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    Clinical Trial Results:
    Efficacy and safety of twice-daily application of delgocitinib cream 20 mg/g for 6 weeks in subjects with active discoid lupus erythematosus. A phase 2a exploratory, randomised, double-blind, vehicle-controlled, within-subject, multi-centre trial.

    Summary
    EudraCT number
    		 2018-003615-22
    Trial protocol
    		 DE   DK   FR  
    Global end of trial date
    30 Apr 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Apr 2021
    First version publication date
    30 Apr 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EXP-1373
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03958955
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    LEO Pharma A/S
    Sponsor organisation address
    Industriparken 55, Ballerup, Denmark, 2750
    Public contact
    Clinical Disclosure Specialist, LEO Pharma A/S, +45 4494 5888, disclosure@leo-pharma.com
    Scientific contact
    Clinical Disclosure Specialist, LEO Pharma A/S, +45 4494 5888, disclosure@leo-pharma.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
    06 Jul 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Apr 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To investigate the efficacy of delgocitinib cream 20 mg/g twice daily on active discoid lupus erythematosus (DLE) target lesions.
    Protection of trial subjects
    This clinical trial was conducted in accordance with the revision, current at the start of the trial, of the World Medical Association’s Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. All subjects received written and verbal information concerning the clinical trial. This information emphasised that participation in the clinical trial was voluntary and that the subject could withdraw from the clinical trial at any time and for any reason. All subjects were given an opportunity to ask questions and were given sufficient time to consider before consenting. Subjects' signed and dated informed consent to participate in the clinical trial were obtained prior to any trial related activities being carried out in accordance with ICH Good Clinical Practice (GCP) Section 4.8 and all applicable laws and regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Jul 2019
    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
    Denmark: 1
    Country: Number of subjects enrolled
    France: 5
    Country: Number of subjects enrolled
    Germany: 17
    Country: Number of subjects enrolled
    United States: 4
    Worldwide total number of subjects
    27
    EEA total number of subjects
    23
    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)
    25
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 37 subjects screened. 27 subjects randomised. 26 subjects completed.

    Pre-assignment
    Screening details
    		 A screening visit took place 7 to 28 days before the first application of investigational medicinal product (IMP). To be eligible for participation in the trial each subject had to have at least 2 discoid lupus erythematosus (DLE) target lesions with active disease (referred to as lesions 1 and 2) fulfilling the inclusion criteria.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    The packaging and labelling of the IMPs were indistinguishable with no evidence of their identity. There was a slight difference in colour between the 2 IMPs, which was only discernible on close inspection with both IMPs compared side by side. To avoid accidental investigator unblinding, the first application of IMPs and instructions to the subjects was only done by designated trial site staff who were not involved in clinical evaluations.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Delgocitinib cream 20 mg/g
    Arm description
    		 This arm represents the DLE lesion that was treated with active IMP - delgocitinib cream 20 mg/g. All 27 subjects received delgocitinib cream 20 mg/g on one DLE target lesion and delgocitinib cream vehicle on another DLE target lesion twice daily for 6 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Delgocitinib cream 20 mg/g
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    The IMPs (delgocitinib cream and vehicle) were administered as topical applications twice daily, approximately 12 hours apart in the morning and in the evening, in an even layer to cover the entire treatment area, for 6 weeks. The treatment area of each of the 2 target lesions (lesions 1 and 2) of a subject was defined as the lesion area at baseline plus a margin of approximately 1 cm. The amount of IMP to be applied to each treatment area was dependent on the size of the target lesions. If a target lesion was: • Unchanged or decreased in size, the treatment area was kept constant during the treatment period, even if the symptoms improved. • Increased in size, the treatment area was increased correspondingly.

    Arm title
    		 Delgocitinib cream vehicle
    Arm description
    		 This arm represents the DLE lesion that was treated with vehicle - delgocitinib cream vehicle. All 27 subjects received delgocitinib cream 20 mg/g on one DLE target lesion and delgocitinib cream vehicle on another DLE target lesion twice daily for 6 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Delgocitinib vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    The IMPs (delgocitinib cream and vehicle) were administered as topical applications twice daily, approximately 12 hours apart in the morning and in the evening, in an even layer to cover the entire treatment area, for 6 weeks. The treatment area of each of the 2 target lesions (lesions 1 and 2) of a subject was defined as the lesion area at baseline plus a margin of approximately 1 cm. The amount of IMP to be applied to each treatment area was dependent on the size of the target lesions. If a target lesion was: • Unchanged or decreased in size, the treatment area was kept constant during the treatment period, even if the symptoms improved. • Increased in size, the treatment area was increased correspondingly.

