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    Clinical Trial Results:
    Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients with Moderate to Severe Ulcerative Colitis

    Summary
    EudraCT number
    2014-001893-32
    Trial protocol
    CZ   HU   BE   DE   PL  
    Global end of trial date
    09 Nov 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    24 Nov 2016
    First version publication date
    24 Nov 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GLPG1205-CL-211
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02337608
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Galapagos NV
    Sponsor organisation address
    Generaal De Wittelaan L11 A3, Mechelen, Belgium, 2800
    Public contact
    Clinical Trial Information Desk, Galapagos NV, +32 15 342 900, rd@glpg.com
    Scientific contact
    Clinical Trial Information Desk, Galapagos NV, +32 15 342 900, rd@glpg.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
    01 Apr 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Nov 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary objective: - To explore the efficacy of GLPG1205 versus placebo in subjects with UC by use of the Mayo score comparing results at Week 8 to baseline. Secondary objectives: - To explore the efficacy of GLPG1205 versus placebo in subjects with UC by use of the partial Mayo score comparing results with baseline. - To explore the efficacy of GLPG1205 versus placebo in subjects with UC by use of the histopathological Geboes Index comparing results at Week 8 with baseline. - To evaluate the safety and tolerability of GLPG1205 given to subjects with moderate to severe UC for 12 weeks compared with placebo. - To characterize the PK of GLPG1205 in subjects with UC. - To explore the effects of GLPG1205 on selected biomarkers (e.g., fecal calprotectin, myeloperoxidase (MPO), C-reactive protein [CRP]).
    Protection of trial subjects
    This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. In addition, this clinical study was conducted in compliance with all international and national laws and regulations, as well as any applicable guidelines of the countries in which the clinical study was performed. A signed and dated informed consent was required before any screen procedures were done. The Investigators were to explain the nature, purpose, and risks of the study to each subject. Each subject was to be informed that he/she could withdraw from the study at any time and for any reason. Each subject was to be given sufficient time to consider the implications of the study before deciding whether to participate. Subjects who chose to participate had to sign an informed consent document. A copy of the signed and dated written informed consent form (ICF) was to be provided to the subject.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    17 Dec 2014
    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
    Belgium: 4
    Country: Number of subjects enrolled
    Czech Republic: 9
    Country: Number of subjects enrolled
    Germany: 7
    Country: Number of subjects enrolled
    Hungary: 6
    Country: Number of subjects enrolled
    Poland: 21
    Country: Number of subjects enrolled
    Russian Federation: 16
    Worldwide total number of subjects
    63
    EEA total number of subjects
    47
    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)
    62
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects were enrolled at study sites in Europe. The first participant was randomised on 17 December 2014. The last visit occurred on 9 November 2015.

    Pre-assignment
    Screening details
    102 subjects were screened.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    GLPG1205
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    GLPG1205
    Investigational medicinal product code
    G321605
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 100 mg GLPG1205 (2 capsules of 50 mg) qd for 12 weeks. The GLPG1205 capsules had to be taken orally with a glass of water in the morning.

    Arm title
    Placebo
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 100 mg placebo (2 capsules of 50 mg) qd for 12 weeks. The placebo capsules had to be taken orally with a glass of water in the morning.

    Number of subjects in period 1
    GLPG1205 Placebo
    Started
    42
    21
    Completed
    31
    18
    Not completed
    11
    3
         Treatment failure
    3
    1
         Adverse event, non-fatal
    6
    1
         Consent withdrawn by subject
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GLPG1205
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Reporting group values
    GLPG1205 Placebo Total
    Number of subjects
    42 21 63
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    0 0 0
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
        Between 18-75 years of age, inclusive
    42 21 63
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    38.7 (20 to 72) 41.5 (19 to 61) -
    Gender categorical
    Units: Subjects
        Female
    11 10 21
        Male
    31 11 42
    Subject analysis sets

    Subject analysis set title
    GLPG1205 change vs Baseline
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    All randomized subjects who had at least 1 dose of study drug and had at least 1 post-baseline assessment with efficacy data.

