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    Summary
    EudraCT Number:2010-019991-55
    Sponsor's Protocol Code Number:CC-10004-PSOR-008
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-09-22
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2010-019991-55
    A.3Full title of the trial
    A Phase 3, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of Apremilast (CC-10004) in subjects with moderate to severe plaque psoriasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 study of the safety and effectiveness of Apremilast versus placebo in patients with moderate to severe plaque psoriasis
    A.4.1Sponsor's protocol code numberCC-10004-PSOR-008
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCelgene Corporation
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCelgene Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointClinicalTrialsDisclosure
    B.5.3 Address:
    B.5.3.1Street Address9900 W. 109th Street, Suite 300, Building 70
    B.5.3.2Town/ cityOverland Park, Kansas
    B.5.3.3Post code66210
    B.5.3.4CountryUnited States
    B.5.4Telephone number001888260 1599
    B.5.5Fax number001913451 3459
    B.5.6E-mailClinicalTrialDisclosure@celgene.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameApremilast
    D.3.2Product code CC-10004
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNApremilast
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameApremilast
    D.3.2Product code CC-10004
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNApremilast
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameApremilast
    D.3.2Product code CC-10004
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNApremilast
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Psoriasis, a chronic inflammatory skin disorder, estimated to affect up to 2.5% of the world's population. Plaque-type psoriasis is the most common form of this disease.
    E.1.1.1Medical condition in easily understood language
    Moderate to severe plaque psoriasis
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10037153
    E.1.2Term Psoriasis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the clinical efficacy of apremilast 30 mg BID, compared with placebo, in subjects with moderate to severe plaque psoriasis
    E.2.2Secondary objectives of the trial
    - Evaluate the safety and tolerability of apremilast 30 mg BID, compared with placebo, in subjects with moderate to severe plaque psoriasis

    - Evaluate the effect of apremilast 30 mg BID compared with placebo on quality of life
    in subjects with moderate to severe plaque psoriasis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males or females, ≥ 18 years of age at the time of signing the informed consent document

    2. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted

    3. Able to adhere to the study visit schedule and other protocol requirements

    4. Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening

    5. Have moderate to severe plaque psoriasis at Screening and Baseline as defined by
    a. PASI score ≥ 12 and
    b. BSA ≥ 10%, and
    c. sPGA ≥ 3 (moderate)

    6. Must be a candidate for phototherapy and/or systemic therapy

    7. Must be in good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination, 12-lead ECG, clinical laboratories, and urinalysis

    8. Must meet the following laboratory criteria
    a. White blood cell count ≥ 3000/mm3 (≥ 3.0 x 109/L) and < 14,000/mm^3
    (< 14 x 10^9/L)
    b. Platelet count ≥100,000/μL (≥ 100 x 10^9/L)
    c. Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L)
    d. AST (SGOT) and ALT (SGPT) ≤ 2 x upper limit of normal (ULN)
    e. Total bilirubin ≤ 2 mg/dL (34 μmol/L)
    f. Hemoglobin ≥ 9 g/dL (≥ 5.6 mmol/L)
    g. Hemoglobin A1c ≤ 9.0 %

    9. Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use contraception† while on study medication and for at least 28 days after taking the last dose of study medication with either: 1) one highly effective form (non-oral hormonal, intrauterine device [IUD], tubal ligation, vasectomized partner); or 2) an oral hormonal contraceptive PLUS one additional form of barrier contraception (male or female latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane], diaphragm with spermicide, cervical cap with spermicide, contraceptive sponge with spermicide); or 3) two forms of barrier contraception (male or female latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) PLUS one of the following (diaphragm with spermicide, cervical cap with spermicide, contraceptive sponge with spermicide).

    Note: The protocol language regarding contraception has been revised. As this study is fully enrolled, the updated language regarding contraception is included in Section 6.2 (Contraception Education) of this amendment.

    † The female subject's chosen form of contraception must be effective by the time the female subject is randomized into the study (for example, hormonal contraception should be initiated at least 28 days before randomization).

    10. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex condom NOT made out of natural [animal] membrane [eg, polyurethane]) while on study medication and for at least 28 days after the last dose of study medication.
    E.4Principal exclusion criteria
    1. Other than psoriasis, history of any clinically significant (as determined by the
    Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease.

    2. Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.

    3. Any condition that confounds the ability to interpret data from the study.

    4. Pregnant or breast feeding

    5. History of allergy to any component of the IP

    6. Hepatitis B surface antigen positive at Screening

    7. Anti-hepatitis C antibody positive at Screening

    8. AST (SGOT) and/or ALT (SGPT) > 1.5 X ULN and total bilirubin > ULN and/or
    albumin < LLN

    9. Active tuberculosis (TB) or a history of incompletely treated TB

    10. Clinically significant abnormality on 12-Lead ECG at Screening

    11. Clinically significant abnormality based upon chest radiograph with at least PA view (radiograph must be taken within 12 weeks prior to Screening or during the Screening visit). An additional lateral view is strongly recommended but not required.

