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    Clinical Trial Results:
    A Multicenter, Randomized, Double-blind, Placebo-controlled Study in Participants With Sarcoidosis-associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral Selexipag

    Summary
    EudraCT number
    2018-004887-74
    Trial protocol
    GB   NL   DE   HU   PL   ES   BE   IT  
    Global end of trial date
    19 Apr 2023

    Results information
    Results version number
    v1(current)
    This version publication date
    26 Apr 2024
    First version publication date
    26 Apr 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AC-065D301
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03942211
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Cilag International NV
    Sponsor organisation address
    Turnhoutseweg 30, Beerse, Belgium, 2340
    Public contact
    Clinical Registry Group, Janssen Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Cilag International NV, ClinicalTrialsEU@its.jnj.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
    11 May 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Apr 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to assess the effect of selexipag compared to placebo on pulmonary artery pressure (PVR) in subjects with sarcoidosis-associated pulmonary hypertension (SAPH) up to Week 26.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practice and applicable regulatory requirements.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    26 Feb 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    United States: 2
    Worldwide total number of subjects
    10
    EEA total number of subjects
    7
    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)
    4
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 10 subjects were enrolled and treated, none of them completed the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Selexipag
    Arm description
    Subjects received a single oral tablet of selexipag 200 mcg on Day 1. The dose was up-titrated by the investigator/delegate at weekly intervals to allow each subject to reach their individual maximum tolerated dose (iMTD), in the range of 200 mcg to 1600 mcg (that is, 1 to 8 tablets) twice daily from Day 2 to Week 12 or until reaching iMTD. From Week 12 onwards, subjects received their iMTD of selexipag orally twice daily until end of treatment (up to 456 days). For subjects with moderate hepatic impairment (Child-Pugh Class B) or who were concomitantly taking moderate CYP2C8 inhibitor(s) the dosing frequency was once daily.
    Arm type
    Experimental

    Investigational medicinal product name
    Selexipag
    Investigational medicinal product code
    JNJ-67896049
    Other name
    ACT-293987
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single dose of selexipag 200 mcg on Day 1. The dose was up-titrated by the investigator/delegate at weekly intervals to allow each subjects to reach their individual iMTD, in the range of 200 mcg to 1600 mcg (that is, 1 to 8 tablets) twice daily from Day 2 to Week 12 or until reaching iMTD. From Week 12 onwards, subjects received their iMTD of selexipag orally twice daily till end of treatment (up to 456 days). For subjects with moderate hepatic impairment (Child-Pugh Class B) or who were concomitantly taking moderate CYP2C8 inhibitor(s) the dosing frequency was once daily.

    Arm title
    Placebo
    Arm description
    Subjects received placebo matching to selexipag 1 to 8 tablets twice daily from Day 1 till end of treatment (up to 456 days). For subjects with moderate hepatic impairment (Child-Pugh Class B) or who were concomitantly taking moderate CYP2C8 inhibitor(s) the dosing frequency was once daily.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received placebo matching to selexipag from Day 1 till end of treatment (up to 456 days).

    Number of subjects in period 1
    Selexipag Placebo
    Started
    6
    4
    Completed
    0
    0
    Not completed
    6
    4
         Adverse event, serious fatal
    1
    -
         Adverse event, non-fatal
    -
    1
         Study terminated by sponsor
    5
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Selexipag
    Reporting group description
    Subjects received a single oral tablet of selexipag 200 mcg on Day 1. The dose was up-titrated by the investigator/delegate at weekly intervals to allow each subject to reach their individual maximum tolerated dose (iMTD), in the range of 200 mcg to 1600 mcg (that is, 1 to 8 tablets) twice daily from Day 2 to Week 12 or until reaching iMTD. From Week 12 onwards, subjects received their iMTD of selexipag orally twice daily until end of treatment (up to 456 days). For subjects with moderate hepatic impairment (Child-Pugh Class B) or who were concomitantly taking moderate CYP2C8 inhibitor(s) the dosing frequency was once daily.

    Reporting group title
    Placebo
    Reporting group description
    Subjects received placebo matching to selexipag 1 to 8 tablets twice daily from Day 1 till end of treatment (up to 456 days). For subjects with moderate hepatic impairment (Child-Pugh Class B) or who were concomitantly taking moderate CYP2C8 inhibitor(s) the dosing frequency was once daily.

    Reporting group values
    Selexipag Placebo Total
    Number of subjects
    6 4 10
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    4 0 4
        From 65 to 84 years
    2 4 6
        85 years and over
    0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    55 ( 14.53 ) 68.5 ( 2.38 ) -
    Title for Gender
    Units: subjects
        Female
    2 2 4
        Male
    4 2 6

    End points

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    End points reporting groups
    Reporting group title
    Selexipag
    Reporting group description
    Subjects received a single oral tablet of selexipag 200 mcg on Day 1. The dose was up-titrated by the investigator/delegate at weekly intervals to allow each subject to reach their individual maximum tolerated dose (iMTD), in the range of 200 mcg to 1600 mcg (that is, 1 to 8 tablets) twice daily from Day 2 to Week 12 or until reaching iMTD. From Week 12 onwards, subjects received their iMTD of selexipag orally twice daily until end of treatment (up to 456 days). For subjects with moderate hepatic impairment (Child-Pugh Class B) or who were concomitantly taking moderate CYP2C8 inhibitor(s) the dosing frequency was once daily.

    Reporting group title
    Placebo
    Reporting group description
    Subjects received placebo matching to selexipag 1 to 8 tablets twice daily from Day 1 till end of treatment (up to 456 days). For subjects with moderate hepatic impairment (Child-Pugh Class B) or who were concomitantly taking moderate CYP2C8 inhibitor(s) the dosing frequency was once daily.

