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    Clinical Trial Results:
    A phase IIb, double-blind, randomised, placebo-controlled trial to evaluate the efficacy and tolerability of ZED1227 in celiac disease subjects experiencing symptoms despite gluten-free diet

    Summary
    EudraCT number
    		 2020-004612-97
    Trial protocol
    		 FI   LT   DE   NO   EE   IE   AT   FR   IT   SE   ES   PL   BG   HR  
    Global end of trial date
    27 Sep 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Nov 2025
    First version publication date
    08 Nov 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CEC-4/CEL
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dr. Falk Pharma GmbH
    Sponsor organisation address
    Leinenweberstr. 5, Freiburg, Germany, 79108
    Public contact
    Dept. of Clinical Research & Develo, Dr. Falk Pharma GmbH, +49 7611514156, mohrbacher@drfalkpharma.de
    Scientific contact
    Dept. of Clinical Research & Develo, Dr. Falk Pharma GmbH, +49 7611514156, mohrbacher@drfalkpharma.de
    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
    09 Apr 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Sep 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Sep 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess 3 different doses and 2 different dosing schedules of ZED1227 capsules for efficacy in improvement of the duodenal mucosal morphology and improvement of celiac disease symptoms assessed by Celiac Disease Symptom Diary (CDSD) in celiac disease subjects experiencing symptoms and having mucosal damage despite gluten-free diet.
    Protection of trial subjects
    Close supervision of subjects by implementing interim visits every 14 days first and then 28 days up to week 12 of double-blind treatment and one follow up vist at week 16 to guarantee their safety and wellbeing. Prior to recruitment of patients, all relevant documents of the clinical study were submitted and approved by the Independent Ethics Committees (IECs) responsible for the participating investigators. Written consent documents embodied the elements of informed consent as described in the Declaration of Helsinki, the ICH Guidelines for Good Clinical Practice (GCP) and were in accordance with all applicable laws and regulations. The informed consent form and patient information sheet described the planned and permitted uses, transfers and disclosures of the patient's personal data and personal health information for purposes of conducting the study. The informed consent form and the patient information sheet further explained the nature of the study, its objectives and potential risks and benefits as well as the date informed consent was given. Before being enrolled in the clinical trial, every patient was informed that participation in this trial was voluntary and that he/she could withdraw from the study at any time without giving a reason and without having to fear any loss in his/her medical care. The patient’s consent was obtained in writing before the start of the study. By signing the informed consent, the patient declared that he/she was participating voluntarily and intended to follow the study protocol instructions and the instructions of the investigator and to answer the questions asked during the course of the trial.
    Background therapy
    		 None.
    Evidence for comparator
    		 As there is no standard therapy, placebo was used as comparator.
    Actual start date of recruitment
    27 Oct 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
    Norway: 26
    Country: Number of subjects enrolled
    Poland: 33
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    Sweden: 36
    Country: Number of subjects enrolled
    Croatia: 9
    Country: Number of subjects enrolled
    Austria: 13
    Country: Number of subjects enrolled
    Bulgaria: 2
    Country: Number of subjects enrolled
    Estonia: 1
    Country: Number of subjects enrolled
    Finland: 40
    Country: Number of subjects enrolled
    France: 11
    Country: Number of subjects enrolled
    Germany: 118
    Country: Number of subjects enrolled
    Ireland: 8
    Country: Number of subjects enrolled
    Italy: 15
    Country: Number of subjects enrolled
    Lithuania: 5
    Country: Number of subjects enrolled
    Serbia: 5
    Country: Number of subjects enrolled
    Romania: 4
    Country: Number of subjects enrolled
    Australia: 35
    Country: Number of subjects enrolled
    New Zealand: 15
    Country: Number of subjects enrolled
    Switzerland: 9
    Country: Number of subjects enrolled
    Bosnia and Herzegovina: 6
    Country: Number of subjects enrolled
    North Macedonia: 2
    Worldwide total number of subjects
    397
    EEA total number of subjects
    325
    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)
    371
    From 65 to 84 years
    26
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 In total 397 patients were included in mentioned countries between October 2021 and September 2024.

    Pre-assignment
    Screening details
    		 Screening Criteria: 1. Signed Informed Consent 2. Aged 18 to 80 years 3. Active Celiac Disease. In total, 1001 patients were screened. Thereof 397 patients were randomised.

    Period 1
    Period 1 title
    Treatment Phase (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
    		 Arm A
    Arm description
    		 Placebo three times a day
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Three capsules per day.

    Arm title
    		 Arm B
    Arm description
    		 10 mg ZED1227 three times a day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    10 mg ZED 1227
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Three 10 mg ZED1227 capsules per day.

    Arm title
    		 Arm C
    Arm description
    		 50 mg ZED1227 once daily in the morning.
    Arm type
    		 Experimental

    Investigational medicinal product name
    50 mg ZED1227
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One 50 mg ZED1227 capsule in the morning. Two placebo ZED1227 capsules at noon and evening each.

