione assistita durante lo studio e per un periodo di 30 giorni dopo aver ricevuto l’ultima dose di farmaco dello studio.
    8. Le donne in età fertile devono avere un test di gravidanza sierico negativo allo screening e un test di gravidanza urinario negativo al Giorno 1 prima della prima dose di farmaco dello studio.
    9. I soggetti di sesso maschile con partner in età fertile devono accettare di usare un metodo contraccettivo altamente efficace (tasso di fallimento <1% quando usato in modo costante e corretto) e accettare di continuare a usare un metodo contraccettivo altamente efficace mentre ricevono il farmaco dello studio e fino a 90 giorni dopo aver ricevuto l’ultima dose di farmaco dello studio (Appendice 6).
    10. I partecipanti di sesso maschile devono accettare di non donare sperma a scopo di riproduzione durante lo studio e per un periodo di 90 giorni dopo aver ricevuto l’ultima dose.
    11. Il soggetto è idoneo secondo i criteri di screening della tubercolosi (TB) specificati nel protocollo (Appendice 3).
    Per i criteri di inclusione relativi alla PArte 2 si prega di fare riferimento al protocollo di studio.
    E.4Principal exclusion criteria
    For exclusion criteria related to Part 1 and 2 of study protocol please refer to the study protocol, as the text space in the Appendix is not sufficient.
    Per i Criteri di esclusione relativi alla Parte 1 e 2 si prega di fare riferimento al protocollo di studio poichè lo spazio di testo in appendice risulta insufficiente.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy
    Proportion of subjects achieving clinical remission at Week 12 compared to placebo.
    Efficacia
    Percentuale di soggetti che raggiungono la remissione clinica alla settimana 12 rispetto al placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 settimane
    E.5.2Secondary end point(s)
    • Comparison of PN-943 high dose and low dose individually to placebo:
    a) Proportion of subjects with endoscopic improvement at Week 12
    b) Proportion of subjects achieving endoscopic remission at Week 12
    c) Proportion of subjects with histological improvement at Week 12
    d) Proportion of subjects achieving histological remission at Week 12

    • Proportion of subjects achieving clinical remission at Week 52. Clinical remission is determined using the Adapted Mayo score (sum of 3 subscores from the Mayo score):
    - Stool frequency subscore (SFS)
    - Rectal bleeding subscore (RBS)
    - Endoscopic subscore (ESS)
    Confronto tra PN-943 ad alta dose e dose bassa individualmente al placebo:
    a) Percentuale di soggetti con miglioramento endoscopico alla settimana 12
    b)Percentuale di soggetti che hanno raggiunto remissione endoscopica alla settimana 12
    c)Percentuale di soggetti con miglioramento istologico alla settimana 12
    d)Percentuale di soggetti che hanno raggiunto remissione istologicaalla settimana 12

    Proporzione di soggetti che raggiungono la remissione clinica alla settimana 52. La remissione clinica è stabilita usando il Punteggio adattato Mayo (somma di 3 sottopunteggi dal punteggio Mayo):
    -Sottopunteggio di frequenza di defecazione (SFS)
    -Sottopunteggio del sanguinamento rettale (RBS)
    -Sottopunteggio endoscopico (ESS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 12 and 52
    setimana 12 e 52
    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 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 trial3
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA52
    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
    Canada
    Georgia
    Korea, Republic of
    Russian Federation
    Serbia
    Ukraine
    United States
    Austria
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 135
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 150
    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)
    nessuno
    nessuno
    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 Decision2020-07-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-02
    P. End of Trial
    P.End of Trial StatusOngoing
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