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    Clinical Trial Results:
    Phase 2/3 Study of Monotherapy LY2157299 Monohydrate in Very Low-, Low-, and Intermediate-Risk Patients with Myelodysplastic Syndromes

    Summary
    EudraCT number
    		 2013-003235-30
    Trial protocol
    		 IT   DE   ES  
    Global end of trial date
    24 Sep 2017

    Results information
    Results version number
    		 v2(current)
    This version publication date
    15 Dec 2022
    First version publication date
    07 Oct 2018
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of full data set

    Trial information

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    Trial identification
    Sponsor protocol code
    H9H-MC-JBAV
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02008318
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 15242
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, United States, 46285
    Public contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-CTLilly,
    Scientific contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-285-4559,
    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
    24 Sep 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Sep 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to investigate the effect of the study drug known as galunisertib in participants with myelodysplastic syndromes (MDS). Participants with different degrees of disease (very low, low, and intermediate risk) will be studied. The study treatment is expected to last about 6 months for each participant.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Mar 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 12
    Country: Number of subjects enrolled
    Germany: 23
    Country: Number of subjects enrolled
    Italy: 8
    Worldwide total number of subjects
    43
    EEA total number of subjects
    43
    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)
    9
    From 65 to 84 years
    34
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This is a single-arm study (Galunisertib at 150 milligram [mg]); the Galunisertib at 80 mg was considered exploratory and only conducted in parallel with the main study, at one site in Spain.

    Pre-assignment
    Screening details
    		 No text.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Galunisertib at 150 mg
    Arm description
    		 Galunisertib at 150 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Completed participants completed at least 6 cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Galunisertib
    Investigational medicinal product code
    Other name
    LY2157299
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Galunisertib at 150 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles).

    Arm title
    		 Galunisertib at 80 mg
    Arm description
    		 Exploratory arm: Galunisertib at 80 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Completed participants completed at least 6 cycles.
    Arm type
    		 Exploratory

    Investigational medicinal product name
    Galunisertib
    Investigational medicinal product code
    Other name
    LY2157299
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Galunisertib at 80 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles).

    Number of subjects in period 1
    		Galunisertib at 150 mg Galunisertib at 80 mg
    Started
    41
    2
    Received At Least 1 Dose of Study Drug
    41
    2
    Completed
    29
    1
    Not completed
    12
    1
         Consent withdrawn by subject
    3
    -
         Physician decision
    2
    -
         Adverse event, non-fatal
    4
    -
         Progressive Disease
    2
    -
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Galunisertib at 150 mg
    Reporting group description
    		 Galunisertib at 150 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Completed participants completed at least 6 cycles.

    Reporting group title
    Galunisertib at 80 mg
    Reporting group description
    		 Exploratory arm: Galunisertib at 80 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Completed participants completed at least 6 cycles.

    Reporting group values
    		 Galunisertib at 150 mg Galunisertib at 80 mg Total
    Number of subjects
    		 41 2 43
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 70.49 ± 7.65 62.50 ± 10.61 -
    Gender categorical
    Units: Subjects
        Female
    		 15 1 16
        Male
    		 26 1 27
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 5 0 5
        Not Hispanic or Latino
    		 32 2 34
        Unknown or Not Reported
    		 4 0 4
    Race (NIH/OMB)
    Units: Subjects
        White
    		 41 2 43
    IPSS-R Prognostic Risk Score
    Measure Description: Revised International Prognostic Scoring System (IPSS-R) is a screening tool used for MDS risk assessment. IPSS-R gives great weight to cytogenetic abnormalities and severity of cytopaenias, while reassigning the weighting for blast percentages. Score Categories: ≤1.5 Very Low, >1.5 - 3 Low, >3 - 4.5 Intermediate, >4.5 - 6 High, >6 Very High. The MDS Foundation website provides a calculator for determining IPSS-R scoring.
    Units: Subjects
        Very Low= (≤1.5)
    		 2 0 2
        Low= (>1.5 - 3)
    		 30 1 31
        Intermediate= (>3 - 4.5)
    		 9 1 10

    End points

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    End points reporting groups
    Reporting group title
    Galunisertib at 150 mg
    Reporting group description
    		 Galunisertib at 150 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Completed participants completed at least 6 cycles.

    Reporting group title
    Galunisertib at 80 mg
    Reporting group description
    		 Exploratory arm: Galunisertib at 80 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Completed participants completed at least 6 cycles.

    Subject analysis set title
    Galunisertib
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All participants who received study drug, regardless of dose.

