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    Clinical Trial Results:
    A Phase 4, Single-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group, Fixed-dose Study of the Effect of Linaclotide on Abdominal Girth in Participants with Irritable Bowel Syndrome with Constipation

    Summary
    EudraCT number
    		 2016-000818-29
    Trial protocol
    		 GB  
    Global end of trial date
    31 Oct 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Oct 2021
    First version publication date
    16 Oct 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MCP-103-403
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02837783
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ironwood Pharmaceuticals Inc.
    Sponsor organisation address
    100 Summer Street Suite 2300, Boston, MA, United States, 02110
    Public contact
    Corporate Communications, Ironwood Pharmaceuticals Inc., +1 617621 7722, Info@ironwoodpharma.com
    Scientific contact
    Corporate Communications, Ironwood Pharmaceuticals Inc., +1 617621 7722, Info@ironwoodpharma.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
    31 Oct 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The objective of this trial is to determine the effect of linaclotide on abdominal girth in IBS-C participants with the baseline symptoms of abdominal bloating and an increased abdominal girth.
    Protection of trial subjects
    It is the responsibility of the Investigator (or qualified designee) to give each participant full and adequate information regarding the objectives and procedures of the study and the possible risks involved. The participants must be informed about their right to withdraw from the study at any time. Furthermore, it is the responsibility of the Investigator to obtain signed and dated written informed consent from all participants, and a dated signature from the persons conducting the informed consent discussion, before undertaking any study-related procedure. The written informed consent form must be approved by the Research Ethics Committee (REC) for the purposes of obtaining and documenting consent. The Investigator must be available to answer all participants’ questions regarding the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Dec 2016
    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
    United Kingdom: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    0
    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)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study included a 14-day screening period and a 7 day pretreatment period. The treatment period began with randomisation and lasted for 4 weeks. Participants who met entry criteria were randomised (1:1) to once daily oral capsules containing 290 μg linaclotide or placebo.

    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, Carer, Assessor
    Blinding implementation details
    Both the participants and the research team were blinded to randomisation and allocation of study drug/placebo.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Matching Placebo
    Arm description
    		 Placebo once daily for 4 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were instructed to take one capsule in the morning at least 30 minutes before breakfast.

    Arm title
    		 290 μg Linaclotide
    Arm description
    		 290 μg linaclotide once daily for 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Linaclotide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were instructed to take one capsule in the morning at least 30 minutes before breakfast.

    Number of subjects in period 1
    		Matching Placebo 290 μg Linaclotide
    Started
    9
    11
    Received >= 1 Dose of Study Drug
    9
    10
    Completed
    7
    9
    Not completed
    2
    2
         Adverse Event
    1
    -
         Other, Not Specified
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Matching Placebo
    Reporting group description
    		 Placebo once daily for 4 weeks

    Reporting group title
    290 μg Linaclotide
    Reporting group description
    		 290 μg linaclotide once daily for 4 weeks

    Reporting group values
    		 Matching Placebo 290 μg Linaclotide Total
    Number of subjects
    		 9 11 20
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35.8 ± 10.38 35.2 ± 12.82 -
    Gender categorical
    Units: Subjects
        Female
    		 9 11 20
        Male
    		 0 0 0
    Race
    Units: Subjects
        Caucasian
    		 9 11 20
        Non-Caucasian
    		 0 0 0
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 0 0
        Not Hispanic or Latino
    		 9 11 20

    End points

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    End points reporting groups
    Reporting group title
    Matching Placebo
    Reporting group description
    		 Placebo once daily for 4 weeks

    Reporting group title
    290 μg Linaclotide
    Reporting group description
    		 290 μg linaclotide once daily for 4 weeks

    Primary: Change From Baseline in Abdominal Girth at Week 4

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    End point title
    		 Change From Baseline in Abdominal Girth at Week 4
    End point description
    Mean change in abdominal girth (physical measure of bloating/distension) as measured by area under the curve (AUC), determined by 24-hour abdominal inductance plesthymography (AIP; with hourly averages). The AUC was calculated using the Trapezoidal method from the first reliable hour of measurement to last measurement (bedtime). The AUC for each participant was then individually standardized by dividing the total AUC over the period by that patient’s number of hours of measurement included in the AUC.
    End point type
    Primary
    End point timeframe
    Baseline, Week 4
    End point values
    		 Matching Placebo 290 μg Linaclotide
    Number of subjects analysed
    7 [1]
    10 [2]
    Units: AUC
        arithmetic mean (standard deviation)
    -3.36 ± 4.04
    -0.632 ± 11.6
    Notes
    [1] - Participants with an assessment at given time point.
    [2] - Participants with an assessment at given time point.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Matching Placebo v 290 μg Linaclotide
    Number of subjects included in analysis
    17
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.283
    Method
    		 Wilcoxon rank sum test
    Confidence interval

