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    Summary
    EudraCT Number:2019-002933-12
    Sponsor's Protocol Code Number:DRM06-AD05
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-10-21
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-002933-12
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS
    Studio randomizzato, in doppio cieco, controllato con placebo per valutare l'efficacia e la sicurezza di lebrikizumab in soggetti con dermatite atopica da moderata a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS
    Studio randomizzato, in doppio cieco, controllato con placebo per valutare l'efficacia e la sicurezza di lebrikizumab in soggetti con dermatite atopica da moderata a grave
    A.3.2Name or abbreviated title of the trial where available
    ADvocate2
    ADvocate2
    A.4.1Sponsor's protocol code numberDRM06-AD05
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04178967
    A.5.4Other Identifiers
    Name:119866Number:J2T-DM-KGAC - Eli Lilly and Company - trial alias
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/151/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDermira, 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 supportDermira, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDermira, Inc.
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post codeIN 46285
    B.5.3.4CountryUnited States
    B.5.4Telephone number0031203018500
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 nameLebrikizumab
    D.3.2Product code [DRM06]
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNLebrikizumab
    D.3.9.1CAS number 953400-68-5
    D.3.9.2Current sponsor codeDRM06
    D.3.9.4EV Substance CodeSUB177213
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Atopic dermatitis
    Dermatite atopica
    E.1.1.1Medical condition in easily understood language
    Atopic dermatitis (AD) or eczema is a common inflammatory skin disease characterized by dry skin, red and crusting rash and intense pruritus (itch) that may affect people of all ages
    La dermatite atopica o eczema è una malattia infiammatoria comune della pelle caratterizzata da pelle secca, arrossata,con irritazione crostosa ed inteso prurito che può colpire soggetti di ogni età
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10003639
    E.1.2Term Atopic dermatitis
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the safety and efficacy of lebrikizumab compared with placebo in patients with moderate-to severe atopic dermatitis
    L'obiettivo principale dello studio è valutare la sicurezza e l'efficacia di lebrikizumab rispetto al placebo in pazienti con dermatite atopica da moderata a grave
    E.2.2Secondary objectives of the trial
    Not applicable
    Non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for >=1 year before the
    screening visit.
    - Eczema Area and Severity Index (EASI) score >=16 at the baseline visit.
    - Investigator Global Assessment (IGA) score >=3 (scale of 0 to 4) at the baseline visit.
    - >=10% body surface area (BSA) of AD involvement at the baseline visit.
    - History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
    - For women of childbearing potential: agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive during the treatment period and for at least 18 weeks after the last dose of lebrikizumab or placebo.
    -Male patients must agree to use an effective barrier method of contraception during the study and for a minimum of 18 weeks following the last dose of study drug if sexually active with a female of child bearing potential
    - Provide signed informed consent/assent.
    Please see Protocol Section 4.1 for the full list of inclusion criteria.
    - Dermatite Atopica (AD) cronica (secondo i criteri dell'America Academy of Dermatology Consensus) presente da almeno 1 anno prima della visita di screening.
    - Punteggio Eczema Area and Severity Index (EASI) >=16 alla visita basale.
    - Punteggio Investigator Global Assessment (IGA) >=3 (scala da 0 a 4) alla visita basale.
    - >=10% della superfice corporea coinvolta da AD alla visita basale.
    - Anamnesi di inadeguata risposta al trattamento con farmaci topici o in alternativa decisione che i trattamenti topici sono medicalmente sconsigliati
    - Per donne in grado di procreare: essere d'accordo all'astinenza (astenersi dai rapporti eterosessuali) o utilizzare un metodo contraccettivo altamente efficace durante il periodo di trattamento e per almeno 18 settimane dopo l'ultima dose di lebrikizumab o placebo.
    - I pazienti devono acconsentire a utilizzare un metodo barriera di contraccezione efficace durante lo studio e per almeno 18 settimane dopo l'ultima dose del farmaco dello studio, se sessualmente attivi con una donna in età fertile
    - firma del consenso/assenso.
    Per la lista completa dei criteri d'inclusione far riferimento alla sezione 4.1 del Protocollo
    E.4Principal exclusion criteria
    - Participation in a prior lebrikizumab clinical study.
    - History of anaphylaxis as defined by the Sampson criteria.
    - Treatment with topical corticosteroids, calcineurin inhibitors or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to the baseline visit.
    - Prior treatment with dupilumab or tralokinumab.
    - Treatment with any of the following agents within 4 weeks prior to the baseline visit:
    a. Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-gamma, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
    b. Phototherapy and photochemotherapy (PUVA) for AD.