    Subject analysis set title
    Placebo vs Baseline
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Mayo Score

    Subject analysis sets values
    GLPG1205 change vs Baseline Placebo vs Baseline
    Number of subjects
    40
    21
    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)
    0
    0
        From 65-84 years
    0
    0
        85 years and over
    0
    0
        Between 18-75 years of age, inclusive
    40
    21
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    GLPG1205
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Subject analysis set title
    GLPG1205 change vs Baseline
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    All randomized subjects who had at least 1 dose of study drug and had at least 1 post-baseline assessment with efficacy data.

    Subject analysis set title
    Placebo vs Baseline
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Mayo Score

    Primary: Efficacy: Mayo Score Week 8

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    End point title
    Efficacy: Mayo Score Week 8
    End point description
    The Mayo score equals the sum of the 4 subscores (stool frequency, rectal bleeding, physician's global assessment and Mayo endoscopic subscore) and therefore ranges from 0 to 12. A score of ≤ 2 is considered remission, a score of 3 to 5 is considered mild, a score of 6 to 10 is considered moderate, and a score of 11 to 12 is considered severe.
    End point type
    Primary
    End point timeframe
    Week 8
    End point values
    GLPG1205 Placebo GLPG1205 change vs Baseline Placebo vs Baseline
    Number of subjects analysed
    40
    21
    40
    21
    Units: Score
    arithmetic mean (full range (min-max))
        Week 8
    6.8 (0 to 11)
    6.3 (0 to 11)
    -2 (-8 to 3)
    -2.4 (-9 to 1)
    Statistical analysis title
    Mayo score Week 8
    Comparison groups
    GLPG1205 v Placebo
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.5005
    Method
    ANCOVA
    Confidence interval

    Primary: Efficacy: Mayo Score: Derived Responses at Week 8

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    End point title
    Efficacy: Mayo Score: Derived Responses at Week 8
    End point description
    A summary of the Mayo clinical response, clinical remission, mucosal healing, and endoscopic response per treatment group at Week 8
    End point type
    Primary
    End point timeframe
    Week 8
    End point values
    GLPG1205 Placebo
    Number of subjects analysed
    40
    21
    Units: Percentage
    number (not applicable)
        Mayo response
    40
    47.6
        Mayo remission
    5
    4.8
        Endoscopic response
    10
    23.8
        Mucosal healing
    5
    9.5
    Statistical analysis title
    Mayo Score: derived responses at week 8
    Comparison groups
    GLPG1205 v Placebo
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.6143 [1]
    Method
    Regression, Logistic
    Confidence interval
    Notes
    [1] - Mayo response (p-value=0.6143) Mayo remission (p-value=0.9084) Endoscopic response (p-value=0.1865) Mucosal healing (p-value=0.5519) There was no statistically significant difference between GLPG1205 and placebo.

    Secondary: Efficacy: Partial Mayo Score

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    End point title
    Efficacy: Partial Mayo Score
    End point description
    The Partial Mayo consists of the clinical components only of the MAYO only, namely stool frequency, rectal bleeding and physician's global assessment. Partial Mayo score ranges from 0 to 9, with higher scores indicating a more severe disease.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 12
    End point values
    GLPG1205 Placebo GLPG1205 change vs Baseline Placebo vs Baseline
    Number of subjects analysed
    40
    21
    40
    21
    Units: Severity
    arithmetic mean (full range (min-max))
        Week 4
    5.2 (1 to 8)
    4.3 (0 to 8)
    -1 (-6 to 2)
    -1.7 (-6 to 2)
        Week 8
    4.3 (0 to 8)
    4 (0 to 8)
    -1.9 (-7 to 2)
    -2 (-6 to 1)
        Week 12
    3.8 (0 to 8)
    3.5 (0 to 9)
    -2.4 (-8 to 2)
    -2.5 (-6 to 2)
    No statistical analyses for this end point

