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    Summary
    EudraCT Number:2015-003007-38
    Sponsor's Protocol Code Number:56021927PCR3003
    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:2021-06-17
    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 number2015-003007-38
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ-56021927 in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment with Primary Radiation Therapy
    Uno studio di fase 3 randomizzato, in doppio cieco, controllato con placebo su JNJ-56021927 in soggetti con carcinoma prostatico ad alto rischio, localizzato o localmente avanzato, sottoposti al trattamento con radioterapia primaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Efficacy and Safety Study of JNJ56021927 (ARN509) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS
    Uno studio di efficacia e sicurezza su JNJ56021927 (ARN509) in pazienti con carcinoma prostatico ad alto rischio candidati a radioterapia primaria (ATLAS)
    A.3.2Name or abbreviated title of the trial where available
    ATLAS
    ATLAS
    A.4.1Sponsor's protocol code number56021927PCR3003
    A.5.4Other Identifiers
    Name:.Number:.
    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 SponsorJANSSEN CILAG INTERNATIONAL NV
    B.1.3.4CountryBelgium
    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 supportJanssen-Cilag International NV
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportJanssen- Cilag SPA - Italia
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Broup
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031715242166
    B.5.5Fax number0031715242110
    B.5.6E-mailClinicalTrialEU@its.jnj.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 nameJNJ-56021927
    D.3.2Product code JNJ-56021927-AAA
    D.3.4Pharmaceutical form Film-coated 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.3.9.1CAS number 956104-40-8
    D.3.9.2Current sponsor codeJNJ-56021927
    D.3.9.4EV Substance CodeSUB127215
    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 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 RoleComparator
    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 Yes
    D.2.1.1.1Trade name Bicalutamid-Actavis
    D.2.1.1.2Name of the Marketing Authorisation holderActavis Group PTC ehf.
    D.2.1.2Country which granted the Marketing AuthorisationIceland
    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 nameBicalutamide
    D.3.2Product code .
    D.3.4Pharmaceutical form Film-coated 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 INNBICALUTAMIDE
    D.3.9.1CAS number 90357-06-5
    D.3.9.2Current sponsor code.....
    D.3.9.4EV Substance CodeSUB05817MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboFilm-coated tablet
    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 placeboFilm-coated tablet
    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
    High- or very-high risk, localized or locally advanced prostate cancer
    Cancro alla prostata ad alto o altissimo rischio, localizzato o localmente avanzato
    E.1.1.1Medical condition in easily understood language
    prostate cancer
    cancro alla prostata
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine if Apalutamide plus gonadotropin releasing hormone (GnRH) agonist in subjects with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT) results in an improvement of metastasis-free survival (MFS) evaluated by blinded independent central review (BICR)
    Determinare se Apalutamide, in associazione con un agonista dell'ormone secernente gonadotropina (GnRH) in soggetti con cancro alla prostata ad alto rischio, localizzato o localmente avanzato, candidati alla radioterapia primaria, porta ad un aumento nella sopravvivenza libera da metastasi (MFS) valutata da review indipendente in cieco (BICR)
    E.2.2Secondary objectives of the trial
    - To characterize the safety profile of Apalutamide plus GnRH agonist in subjects with high-risk, localized or locally advanced prostate cancer receiving primary RT
    - To determine if JNJ-56021927 plus GnRH agonist in subjects with highrisk, localized or locally advanced prostate cancer receiving primary RT
    results in an improvement of:
    -- Time to local-regional recurrence
    -- Time to castration-resistant prostate cancer (CRPC)
    -- Time to distant metastasis
    -- Overall survival (OS)
    - Caratterizzare il profilo di sicurezza di Apalutamide in associazione con un agonista del GnRH in pazienti con cancro alla prostata ad alto rischio, localizzato o localmente avanzato, candidati a radioterapia primaria (RT)
    - determinare se Apalutamide in associazione con un agonista di GnRH in pazienti con cancro alla prostata ad alto rischio, localizzato o localmente avanzato, candidati a radioterapia primaria (RT) porta a miglioramento in:
    -- tempo alla ricorrenza loco-regionale
    -- tempo di resistenza alla castrazione del carcinoma prostatico (CRPC)
    -- tempo alla comparsa di una metastasi distante
    -- sopravvivenza globale (overall survival)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >= 18 years
    - Indicated and planned to receive primary radiation therapy for prostate cancer
    - Histologically confirmed adenocarcinoma of an intact prostate, and 1 of the following at diagnosis:
    1) Gleason score >=8 and >=cT2c stage per AJCC 8th Edition,
    2) Gleason score >=7, PSA >=20 nanogram per mililiters (ng/mL), and >=cT2c stage per AJCC 8th Edition
    - Charlson comorbidity index (CCI) <=3
    - An Eastern Cooperative Oncology Group (ECOG) Performance Status(PS) grade of 0 or 1
    - Adequate organ function: aspartate aminotransferase (AST), alanine aminotransferase (ALT), <2 * within limit of normal (ULN).
