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    Clinical Trial Results:
    Randomized, open-label, parallel-group, multi-centre phase II clinical trial of active cellular immunotherapy DCVAC/PCa in patients with localized prostate cancer after primary radical prostatectomy

    Summary
    EudraCT number
    		 2011-004985-14
    Trial protocol
    		 CZ  
    Global end of trial date
    22 May 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Apr 2018
    First version publication date
    01 Apr 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SP003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02107404
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sotio a.s.
    Sponsor organisation address
    Jankovcova 1518/2, Prague, Czech Republic, 17000
    Public contact
    Clinical Trials Sotio, Sotio a.s., +420 224175111, clinicaltrial@sotio.com
    Scientific contact
    Clinical Trials Sotio, Sotio a.s., +420 224175111, clinicaltrial@sotio.com
    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
    22 May 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 May 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    22 May 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objectives of the study SP003 were to evaluate prostate-specific antigen (PSA) doubling time (PSADT) in patients in the immunotherapy group and in the control group in the treatment phase of the study; to compare PSADT measured in the treatment phase with PSADT prior to randomization in patients in both groups; to evaluate PSADT in patients in the immunotherapy group and in the control group in the follow-up phase of the study; to monitor the incidence of adverse events (AEs); to determine the proportion of patients with biochemical relapse, progressive increase in PSA, objective disease progression, or further anticancer therapy introduction within 2 years of randomization; and to compare overall survival (OS) between the two groups.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    23 Apr 2012
    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
    Czech Republic: 150
    Worldwide total number of subjects
    150
    EEA total number of subjects
    150
    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)
    60
    From 65 to 84 years
    90
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Nineteen clinical study centers in the Czech Republic participated in the study SP003 and 15 recruited (screened) at least 1 patient. Recruitment started on 23-Apr-2012 (first patient signed the informed consent form) and ended on 25-May-2015 (last patient signed the informed consent form).

    Pre-assignment
    Screening details
    		 Screened: 169 Randomized: 150 Analyzed for efficacy: 150 Analyzed for safety: 137

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Immunotherapy group
    Arm description
    		 DCVAC/PCa; patients in the immunotherapy group were treated with 50 mg/day of oral cyclophosphamide for 7 days before the first dose of DCVAC/PCa and applied imiquimod cream to the planned DCVAC/PCa injection sites 24 hours before each DCVAC/PCa administration
    Arm type
    		 Experimental

    Investigational medicinal product name
    DCVAC/PCa
    Investigational medicinal product code
    Not applicable
    Other name
    Not applicable
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection of approximately 1×10e7 autologous dendritic cells; oral cyclophosphamide 50 mg/day for 7 days before the first dose of DCVAC/PCa; imiquimod cream applied to the planned DCVAC/PCa injection sites 24 hours before each DCVAC/PCa administration

    Arm title
    		 Control group
    Arm description
    		 No investigational medicinal product assigned in this arm
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Immunotherapy group Control group
    Started
    74
    76
    Completed
    53
    55
    Not completed
    21
    21
         Consent withdrawn by subject
    3
    5
         Physician decision
    1
    1
         Adverse event, non-fatal
    3
    -
         Death due to underlying disease
    1
    -
         Manufacturing failure
    5
    -
         Progressive disease
    7
    11
         Protocol deviation
    1
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Immunotherapy group
    Reporting group description
    		 DCVAC/PCa; patients in the immunotherapy group were treated with 50 mg/day of oral cyclophosphamide for 7 days before the first dose of DCVAC/PCa and applied imiquimod cream to the planned DCVAC/PCa injection sites 24 hours before each DCVAC/PCa administration

    Reporting group title
    Control group
    Reporting group description
    		 No investigational medicinal product assigned in this arm

    Reporting group values
    		 Immunotherapy group Control group Total
    Number of subjects
    		 74 76 150
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 66.48 (50.36 to 78.38) 66.27 (47.73 to 79.4) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 74 76 150

    End points

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    End points reporting groups
    Reporting group title
    Immunotherapy group
    Reporting group description
    		 DCVAC/PCa; patients in the immunotherapy group were treated with 50 mg/day of oral cyclophosphamide for 7 days before the first dose of DCVAC/PCa and applied imiquimod cream to the planned DCVAC/PCa injection sites 24 hours before each DCVAC/PCa administration