    Secondary: Efficacy: Geboes Index

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    End point title
    Efficacy: Geboes Index
    End point description
    The Geboes Index is the highest grade with a sub-grade above 0 and ranges from 0.0 to 5.4, with higher scores indicating a more severe disease. Scores: 0 = Structural (architectural change), 1 = Chronic inflammatory infiltrate, 2A = Lamina propria eosinophils, 2B = Lamina propria neutrophils, 3 = Neutrophils in epithelium, 4 = Cruypt destruction, 5 = Erosion or ulceration.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    GLPG1205 Placebo
    Number of subjects analysed
    40
    21
    Units: Subjects
    40
    21
    Attachments
    Untitled (Filename: Table 20 Week 8 Geboes Index Shift Table.pdf)
    No statistical analyses for this end point

    Secondary: Pharmacokinetics

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    End point title
    Pharmacokinetics
    End point description
    On average, the plasma concentration of GLPG1205 in subjects with UC were within the range of the GLPG1205 plasma concentrations seen in healthy subjects who were administered GLPG1205 100 mg qd. However, some subjects showed GLPG1205 plasma concentrations that were out of the range that was observed in healthy subjects who were administered GLPG1205 at the same dose of 100 mg qd.
    End point type
    Secondary
    End point timeframe
    A blood sample for analysis of GLPG1205 in blood plasma was collected at Week 4, 8 and 12
    End point values
    GLPG1205 Placebo
    Number of subjects analysed
    37
    0 [2]
    Units: Subjects
    37
    Notes
    [2] - Not applicable
    No statistical analyses for this end point

    Secondary: Pharmacodynamics: Fecal Calprotectin

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    End point title
    Pharmacodynamics: Fecal Calprotectin
    End point description
    A stool sample for the assessment of fecal calprotectin levels will be assessed as a marker for intestinal inflammatory activity.
    End point type
    Secondary
    End point timeframe
    Fecal calprotectin analysis on stool samples: Week 4, 8 and 12
    End point values
    GLPG1205 Placebo GLPG1205 change vs Baseline Placebo vs Baseline
    Number of subjects analysed
    40
    21
    40
    21
    Units: mg/kg
    arithmetic mean (full range (min-max))
        Week 4
    748.5 (8 to 5546)
    490.8 (8 to 3791)
    -268.2 (-6363 to 3815)
    45.9 (-881 to 2206)
        Week 8
    563.3 (8 to 5546)
    540.3 (8 to 5063)
    -453.1 (-6394 to 2455)
    95.3 (-1396 to 4140)
        Week 12
    781 (8 to 5937)
    655.2 (8 to 4582)
    -235.7 (-6394 to 5590)
    210.2 (-1396 to 3659)
    No statistical analyses for this end point

    Secondary: Pharmacodynamics: Myeloperoxidase Week 8

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    End point title
    Pharmacodynamics: Myeloperoxidase Week 8
    End point description
    Lamina Propria MPO Positive vs. Stromal (%)
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    GLPG1205 Placebo GLPG1205 change vs Baseline Placebo vs Baseline
    Number of subjects analysed
    40
    21
    40
    21
    Units: % of MPO positive cells vs stromal cells
    arithmetic mean (full range (min-max))
        Week 8 25 cm (Distal Sigmoid)
    8.9 (1 to 35)
    9 (1 to 37)
    0.6 (-2.2 to 3.3)
    0.7 (-12 to 33)
        Week 8 (Most Inflammed)
    10.2 (1 to 35)
    10.8 (2 to 35)
    1 (-1.4 to 3.5)
    0.7 (-9 to 26)
    No statistical analyses for this end point