    Secondary: Change From Baseline in Abdominal Girth at Week 2

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    End point title
    		 Change From Baseline in Abdominal Girth at Week 2
    End point description
    Mean change in abdominal girth (physical measure of bloating/distention) as measured by AUC, determined by 24-hour AIP (with hourly averages). The AUC was calculated using the Trapezoidal method from the first reliable hour of measurement to last measurement (bedtime). The AUC for each participant was then individually standardized by dividing the total AUC over the period by that patient's number of hours of measurement included in the AUC.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2
    End point values
    		 Matching Placebo 290 μg Linaclotide
    Number of subjects analysed
    8 [3]
    10 [4]
    Units: AUC
        arithmetic mean (standard deviation)
    0.535 ± 9.15
    -2.3 ± 13.7
    Notes
    [3] - Participants with an assessment at given time point.
    [4] - Participants with an assessment at given time point.
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Maximal Abdominal Girth at Week 4

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    End point title
    		 Percent Change From Baseline in Maximal Abdominal Girth at Week 4
    End point description
    The maximum change in girth from the first hour, over the period from the 2nd hour to bedtime. The percentage change in maximum distension from baseline to 4 weeks will also be calculated.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    End point values
    		 Matching Placebo 290 μg Linaclotide
    Number of subjects analysed
    7 [5]
    9 [6]
    Units: percent change
        arithmetic mean (standard deviation)
    -7.13 ± 33.4
    15.4 ± 80.3
    Notes
    [5] - Participants with an assessment at given time point.
    [6] - Participants with an assessment at given time point.
    No statistical analyses for this end point

    Secondary: Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 1

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    End point title
    		 Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 1
    End point description
    Symptom severity was assessed daily on an 11-point numerical rating scale (NRS) from 0 to 10, where 0 represents no symptoms and 10 represents very severe symptoms. Participants rated their abdominal pain, discomfort, bloating, and distension at its worst over the last 24 hours. Weekly average scores were calculated individually for abdominal pain, discomfort, bloating, distension. The abdominal score was calculated as the weekly average from the daily scores of the individual items of pain, discomfort, bloating combined. The abdominal score plus distension was calculated as the weekly average from the daily scores of the individual items of pain, discomfort, bloating and distension combined.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1
    End point values
    		 Matching Placebo 290 μg Linaclotide
    Number of subjects analysed
    8 [7]
    11 [8]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Pain
    -1.25 ± 1.76
    -0.75 ± 1.88
        Discomfort
    -1.93 ± 1.54
    -0.97 ± 2.05
        Bloating
    -2.00 ± 1.48
    -0.40 ± 1.23
        Distension
    -1.91 ± 1.41
    -0.15 ± 1.02
        Abdominal Score
    -1.73 ± 1.50
    -0.71 ± 1.58
        Abdominal Score + Distension
    -1.77 ± 1.43
    -0.57 ± 1.36
    Notes
    [7] - Participants with an assessment at given time point.
    [8] - Participants with an assessment at given time point.
    No statistical analyses for this end point

    Secondary: Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 2

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    End point title
    		 Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 2
    End point description
    Symptom severity was assessed daily on an 11-point NRS from 0 to 10, where 0 represents no symptoms and 10 represents very severe symptoms. Participants rated their abdominal pain, discomfort, bloating, and distension at its worst over the last 24 hours. Weekly average scores were calculated individually for abdominal pain, discomfort, bloating, distension. The abdominal score was calculated as the weekly average from the daily scores of the individual items of pain, discomfort, bloating combined. The abdominal score plus distension was calculated as the weekly average from the daily scores of the individual items of pain, discomfort, bloating and distension combined.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2
    End point values
    		 Matching Placebo 290 μg Linaclotide
    Number of subjects analysed
    8 [9]
    10 [10]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Pain
    -1.97 ± 1.60
    -1.42 ± 1.88
        Discomfort
    -2.51 ± 1.15
    -1.73 ± 2.27
        Bloating
    -2.65 ± 1.30
    -1.04 ± 1.54
        Distension
    -2.51 ± 1.37
    -0.78 ± 1.33
        Abdominal Score
    -2.38 ± 1.19
    -1.40 ± 1.69
        Abdominal Score + Distension
    -2.41 ± 1.18
    -1.25 ± 1.52
    Notes
    [9] - Participants with an assessment at given time point.
    [10] - Participants with an assessment at given time point.
    No statistical analyses for this end point