    - Treatment with the following prior to the baseline visit:
    a. An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
    b. B Cell-depleting biologics, including to rituximab, within 6 months.
    c. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.
    - Use of prescription moisturizers within 7 days of the baseline visit.
    - Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit.
    - Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
    - Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma (defined by an ACQ-5 score >=1.5 or a history of >= 2 asthma exacerbations within the last 12 months requiring systemic [oral and/or parenteral] corticosteroid treatment or hospitalization for > 24 hours).
    - Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
    Please see Protocol Section 4.2 for the full list of exclusion criteria.
    - Partecipazione ad uno studio clinico precedente con lebrikizumab
    - Anamnesi di anafilassi come definito dai criteri Sampson
    - Trattamento con corticosteroidi topici, inibitori della calcineurina o inibitori della fosfodiesterasi-4, come il crisaborolo, nella settimana precedente alla visita basale.
    - Trattamento precedente con dupilumab o tralokinumab.
    - Trattamento con uno dei seguenti agenti nelle 4 settimane antecedenti la visita basale:
    a. Farmaci Immunosoppressivi/immunomodulanti (i.e., corticosteroidi sistemici, ciclosporine, micofenolato-mofetil, IFN-gamma, inibitori della Janus kinasi, azatioprine, metotrexato, etc.)
    b. Fototerapia e fotochemioterapia (PUVA) per AD.
    - Trattamento con i seguenti prima della visita basale:
    a. un farmaco sperimentale entro 8 settimane o entro 5 emi-vite (se noto), a seconda del tempo più lungo.
    b. biologici per la deplezione delle cellule B, incluso rituximab, negli ultimi 6 mesi.
    c. Altri farmaci biologici entro 5 emi-vite (se noto) o 16 settimane, or 16 weeks, a seconda del tempo più lungo.
    - Utilizzo di creme idratanti da prescrizione entro 7 giorni dalla visita basale.
    - Uso regolare (più di 2 sedute alla settimana) di cabine abbronzanti entro le 4 settimane antecedenti la visita di screening.
    - Trattamento con un vaccino vivo (attenuato) entro 12 settimane dalla visita basale o pianificato durante lo studio.
    - Malattia cronica non controllata che potrebbe richiedere utilizzo inaspettato di corticosteroidi orali, i.e., asma grave non controllata in co-morbidità (definita da un punteggio ACQ-5 >=1.5 o anamnesi di >= 2 esacerbazioni asmatiche negli ultimi 12 mesi che hanno richiesto trattamento corticosteroide sistemico (orale o parenterale) o l'ospedalizzazione per > 24 ore).
    - Donne in gravidanza o in allattamento o donne che pianificano una gravidanza o di allattare durante lo studio.
    La lista completa dei criteri di esclusione è disponibile nella sezione 4.2 del protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    - Percentage of patients achieving EASI-75 (=75% reduction from Baseline in EASI score) at Week 16.
    - Percentage of patients with an IGA score of 0 or 1 and a reduction =2 points from baseline to Week 16.
    - Percentuale di pazienti con un punteggio IGA di 0 o 1 e una riduzione =2 punti dal basale alla settimana 16.
    - Percentuale di pazienti che raggiungono EASI-75 (riduzione =75% del punteggio EASI dal basale) alla settimana 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    at Week 16
    Settimana 16
    E.5.2Secondary end point(s)
    - Percentage of patients achieving EASI-90 (=90% reduction from Baseline in EASI score) at Week 16
    - Percentage change in Pruritus Numerical Rating Scale (NRS) score from Baseline to Week 16
    - Percentage of patients with a Pruritus NRS of =5-points at Baseline who achieve a =4-point reduction from Baseline to Week 16
    - Percentage of patients with a Pruritus NRS of =4-points at Baseline who achieve a =4-point reduction from Baseline to Week 16
    - Percentage change in EASI score from Baseline to Week 16
    - Percentage of patients achieving EASI-90 at Week 4
    - Change from baseline in DLQI at Week 16
    - Percentage of patients achieving =4-point improvement in DLQI from baseline to Week 16
    - Percentage change in Sleep-loss score from Baseline to Week 16
    - Change from Baseline in Sleep-loss score at Week 16
    - Percentage of patients with a Pruritus NRS of =5-points at Baseline who achieve a =4-point reduction from Baseline to Weeks 1, 2 and 4
    - Percentage of patients with a Pruritus NRS of =4-points at Baseline who achieve a =4-point reduction from Baseline to Weeks 1, 2 and 4; Specific for Maintenance Period:
    - Percentage of patients from those re-randomized having achieved
    EASI-75 at Week 16 who continue to exhibit EASI-75 at Week 52 (EASI-
    75 calculated relative to baseline EASI score)
    - Percentage of patients from those re-randomized having achieved IGA
    0 or 1 and a =2-point improvement from Baseline at Week 16 who
    continue to exhibit an IGA 0 or 1 and a =2-point improvement from
