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    Clinical Trial Results:
    A Randomized, Parallel, Double-Blind, Placebo-Controlled Phase 2b Study to Assess the Safety, Tolerability and Efficacy of AZD8233 Treatment in Participants with Hyperlipidaemia (SOLANO)

    Summary
    EudraCT number
    2020-005845-18
    Trial protocol
    SK   DK   CZ   NL   HU   ES   PL  
    Global end of trial date
    15 Jul 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    28 Jul 2023
    First version publication date
    28 Jul 2023
    Other versions
    Summary report(s)
    additioanlData

    Trial information

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    Trial identification
    Sponsor protocol code
    D7990C00004
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04964557
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    AstraZeneca, Södertälje, Sweden, 151 85
    Public contact
    Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.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
    15 Nov 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jul 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jul 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary safety: To assess the safety and tolerability of AZD8233 as compared with placebo in participants with hyperlipidaemia receiving maximally tolerated statin and/or ezetimibe therapy as defined by the investigator. Primary efficacy: To assess the effect of AZD8233 versus placebo on serum LDL-C at the end of Week 28 compared with baseline, in participants with hyperlipidaemia, receiving maximally tolerated statin and/or ezetimibe therapy as defined by the investigator.
    Protection of trial subjects
    Not applicable
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    07 Jul 2021
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 87
    Country: Number of subjects enrolled
    Hungary: 29
    Country: Number of subjects enrolled
    Denmark: 52
    Country: Number of subjects enrolled
    Slovakia: 78
    Country: Number of subjects enrolled
    Netherlands: 19
    Country: Number of subjects enrolled
    Czechia: 89
    Country: Number of subjects enrolled
    Poland: 14
    Country: Number of subjects enrolled
    Spain: 43
    Worldwide total number of subjects
    411
    EEA total number of subjects
    324
    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)
    231
    From 65 to 84 years
    180
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This study was conducted at a total of 66 study centres in 8 countries: Czech Republic (10 centres), Denmark (8 centres), Hungary (4 centres), Netherlands (6 centres), Poland (8 centres), Slovakia (7 centres), Spain (7 centres), and United States (16 centres). First subject enrolled: 07 July 2021 and Last subject last visit: 15 July 2022.

    Pre-assignment
    Screening details
    A total of 593 subjects were screened in the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    AZD8233
    Arm description
    AZD8233 for subcutaneous use.
    Arm type
    Experimental

    Investigational medicinal product name
    AZD8233 for subcutaneous use.
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    60mg SC Q4W

    Arm title
    Placebo
    Arm description
    Matching placebo solution for subcutaneous injection.
    Arm type
    Placebo

    Investigational medicinal product name
    Matching placebo.
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    60mg matching place SC Q4W.

    Number of subjects in period 1
    AZD8233 Placebo
    Started
    206
    205
    Completed
    196
    201
    Not completed
    10
    4
         Adverse event, serious fatal
    3
    -
         Consent withdrawn by subject
    3
    2
         Physician decision
    2
    -
         Lost to follow-up
    1
    2
         Reported as completed but didn’t fulfil study def.
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AZD8233
    Reporting group description
    AZD8233 for subcutaneous use.

    Reporting group title
    Placebo
    Reporting group description
    Matching placebo solution for subcutaneous injection.

    Reporting group values
    AZD8233 Placebo Total
    Number of subjects
    206 205 411
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    110 121 231
        From 65-84 years
    96 84 180
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    62.4 ( 8.1 ) 62.2 ( 7.7 ) -
    Sex: Female, Male
    Units: Participants
        Female
    101 94 195
        Male
    105 111 216
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    1 0 1
        Asian
    2 2 4
        Black or African American
    9 3 12
        Native Hawaiian or other Pacific Islander
    0 1 1
        White
    194 199 393
    Region of Enrollment
    Units: Subjects
        USA
    48 39 87
        Czech Republic
    45 44 89
        Denmark
    31 21 52
        Hungary
    15 14 29
        Netherlands
    12 7 19
        Poland
    4 10 14
        Slovakia
    35 43 78
        Spain
    16 27 43
    LDL-C
    Baseline LDL-C
    Units: mg/dL
        arithmetic mean (standard deviation)
    103 ( 31.8 ) 107.4 ( 31.9 ) -
    Subject analysis sets

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All subjects who were randomly assigned to study intervention. Subjects will be analysed according to their randomised study medication assignment, irrespective of the treatment actually received.

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received. A subject who has on one or several occasions received active IP is classified as active and is accounted for the active IP treatment group.

    Subject analysis sets values
    Full analysis set Safety analysis set
    Number of subjects
    411
    410
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    231
        From 65-84 years
    180
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    62.3 ( 7.9 )
    ( )
    Sex: Female, Male
    Units: Participants
        Female
    195
        Male
    216
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    1
        Asian
    4
        Black or African American
    12
        Native Hawaiian or other Pacific Islander
    1
        White
    393
    Region of Enrollment
    Units: Subjects
        USA
    87
        Czech Republic
    89
        Denmark
    52
        Hungary
    29
        Netherlands
    19
        Poland
    14
        Slovakia
    78
        Spain
    43
    LDL-C
    Baseline LDL-C
    Units: mg/dL
        arithmetic mean (standard deviation)
    105.2 ( 31.9 )
    ( )

    End points

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    End points reporting groups
    Reporting group title
    AZD8233
    Reporting group description
    AZD8233 for subcutaneous use.

