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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy, Safety, And Tolerability Of Serlopitant For The Treatment Of Refractory Chronic Cough

    Summary
    EudraCT number
    		 2017-003250-16
    Trial protocol
    		 GB  
    Global end of trial date
    06 Sep 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jan 2020
    First version publication date
    04 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MTI-110
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03282591
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Menlo Therapeutics Inc.
    Sponsor organisation address
    200 Cardinal Way, 2nd Floor, Redwood City, United States, CA 94063
    Public contact
    Chief Medical Officer, Menlo Therapeutics Inc., +1 6504861416, pkwon@menlotx.com
    Scientific contact
    Chief Medical Officer, Menlo Therapeutics Inc., +1 6504861416, pkwon@menlotx.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 Sep 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Sep 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Sep 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effectiveness of serlopitant for the treatment of refractory chronic cough after 12 weeks of treatment in reducing 24-hour objective cough frequency. Secondary objectives were: To evaluate the effectiveness of serlopitant as compared to placebo after 4 and 8 weeks of treatment in reducing 24-hour objective cough frequency. To evaluate the effectiveness of serlopitant as compared to placebo after 4, 8, and 12 weeks of treatment in reducing awake objective cough frequency. To evaluate the effectiveness of serlopitant as compared to placebo after 4, 8, and 12 weeks of treatment in reducing sleep objective cough frequency. To evaluate the effectiveness of serlopitant in: Reducing the cough severity measured by a Visual Analog Scale (VAS) Improving cough-specific quality of life (Leicester Cough Questionnaire) To assess the safety and tolerability of repeated oral doses of serlopitant in subjects with treatment-refractory chronic cough.
    Protection of trial subjects
    Safety was analyzed for all randomized subjects who received at least one dose of study medication. Treatment-emergent adverse events were classified by system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA) version 20.1 and summarized. Summary statistics were provided for actual values and change from Baseline for clinical laboratory evaluations and vital signs. Shifts from Baseline clinical laboratory values based upon the normal range were tabulated. The observed vital signs and electrocardiogram data and change from Baseline were summarized by visit and treatment group descriptively. Criteria were defined for potentially clinically important findings of vital signs and results were summarized. The count and percentage of subjects with QTc interval corrected by Fredericia’s formula (QTcF) > 450, 480, and 500 msec and a change from Baseline of > 30 and 60 msec were summarized by visit and treatment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Oct 2017
    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
    United States: 144
    Country: Number of subjects enrolled
    United Kingdom: 41
    Worldwide total number of subjects
    185
    EEA total number of subjects
    41
    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)
    89
    From 65 to 84 years
    96
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was started on the 3rd October 2017 and took place in the UK and USA.

    Pre-assignment
    Screening details
    		 During the screening period, subjects underwent eligibility evaluation and had their baseline cough monitoring conducted. Subjects must have been willing to comply with restrictions on allowable concomitant therapies for the duration of the study.

    Period 1
    Period 1 title
    Period 1 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Assessor
    Blinding implementation details
    The placebo was formulated to be indistinguishable from the active study product(s). Study materials were packaged and issued in a manner designed to maintain the blind for subjects and all study personnel involved in the direction and execution of study procedures, study assessments, and collection of data.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Serlopitant 5 mg
    Arm description
    		 Subjects received Serlopitant 5 mg.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Serlopitant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received daily oral doses of Serlopitant 5 mg for 84 days.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received placebo.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo for Serlopitant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received daily oral doses of Placebo for Serlopitant for 84 days.

    Number of subjects in period 1
    		Serlopitant 5 mg Placebo
    Started
    92
    93
    Completed
    81
    84
    Not completed
    11
    9
         Consent withdrawn by subject
    2
    3
         Adverse event, non-fatal
    2
    3
         Death
    1
    -
         Excluded therapy
    -
    1
         Lack of efficacy
    6
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Serlopitant 5 mg
    Reporting group description
    		 Subjects received Serlopitant 5 mg.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo.