    12. History of positive human immunodeficiency virus (HIV), or have congenital or
    acquired immunodeficiency (eg, common variable immunodeficiency disease)

    13. Active substance abuse or a history of substance abuse within 6 months prior to
    Screening

    14. Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening. Any treatment for such infections must have been completed at least 4 weeks prior to Screening.

    15. Malignancy or history of malignancy (except for treated [ie, cured] basal cell or
    squamous cell in situ skin carcinomas and treated [ie, cured] cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix with no evidence of recurrence)

    16. Psoriasis flare or rebound within 4 weeks prior to Screening

    17. Evidence of skin conditions that would interfere with clinical assessments

    18. Topical therapy within 2 weeks of randomization (including but not limited to topical corticosteroids, topical retinoid or vitamin D analog preparations, tacrolimus,
    pimecrolimus, or anthralin/dithranol). Exceptions: low-potency corticosteroids (Class 6 or 7; please refer to the Investigators’ Manual) will be allowed as background therapy for treatment of the face, axillae, and groin in accordance with the manufacturers’ suggested usage during the course of the study. Subjects with scalp psoriasis will be permitted to use coal tar shampoo and/or salicylic acid scalp preparations on scalp lesions. An unmedicated skin moisturizer (eg, Eucerin®) will be also permitted for body lesions only. Subjects should not use these topical treatments within 24 hours prior to the clinic visit.

    19. Systemic therapy for psoriasis within 4 weeks prior to randomization (including but not limited to cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine, fumaric acid esters)

    20. Use of phototherapy within 4 weeks prior to randomization (ie, UVB, PUVA)

    21. Adalimumab, etanercept, efalizumab, infliximab, or certolizumab pegol within 12 weeks prior to randomization

    22. Alefacept, briakinumab, or ustekinumab within 24 weeks prior to randomization

    23. Use of any investigational drug within 4 weeks prior to randomization, or 5
    pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer)

    24. Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources

    25. Prior treatment with apremilast
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects treated with either apremilast 30 mg BID or placebo who achieve at least a 75% reduction in PASI (PASI-75) at Week 16 from baseline
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Baseline (pre-dose) to Week 16
    E.5.2Secondary end point(s)
    Major Secondary
    1) Proportion of subjects treated with either apremilast 30 mg BID or placebo with a sPGA score of clear (0) or almost clear (1) with at least 2 points reduction from baseline at Week 16 [Time Frame: From Baseline (pre-dose) to Week 16]

    Efficacy
    1) Percent change from Baseline in percent of affected BSA at Week 16 [Time Frame: From Baseline (pre-dose) to Week 16]
    2) Percent change in the PASI score from the Baseline Visit at Week 16 [Time Frame: From Baseline (pre-dose) to Week 16]
    3) Proportion of subjects who achieve PASI-50 at Week 16 [Time Frame: Week 16]
    4) Change from Baseline in Pruritus VAS at Week 16 [Time Frame: From Baseline (pre-dose) to Week 16]
    5) Change from baseline in DLQI total score at Week 16 [Time Frame: From baseline (pre-dose) to Week 16]
    6) Change from baseline in Mental Component Summary (MCS) score of SF-36 at Week 16 [Time Frame: From Baseline (pre-dose) to Week 16]
    7) Proportion of subjects who achieve both PASI-75 and sPGA score of clear (0) or almost clear (1) with at least 2 points reduction from Baseline at Week 16 [Time Frame: From Baseline (pre-dose) to Week 16]
    8) Time to loss of PASI-75 response (loss of effect) during the Randomized Treatment Withdrawal Phase [Time Frame: Week 32 until approximately Week 52]

    Safety

    Safety as defined by:
    - Type, frequency, severity, seriousness, and relationship of adverse events to apremilast [Time Frame: From the time of Informed Consent, through dosing, and for 28 days after the last dose of study medication.]
    - Number of subjects who prematurely discontinue IP due to an adverse event [Time Frame: From the time of Informed Consent, through dosing, and for 28 days after the last dose of study medication.]
    - Frequency of clinically significant changes in physical examination, vital signs, electrocardiogram, and/or laboratory findings [Time Frame: From the time of Informed Consent, through dosing, and for 28 days after the last dose of study medication.]
    - Psoriasis flare or rebound [Time Frame: From the time of Informed Consent, through dosing, and for 28 days after the last dose of study medication.]
    E.5.2.1Timepoint(s) of evaluation of this end point
    SEE ABOVE FOR TIME POINTS
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    See protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 740
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 85
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 505
    F.4.2.2In the whole clinical trial 825
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    see protocol
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-11-22
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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