    - total bilirubin WNL
    - Serum Creatinine <1.5 mg / dL (<133 µmol / L)
    - Platelets> = 140,000 / µL, independent of transfusion and / or growth factors within 3 months before randomization
    - Hemoglobin> = 12.0 g / dL (7.4 mmol), independent of transfusion and / or growth factors within 3 months before randomization
    - Participants who are sexually active (even men with vasectomies) and willing to use a condom and agree not to donate sperm during the trial
    - Signed, written, informed consent
    - Be able to swallow whole study drug tablets
    - età maggiore di 18 anni;
    - candidati a radioterapia primaria per cancro alla prostata;
    - adenocarciroma di una prostata intatta istologicamente confermato, e una delle seguenti diagnosi:
    1) Punteggio Gleason >=8 e >=cT2c stage per AJCC 8th Edition;
    2) Punteggio Gleason >=7, PSA >=20 nanogrammi per millilitro e >=cT2c stage per AJCC 8th Edition;
    - Charlson comorbidity index (CCI) <=3
    - Eastern Cooperative Oncology Group (ECOG) Performance Status(PS) grado 0 o 1;
    - adeguata funzionalità dell’organo determinata dai seguenti valori del laboratorio centrale:
    1) aspartato aminotransferasi (AST), alanina aminotrasferasi (ALT) entro limiti di normalità (WNL)
    - bilirubina totale WNL
    - Creatinina Sierica <1.5 mg/dL (<133 µmol/L)
    - Piastrine >= 140.000/µL, indipendente da trasfusione e/o dai fattori di crescita entro 3 mesi prima della randomizzazione
    - Emoglobina >= 12.0 g/dL (7.4 mmol), indipendente da trasfusione e/o dai fattori di crescita entro 3 mesi prima della randomizzazione.
    - partecipanti sessualmente attivi (anche uomini vasectomizzati) disposti ad utilizzare preservativo e acconsentono a non donare lo sperma durante lo studio;
    - firmare un consenso informato scritto;
    - essere in grado di inghiottire le compresse intere
    E.4Principal exclusion criteria
    - Presence of distal metastases (clinical stage M1). Pelvic nodal disease isolated under the iliac bifurcation (clinical
    stage N1) is not an exclusion. The diagnosis of distal metastases (clinical M stage; M0 versus M1a, M1b, M1c) and
    pelvic nodal disease (clinical N stage; N1 versus N0) will be assessed by central radiological examination. Patients
    are considered eligible only if the central radiological examination confirms the clinical stage M0.
    - Prior treatment with GnRH analogue or antiandrogen or both for >3 months prior to randomization
    - Bilateral orchiectomy
    - History of pelvic radiation
    - Prior systemic (eg, chemotherapy) or local (eg, prostatectomy, cryotherapy) treatment for prostate cancer
    - History of seizure or any other condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness <= 1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
    - Prior treatment with enzalutamide, abiraterone acetate, orteronel, galeterone, ketoconazole, aminoglutethimide, estrogens, megestrol acetate, and progestational agents for prostate cancer (cyproterone acetate included)
    - Prior treatment with radiopharmaceutical agents (eg, strontium 89) or immunotherapy (eg, sipuleucel-T) for prostate cancer
    - Prior treatment with systemic glucocorticoids =4 weeks prior to randomization or is expected to require long-term use of corticosteroids
    during the study
    - Use of 5-alpha reductase inhibitors (eg, dutasteride, finasteride) <=4 weeks prior to randomization
    - Use of any investigational agent <=4 weeks prior to randomization
    - Current chronic use of opioid analgesics for >=3 weeks for oral or >7 days for non-oral formulations
    - Major surgery <=4 weeks prior to randomization
    - Current or prior treatment with antiepileptic medications for the treatment of seizures
    - Gastrointestinal conditions affecting absorption
    - Known or suspected contraindications or hypersensitivity to Apalutamide, bicalutamide or GnRH agonists or any of the components of
    the formulations
    - Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject
    - Presenza di metastasi distali (clinical stage M1). La malattia nodale pelvica isolata sotto la biforcazione iliaca (clinical stage N1) non è un’esclusione. La diagnosi di metastasi distali (clinical M stage; M0 versus M1a, M1b, M1c) e la malattia nodale pelvica (clinical N stage; N1 versus N0) sarà valutata mediante esame radiologico centrale. I pazienti sono considerati eleggibili solo se l’esame radiologico centrale conferma il clinical stage M0.