    Primary: Pulmonary Vascular Resistance (PVR) up to Week 26

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    End point title
    Pulmonary Vascular Resistance (PVR) up to Week 26 [1]
    End point description
    PVR represents the resistance against which the right ventricle needs to pump and determined by right heart catheterization (RHC). It was measured as the ratio of the PVR value post-treatment initiation up to Week 26 (post) versus the PVR value pre-treatment initiation at baseline (pre), expressed as a percentage of baseline value. The baseline reference value for PVR was based on the last RHC performed prior to study intervention initiation. As specified in the statistical analysis plan, data was not planned to be summarised for this endpoint and only individual subject wise data was collected. Randomised analysis set: subjects assigned to the study intervention. 'N' (number of subjects analyzed): subjects evaluable for this endpoint; 'n' (number analysed): number of subjects randomised and analysed in respective treatment arm. Here, 99999 signifies PVR data was not reported as no subject was randomised in that treatment arm.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 26
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics was done, no inferential statistical analysis was performed.
    End point values
    Selexipag Placebo
    Number of subjects analysed
    5
    3
    Units: percentage of baseline PVR
    number (not applicable)
        Subject 1 (n=0,1)
    99999
    89.0
        Subject 2 (n=0,1)
    99999
    201
        Subject 3 (n=0,1)
    99999
    56
        Subject 4 (n=1,0)
    88
    99999
        Subject 5 (n=1,0)
    100
    99999
        Subject 6 (n=1,0)
    47.0
    99999
        Subject 7 (n=1,0)
    82.0
    99999
        Subject 8 (n=1,0)
    86.0
    99999
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Day 1 up to 456 days
    Adverse event reporting additional description
    Safety assessments were based on the safety analysis set which included all participants who received at least one dose of study intervention.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Selexipag
    Reporting group description
    Subjects were up-titrated and received Selexipag in the range of 200 micrograms (mcg) to 1600 mcg (that is, 1 to 8 tablets) once or twice from daily Day 1 till Week 26 to allow each subject to reach their individual maximum tolerated dose (iMTD). For subjects with moderate hepatic impairment (Child-Pugh Class B) or who were concomitantly taking a moderate cytochrome P450 (CYP)2C8 inhibitor(s) received Selexipag once daily.

    Reporting group title
    Placebo
    Reporting group description
    Subjects received placebo matching to selexipag 1 to 8 tablets twice daily from Day 1 till Week 26. Subjects with moderate hepatic impairment (Child-Pugh Class B) or who concomitantly received moderate cytochrome P450 (CYP)2C8 inhibitor(s) received Selexipag matching placebo once daily from Day 1 till Week 26.

    Serious adverse events
    Selexipag Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 6 (33.33%)
    3 / 4 (75.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina Pectoris
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Failure
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Hypertension
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Urinary Tract Infection
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Aspiration
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Selexipag Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    3 / 4 (75.00%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Cyanosis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Oedema Peripheral
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Malaise
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Dyspnoea
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Investigations
    Platelet Count Decreased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Neutrophil Count Increased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    N-Terminal Prohormone Brain Natriuretic Peptide Increased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Mean Cell Volume Increased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Mean Cell Haemoglobin Increased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Lymphocyte Count Decreased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Glycosylated Haemoglobin Increased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Alanine Aminotransferase Increased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Blood Alkaline Phosphatase Increased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Red Blood Cell Count Decreased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    White Blood Cell Count Decreased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Injury, poisoning and procedural complications
    Injection Related Reaction
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Wound
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 6 (83.33%)
    1 / 4 (25.00%)
         occurrences all number
    11
    2
    Migraine
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 6 (66.67%)
    1 / 4 (25.00%)
         occurrences all number
    13
    1
    Nausea
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    6
    0
    Vomiting
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Dysphagia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Papulopustular Rosacea
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Pain in Jaw
         subjects affected / exposed
    3 / 6 (50.00%)
    0 / 4 (0.00%)
         occurrences all number
    4
    0
    Limb Discomfort
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Back Pain
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Pain in Extremity
         subjects affected / exposed
    4 / 6 (66.67%)
    0 / 4 (0.00%)
         occurrences all number
    5
    0
    Musculoskeletal Pain
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal Chest Pain
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Arthralgia
         subjects affected / exposed
    4 / 6 (66.67%)
    0 / 4 (0.00%)
         occurrences all number
    4
    0
    Infections and infestations
    Sputum Purulent
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Lower Respiratory Tract Infection
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Covid-19
         subjects affected / exposed
    3 / 6 (50.00%)
    0 / 4 (0.00%)
         occurrences all number
    3
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Vitamin B12 Deficiency
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Vitamin D Deficiency
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Dec 2019
    The purpose of the amendment was to to revise the study design following Health Authority (HA) feedback that recommended that the study should also be powered for clinical endpoints such as time to clinical worsening, 6-minute walk distance (6MWD) and patient reported outcomes (PRO).
    21 Sep 2020
    The purpose of the amendment was to clarify the Child-Pugh assessments, add a Coronavirus Disease 2019 (COVID-19) appendix, adapt internal safety reporting processes, align with TransCelerate template, make minor corrections, and perform editorial document formatting revisions.
    25 Feb 2022
    The purpose of the amendment was to modify some inclusion and exclusion criteria aiming to facilitate enrollment (based on inputs from the Steering Committee [SC] of the SPHINX study), update Coronavirus Disease 2019 (COVID-19) appendix with recent updates pertaining to study conduct related to COVID-19 vaccine deployment for non-COVID-19 clinical trials, and implement miscellaneous minor corrections and clarifications.

    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.
    All planned efficacy analyses could not be performed due to early termination of study.
    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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