    Arm title
    		 Arm D
    Arm description
    		 25 mg ZED1227 three times per day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    25 mg ZED1227
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Three 25 mg ZED1227 capsules per day.

    Number of subjects in period 1
    		Arm A Arm B Arm C Arm D
    Started
    99
    100
    99
    99
    Completed
    91
    94
    91
    92
    Not completed
    8
    6
    8
    7
         Consent withdrawn by subject
    3
    2
    6
    2
         Inclusion crit. not fulfilled
    -
    -
    -
    1
         withdrawal of consent
    -
    -
    -
    1
         Adverse event, non-fatal
    5
    2
    -
    1
         participant decision/decline in health, unrelated
    -
    -
    1
    -
         personal circumstances/relocated
    -
    1
    -
    -
         personal circumstances
    -
    -
    1
    -
         planned vacation/wish to finish trial
    -
    1
    -
    -
         Lack of efficacy
    -
    -
    -
    1
         detection of H. pylori
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Phase
    Reporting group description
    		 -

    Reporting group values
    		 Treatment Phase Total
    Number of subjects
    		 397 397
    Age categorical
    397 patients were finally randomised in one of the four treatment groups.
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 371 371
        From 65-84 years
    		 26 26
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.63 ( 14.35 ) -
    Gender categorical
    Units: Subjects
        Female
    		 288 288
        Male
    		 109 109
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    includes all randomised participants (as randomised at Baseline Visit B)

    Subject analysis set title
    mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Modified intention-to-treat (mITT) analysis set includes all participants from the intention-to-treat (ITT) analysis set who had acceptable VH:CrD and CDSD results for baseline and end of treatment

    Subject analysis set title
    SAS
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety analysis set (SAS) includes all randomised participants (as treated) who received at least one dose of the IMP. If there was any uncertainty about whether a participant received any IMP, the participant was included in the SAS.

    Subject analysis sets values
    		 ITT mITT SAS
    Number of subjects
    397
    338
    396
    Age categorical
    397 patients were finally randomised in one of the four treatment groups.
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    371
    314
    370
        From 65-84 years
    26
    24
    26
        85 years and over
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    40.63 ( 14.35 )
    41.28 ( 14.42 )
    40.64 ( 14.36 )
    Gender categorical
    Units: Subjects
        Female
    288
        Male
    109

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Placebo three times a day

    Reporting group title
    Arm B
    Reporting group description
    		 10 mg ZED1227 three times a day.

    Reporting group title
    Arm C
    Reporting group description
    		 50 mg ZED1227 once daily in the morning.

    Reporting group title
    Arm D
    Reporting group description
    		 25 mg ZED1227 three times per day.

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    includes all randomised participants (as randomised at Baseline Visit B)

    Subject analysis set title
    mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Modified intention-to-treat (mITT) analysis set includes all participants from the intention-to-treat (ITT) analysis set who had acceptable VH:CrD and CDSD results for baseline and end of treatment

    Subject analysis set title
    SAS
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety analysis set (SAS) includes all randomised participants (as treated) who received at least one dose of the IMP. If there was any uncertainty about whether a participant received any IMP, the participant was included in the SAS.

    Primary: Responder rate (histological and symptom improvement)

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    End point title
    		 Responder rate (histological and symptom improvement)
    End point description
    Responder rate (histological and symptom improvement)
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    		 Arm A Arm B Arm C Arm D mITT
    Number of subjects analysed
    83
    85
    87
    83
    0 [1]
    Units: Responder risk estimate
    least squares mean (confidence interval 95%)
        Least square risk estimates
    19.3 (12.4 to 30.0)
    27.1 (19.1 to 38.4)
    25.3 (17.6 to 36.3)
    16.9 (10.4 to 27.2)
    ( to )
    Notes
    [1] - Overall analysis does not make sense.
    Statistical analysis title
    		 Primary analysis
    Comparison groups
    Arm A v Arm B
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2377
    Method
    		 generalized linear model
    Confidence interval
    Statistical analysis title
    		 Primary analysis
    Comparison groups
    Arm A v Arm C
    Number of subjects included in analysis
    170
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3509
    Method
    		 generalized linear model
    Confidence interval
    Statistical analysis title
    		 Primary analysis
    Comparison groups
    Arm A v Arm D
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6873
    Method
    		 generalized linear model
    Confidence interval