    Number of subjects in period 1
    		Delgocitinib cream 20 mg/g Delgocitinib cream vehicle
    Started
    27
    27
    Completed
    26
    26
    Not completed
    1
    1
         Adverse event, non-fatal
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 Baseline

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 27 27
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 25 25
        From 65-84 years
    		 2 2
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45.7 ± 13.4 -
    Gender categorical
    Units: Subjects
        Female
    		 15 15
        Male
    		 12 12
    Subject analysis sets

    Subject analysis set title
    Randomised subjects
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All 27 randomised subjects were included in the full analysis set (FAS).

    Subject analysis set title
    Exposed subjects
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    27 subjects received at least 1 dose of IMP.

    Subject analysis set title
    Primary analysis set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    5 subjects were excluded from the per protocol (PP) analysis set as the primary endpoint data were compromised. The PP analysis set hence comprised 22 (81.5%) subjects. Data at Week 8 was excluded from the PP analysis set for 2 subjects, as they used prohibited concomitant medication in the safety follow-up period.

    Subject analysis sets values
    		 Randomised subjects Exposed subjects Primary analysis set
    Number of subjects
    27
    27
    22
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    25
    25
        From 65-84 years
    2
    2
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    Delgocitinib cream 20 mg/g
    Reporting group description
    		 This arm represents the DLE lesion that was treated with active IMP - delgocitinib cream 20 mg/g. All 27 subjects received delgocitinib cream 20 mg/g on one DLE target lesion and delgocitinib cream vehicle on another DLE target lesion twice daily for 6 weeks.

    Reporting group title
    Delgocitinib cream vehicle
    Reporting group description
    		 This arm represents the DLE lesion that was treated with vehicle - delgocitinib cream vehicle. All 27 subjects received delgocitinib cream 20 mg/g on one DLE target lesion and delgocitinib cream vehicle on another DLE target lesion twice daily for 6 weeks.

    Subject analysis set title
    Randomised subjects
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All 27 randomised subjects were included in the full analysis set (FAS).

    Subject analysis set title
    Exposed subjects
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    27 subjects received at least 1 dose of IMP.

    Subject analysis set title
    Primary analysis set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    5 subjects were excluded from the per protocol (PP) analysis set as the primary endpoint data were compromised. The PP analysis set hence comprised 22 (81.5%) subjects. Data at Week 8 was excluded from the PP analysis set for 2 subjects, as they used prohibited concomitant medication in the safety follow-up period.

    Primary: Target lesions with Investigator’s Global Assessment (IGA)a score of 0 or 1 at Week 6.

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    End point title
    		 Target lesions with Investigator’s Global Assessment (IGA)a score of 0 or 1 at Week 6.
    End point description
    End point type
    Primary
    End point timeframe
    At week 6
    End point values
    		 Delgocitinib cream 20 mg/g Delgocitinib cream vehicle
    Number of subjects analysed
    22
    22
    Units: lesions
    3
    6
    Statistical analysis title
    		 Primary endpoint: IGA score of 0 or 1
    Statistical analysis description
    22 subjects with 2 DLE lesions each (44 DLE lesions in total). Each subject had one DLE lesion treated with delgocitinib cream 20 mg/g and another DLE lesion treated with delgocitinib cream vehicle. Attributable risk is defined as the difference in estimated probability of treatment success of delgocitinib compared to vehicle. Success is defined as having an IGA score of 0 (clear) or 1 (almost clear) at Week 6.
    Comparison groups
    Delgocitinib cream 20 mg/g v Delgocitinib cream vehicle
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4531 [1]
    Method
    		 Mcnemar
    Parameter type
    		 Attributable risk
    Point estimate
    -0.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.37
         upper limit
    		 0.09
    Notes
    [1] - Exact p-value of McNemar's test

    Secondary: Number of Adverse Events (AEs) up to Week 6

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    End point title
    		 Number of Adverse Events (AEs) up to Week 6
    End point description
    End point type
    Secondary
    End point timeframe
    Week 0 to week 6
    End point values
    		 Exposed subjects
    Number of subjects analysed
    27 [2]
    Units: Adverse events
    8
    Notes
    [2] - Safety analysis set
    No statistical analyses for this end point