    Reporting group values
    		 Serlopitant 5 mg Placebo Total
    Number of subjects
    		 92 93 185
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 62.7 (28 to 79) 62.8 (26 to 80) -
    Gender categorical
    Units: Subjects
        Female
    		 71 71 142
        Male
    		 21 22 43
    Race
    Units: Subjects
        Asian
    		 1 1 2
        Black of African American
    		 4 4 8
        White
    		 86 88 174
        Other
    		 1 0 1
    Ethnicity
    Units: Subjects
        Hispanic
    		 5 1 6
        Non-hispanic
    		 87 92 179
    Country
    Units: Subjects
        USA
    		 71 72 143
        UK
    		 21 21 42
    Duration of Chronic Cough
    Units: Years
        arithmetic mean (standard deviation)
    		 14.5 ± 10.88 15.7 ± 11.63 -
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 29.0 ± 5.10 28.7 ± 5.32 -

    End points

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    End points reporting groups
    Reporting group title
    Serlopitant 5 mg
    Reporting group description
    		 Subjects received Serlopitant 5 mg.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo.

    Primary: Change from Baseline in 24-Hour Cough Frequency

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    End point title
    		 Change from Baseline in 24-Hour Cough Frequency
    End point description
    End point type
    Primary
    End point timeframe
    For the primary endpoint analysis of change from Baseline in 24-hour cough frequency after 12 weeks (Day 84) of treatment.
    End point values
    		 Serlopitant 5 mg Placebo
    Number of subjects analysed
    88
    88
    Units: LS Mean Change
        arithmetic mean (standard error)
    -0.18 ± 0.09
    -0.45 ± 0.08
    Statistical analysis title
    		 Change from Baseline in 24-hr Cough Frequency
    Statistical analysis description
    Mixed Model Repeated Measures Analysis of Change from Baseline in 24-hr Cough Frequency (coughs/hr) Based on Log Transformed Data (Full Analysis Set)
    Comparison groups
    Serlopitant 5 mg v Placebo
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9942 [1]
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [1] - 1-sided p-value (Serlopitant vs. Placebo) 0.9942 Baseline 0.0018 Treatment 0.0302 Visit 0.2830 Country 0.0764 Sex 0.7259 Treatment-by-visit-interaction 0.2760

    Secondary: Change from Baseline in awake objective cough frequency

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    End point title
    		 Change from Baseline in awake objective cough frequency
    End point description
    End point type
    Secondary
    End point timeframe
    Change from Baseline in awake objective cough frequency after 12 weeks (Day 84) of treatment
    End point values
    		 Serlopitant 5 mg Placebo
    Number of subjects analysed
    88
    88
    Units: LS Mean Change
    arithmetic mean (standard error)
        LS Mean Change
    -0.19 ± 0.09
    -0.46 ± 0.09
    Statistical analysis title
    		 Change from Baseline in Awake Cough Frequency
    Statistical analysis description
    Mixed Model Repeated Measures Analysis of Change from Baseline in Awake Cough Frequency (coughs/hr) Based on Log Transformed Data (Full Analysis Set)
    Comparison groups
    Serlopitant 5 mg v Placebo
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.991 [2]
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [2] - 1-sided p-value (Serlopitant vs. Placebo) 0.9910 Baseline 0.0015 Treatment 0.0487 Visit 0.1434 Country 0.0779 Sex 0.5517 Treatment-by-Visit Interaction 0.1884

    Secondary: Proportion of subjects with ≥ 30% reduction in 24-hour objective cough frequency per hour

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    End point title
    		 Proportion of subjects with ≥ 30% reduction in 24-hour objective cough frequency per hour
    End point description
    End point type
    Secondary
    End point timeframe
    Proportion of subjects with ≥ 30% reduction in 24-hour objective cough frequency per hour at Week 12 (Day 84)
    End point values
    		 Serlopitant 5 mg Placebo
    Number of subjects analysed
    88
    88
    Units: LS Mean Response Rate
        arithmetic mean (standard error)
    0.38 ± 0.06
    0.48 ± 0.06
    Statistical analysis title
    		 Responder Analysis of 24hr Cough Frequency
    Statistical analysis description
    Responder Analysis (>=30% Reduction) of 24-hr Cough Frequency - Generalized Mixed Model (Full Analysis Set)
    Comparison groups
    Placebo v Serlopitant 5 mg
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8886 [3]
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [3] - 1-sided p-value for Odds Ratio 0.8886 Treatment 0.0527 Visit 0.3957 Country 0.0029 Sex 0.3719 Treatment-by-Visit Interaction 0.6067