    - trattamento precedente con analoghi del GnRH o antiandrogeni o entrambi per un tempo superiore a 3 mesi prima della randomizzazione;
    - orchiectomia bilaterale;
    - storia di terapia con radiazioni alle pelvi;
    - precedenti trattamenti sistemici (chemioterapia) o locali(prostatectomia radicale, crioterapia) per il trattamento del cancro alla prostata;
    - storia di convulsioni o qualsiasi condizioni che potrebbero predisporre a convulsioni (incluso ma non limitato a: ictus, attacchi ischemici transitori o perdita di coscienza nell'ultimo anno prima della randomizzazione); malformazioni cerebrali aterovenose, masse intracraniche come schwannomi e meningiomi che causino edema o compressione;
    - trattamenti precedenti con enzalutamide, abiraterone acetato, orteronel, galeterone, chetoconazolo, aminoglutetimide, estrogeni, megestrol acetato, agenti progestinici (incluso il ciproterone acetato) per cancro alla prostata;
    - trattamenti precedenti con radiofarmaci (es: stronzio 89) o immunoterapia (es: sipuleucel-T) per il cancro alla prostata;
    - trattamenti precedenti con glucocorticoidi sistemici, entro 4 settimane dalla randomizzazione o ci si aspetta un uso a lungo termine di corticosteroidi durante lo studio;
    - uso di inibitori della 5-alfa-reduttasi (es: dutasteride e finasteride) entro 4 settimane prima della randomizzazione);
    - uso di altri farmaci sperimentali entro 4 settimane prima della randomizzazione;
    - uso cronico o attuale di analgesici oppioidi per un periodo maggiore uguale a 3 settimane per via orale o maggiore a 7 giorni per formulazioni non orali;
    - chirurgia maggiore entro 4 settimane dalla randomizzazione;
    trattamenti correnti o precedenti con farmaci antiepilettici per il trattamento delle convulsioni;
    condizioni gastrointestinali agenti sull'assorbimento;
    -controindicazioni o ipersensibilità conosciute o sospettate al prodotto Apalutamide, alla bicalutamide, o agli agonisti GnRH o qualsiasi componente delle formulazioni;
    - qualsiasi condizione per cui, secondo l'opinione del medico, la partecipazione allo studio non sarebbe nell'interesse del paziente
    E.5 End points
    E.5.1Primary end point(s)
    Metastasis-free survival
    sopravvivenza libera da metastasi
    E.5.1.1Timepoint(s) of evaluation of this end point
    72 months
    72 mesi
    E.5.2Secondary end point(s)
    - Time to Local-regional Recurrence
    - Time to Castration-resistant Prostate Cancer (CRPC)
    - Time to Distant Metastasis
    - overall survival (OS)
    - tempo alla ricorrenza loco-regionale
    - tempo di resistenza alla castrazione del carcinoma prostatico (CRPC)
    - tempo alla comparsa di una metastasi distante
    - sopravvivenza globale (OS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 72 months
    - 72 months
    - 72 months
    - 72 months
    - 72 mesi
    - 72 mesi
    - 72 mesi
    - 72 mesi
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA375
    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
    Brazil
    Canada
    China
    Israel
    Korea, Republic of
    Malaysia
    Mexico
    Russian Federation
    Taiwan
    Turkey
    United States
    Belgium
    Bulgaria
    France
    Germany
    Italy
    Netherlands
    Poland
    Romania
    Spain
    Sweden
    United Kingdom
    Czechia
    Argentina
    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 years9
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years9
    E.8.9.2In all countries concerned by the trial months6
    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: 900
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 600
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 820
    F.4.2.2In the whole clinical trial 1500
    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)
    not different from the expected normal treatment of that condition
    lo stesso trattamento previsto per questa condizione clinica
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-20
    P. End of Trial
    P.End of Trial StatusOngoing
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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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