    Reporting group title
    Control group
    Reporting group description
    		 No investigational medicinal product assigned in this arm

    Subject analysis set title
    ITT-derived populations
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The ITT population consisted of all randomized patients except those for whom no data were available following randomization. Inclusion criterion 4 was changed in version 5.0 of the Protocol, and patients who did not fulfill this criterion were excluded from the primary efficacy analysis. For that reason, the ITT-eligible population according to inclusion criterion 4 (ITTe) was introduced. For endpoints where PSADT was the main interest, only patients who had 2 or more PSA values in the examined time period were taken into consideration. It means that for the treatment phase, the ITT population with 2 or more PSA values in the treatment phase (ITT2t) and the same population additionally being eligible according to inclusion criterion 4 in SP003 (ITT2te) were examined. The same applied to the follow-up phase with the populations ITT2f and ITT2fe. Patients who did not start treatment were not analyzed for PSADT in the follow-up phase.

    Primary: PSADT in the treatment phase

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    End point title
    		 PSADT in the treatment phase
    End point description
    End point type
    Primary
    End point timeframe
    From randomization to visit (V)10 at week 40
    End point values
    		 Immunotherapy group Control group
    Number of subjects analysed
    34 [1]
    37 [2]
    Units: Months
        median (full range (min-max))
    12.16 (3.33 to 100)
    13.19 (3.26 to 100)
    Notes
    [1] - ITT2te
    [2] - ITT2te
    Statistical analysis title
    		 Primary analysis
    Statistical analysis description
    2-sided Wilcoxon Mann Whitney test
    Comparison groups
    Immunotherapy group v Control group
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4744
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Comparing PSADT measured in the treatment phase with PSADT prior to randomization

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    End point title
    		 Comparing PSADT measured in the treatment phase with PSADT prior to randomization
    End point description
    End point type
    Secondary
    End point timeframe
    Treatment phase and prior to randomization
    End point values
    		 Immunotherapy group Control group
    Number of subjects analysed
    34 [3]
    37 [4]
    Units: Months
        median (full range (min-max))
    8.62 (-2.97 to 97.7)
    9.31 (-7.08 to 98.45)
    Notes
    [3] - ITT2te
    [4] - ITT2te
    Statistical analysis title
    		 Secondary analysis
    Statistical analysis description
    2-sided Wilcoxon Mann Whitney test
    Comparison groups
    Immunotherapy group v Control group
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8765
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Value of PSADT in the follow-up phase

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    End point title
    		 Value of PSADT in the follow-up phase
    End point description
    End point type
    Secondary
    End point timeframe
    From the completed visit at week 40 to 2 years from randomization
    End point values
    		 Immunotherapy group Control group
    Number of subjects analysed
    54 [5]
    54 [6]
    Units: Months
        median (full range (min-max))
    22.03 (1.89 to 100)
    24.3 (4.14 to 100)
    Notes
    [5] - ITT2f
    [6] - ITT2f
    Statistical analysis title
    		 Secondary analysis
    Statistical analysis description
    2-sided Wilcoxon Mann Whitney
    Comparison groups
    Immunotherapy group v Control group
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6838
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Proportion of patients with objective disease progression (metastatic disease development [distant failure])

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    End point title
    		 Proportion of patients with objective disease progression (metastatic disease development [distant failure])
    End point description
    - Progression free: patients for whom objective tumor assessment (CT scan and scintigraphy) at 2 years (-6 months) or later showed evidence of non-progressive disease - Progressed: patients for whom objective tumor assessment (CT scan and scintigraphy) at 2 years (+4 weeks) or earlier showed evidence of disease progression, patients who died at 2 years (+4 weeks) or earlier, or patients who started further anticancer therapy within 2 years (+4 weeks) after randomization Patients with an unknown status at 2 years were excluded from this analysis.
    End point type
    Secondary
    End point timeframe
    Within 2 years of randomization
    End point values
    		 Immunotherapy group Control group
    Number of subjects analysed
    74 [7]
    76 [8]
    Units: Proportion of pts with progression
        number (confidence interval 95%)
    0.400 (0.260 to 0.570)
    0.350 (0.240 to 0.490)
    Notes
    [7] - ITT
    [8] - ITT
    Statistical analysis title
    		 Secondary analysis
    Statistical analysis description
    Fisher’s exact test
    Comparison groups
    Immunotherapy group v Control group
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.68
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Proportion of patients who required any further anticancer therapy