    Secondary: Proportion of subjects with ≥ 30% reduction in awake objective cough frequency per hour

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    End point title
    		 Proportion of subjects with ≥ 30% reduction in awake objective cough frequency per hour
    End point description
    End point type
    Secondary
    End point timeframe
    Proportion of subjects with ≥ 30% reduction in awake objective cough frequency per hour at Week 12 (Day 84)
    End point values
    		 Serlopitant 5 mg Placebo
    Number of subjects analysed
    88
    88
    Units: LS Mean Response Rate
        arithmetic mean (standard error)
    0.37 ± 0.06
    0.42 ± 0.06
    Statistical analysis title
    		 Responder Analysis of Awake Cough Frequency
    Statistical analysis description
    Responder Analysis (>=30% Reduction) of Awake Cough Frequency - Generalized Mixed Model (Full Analysis Set)
    Comparison groups
    Serlopitant 5 mg v Placebo
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7348 [4]
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [4] - 1-sided p-value for Odds Ratio 0.7348 Treatment 0.1518 Visit 0.4407 Country 0.0021 Sex 0.1075 Treatment-by-Visit Interaction 0.4671

    Secondary: Change from Baseline in Cough Severity Visual Analogue Scale (VAS)

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    End point title
    		 Change from Baseline in Cough Severity Visual Analogue Scale (VAS)
    End point description
    End point type
    Secondary
    End point timeframe
    Change from Baseline in Cough Severity Visual Analogue Scale (VAS) at Week 12 (Day 84)
    End point values
    		 Serlopitant 5 mg Placebo
    Number of subjects analysed
    88
    88
    Units: LS Mean
        arithmetic mean (standard error)
    -14.2 ± 2.99
    -9.9 ± 3.04
    Statistical analysis title
    		 Change from Baseline in Cough Severity VAS
    Statistical analysis description
    Mixed Model Repeated Measures Analysis of Change from Baseline in Cough Severity Visual Analogue Scale (VAS) (Full Analysis Set)
    Comparison groups
    Serlopitant 5 mg v Placebo
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9081 [5]
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [5] - 1-sided p-value (Serlopitant vs. Placebo) 0.9081 Baseline 0.0003 Treatment 0.1561 Visit 0.5537 Country 0.0017 Sex 0.5114 Treatment-by-Visit Interaction 0.0912