    Secondary: Number of Subjects With AEs up to Week 6

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    End point title
    		 Number of Subjects With AEs up to Week 6
    End point description
    End point type
    Secondary
    End point timeframe
    Week 0 to week 6
    End point values
    		 Exposed subjects
    Number of subjects analysed
    27 [3]
    Units: subjects
    8
    Notes
    [3] - Safety analysis set
    No statistical analyses for this end point

    Secondary: Number of Lesion-specific, Treatment-related AEs up to Week 6.

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    End point title
    		 Number of Lesion-specific, Treatment-related AEs up to Week 6.
    End point description
    End point type
    Secondary
    End point timeframe
    Week 0 to week 6
    End point values
    		 Delgocitinib cream 20 mg/g Delgocitinib cream vehicle Exposed subjects
    Number of subjects analysed
    27
    27
    27 [4]
    Units: adverse events
    2
    0
    2
    Notes
    [4] - Per protocol (PP) analysis set
    Statistical analysis title
    		 Lesions with IMP related lesion-specific AEs
    Statistical analysis description
    27 subjects with 2 DLE lesions each (54 DLE lesions in total). Each subject had one DLE lesion treated with delgocitinib cream 20 mg/g and another DLE lesion treated with delgocitinib cream vehicle. Attributable risk is defined as the difference in estimated probability of treatment success of delgocitinib compared to vehicle.
    Comparison groups
    Delgocitinib cream 20 mg/g v Delgocitinib cream vehicle
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5 [5]
    Method
    		 Mcnemar
    Parameter type
    		 Attributable risk
    Point estimate
    0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.02
         upper limit
    		 0.17
    Notes
    [5] - Exact p-value of McNemar's test.

    Secondary: A ≥2-point Reduction in IGA Score at Week 6 Compared to Baseline.

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    End point title
    		 A ≥2-point Reduction in IGA Score at Week 6 Compared to Baseline.
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to Week 6
    End point values
    		 Delgocitinib cream 20 mg/g Delgocitinib cream vehicle
    Number of subjects analysed
    22
    22
    Units: lesions ≥2-point reduction in IGA at W6
        number (not applicable)
    3
    6
    Statistical analysis title
    		 At least 2-point reduction in IGA score at Week 6
    Statistical analysis description
    22 subjects with 2 DLE lesions each (44 DLE lesions in total). Each subject had one DLE lesion treated with delgocitinib cream 20 mg/g and another DLE lesion treated with delgocitinib cream vehicle. Attributable risk is defined as the difference in estimated probability of treatment success of delgocitinib compared to vehicle. Success is defined as having at least a 2-point reduction in IGA score from baseline to Week 6.
    Comparison groups
    Delgocitinib cream 20 mg/g v Delgocitinib cream vehicle
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4531 [6]
    Method
    		 Mcnemar
    Parameter type
    		 Attributable risk
    Point estimate
    -0.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.37
         upper limit
    		 0.09
    Notes
    [6] - Exact p-value of McNemar's test.

    Secondary: A ≥2-point Reduction in Erythema Score at Week 6 Compared to Baseline.

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    End point title
    		 A ≥2-point Reduction in Erythema Score at Week 6 Compared to Baseline.
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to Week 6
    End point values
    		 Delgocitinib cream 20 mg/g Delgocitinib cream vehicle
    Number of subjects analysed
    22
    22
    Units: lesions with ≥2-point reduction at W6
        number (not applicable)
    5
    5
    Statistical analysis title
    		 At least 2-point reduction in erythema score at W6
    Statistical analysis description
    22 subjects with 2 DLE lesions each (44 DLE lesions in total). Each subject had one DLE lesion treated with delgocitinib cream 20 mg/g and another DLE lesion treated with delgocitinib cream vehicle. Attributable risk is defined as the difference in estimated probability of treatment success of delgocitinib compared to vehicle. Success is defined as having at least a 2-point reduction in IGA score from baseline to Week 6.
    Comparison groups
    Delgocitinib cream 20 mg/g v Delgocitinib cream vehicle
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1 [7]
    Method
    		 McNemar's test
    Parameter type
    		 Attributable risk
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.22
         upper limit
    		 0.22
    Notes
    [7] - Exact p-value of McNemar's test.