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    End point title
    		 Proportion of patients who required any further anticancer therapy
    End point description
    End point type
    Secondary
    End point timeframe
    Within 2 years of randomization
    End point values
    		 Immunotherapy group Control group
    Number of subjects analysed
    74 [9]
    76 [10]
    Units: Proportion of pts with further therapy
        number (confidence interval 95%)
    0.1892 (0.1075 to 0.2970)
    0.2632 (0.1687 to 0.3768)
    Notes
    [9] - ITT
    [10] - ITT
    Statistical analysis title
    		 Secondary analysis
    Statistical analysis description
    Fisher’s exact test
    Comparison groups
    Immunotherapy group v Control group
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3315
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Secondary analysis
    Statistical analysis description
    Fisher’s exact test
    Comparison groups
    Immunotherapy group v Control group
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3315
    Method
    		 Fisher exact
    Confidence interval

    Secondary: For the subgroup of patients who did not undergo salvage radiotherapy (only RPE), the proportion of patients who had biochemical relapse

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    End point title
    		 For the subgroup of patients who did not undergo salvage radiotherapy (only RPE), the proportion of patients who had biochemical relapse
    End point description
    End point type
    Secondary
    End point timeframe
    Within 2 years of randomization
    End point values
    		 Immunotherapy group Control group
    Number of subjects analysed
    52 [11]
    49 [12]
    Units: Proportion of pts with PSA relapse
        number (confidence interval 95%)
    0.530 (0.381 to 0.659)
    0.497 (0.349 to 0.629)
    Notes
    [11] - ITT population without patients who had salvage radiotherapy
    [12] - ITT population without patients who had salvage radiotherapy
    Statistical analysis title
    		 Secondary analysis
    Statistical analysis description
    Kaplan-Meier analysis and log-rank test
    Comparison groups
    Immunotherapy group v Control group
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8826
    Method
    		 Logrank
    Confidence interval

    Secondary: Proportion of patients who had progressive increase in PSA

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    End point title
    		 Proportion of patients who had progressive increase in PSA
    End point description
    End point type
    Secondary
    End point timeframe
    Within 2 years of randomization
    End point values
    		 Immunotherapy group Control group
    Number of subjects analysed
    31 [13]
    24 [14]
    Units: Proportion of pts with progressive PSA
        number (confidence interval 95%)
    0.133 (0.042 to 0.278)
    0.200 (0.069 to 0.380)
    Notes
    [13] - ITT with PSA values
    [14] - ITT with PSA values
    Statistical analysis title
    		 Secondary analysis
    Statistical analysis description
    Kaplan-Meier analysis and log-rank test
    Comparison groups
    Immunotherapy group v Control group
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6986
    Method
    		 Logrank
    Confidence interval

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    End point type
    Secondary
    End point timeframe
    2 years after randomization
    End point values
    		 Immunotherapy group Control group
    Number of subjects analysed
    74 [15]
    76 [16]
    Units: Proportion of pts alive
        number (confidence interval 95%)
    0.973 (0.896 to 0.993)
    1.000 (1.000 to 1.000)
    Notes
    [15] - ITT
    [16] - ITT
    Statistical analysis title
    		 Secondary analysis
    Statistical analysis description
    Kaplan-Meier analysis and log-rank test
    Comparison groups
    Immunotherapy group v Control group
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6357
    Method
    		 Logrank
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent AEs and SAEs: from V1 to 30 days after the last dose of DCVAC/PCa (immunotherapy group) or from V1 to 30 days after V10 (treatment phase discontinuation) (control group) Deaths: from consent signature to trial termination
    Adverse event reporting additional description
    The tables include information on treatment-emergent AEs, treatment-emergent SAEs, and all deaths. An event causally related to treatment was one which was assessed by investigators as causally related to DCVAC/PCa administration. The SAE 'Acute myocardial infarction' was later reported by the sponsor as a SUSAR.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Immunotherapy group
    Reporting group description
    		 DCVAC/PCa