    Secondary: Pharmacodynamics: serum C-reactive Protein (CRP) Week 4, 8, 12

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    End point title
    Pharmacodynamics: serum C-reactive Protein (CRP) Week 4, 8, 12
    End point description
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 12
    End point values
    GLPG1205 Placebo GLPG1205 change vs Baseline Placebo vs Baseline
    Number of subjects analysed
    40
    21
    40
    21
    Units: mg/L
    arithmetic mean (full range (min-max))
        Week 4
    10.7 (1 to 153)
    5.6 (0 to 24)
    2 (-55 to 140)
    0.5 (-16 to 20)
        Week 8
    11.4 (0 to 153)
    4.9 (0 to 23)
    2.7 (-56 to 140)
    -0.3 (-17 to 6)
        Week 12
    10.6 (0 to 153)
    4.5 (0 to 22)
    1.9 (-56 to 140)
    -0.7 (-16 to 21)
    No statistical analyses for this end point

    Secondary: Safety: TEAE

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    End point title
    Safety: TEAE
    End point description
    (S)AE / TEAE: reference is made to the adverse events section. The total number of subjects with at least one treatment-emergent adverse event (TEAE) was 9 (42.9%) subjects in the placebo group and 26 (61.9%) subjects in the GLPG1205 group.
    End point type
    Secondary
    End point timeframe
    From screening untill follow-up visit
    End point values
    GLPG1205 Placebo
    Number of subjects analysed
    42
    21
    Units: subjects
        TEAE
    26
    9
        SAE
    8
    0
    No statistical analyses for this end point

    Secondary: Safety: physical examination, vital signs, ECG, clinical laboratory

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    End point title
    Safety: physical examination, vital signs, ECG, clinical laboratory
    End point description
    There were no clinically meaningful trends in changes from baseline for any vital signs, ECG, or physical examination variables. There were no clinically relevant abnormalities reported on laboratory assessments. However, in the GLPG1205 group, there was a larger increase in creatinine compared to the placebo group.
    End point type
    Secondary
    End point timeframe
    Week 4, 8 , 12 and follow-up for physical exam, no week 8
    End point values
    GLPG1205 Placebo
    Number of subjects analysed
    42
    21
    Units: Subjects
    42
    21
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From screening until follow-up visit
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    GLPG1205
    Reporting group description
    The total number of subjects with at least one treatment-emergent adverse event (TEAE) was 26 (61.9%) subjects in the GLPG1205 group . In the GLPG1205 group, the highest number of subjects with TEAEs were observed the Gastrointestinal disorders SOC (11 [26.2%]), mainly with the preferred term (PT) of UC (4 [9.5%]) and nausea (3 [7.1%]).

    Reporting group title
    Placebo
    Reporting group description
    The total number of subjects with at least one treatment-emergent adverse event (TEAE) was 9 (42,9%) subjects in the placebo group. In the placebo group, the highest number of subjects with TEAEs came from the Gastrointestinal disorders SOC (3 [14.3%]) and Nervous system disorders SOC (3 [14.3%]).

    Serious adverse events
    GLPG1205 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 42 (19.05%)
    0 / 21 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    anemia
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    4 / 42 (9.52%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash macular
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    1 / 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
    GLPG1205 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 42 (61.90%)
    9 / 21 (42.86%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 21 (4.76%)
         occurrences all number
    3
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 42 (11.90%)
    1 / 21 (4.76%)
         occurrences all number
    5
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 42 (9.52%)
    2 / 21 (9.52%)
         occurrences all number
    4
    2
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    5 / 42 (11.90%)
    1 / 21 (4.76%)
         occurrences all number
    5
    1
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    4 / 42 (9.52%)
    0 / 21 (0.00%)
         occurrences all number
    4
    0
    Nausea
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 21 (0.00%)
         occurrences all number
    3
    0
    Flatulence
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 42 (4.76%)
    1 / 21 (4.76%)
         occurrences all number
    2
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Nov 2014
    The reasons for clinical study protocol amendment (CSPA) 1 were as follows: - Updated the emergency contact email address. - In the Risk Benefit section, the interaction with several CYPs was clarified and information about drug transporters was added. - In the Removal from Subjects from Therapy Assessment section, the definition of disease worsening was added. - In the Prior and Concomitant Therapy section, guidance on possible drug-drug interactions was added.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    The status of studies in GB is no longer updated from 1.1.2021
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