    Baseline at Week 52
    - Percentage of patients from those with a Pruritus NRS of =4-points at
    baseline re-randomized having achieved =4-point reduction from
    baseline at Week 16 who continue to exhibit =4-point reduction from
    baseline at Week 52
    - Percentage of patients from those with a Pruritus NRS of =5-points at
    baseline re-randomized having achieved =4-point reduction from
    baseline at Week 16 who continue to exhibit =4-point reduction from
    baseline at Week 52
    - Percentage change in SCORAD (having achieved EASI-75 at Week 16)
    from baseline at Week 52
    - Evaluate the pharmacokinetics of lebrikizumab
    • Average serum lebrikizumab concentration
    • Percentuale di pazienti che raggiungono EASI-90 (riduzione =90% del punteggio EASI dal basale) alla settimana 16
    • Variazione percentuale del punteggio della scala numerica di classificazione (NRS) del prurito dal basale alla settimana 16
    • Percentuale di pazienti con NRS del prurito =5 punti al basale, che ottengono una riduzione =4 punti dal basale alla settimana 16
    • Percentuale di pazienti con NRS del prurito =4 punti al basale, che ottengono una riduzione =4 punti dal basale alla settimana 16
    • Variazione percentuale del punteggio EASI dal basale alla settimana 16
    • Percentuale di pazienti che raggiungono EASI-90 alla settimana 4
    • Variazione del DLQI dal basale alla settimana 16
    • Percentuale di pazienti che ottengono un miglioramento del DLQI =4 punti dal basale alla settimana 16
    • Variazione percentuale del punteggio della perdita di sonno dal basale alla settimana 16
    • Variazione del punteggio della perdita di sonno dal basale alla settimana 16
    • Percentuale di pazienti con NRS del prurito =5 punti al basale, che ottengono una riduzione =4 punti dal basale alle settimane 1, 2 e 4
    • Percentuale di pazienti con NRS del prurito =4 punti al basale, che ottengono una riduzione =4 punti dal basale alle settimane 1, 2 e 4; Specifici per il periodo di mantenimento:
    • Percentuale di pazienti, tra quelli ri randomizzati dopo aver raggiunto EASI 75 alla settimana 16, che continuano a presentare EASI-75 alla settimana 52 (EASI-75 calcolato rispetto al punteggio EASI basale)
    • Percentuale di pazienti, tra quelli ri-randomizzati dopo aver ottenuto un IGA 0 o 1 e un miglioramento =2 punti dal basale alla settimana 16, che continuano a presentare un IGA 0 o 1 e un miglioramento =2 punti dal basale alla settimana 52
    • Percentuale di pazienti, tra quelli con NRS del prurito =4 punti al basale ri-randomizzati dopo aver ottenuto una riduzione =4 punti dal basale alla settimana 16, che continuano a presentare una riduzione =4 punti dal basale alla settimana 52
    • Percentuale di pazienti, tra quelli con NRS del prurito =5 punti al basale ri-randomizzati dopo aver ottenuto una riduzione =4 punti dal basale alla settimana 16, che continuano a presentare una riduzione =4 punti dal basale alla settimana 52
    • Variazione percentuale del punteggio SCORAD (dopo aver raggiunto EASI-75 alla settimana 16) dal basale alla settimana 52
    - Valutare la farmacocinetica di lebrikizumab.
    • Concentrazione sierica media di lebrikizumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    At predetermined time points as listed in the protocol; At predetermined time points as listed in the protocol.
    Ai tempi stabiliti come da protocollo; Ai tempi stabiliti come da protocollo
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    QOL, Immunogenicity
    Qualitù della vita, Immunogenicità
    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) No
    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 Yes
    E.8.1.7.1Other trial design description
    Periodo d'induzione, Periodo di mantenimento
    Induction Period, Maintenance Period
    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 trial6
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    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
    Bulgaria
    Canada
    Germany
    Italy
    Mexico
    Romania
    Singapore
    Taiwan
    Ukraine
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days8
    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) 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: 50
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 330
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 204
    F.4.2.2In the whole clinical trial 400
    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)
    Patients completing this 52-week study will be offered treatment in an open-label separate long-term extension study (DRM06-AD07).
    Ai pazienti che hanno completato questio studio di 52 settimane sarà proposto il trattamento in uno studio separato in aperto di estensione a lungo termine (DRM06-AD07).
    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 Decision2020-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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