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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled, multi-center study of the efficacy and safety of STG320 sublingual tablets of house dust mite (HDM) allergen extracts in adults and adolescents with HDM-associated allergic rhinitis

    Summary
    EudraCT number
    		 2014-004223-46
    Trial protocol
    		 BE   SK   DE   CZ   BG   PL   ES   IT  
    Global end of trial date
    25 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Oct 2019
    First version publication date
    04 Oct 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SL75.14
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02443805
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 16252: IND Number
    Sponsors
    Sponsor organisation name
    Stallergenes Greer
    Sponsor organisation address
    6 rue Alexis de Tocqueville, Antony, France, 92160
    Public contact
    Director of Clinical Development, Stallergenes Greer, 0033 155592556, martine.legall@stallergenesgreer.com
    Scientific contact
    Director of Clinical Development, Stallergenes Greer, 0033 155592556, martine.legall@stallergenesgreer.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
    12 Jul 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Jun 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study was to assess the efficacy and safety of 12 months of treatment with 300 IR of STG320 sublingual tablets compared with placebo in adults and adolescents with HDM-associated allergic rhinitis.
    Protection of trial subjects
    An independent Data and Safety Monitoring Board was responsible for assuring that study patients were not exposed to unnecessary or unreasonable risks and that the study was being conducted according to high scientific and ethical standards.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Sep 2015
    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
    Belgium: 40
    Country: Number of subjects enrolled
    Bulgaria: 74
    Country: Number of subjects enrolled
    Canada: 173
    Country: Number of subjects enrolled
    Czech Republic: 138
    Country: Number of subjects enrolled
    France: 37
    Country: Number of subjects enrolled
    Germany: 88
    Country: Number of subjects enrolled
    Israel: 50
    Country: Number of subjects enrolled
    Italy: 16
    Country: Number of subjects enrolled
    Poland: 382
    Country: Number of subjects enrolled
    Russian Federation: 49
    Country: Number of subjects enrolled
    Slovakia: 158
    Country: Number of subjects enrolled
    Spain: 60
    Country: Number of subjects enrolled
    United States: 342
    Worldwide total number of subjects
    1607
    EEA total number of subjects
    993
    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)
    343
    Adults (18-64 years)
    1262
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted between 29 September 2015 (first patient, first visit) and 25 June 2018 (last patient, last visit).

    Pre-assignment
    Screening details
    		 A total of 4,267 patients were screened and 1,607 patients were randomized. 2 174 (50.9%) and 486 (11.4%) patients were excluded before and during the placebo run-in period, respectively. The main reason for screen failures at these two stages was a failure to meet randomization criteria.

    Pre-assignment period milestones
    Number of subjects started
    		 1607
    Number of subjects completed
    		 1607

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 300 IR
    Arm description
    		 300 IR tablet of HDM Allergen Extracts
    Arm type
    		 Experimental

    Investigational medicinal product name
    300 IR tablet of HDM Allergen Extracts
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sublingual tablet
    Routes of administration
    Sublingual use
    Dosage and administration details
    300 IR tablet of HDM Allergen Extracts Initiation phase: patients took 1 tablet of 100 IR on Day 1 and 2 tablets of 100 IR on Day 2. Maintenance phase: from the 3rd day until the end of treatment patients took 1 tablet of 300 IR per day.

    Arm title
    		 Placebo
    Arm description
    		 Placebo tablet
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sublingual tablet
    Routes of administration
    Sublingual use
    Dosage and administration details
    Placebo tablet Initiation phase: patients took 1 tablet of placebo on Day 1 and 2 tablets of placebo on Day 2. Maintenance phase: from the 3rd day until the end of treatment patients took 1 tablet of placebo per day.

    Number of subjects in period 1
    		300 IR Placebo
    Started
    802
    805
    Completed
    589
    678
    Not completed
    213
    127
         Consent withdrawn by subject
    73
    74
         Any other reason not above-mentioned
    3
    2
         Adverse event, non-fatal
    100
    18
         Pregnancy
    6
    5
         Non-compliance with study drug
    6
    4
         Lost to follow-up
    19
    14
         Withdrawal by parent/guardian
    3
    5
         Protocol deviation
    2
    4
         Lack of efficacy
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    300 IR
    Reporting group description
    		 300 IR tablet of HDM Allergen Extracts

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo tablet

    Reporting group values
    		 300 IR Placebo Total
    Number of subjects
    		 802 805 1607
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 179 164 343
        Adults (18-64 years)
    		 621 641 1262
        From 65-84 years
    		 2 0 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 29.3 ± 12.89 29.5 ± 12.56 -
    Gender categorical
    Units: Subjects
        Female
    		 413 416 829
        Male
    		 389 389 778
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 57 50 107
        Not Hispanic or Latino
    		 744 755 1499
        Unknown or not reported
    		 1 0 1
    Race
    Units: Subjects
        Black or African American
    		 28 40 68
        American Indian or Alaska Native
    		 0 1 1
        Asian
    		 23 22 45
        Native Hawaiian or Other Pacific Islander
    		 2 0 2
        White
    		 746 736 1482
        Multiple
    		 2 3 5
        Unknown
    		 1 3 4
    Region of Enrollment
    Units: Subjects
        North America
    		 256 259 515
        Rest of World
    		 546 546 1092

    End points

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    End points reporting groups
    Reporting group title
    300 IR
    Reporting group description
    		 300 IR tablet of HDM Allergen Extracts

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo tablet

    Primary: Total Combined Score (TCS)