    Secondary: Attenuation of gluten-induced mucosal damage

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    End point title
    		 Attenuation of gluten-induced mucosal damage
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Arm A Arm B Arm C Arm D mITT
    Number of subjects analysed
    83
    85
    87
    83
    0 [2]
    Units: Ratio of villus height to crypt depth
        least squares mean (confidence interval 95%)
    0.13 (0.03 to 0.22)
    0.21 (0.12 to 0.31)
    0.26 (0.17 to 0.36)
    0.18 (0.08 to 0.27)
    ( to )
    Notes
    [2] - Overall analysis does not make sense.
    Statistical analysis title
    		 Secondary analysis
    Comparison groups
    Arm A v Arm B
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1903
    Method
    		 generalized linear model
    Confidence interval
    Statistical analysis title
    		 Secondary analysis
    Comparison groups
    Arm A v Arm C
    Number of subjects included in analysis
    170
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0375
    Method
    		 generalized linear model
    Confidence interval
    Statistical analysis title
    		 Secondary analysis
    Comparison groups
    Arm A v Arm D
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4454
    Method
    		 generalized linear model
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were assessed at all visits.
    Adverse event reporting additional description
    Treatment-Emergent AEs during Treatment and Follow-up
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Placebo

    Reporting group title
    Arm B
    Reporting group description
    		 10 mg three times a day

    Reporting group title
    Arm C
    Reporting group description
    		 50 mg once a day

    Reporting group title
    Arm D
    Reporting group description
    		 25 mg three times a day

    Serious adverse events
    		 Arm A Arm B Arm C Arm D
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 99 (2.02%)
    4 / 100 (4.00%)
    0 / 99 (0.00%)
    1 / 98 (1.02%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Maternal exposure during pregnancy
         subjects affected / exposed
    1 / 99 (1.01%)
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tenoplasty
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm A Arm B Arm C Arm D
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    73 / 99 (73.74%)
    81 / 100 (81.00%)
    80 / 99 (80.81%)
    68 / 98 (69.39%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    15 / 99 (15.15%)
    15 / 100 (15.00%)
    21 / 99 (21.21%)
    11 / 98 (11.22%)
         occurrences all number
    19
    31
    33
    18
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 99 (3.03%)
    4 / 100 (4.00%)
    4 / 99 (4.04%)
    5 / 98 (5.10%)
         occurrences all number
    3
    6
    4
    5
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    4 / 99 (4.04%)
    3 / 100 (3.00%)
    6 / 99 (6.06%)
    10 / 98 (10.20%)
         occurrences all number
    4
    3
    6
    10
    Diarrhoea
         subjects affected / exposed
    6 / 99 (6.06%)
    15 / 100 (15.00%)
    9 / 99 (9.09%)
    8 / 98 (8.16%)
         occurrences all number
    7
    18
    9
    14
    Abdominal pain
         subjects affected / exposed
    4 / 99 (4.04%)
    4 / 100 (4.00%)
    3 / 99 (3.03%)
    7 / 98 (7.14%)
         occurrences all number
    4
    4
    3
    7
    Abdominal pain upper
         subjects affected / exposed
    3 / 99 (3.03%)
    4 / 100 (4.00%)
    5 / 99 (5.05%)
    5 / 98 (5.10%)
         occurrences all number
    5
    4
    5
    6
    Vomiting
         subjects affected / exposed
    3 / 99 (3.03%)
    2 / 100 (2.00%)
    1 / 99 (1.01%)
    5 / 98 (5.10%)
         occurrences all number
    3
    2
    3
    6
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    5 / 99 (5.05%)
    3 / 100 (3.00%)
    3 / 99 (3.03%)
    0 / 98 (0.00%)
         occurrences all number
    5
    3
    3
    0
    Psychiatric disorders
    Procedural anxiety
         subjects affected / exposed
    2 / 99 (2.02%)
    5 / 100 (5.00%)
    3 / 99 (3.03%)
    1 / 98 (1.02%)
         occurrences all number
    2
    5
    3
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    4 / 99 (4.04%)
    5 / 100 (5.00%)
    5 / 99 (5.05%)
    5 / 98 (5.10%)
         occurrences all number
    5
    6
    5
    5
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    19 / 99 (19.19%)
    13 / 100 (13.00%)
    18 / 99 (18.18%)
    12 / 98 (12.24%)
         occurrences all number
    23
    14
    19
    14
    COVID-19
         subjects affected / exposed
    3 / 99 (3.03%)
    6 / 100 (6.00%)
    4 / 99 (4.04%)
    4 / 98 (4.08%)
         occurrences all number
    3
    6
    4
    4
    Influenza
         subjects affected / exposed
    5 / 99 (5.05%)
    2 / 100 (2.00%)
    4 / 99 (4.04%)
    4 / 98 (4.08%)
         occurrences all number
    6
    2
    4
    4
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 99 (2.02%)
    5 / 100 (5.00%)
    3 / 99 (3.03%)
    3 / 98 (3.06%)
         occurrences all number
    2
    5
    3
    4
    Urinary tract infection
         subjects affected / exposed
    5 / 99 (5.05%)
    2 / 100 (2.00%)
    3 / 99 (3.03%)
    2 / 98 (2.04%)
         occurrences all number
    6
    3
    3
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jul 2022
    Amendment 01 forming integrated protocol version 2.0/29.07.2022
    14 Jul 2023
    Amendment 02 forming integrated protocol version 3.0/14.07.2023
    22 Nov 2023
    Amendment 03 forming integrated protocol version 4.0/22.11.2023

    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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