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    Clinical Trial Results:
    A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis

    Summary
    EudraCT number
    2013-002778-38
    Trial protocol
    IT   ES   GB   CZ   FI   DK   BE   AT   IE   EE  
    Global end of trial date
    28 Oct 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    04 Dec 2016
    First version publication date
    04 Dec 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CL2-78989-012
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    U1111-1144-7133
    Sponsors
    Sponsor organisation name
    Laboratorios Servier SL
    Sponsor organisation address
    Avd de los Madronos 33, Madrid, Spain, 28043
    Public contact
    Loreto TABOADA, Laboratorios Servier SL, 0034 917489630178, loreto.taboada@es.netgrs.com
    Scientific contact
    Loreto TABOADA, Laboratorios Servier SL, 0034 917489630178, loreto.taboada@es.netgrs.com
    Sponsor organisation name
    Institut de Recherches Internationales Servier
    Sponsor organisation address
    50, rue Carnot, Suresnes, France, 92284
    Public contact
    Clinical Studies Department , Institut de Recherches Internationales Servier , 0033 1 55 72 43 66, clinicaltrials@servier.com
    Scientific contact
    Clinical Studies Department , Institut de Recherches Internationales Servier , 0033 1 55 72 43 66, clinicaltrials@servier.com
    Sponsor organisation name
    Servier Research and Development Ltd
    Sponsor organisation address
    Rowley, Wexham Springs, Framewood Road, Wexham, United Kingdom, Slough SL3 6PJ
    Public contact
    helen.whitrow@servier.com, Servier Research and Development Ltd, +44 1753 662 281,
    Scientific contact
    helen.whitrow@servier.com, Servier Research and Development Ltd, +44 1753 662 281,
    Sponsor organisation name
    Servier Canada Inc.
    Sponsor organisation address
    235, Armand Frappier Blvd, Laval, Quebec, Canada, H7V 4A7
    Public contact
    tat-luan.tran@servier.com, Servier Canada Inc., +1 450 978 9700,
    Scientific contact
    tat-luan.tran@servier.com, Servier Canada Inc., +1 450 978 9700,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Oct 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Oct 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Oct 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The objective of this study is to evaluate the efficacy and safety of gevokizumab on symptoms of giant cell arteritis (GCA) in relapsing patients receiving systemic oral corticosteroids (CS)
    Protection of trial subjects
    This study was conducted in accordance with Good Clinical Practice standards, ethical principles stated in the Declaration of Helsinki and applicable regulatory requirements. After the subject has ended his/her participation in the trial, the investigator provided appropriate medication and/or arranged access to appropriate care for the patient.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    22 Aug 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Switzerland: 1
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Czech Republic: 1
    Country: Number of subjects enrolled
    Denmark: 1
    Country: Number of subjects enrolled
    Ireland: 1
    Country: Number of subjects enrolled
    Norway: 3
    Country: Number of subjects enrolled
    Russian Federation: 5
    Worldwide total number of subjects
    13
    EEA total number of subjects
    7
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    2
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Patients were male or female of age  50 years, with GCA according to modified American College of Rheumatology criteria, with symptoms of relapse restricted to PolyMyalgia Rheumatica -like or systemic symptoms associated with elevated Erythrocyte Sedimentation Rate and/or C Reactive Protein and receiving oral CS (range: 5 - 30 mg/day).

    Period 1
    Period 1 title
    Double-blind treatment period (W0-W24)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Gevokizumab 60mg
    Arm description
    Gevokizumab 60mg [W0-W24]
    Arm type
    Experimental

    Investigational medicinal product name
    Gevokizumab
    Investigational medicinal product code
    S78989
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    One subcutaneous administration of Gevokizumab every 4 weeks (i.e. Q4W) until W20, with a supplementary injection at W002, for a total of 7 doses in the first period of the study.

    Arm title
    Placebo
    Arm description
    Placebo [W0-W24]
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    One subcutaneous administration of Placebo every 4 weeks (i.e. Q4W) until W20, with a supplementary injection at W002, for a total of 7 doses in the first period of the study.

    Number of subjects in period 1
    Gevokizumab 60mg Placebo
    Started
    6
    7
    Completed
    2
    5
    Not completed
    4
    2
         Adverse event, non-fatal
    1
    -
         Study discontinuation
    2
    2
         Protocol deviation
    1
    -
    Period 2
    Period 2 title
    Open label period (W24-W52)
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Gevokizumab 60mg
    Arm description
    Gevokizumab 60mg (W24-W52)
    Arm type
    Experimental

    Investigational medicinal product name
    Gevokizumab
    Investigational medicinal product code
    S78989
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    One subcutaneous injection of Gevokizumab 60 mg at each visit (except W052) for a maximum of 7 administrations.