    Secondary: Erythema Score at Week 6

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    End point title
    		 Erythema Score at Week 6
    End point description
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Delgocitinib cream 20 mg/g Delgocitinib cream vehicle
    Number of subjects analysed
    22 [8]
    22 [9]
    Units: Erythema score
        median (inter-quartile range (Q1-Q3))
    1.5 (1 to 2)
    1.5 (1 to 2)
    Notes
    [8] - Per protocol (PP) analysis set
    [9] - Per protocol (PP) analysis set
    Statistical analysis title
    		 Erythema score at Week 6
    Statistical analysis description
    22 subjects with 2 DLE lesions each (44 DLE lesions in total). Each subject had one DLE lesion treated with delgocitinib cream 20 mg/g and another DLE lesion treated with delgocitinib cream vehicle. Erythema is scored as 0=absent, 1=pink, faint, 2=red, 3=dark red, purple/violaceous/crusted/haemorrhagic.
    Comparison groups
    Delgocitinib cream 20 mg/g v Delgocitinib cream vehicle
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5797 [10]
    Method
    		 Wilcoxon signed rank test
    Confidence interval
    Notes
    [10] - p-value of the Wilcoxon signed rank test.

    Secondary: Total Skin Disease Activity Score (Sum of Scores for Erythema, Scaling/Hyperkeratosis, and Oedema/Infiltration) at Week 6.

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    End point title
    		 Total Skin Disease Activity Score (Sum of Scores for Erythema, Scaling/Hyperkeratosis, and Oedema/Infiltration) at Week 6.
    End point description
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Delgocitinib cream 20 mg/g Delgocitinib cream vehicle
    Number of subjects analysed
    22 [11]
    22 [12]
    Units: Total Skin Disease Activity Score
        median (inter-quartile range (Q1-Q3))
    2.5 (2 to 4)
    2.5 (1 to 4)
    Notes
    [11] - Per protocol (PP) analysis set
    [12] - Per protocol (PP) analysis set
    Statistical analysis title
    		 Total skin disease activity score at Week 6
    Statistical analysis description
    22 subjects with 2 DLE lesions each (44 DLE lesions in total). Each subject had one DLE lesion treated with delgocitinib cream 20 mg/g and another DLE lesion treated with delgocitinib cream vehicle. Total skin disease activity score is the sum of the scores for erythema, scaling/hyperkeratosis, and oedema/infiltration. Total skin disease activity score ranges from 0 to 7 with lower score indicating better state.
    Comparison groups
    Delgocitinib cream 20 mg/g v Delgocitinib cream vehicle
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7862 [13]
    Method
    		 Wilcoxon signed rank test
    Confidence interval
    Notes
    [13] - p-value of the Wilcoxon signed rank test.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to Week 8
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Randomised subjects
    Reporting group description
    		 All subjects received delgocitinib cream 20 mg/g on one DLE target lesion and delgocitinib cream vehicle on another DLE target lesion twice daily for 6 weeks. Delgocitinib cream 20 mg/g: Cream for topical application. Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.

    Serious adverse events
    		 Randomised subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 27 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Randomised subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 27 (29.63%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    General disorders and administration site conditions
    Application site pain
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    2
    Application site pruritus
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Middle ear inflammation
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Gastrointestinal disorders
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Cutaneous lupus erythematosus
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Rash erythematous
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 27 (14.81%)
         occurrences all number
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 May 2019
    Amendment 1 (substantial, global, 15-May-2019): The protocol was amended to address comments mainly from the German authorities and ethics committee, who requested further specification of details about e.g. lab procedures, re-assessment of eligibility, and discontinuation of IMP, as well as correction of inconsistencies regarding wording of the primary endpoint and exclusion criteria.
    22 Oct 2019
    Amendment 2 (substantial, global, 22-Oct-2019): The protocol was amended to address recruitment issues. DLE is a rare disease, and the number of patients eligible for this trial was limited. The exclusion criteria concerning tobacco use and hepatitis B serology (exclusion criteria 17 and 26) were therefore modified to ease recruitment without compromising the safety of the subjects and the evaluation of trial results.

    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 trial was terminated prematurely due to slow recruitment, and due to an anticipation that recruitment would become further delayed due to the COVID-19 pandemic affecting recruitment activities.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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