    Reporting group title
    Control group
    Reporting group description
    		 No treatment

    Serious adverse events
    		 Immunotherapy group Control group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 64 (12.50%)
    1 / 73 (1.37%)
         number of deaths (all causes)
    3
    2
         number of deaths resulting from adverse events
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colorectal cancer
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Humerus fracture
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal disorders
    Inguinal hernia
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus bladder
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Vestibular neuronitis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Immunotherapy group Control group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 64 (48.44%)
    17 / 73 (23.29%)
    Investigations
    Antinuclear antibody positive
         subjects affected / exposed
    2 / 64 (3.13%)
    1 / 73 (1.37%)
         occurrences all number
    2
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 64 (7.81%)
    1 / 73 (1.37%)
         occurrences all number
    5
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 64 (1.56%)
    2 / 73 (2.74%)
         occurrences all number
    1
    2
    Fatigue
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 73 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Inguinal hernia
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 73 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 73 (0.00%)
         occurrences all number
    2
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 64 (0.00%)
    6 / 73 (8.22%)
         occurrences all number
    0
    6
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 64 (3.13%)
    1 / 73 (1.37%)
         occurrences all number
    2
    1
    Infections and infestations
    Cystitis
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 73 (0.00%)
         occurrences all number
    2
    0
    Viral infection
         subjects affected / exposed
    1 / 64 (1.56%)
    2 / 73 (2.74%)
         occurrences all number
    1
    2
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 73 (2.74%)
         occurrences all number
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Dec 2011
    - European Pharminvent Services to be responsible for pharmacovigilance (PV) services - Definition of disease progresion was detailed and the corresponding secondary endpoint was updated - Specification of vein access evaluation before leukapheresis for patients in the immunotherapy group - Specification of HIV tests (CE-marked kits; an accredited laboratory)
    07 Jun 2012
    - Extension of the time window for leukapheresis and for vein access evaluation before leukapheresis - Clarification of cyclophosphamide dosing - Screening phase prolonged to 4 weeks - Changed time window for visits in the screening phase (±14 days) - Added tests in the study schedule - Modified wording of inclusion criterion E-6 - Updated SAE reporting - Explanation added why leukapheresis was not performed in the control group - Details provided about CT/scintigraphy readings - Added criteria for premature termination of participation in the study - DCVAC/PCa transport and application description updated - Explanation added that missed DCVAC/PCa administration was not considered a reason for termination of a patient’s participation in the trial - Extension of the time window for immunology and immunomonitoring sampling to 6 months
    12 Aug 2013
    - Added a secondary endpoint (PSADT on treatment vs PSADT pre-treatment) - The number of patients was changed to 150 - Terminology was separated for the investigational medicinal product (DCVAC/PCa) and stimulating medication (cyclophosphamide and imiquimod) - Detailed inclusion criterion Inc-5b - Added a reason for early termination of patient participation in the study due to the investigator’s decision
    15 Aug 2014
    - Updated study objectives and added a detailed description of exploratory objectives - Updated primary and secondary endpoints - Modified inclusion criterion Inc-4 - Exclusion criterion E-6 was specified in more detail - Clearly distinguishing the IMP from stimulating medication - Detailed description of laboratory testing, including samples for research - Statistical analysis section updated in relation to modified inclusion criterion Inc-4 - Information about phase I/II clinical trials conducted by the University Hospital in Motol updated per current knowledge - Section on concomitant medication was updated - Updated safety reporting sections - Introduction of new terminology: EoT, End of study, EoS visit, follow-up, and follow-up after the EoS examinations visit - Updated section “Rationale for prostate cancer immunotherapy” - Terminology harmonization
    23 Jul 2015
    - Updated safety reporting sections to capture the transfer of safety monitoring responsibilities from the European Pharminvent Services to SOTIO a.s. - Implementation of the Pregnancy Data Collection Form and wording updates in the PV section - Wording for exploratory endpoints and analysis was detailed - Clarification of the CT/bone scintigraphy schedule

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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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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