    Primary: Percentage of Participants with Hematological Improvement (HI)

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    End point title
    		 Percentage of Participants with Hematological Improvement (HI)
    End point description
    Percentage of participants with hematological improvement (HI) based on International Working Group (IWG) 2006 criteria in participants with very low, low, and intermediate-risk myelodysplastic syndromes treated with Galunisertib plus best supportive care, as assessed by the International Prognostic Scoring System (IPSS-R). To be classified as an HI responder, the HI response must have lasted at least 8 weeks (56 days). Analysis Population Description: participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Baseline through end of study treatment (24 weeks)
    End point values
    		 Galunisertib at 150 mg Galunisertib at 80 mg
    Number of subjects analysed
    41
    2
    Units: percentage of participants
        number (confidence interval 95%)
    31.7 (18.1 to 48.1)
    0.0 (0.0 to 84.2)
    Statistical analysis title
    		 Overall HI Response Rate Statisical Analysis
    Comparison groups
    Galunisertib at 150 mg v Galunisertib at 80 mg
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Clopper-Pearson Method
    Confidence interval

    Primary: Percentage of Participants who are Transfusion-free or have Hemoglobin (Hb) Increase ≥1.5 Grams/Deciliter Maintained for 8 Weeks During Phase 3

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    End point title
    		 Percentage of Participants who are Transfusion-free or have Hemoglobin (Hb) Increase ≥1.5 Grams/Deciliter Maintained for 8 Weeks During Phase 3 [1]
    End point description
    Comparison of the percentage of participants with very low-, low-,and intermediate-risk MDS who were transfusion-free or had an increase ≥1.5 g/dL in hemoglobin (Hb) maintained for at least 8 weeks within the first 24 weeks of treatment with galunisertib plus best supportive care or placebo plus best supportive care and assessed by IPSS-R. The Phase 3 portion of this study was not conducted because efficacy level required in phase 2 to move forward to phase 3 was not achieved. Analysis Population Description: participants who received at least one dose of study drug during Phase 3.
    End point type
    Primary
    End point timeframe
    Baseline through end of study treatment (24 weeks)
    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: No inferential statistical methods planned for this outcome.
    End point values
    		 Galunisertib at 150 mg Galunisertib at 80 mg
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: percentage of participants
        number (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [2] - Efficacy level required in phase 2 to move forward to phase 3 was not achieved.
    [3] - Efficacy level required in phase 2 to move forward to phase 3 was not achieved.
    No statistical analyses for this end point

    Secondary: Change from Baseline in Brief Fatigue Inventory (BFI)

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    End point title
    		 Change from Baseline in Brief Fatigue Inventory (BFI)
    End point description
    The Brief Fatigue Inventory (BFI) is a brief participant-reported questionnaire that measures the severity of fatigue based on the worst fatigue experienced during the past 24-hours. The severity of fatigue is assessed using an 11-point numeric scale, with 0 = no fatigue and 10 = fatigue as bad as you can imagine. Population Analysis Description: participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline, Follow up (final visit up to 24 months)
    End point values
    		 Galunisertib at 150 mg Galunisertib at 80 mg
    Number of subjects analysed
    41
    2
    Units: units on a scale
    least squares mean (standard error)
        Current Fatigue at Follow-up
    0.818 ± 0.42
    -1.005 ± 2.08
        Usual Fatigue at Follow-up
    -0.017 ± 0.37
    -0.157 ± 1.87
        Worst Fatigue at Follow-up
    -0.191 ± 0.38
    -0.063 ± 1.93
    No statistical analyses for this end point

    Secondary: Change from Baseline in EuroQol 5-Dimension 5 Level Instrument

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    End point title
    		 Change from Baseline in EuroQol 5-Dimension 5 Level Instrument
    End point description
    EuroQol 5-Dimension 5 Level Instrument (EQ-5D-5L) was not conducted, trial terminated prior to Phase 3. No data collected. Analysis Population Description: participants who received at least one dose of study drug during Phase 3.
    End point type
    Secondary
    End point timeframe
    Phase 3: Baseline, Cycle 2, Cycle 4, Cycle 6 (Cycle = 28 days)
    End point values
    		 Galunisertib at 150 mg Galunisertib at 80 mg
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: Units on a scale
    Notes
    [4] - EQ-5D-5L was not conducted, trial terminated prior to Phase 3. No data collected.
    [5] - EQ-5D-5L was not conducted, trial terminated prior to Phase 3. No data collected.
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Cytogenetic Response

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    End point title
    		 Percentage of Participants with Cytogenetic Response
    End point description
    Percentage of Participants with Cytogenetic Response with either complete or partial response. Complete cytogenetic response is the disappearance of the chromosomal abnormality without appearance of new ones. Partial cytogenetic response is at least 50% reduction of the chromosomal abnormality. Analysis Population Description: participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline, Cycle 3, Cycle 6 (Cycle = 28 days)
    End point values
    		 Galunisertib at 150 mg Galunisertib at 80 mg
    Number of subjects analysed
    41
    2
    Units: percentage of participants
        number (confidence interval 95%)
    2.4 (0.1 to 12.9)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants who are Hospitalized (Resource Utilization)

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    End point title
    		 Percentage of Participants who are Hospitalized (Resource Utilization)
    End point description
    Percentage of any participant with a hospitalization admission and discharge date on the same day are counted as a half-day in the duration of hospitalization. Analysis Population Description: participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline through end of study treatment (24 weeks)
    End point values
    		 Galunisertib at 150 mg Galunisertib at 80 mg
    Number of subjects analysed
    41
    2
    Units: percentage of participants
        number (not applicable)
    24.3
    0
    No statistical analyses for this end point