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    End point title
    		 Total Combined Score (TCS)
    End point description
    Average Total Combined Score (TCS), calculated for each patient as the average of the daily TCSs during the primary evaluation period in FAS. The daily TCS (scale 0-15) was the sum of the patient's daily Rhinitis Total Symptom Score (RTSS, scale 0-12) and daily Rescue Medication Score (RMS, scale 0-3). Lower is better.
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    		 300 IR Placebo
    Number of subjects analysed
    586
    676
    Units: Units on a scale
        least squares mean (confidence interval 95%)
    3.62 (3.33 to 3.92)
    4.35 (4.06 to 4.66)
    Statistical analysis title
    		 LS Means Difference (300 IR vs Placebo)
    Comparison groups
    300 IR v Placebo
    Number of subjects included in analysis
    1262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Rhinitis Total Symptom Score (RTSS)

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    End point title
    		 Rhinitis Total Symptom Score (RTSS)
    End point description
    Average Rhinitis Total Symptom Score (RTSS) during the primary evaluation period in FAS. The daily RTSS was the sum of the 4 rhinitis symptom scores: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, each graded on a 4-point scale (0: absent, 1: mild, 2: moderate, 3: severe). It ranges from 0 to 12. Lower is better.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 300 IR Placebo
    Number of subjects analysed
    586
    676
    Units: Units on a scale
        least squares mean (confidence interval 95%)
    3.16 (2.89 to 3.43)
    3.79 (3.53 to 4.07)
    Statistical analysis title
    		 LS Means Difference (300 IR vs Placebo)
    Comparison groups
    300 IR v Placebo
    Number of subjects included in analysis
    1262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Rescue Medication Score (RMS)

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    End point title
    		 Rescue Medication Score (RMS)
    End point description
    Average Rescue Medication Score (RMS) during the primary evaluation period in FAS. It ranges from 0 to 3. Lower is better.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 300 IR Placebo
    Number of subjects analysed
    586
    676
    Units: Units on a scale
        least squares mean (confidence interval 95%)
    0.21 (0.17 to 0.25)
    0.30 (0.26 to 0.35)
    Statistical analysis title
    		 LS Means Difference (300 IR vs Placebo)
    Comparison groups
    300 IR v Placebo
    Number of subjects included in analysis
    1262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0004
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 months
    Adverse event reporting additional description
    Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    300 IR
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 300 IR Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 800 (2.63%)
    9 / 801 (1.12%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 800 (0.13%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hodgkin's disease
         subjects affected / exposed
    0 / 800 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 800 (0.13%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid neoplasm
         subjects affected / exposed
    1 / 800 (0.13%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    0 / 800 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 800 (0.13%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 800 (0.13%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic fatigue syndrome
         subjects affected / exposed
    0 / 800 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst ruptured
         subjects affected / exposed
    1 / 800 (0.13%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pharyngeal disorder
         subjects affected / exposed
    2 / 800 (0.25%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 800 (0.13%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 800 (0.13%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 800 (0.13%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 800 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    0 / 800 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 800 (0.13%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Intracranial aneurysm
         subjects affected / exposed
    0 / 800 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 800 (0.13%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Meniere's disease
         subjects affected / exposed
    0 / 800 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 800 (0.13%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    2 / 800 (0.25%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 800 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    1 / 800 (0.13%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Chondromalacia
         subjects affected / exposed
    1 / 800 (0.13%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plica syndrome
         subjects affected / exposed
    1 / 800 (0.13%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    3 / 800 (0.38%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 800 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 800 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tick-borne viral encephalitis
         subjects affected / exposed
    1 / 800 (0.13%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 800 (0.13%)
    0 / 801 (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
    		 300 IR Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    424 / 800 (53.00%)
    223 / 801 (27.84%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    57 / 800 (7.13%)
    68 / 801 (8.49%)
         occurrences all number
    158
    214
    Ear and labyrinth disorders
    Ear pruritus
         subjects affected / exposed
    115 / 800 (14.38%)
    13 / 801 (1.62%)
         occurrences all number
    206
    17
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    43 / 800 (5.38%)
    12 / 801 (1.50%)
         occurrences all number
    64
    16
    Dysphagia
         subjects affected / exposed
    53 / 800 (6.63%)
    2 / 801 (0.25%)
         occurrences all number
    71
    2
    Lip oedema
         subjects affected / exposed
    61 / 800 (7.63%)
    8 / 801 (1.00%)
         occurrences all number
    100
    10
    Nausea
         subjects affected / exposed
    47 / 800 (5.88%)
    8 / 801 (1.00%)
         occurrences all number
    65
    8
    Oedema mouth
         subjects affected / exposed
    112 / 800 (14.00%)
    3 / 801 (0.37%)
         occurrences all number
    186
    3
    Oral pruritus
         subjects affected / exposed
    189 / 800 (23.63%)
    29 / 801 (3.62%)
         occurrences all number
    329
    35
    Tongue oedema
         subjects affected / exposed
    68 / 800 (8.50%)
    3 / 801 (0.37%)
         occurrences all number
    100
    3
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    45 / 800 (5.63%)
    31 / 801 (3.87%)
         occurrences all number
    67
    52
    Pharyngeal oedema
         subjects affected / exposed
    46 / 800 (5.75%)
    1 / 801 (0.12%)
         occurrences all number
    62
    1
    Throat irritation
         subjects affected / exposed
    136 / 800 (17.00%)
    27 / 801 (3.37%)
         occurrences all number
    233
    37
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    107 / 800 (13.38%)
    117 / 801 (14.61%)
         occurrences all number
    169
    173

    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.
    None reported
    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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