    Number of subjects in period 2
    Gevokizumab 60mg
    Started
    7
    Completed
    1
    Not completed
    6
         Adverse event, non-fatal
    1
         Study discontinuation
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Gevokizumab 60mg
    Reporting group description
    Gevokizumab 60mg [W0-W24]

    Reporting group title
    Placebo
    Reporting group description
    Placebo [W0-W24]

    Reporting group values
    Gevokizumab 60mg Placebo Total
    Number of subjects
    6 7 13
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    1 1 2
        From 65-84 years
    5 6 11
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    71.7 ± 6.7 71.6 ± 5.8 -
    Gender categorical
    Units: Subjects
        Female
    6 4 10
        Male
    0 3 3

    End points

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    End points reporting groups
    Reporting group title
    Gevokizumab 60mg
    Reporting group description
    Gevokizumab 60mg [W0-W24]

    Reporting group title
    Placebo
    Reporting group description
    Placebo [W0-W24]
    Reporting group title
    Gevokizumab 60mg
    Reporting group description
    Gevokizumab 60mg (W24-W52)

    Primary: Response on a composite endpoint

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    End point title
    Response on a composite endpoint [1]
    End point description
    Response to treatment at the W004 visit: - Normalisation or ≥ 70% decrease in ESR and/or CRP, and - ≥70% improvement in PMR-like/systemic symptoms according to the PaGA using a VAS, and - ≥70% improvement in morning stiffness duration and intensity (VAS), and - No appearance of other GCA features, and - No CS dose increase.
    End point type
    Primary
    End point timeframe
    Response at W4
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only a descriptive analysis of the primary endpoint was specified (proportion of responders) in view of the small sample size (premature discontinuation of study).
    End point values
    Gevokizumab 60mg Placebo
    Number of subjects analysed
    5
    7
    Units: Number of responders
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Over the double-blind treatment period (W0 - W24): all adverse events occurred, worsened or became serious between the first IMP intake date (included) during the double-blind treatment and the first IMP intake date during open-label period (excluded).
    Adverse event reporting additional description
    Over the open-label period: All adverse events occurring after W24 (included)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Gevokizumab 60mg [W0-W24]
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Reporting group title
    Gevokizumab 60mg [W24-W52]
    Reporting group description
    -

    Serious adverse events
    Gevokizumab 60mg [W0-W24] Placebo Gevokizumab 60mg [W24-W52]
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    2 / 7 (28.57%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Cardiac disorders
    Cardiac failure congestive
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Radiotherapy to brain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Insulin-requiring type 2 diabetes mellitus
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Gevokizumab 60mg [W0-W24] Placebo Gevokizumab 60mg [W24-W52]
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 6 (83.33%)
    6 / 7 (85.71%)
    5 / 7 (71.43%)
    Vascular disorders
    Temporal arteritis
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 7 (28.57%)
    2 / 7 (28.57%)
         occurrences all number
    1
    2
    2
    Hypertension
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Hypotension
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    0
    Reproductive system and breast disorders
    Endometrial hyperplasia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Dysphonia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Dyspnoea paroxysmal nocturnal
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    0
    2
    0
    Investigations
    Blood pressure systolic increased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    0
    2
    0
    Platelet count decreased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Blood creatinine increased
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Weight decreased
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Eye symptom
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Headache
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Trigeminal neuralgia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    1
    0
    1
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Dyspepsia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Inguinal hernia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Gastroduodenitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 7 (28.57%)
    0 / 7 (0.00%)
         occurrences all number
    0
    2
    0
    Leukocyturia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Muscular weakness
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Myalgia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Neck pain
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Bacteriuria
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
         occurrences all number
    1
    1
    1
    Asymptomatic bacteriuria
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Streptococcal urinary tract infection
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Dec 2013
    Applicable in all countries. 2 main objectives: - The inclusion of patients whose diagnosis of Giant Cell Arteritis (GCA) had been confirmed by high-resolution colour Doppler Ultrasound (US). - An alternative CS tapering schedule in case of non-availability of the 1 mg prednisone dose in some countries.
    01 Oct 2014
    Applicable in all countries. Mainly aimed at modifying the medical and therapeutic eligibility criteria, authorizing the selection of the following patient profiles: - Patients experiencing their first GCA relapse. - Patients on continuous CS treatment for more than 2 years. - Patients with a positive imaging confirming the GCA diagnosis performed more than 12 weeks before inclusion in case of absent or negative biopsy at the time of diagnosis.
    23 Dec 2014
    Applicable in all countries. The main changes were: - Authorised the selection of patients with an increase in CS dose to treat the current relapse if the increase occurred more than one month before selection and the dosage was stable since then. - Modified the ACR criteria: * Replacement of “ESR >=50 mm/hour” by “ESR >= 50 mm/hour and/or CRP >= 2.5 mg/dL (i.e. 25 mg/L)”. * Inclusion of the imaging exam, which was already an eligibility criterion in case of absent or negative temporal biopsy, within the ACR criteria. - Suppressed the non-selection criterion “patients with a history of chronic inflammatory disease”. - Added chronic immunosuppressants for indications other than GCA as forbidden concomitant treatments.
    11 Aug 2015
    Applicable in all countries. This amendment added a new dose (120 mg) of gevokizumab to be tested in the study for newly-included patients. No patients were included after its approval; the higher dose was not therefore used in the study. Amendment 5 also specified that the 5th criterion of the modified ACR classification for GCA diagnosis (positive biopsy or imaging) was mandatory for patient inclusion.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    30 Sep 2015
    The Sponsor took the decision to prematurely discontinue the study for strategic reasons that were unrelated to any safety issue.
    -

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    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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