    Secondary: Population Pharmacokinetics (PK): Mean Population Clearance of Galunisertib

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    End point title
    		 Population Pharmacokinetics (PK): Mean Population Clearance of Galunisertib
    End point description
    Population mean (between-participant coefficient variation [CV%]) apparent clearance. Analysis Population Description: participants who received at least one dose of study drug with evaluable PK data.
    End point type
    Secondary
    End point timeframe
    Day 1 pre-dose & 0.5 between2 hours post dose; Day 14 pre-dose, 0.5 between 2 & 3 between 5 hours post dose; Days 15 & 16 (if logistically possible) 0.5 between 2 hours post dose
    End point values
    		 Galunisertib
    Number of subjects analysed
    43
    Units: Liter per hour (L/h)
        geometric mean (geometric coefficient of variation)
    32 ± 52
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS) [6]
    End point description
    Overall survival is defined as the time from the date of first dose to the date of death from any cause. Analysis Population Description: participants who received at least one dose of study drug excluding the exploratory participants.
    End point type
    Secondary
    End point timeframe
    Baseline to date of death from any cause (Up to 2 years)
    Notes
    [6] - 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: The outcome was planned for Galunisertib at 150 mg per SAP.
    End point values
    		 Galunisertib at 150 mg
    Number of subjects analysed
    41
    Units: Median
        median (full range (min-max))
    679 (29 to 729)
    No statistical analyses for this end point

    Secondary: Number of Participants with a Change From Baseline in Bone Marrow Fibrosis Grading

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    End point title
    		 Number of Participants with a Change From Baseline in Bone Marrow Fibrosis Grading [7]
    End point description
    Change from baseline in bone marrow fibrosis measured the number of participants with a change in bone marrow fibrosis grading (negative, mild, moderate, and severe). Analysis Population Description: participants who received at least one dose of study drug and had both a baseline and postbaseline assessment excluding the exploratory participants.
    End point type
    Secondary
    End point timeframe
    Baseline, Cycle 3, Cycle 6 (Cycle = 28 days)
    Notes
    [7] - 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: No inferential statistical methods planned for this outcome.
    End point values
    		 Galunisertib at 150 mg
    Number of subjects analysed
    41
    Units: participants
        number (not applicable)
    11
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline through end of study treatment or death from any cause (Up to 2 years)
    Adverse event reporting additional description
    H9H-MC-JBAV
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Galunisertib at 150 mg
    Reporting group description
    		 Galunisertib at 150 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Participants will receive best supportive care (BSC) according to institutional guidelines.

    Reporting group title
    Galunisertib at 80 mg
    Reporting group description
    		 Exploratory arm: Galunisertib at 80 mg given orally twice daily (BID) for 14 days followed by 14... more days with no study drug (28 day cycles). Completed participants completed at least 6 cycles.

    Serious adverse events
    		 Galunisertib at 150 mg Galunisertib at 80 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 41 (19.51%)
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    cardiac failure
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    2 / 41 (4.88%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    febrile neutropenia
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lymphadenopathy
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    crohn's disease
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    retroperitoneal haemorrhage
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    respiratory failure
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    2 / 41 (4.88%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Infections and infestations
    pneumonia
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    respiratory syncytial virus infection
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tongue abscess
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 2 (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
    		 Galunisertib at 150 mg Galunisertib at 80 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    33 / 41 (80.49%)
    2 / 2 (100.00%)
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    3 / 41 (7.32%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    3 / 41 (7.32%)
    0 / 2 (0.00%)
         occurrences all number
    18
    0
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    5 / 41 (12.20%)
    1 / 2 (50.00%)
         occurrences all number
    13
    1
    fatigue
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    4 / 41 (9.76%)
    0 / 2 (0.00%)
         occurrences all number
    4
    0
    oedema peripheral
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    3 / 41 (7.32%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    pyrexia
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    5 / 41 (12.20%)
    0 / 2 (0.00%)
         occurrences all number
    8
    0
    Gastrointestinal disorders
    diarrhoea
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    7 / 41 (17.07%)
    0 / 2 (0.00%)
         occurrences all number
    8
    0
    nausea
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    3 / 41 (7.32%)
    0 / 2 (0.00%)
         occurrences all number
    4
    0
    vomiting
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    5 / 41 (12.20%)
    0 / 2 (0.00%)
         occurrences all number
    6
    0
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    rhinorrhoea
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    back pain
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    3 / 41 (7.32%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    Infections and infestations
    nasopharyngitis
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    4 / 41 (9.76%)
    0 / 2 (0.00%)
         occurrences all number
    4
    0

    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.
    The response rate at interim analysis did not meet the predefined rate. The Phase 3 portion was not initiated and the sponsor decided on early discontinuation of the study at the conclusion of Phase 2.
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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
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