    Reporting group title
    Placebo
    Reporting group description
    Matching placebo solution for subcutaneous injection.

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All subjects who were randomly assigned to study intervention. Subjects will be analysed according to their randomised study medication assignment, irrespective of the treatment actually received.

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received. A subject who has on one or several occasions received active IP is classified as active and is accounted for the active IP treatment group.

    Primary: Percentage change from baseline on serum LDL-C

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    End point title
    Percentage change from baseline on serum LDL-C
    End point description
    Percentage change in Low-density Lipoprotein Cholesterol (LDL-C) from baseline to Day 197.
    End point type
    Primary
    End point timeframe
    From baseline to Day 197
    End point values
    AZD8233 Placebo
    Number of subjects analysed
    206
    205
    Units: Relative change from baseline in LDL-C %
        least squares mean (confidence interval 95%)
    -56.7 (-60.8 to -52.7)
    5.6 (1.5 to 9.6)
    Statistical analysis title
    Relative change in LDL-C
    Statistical analysis description
    Relative change in serum LDL-C from baseline to end of W28
    Comparison groups
    Placebo v AZD8233
    Number of subjects included in analysis
    411
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [1]
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -62.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -68
         upper limit
    -56.6
    Notes
    [1] - P-Value is <0.001

    Secondary: Percentage change from baseline on serum PCSK9

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    End point title
    Percentage change from baseline on serum PCSK9
    End point description
    Percentage change in Proprotein convertase subtilisin/kexin type-9 (PCSK9) from baseline to Day 197.
    End point type
    Secondary
    End point timeframe
    From baseline to Day 197
    End point values
    AZD8233 Placebo
    Number of subjects analysed
    206
    205
    Units: Relative change from baseline in PCSK9 %
        least squares mean (confidence interval 95%)
    -77.5 (-81.1 to -74)
    -0.8 (-4.3 to 2.6)
    Statistical analysis title
    Relative change concentrations of PCSK9
    Statistical analysis description
    Relative change concentrations of PCSK9 from baseline to end of week 28.
    Comparison groups
    AZD8233 v Placebo
    Number of subjects included in analysis
    411
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [2]
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -76.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -81.7
         upper limit
    -71.7
    Notes
    [2] - P-Value is <0.001

    Secondary: Plasma concentration of AZD8233

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    End point title
    Plasma concentration of AZD8233 [3]
    End point description
    AZD8233 full length ASO concentrations in plasma (pre-dose) will be summarised by descriptive statistics by sampling time point and listed on individual level based on the PK analysis set.
    End point type
    Secondary
    End point timeframe
    Day 29, Day 85, Day 141, Day 183, Day 197
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only the AZD8233 treatment group has valid PK measurements.
    End point values
    AZD8233
    Number of subjects analysed
    200
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Day 29
    0.2648 ( 82.8352 )
        Day 85
    0.3927 ( 84.9378 )
        Day 141
    0.5749 ( 161.9301 )
        Day 183
    1.0441 ( 178.5196 )
        Day 197
    0.6975 ( 208.2431 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    On-study: includes adverse events with an onset date on or after the date of first dose of IP.
    Adverse event reporting additional description
    The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Matching Placebo for subcutaneous use.

    Reporting group title
    AZD8233
    Reporting group description
    AZD8233 for subcutaneous use.

    Serious adverse events
    Placebo AZD8233
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 203 (5.91%)
    18 / 207 (8.70%)
         number of deaths (all causes)
    0
    3
         number of deaths resulting from adverse events
    0
    3
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung adenocarcinoma
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 207 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bladder transitional cell carcinoma
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 207 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic malignant melanoma
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 207 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 207 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell carcinoma urethra
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 207 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 207 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypovolaemic shock
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 207 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iliac artery stenosis
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 207 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Sudden death
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 207 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 203 (0.99%)
    0 / 207 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Haemothorax
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 207 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 207 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Bipolar i disorder
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 207 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental disorder
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 207 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Coagulation time prolonged
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 207 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 207 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 207 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 207 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 203 (0.49%)
    1 / 207 (0.48%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 207 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 203 (0.49%)
    1 / 207 (0.48%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 207 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 207 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Carotid artery stenosis
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 207 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 207 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute vestibular syndrome
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 207 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Amaurosis fugax
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 207 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Inguinal hernia
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 207 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 207 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 207 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 207 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 207 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Covid-19 pneumonia
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 207 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Urosepsis
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 207 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 207 (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: 5%
    Non-serious adverse events
    Placebo AZD8233
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    62 / 203 (30.54%)
    69 / 207 (33.33%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    13 / 203 (6.40%)
    11 / 207 (5.31%)
         occurrences all number
    16
    11
    General disorders and administration site conditions
    Injection site reaction
         subjects affected / exposed
    5 / 203 (2.46%)
    22 / 207 (10.63%)
         occurrences all number
    7
    56
    Infections and infestations
    Covid-19
         subjects affected / exposed
    36 / 203 (17.73%)
    33 / 207 (15.94%)
         occurrences all number
    37
    33
    Metabolism and nutrition disorders
    Diabetes mellitus inadequate control
         subjects affected / exposed
    14 / 203 (6.90%)
    18 / 207 (8.70%)
         occurrences all number
    14
    19

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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.
    ADA and safety endpoints were evaluated using the safety analysis set and could not be reported in the end points section, thus tables are reported in a separate PDF attachment.
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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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