    Secondary: Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 3

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    End point title
    		 Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 3
    End point description
    Symptom severity was assessed daily on an 11-point NRS from 0 to 10, where 0 represents no symptoms and 10 represents very severe symptoms. Participants rated their abdominal pain, discomfort, bloating, and distension at its worst over the last 24 hours. Weekly average scores were calculated individually for abdominal pain, discomfort, bloating, distension. The abdominal score was calculated as the weekly average from the daily scores of the individual items of pain, discomfort, bloating combined. The abdominal score plus distension was calculated as the weekly average from the daily scores of the individual items of pain, discomfort, bloating and distension combined.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 3
    End point values
    		 Matching Placebo 290 μg Linaclotide
    Number of subjects analysed
    8 [11]
    10 [12]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Pain
    -1.60 ± 2.66
    -2.07 ± 1.88
        Discomfort
    -2.01 ± 1.86
    -2.25 ± 2.26
        Bloating
    -2.02 ± 1.67
    -1.16 ± 1.51
        Distension
    -1.79 ± 1.80
    -1.05 ± 1.37
        Abdominal Score
    -1.88 ± 1.95
    -1.82 ± 1.64
        Abdominal Score + Distension
    -1.86 ± 1.87
    -1.64 ± 1.46
    Notes
    [11] - Participants with an assessment at given time point.
    [12] - Participants with an assessment at given time point.
    No statistical analyses for this end point

    Secondary: Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 4

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    End point title
    		 Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 4
    End point description
    Symptom severity was assessed daily on an 11-point NRS from 0 to 10, where 0 represents no symptoms and 10 represents very severe symptoms. Participants rated their abdominal pain, discomfort, bloating, and distension at its worst over the last 24 hours. Weekly average scores were calculated individually for abdominal pain, discomfort, bloating, distension. The abdominal score was calculated as the weekly average from the daily scores of the individual items of pain, discomfort, bloating combined. The abdominal score plus distension was calculated as the weekly average from the daily scores of the individual items of pain, discomfort, bloating and distension combined.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    End point values
    		 Matching Placebo 290 μg Linaclotide
    Number of subjects analysed
    8 [13]
    10 [14]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Pain
    -1.71 ± 2.44
    -1.90 ± 1.50
        Discomfort
    -1.94 ± 1.63
    -2.24 ± 1.92
        Bloating
    -1.84 ± 1.64
    -1.64 ± 1.74
        Distension
    -1.70 ± 1.60
    -1.22 ± 1.69
        Abdominal Score
    -1.83 ± 1.84
    -1.91 ± 1.39
        Abdominal Score + Distension
    -1.80 ± 1.75
    -1.74 ± 1.37
    Notes
    [13] - Participants with an assessment at given time point.
    [14] - Participants with an assessment at given time point.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Digestive Sensations (Subjective Bloating, Abdominal Discomfort, Abdominal Distension and Abdominal Pain) at Week 2

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    End point title
    		 Change From Baseline in Digestive Sensations (Subjective Bloating, Abdominal Discomfort, Abdominal Distension and Abdominal Pain) at Week 2
    End point description
    A digestive sensations questionnaire was used to record abdominal pain, discomfort, bloating, and distension symptoms on an hourly basis (waking hours only) during the 24 hours the participants are fitted with the AIP belt, using an 11-point NRS, with 0=no symptomatic sensations and 10=most severe symptomatic sensations. Daily diary scores for each of the digestive symptoms was averaged to obtain ‘weekly’ scores.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2
    End point values
    		 Matching Placebo 290 μg Linaclotide
    Number of subjects analysed
    8 [15]
    10 [16]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Pain
    -1.13 ± 1.38
    -0.61 ± 1.10
        Discomfort
    -1.01 ± 1.53
    -1.00 ± 1.34
        Bloating
    -1.03 ± 1.54
    -0.58 ± 1.33
        Distension
    -0.97 ± 1.50
    -0.36 ± 1.14
    Notes
    [15] - Participants with an assessment at given time point.
    [16] - Participants with an assessment at given time point.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Digestive Sensations (Subjective Bloating, Abdominal Discomfort, Abdominal Distension and Abdominal Pain) at Week 4