    Secondary: Safety and tolerability of repeated oral doses of serlopitant

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    End point title
    		 Safety and tolerability of repeated oral doses of serlopitant
    End point description
    End point type
    Secondary
    End point timeframe
    During the study treatment period.
    End point values
    		 Serlopitant 5 mg Placebo
    Number of subjects analysed
    92
    92
    Units: Adverse events
    65
    52
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Any adverse event occurrence during the study was recorded on source documentation and electronic case report form at the site, in accordance with protocol instructions.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Serlopitant 5mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Serlopitant 5mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 92 (3.26%)
    3 / 92 (3.26%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastatic malignant melanoma
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 92 (1.09%)
         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
    Pelvic pain
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 92 (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
    Pulmonary embolism
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Urosepsis
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 92 (1.09%)
    0 / 92 (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: 2%
    Non-serious adverse events
    		 Serlopitant 5mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    65 / 92 (70.65%)
    52 / 92 (56.52%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    2 / 92 (2.17%)
    0 / 92 (0.00%)
         occurrences all number
    2
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 92 (3.26%)
    0 / 92 (0.00%)
         occurrences all number
    3
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 92 (6.52%)
    8 / 92 (8.70%)
         occurrences all number
    6
    8
    Dizziness
         subjects affected / exposed
    4 / 92 (4.35%)
    1 / 92 (1.09%)
         occurrences all number
    4
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    5 / 92 (5.43%)
    6 / 92 (6.52%)
         occurrences all number
    5
    6
    Oedema peripheral
         subjects affected / exposed
    2 / 92 (2.17%)
    1 / 92 (1.09%)
         occurrences all number
    2
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 92 (5.43%)
    3 / 92 (3.26%)
         occurrences all number
    5
    3
    Dry mouth
         subjects affected / exposed
    3 / 92 (3.26%)
    2 / 92 (2.17%)
         occurrences all number
    3
    2
    Abdominal distension
         subjects affected / exposed
    2 / 92 (2.17%)
    0 / 92 (0.00%)
         occurrences all number
    2
    0
    Constipation
         subjects affected / exposed
    2 / 92 (2.17%)
    2 / 92 (2.17%)
         occurrences all number
    2
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 92 (2.17%)
    2 / 92 (2.17%)
         occurrences all number
    2
    2
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    4 / 92 (4.35%)
    0 / 92 (0.00%)
         occurrences all number
    4
    0
    Cough
         subjects affected / exposed
    3 / 92 (3.26%)
    6 / 92 (6.52%)
         occurrences all number
    3
    6
    Asthma
         subjects affected / exposed
    2 / 92 (2.17%)
    0 / 92 (0.00%)
         occurrences all number
    2
    0
    Paranasal sinus discomfort
         subjects affected / exposed
    2 / 92 (2.17%)
    0 / 92 (0.00%)
         occurrences all number
    2
    0
    Productive cough
         subjects affected / exposed
    2 / 92 (2.17%)
    0 / 92 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 92 (2.17%)
    1 / 92 (1.09%)
         occurrences all number
    2
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    2 / 92 (2.17%)
    0 / 92 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 92 (3.26%)
    3 / 92 (3.26%)
         occurrences all number
    3
    3
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 92 (7.61%)
    6 / 92 (6.52%)
         occurrences all number
    7
    6
    Urinary tract infection
         subjects affected / exposed
    6 / 92 (6.52%)
    3 / 92 (3.26%)
         occurrences all number
    6
    3
    Bronchitis
         subjects affected / exposed
    5 / 92 (5.43%)
    1 / 92 (1.09%)
         occurrences all number
    5
    1
    Sinusitis
         subjects affected / exposed
    4 / 92 (4.35%)
    4 / 92 (4.35%)
         occurrences all number
    4
    4
    Acute sinusitis
         subjects affected / exposed
    3 / 92 (3.26%)
    0 / 92 (0.00%)
         occurrences all number
    3
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 92 (2.17%)
    2 / 92 (2.17%)
         occurrences all number
    2
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 92 (2.17%)
    3 / 92 (3.26%)
         occurrences all number
    2
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Aug 2017
    Version 2.0: Section 5.6 Study drug discontinuation was updated to comply with 21 August 2017 FDA Clinical Information Request. One of the discontinuation criterion were revised so that a subject will be discontinued from study drug if experiencing a National Cancer Institute Common Terminology Criteria for Adverse Events Grade 2 or higher treatment emergent adverse event that is assessed as likely related to study drug. Changed the language from Grade 3 to Grade 2: “The subject experiences a National Cancer Institute Common Terminology Criteria for Adverse Events Grade 2 or higher treatment emergent adverse event that is assessed as likely related to study drug”.
    08 Mar 2018
    Version 3.0: A secondary endpoint was amended from 'Change from Baseline in 24-hour objective cough frequency at the Follow-Up visit (Day 112)' to 'Change from Baseline and change from Day 84 in 24-hour objective cough frequency at the Follow-Up visit (Day 112)'. This Secondary Efficacy Endpoint was inadvertently omitted in version 2.0 of the protocol. It is important to compare the change in 24-hour objective cough frequency at the end of treatment (Day 84) to the Follow-Up visit (Day 112). The study design was also amended to remove restrictions on food intake when taking the study drug following a recent food effect study with serlopitant (MTI-111) which demonstrated that the increase in Cmax and AUC0-inf of 28% and 37%, respectively, under fed condition, is not clinically significant. Therefore, serlopitant may be taken with or without food.

    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
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    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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