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    End point title
    		 Change From Baseline in Digestive Sensations (Subjective Bloating, Abdominal Discomfort, Abdominal Distension and Abdominal Pain) at Week 4
    End point description
    A digestive sensations questionnaire was used to record abdominal pain, discomfort, bloating, and distension symptoms on an hourly basis (waking hours only) during the 24 hours the participants are fitted with the AIP belt, using an 11-point NRS, with 0=no symptomatic sensations and 10=most severe symptomatic sensations. Daily diary scores for each of the digestive symptoms was averaged to obtain ‘weekly’ scores.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    End point values
    		 Matching Placebo 290 μg Linaclotide
    Number of subjects analysed
    7 [17]
    9 [18]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Pain
    -0.97 ± 1.55
    -0.87 ± 1.33
        Discomfort
    -0.89 ± 1.51
    -1.81 ± 1.11
        Bloating
    -1.01 ± 1.57
    -1.66 ± 1.03
        Distension
    -1.03 ± 1.49
    -1.42 ± 0.64
    Notes
    [17] - Participants with an assessment at given time point.
    [18] - Participants with an assessment at given time point.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Bristol Stool Form Scale (BSFS) Over Time

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    End point title
    		 Change From Baseline in Bristol Stool Form Scale (BSFS) Over Time
    End point description
    Daily stool consistency analyses were performed using the 7-point Bristol Stool Form Scale (BSFS), whereby a score of 1 = separate hard lumps like nuts (difficult to pass); 2 = sausage shaped but lumpy; 3 = like a sausage but with cracks on surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges (passed easily); 6 = fluffy pieces with ragged edges, a mushy stool; and 7 = watery, no solid pieces (entirely liquid). Daily average recorded BSFS scores for each participant were computed for each week.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, Week 2, Week 3, Week 4
    End point values
    		 Matching Placebo 290 μg Linaclotide
    Number of subjects analysed
    8 [19]
    11 [20]
    Units: score on a scale
    arithmetic mean (standard deviation)
        Week 1; n=8, 11
    0.33 ± 0.88
    1.53 ± 1.57
        Week 2; n=8, 10
    0.57 ± 0.86
    1.51 ± 1.27
        Week 3; n=8, 10
    0.39 ± 1.15
    2.11 ± 1.43
        Week 4; n=8, 10
    0.35 ± 1.11
    1.56 ± 1.13
    Notes
    [19] - n=participants with an assessment at given time point.
    [20] - n=participants with an assessment at given time point.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug through Day 36 (± 2 days).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Matching Placebo
    Reporting group description
    		 Placebo once daily for 4 weeks

    Reporting group title
    290 μg Linaclotide
    Reporting group description
    		 290 μg linaclotide once daily for 4 weeks

    Serious adverse events
    		 Matching Placebo 290 μg Linaclotide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Loss of consciousness
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 10 (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: 0%
    Non-serious adverse events
    		 Matching Placebo 290 μg Linaclotide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 9 (11.11%)
    7 / 10 (70.00%)
    Injury, poisoning and procedural complications
    Back injury
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Anal haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 9 (0.00%)
    5 / 10 (50.00%)
         occurrences all number
    0
    7
    Nausea
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Jul 2016
    • Defined the End of Study as the last participant Follow-up Telephone Call (Day 36) • Updated exclusion criteria to exclude participants with known or suspected mechanical gastrointestinal obstruction and participants with hypersensitivity to linaclotide or to any of the excipients • Specified that the United States product insert serves as the Reference Safety Information for the study • Clarified the investigator and sponsor reporting responsibilities for serious adverse events and suspected unexpected serious adverse reactions, consistent with European Directive 2001/20/EC
    25 Apr 2017
    • Removed the rectal screening at each physical exam; sigmoidoscopy or colonoscopy will be performed if needed, at the discretion of the investigator • Added window of ±2 days for the Follow-up Period to the Schedule of Evaluations and subsequent sections for consistency with study design figure • Updated inclusion criteria to increase the body mass index (BMI) upper limit to 34.9 kg/m2 • Updated the number of capsules per bottle of study drug from 30 to 35 capsules to reflect how study drug is currently supplied • Removed urinalysis from the screening visit assessments; urine samples still collected for pregnancy testing • Removed the differential white blood cell count from the Clinical Laboratory Determinations • Administrative updates

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was terminated early due to insufficient enrollment. Due to an insufficient sample size, no conclusions could be drawn regarding efficacy.
    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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