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    Clinical Trial Results:
    A double-blind, randomized, placebo-controlled, phase 2a study to evaluate the safety, tolerability, and pharmacodynamic (PD) effects of two infusions of escalating doses of TPM502 in adults diagnosed with celiac disease (CeD)

    Summary
    EudraCT number
    		 2022-001656-41
    Trial protocol
    		 NO   FI   SE   DE   NL  
    Global end of trial date
    08 Aug 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Sep 2025
    First version publication date
    04 Sep 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TCeD21
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05660109
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Topas Therapeutics GmbH
    Sponsor organisation address
    Martinistrasse 64, Hamburg, Germany, 20251
    Public contact
    Veronica Asnaghi, Head of Clinical Science, Topas Therapeutics GmbH , asnaghi@topas-therapeutics.com
    Scientific contact
    Veronica Asnaghi, Head of Clinical Science, Topas Therapeutics GmbH , asnaghi@topas-therapeutics.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 Jul 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Aug 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Aug 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of two infusions of escalating doses of TPM502 in CeD patients.
    Protection of trial subjects
    No safety signal associated with the administration of the study drug has been documented. Nonetheless, acknowledging the early phase of clinical development, a number of activities were implemented to mitigate the potential risks of hypersensitivity reactions, cytokine release syndrome, hepatotoxicity and disease flare. They included the following: • Patients with history of hypersensitivity to i.v. iron preparations were not eligible • Patients were closely monitored for 6 hours post administration of IMP, and longer if needed, and were required to return to the site 24 hours post-IMP administration • Sequential treatment of patients, starting with a sentinel patient at the first dose level, was foreseen • Independent data monitoring committee (iDMC) review of data before the inception of dosing at the next dose level was foreseen • Patients with active moderate to severe liver disease, iron-storage disease, or any disease requiring regular blood transfusions were excluded from this study • Iron-related parameters were monitored during the study together with liver function tests with stopping rules in place should a patient develop signs of severe hepatotoxicity • The planned gluten challenge could lead to onset/worsening of celiac disease symptoms, and for this reason patients developing intolerable symptoms after the screening GC were excluded from the study.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    01 Dec 2022
    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
    Australia: 2
    Country: Number of subjects enrolled
    Netherlands: 17
    Country: Number of subjects enrolled
    Norway: 8
    Country: Number of subjects enrolled
    Sweden: 6
    Country: Number of subjects enrolled
    Finland: 5
    Worldwide total number of subjects
    38
    EEA total number of subjects
    36
    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)
    35
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Norway: 2 sites; regulatory approval 7/12/22; FPI 20/12/22 Germany: 1 site; reg. approval 21/4/23; FPI N/A Finland: 2 sites; reg. approval 27/12/22; FPI 11/4/23 Netherlands: 1 site; reg. approval 22/2/23; FPI 14/3/23 Sweden: 1 site; reg. approval 24/4/23; FPI 29/6/23 Australia: 2 sites; reg. approval 16/10/23; FPI 6/12/23

    Pre-assignment
    Screening details
    		 391 patients were screened. Main reasons for screen failure were: not being HLA-DQ2.5 positive but HLA-DQ8 and HLA-DQ2.2 negative (35%) and not meeting the requirement to show IL-2 response post-gluten challenge above a pre-defined threshold (20%).

    Pre-assignment period milestones
    Number of subjects started
    		 391 [1]
    Number of subjects completed
    		 38

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Did not meet exclusion criteria: 49
    Reason: Number of subjects
    		 Did not meet inclusion criteria: 228
    Reason: Number of subjects
    		 Consent withdrawn by subject: 31
    Reason: Number of subjects
    		 Physician decision: 3
    Reason: Number of subjects
    		 Miscellaneous: 42
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Pre-assignment period is defined as all patients signing a consent form and being screened, while the number enrolled is defined as the number who met screening criteria and were randomised.
    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, Monitor, Data analyst
    Blinding implementation details
    The CRO unblinded statistician, the unblinded monitor and the clinical sites´ personnel involved in IMP and placebo preparation were unblinded to the study treatment. The IMP and the placebo are of similar colour and appearance, and the blinded labels on the syringe containing either TPM502 or placebo were designed to prevent identification of the treatment of the patients to blinded personnel involved in the study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 TPM502 0.72 μmol
    Arm description
    		 Participants randomised to this arm received TPM502 at the total dose of 0.72 μmol in two divided doses (0.36 μmol each). Each dose was prepared as a 30 mL solution for infusion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TPM502
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received TPM502 in two divided doses, two weeks apart.

    Arm title
    		 TPM502 2.4 μmol
    Arm description
    		 Participants randomised to this arm received TPM502 at the total dose of 2.4 μmol in two divided doses (1.2 μmol each). Each dose was prepared as a 30 mL solution for infusion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TPM502
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received TPM502 in two divided doses, two weeks apart.

    Arm title
    		 TPM502 4.8 μmol
    Arm description
    		 Participants in this arm received TPM502 at the total dose of 4.8 μmol in two divided doses (2.4 μmol each). Each dose was prepared as a 30 mL solution for infusion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TPM502
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received TPM502 in two divided doses, two weeks apart.

    Arm title
    		 TPM502 7.2 μmol
    Arm description
    		 Participants randomised to this arm received TPM502 at the total dose of 7.2 μmol in two divided doses (3.6 μmol each). Each dose was prepared as a 30 mL solution for infusion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TPM502
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received TPM502 in two divided doses, two weeks apart.

    Arm title
    		 Placebo
    Arm description
    		 Ferinject solution diluted to 2 mg iron/ml was used as placebo and administered as 30 ml infusion. Ferinject, an iron preparation, was chosen as placebo in this study because of its visual characteristics (i.e., its colour), relevant to maintain the study blinding.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Ferinject
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ferinject solution diluted to 2 mg iron/ml was used as placebo and administered as 30 ml infusion.

    Number of subjects in period 1
    		TPM502 0.72 μmol TPM502 2.4 μmol TPM502 4.8 μmol TPM502 7.2 μmol Placebo
    Started
    8
    6
    6
    6
    12
    Completed 1st IMP dose (Day 1)
    8
    6
    6
    6
    12
    Completed 2nd IMP dose (Day 15)
    7
    6
    6
    6
    12
    Completed 2nd gluten challenge (Day 22)
    7
    6
    6
    6
    12
    Completed
    7
    6
    6
    6
    12
    Not completed
    1
    0
    0
    0
    0
         Consent withdrawn by subject
    1
    -
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    TPM502 0.72 μmol
    Reporting group description
    		 Participants randomised to this arm received TPM502 at the total dose of 0.72 μmol in two divided doses (0.36 μmol each). Each dose was prepared as a 30 mL solution for infusion.

    Reporting group title
    TPM502 2.4 μmol
    Reporting group description
    		 Participants randomised to this arm received TPM502 at the total dose of 2.4 μmol in two divided doses (1.2 μmol each). Each dose was prepared as a 30 mL solution for infusion.

    Reporting group title
    TPM502 4.8 μmol
    Reporting group description
    		 Participants in this arm received TPM502 at the total dose of 4.8 μmol in two divided doses (2.4 μmol each). Each dose was prepared as a 30 mL solution for infusion.

    Reporting group title
    TPM502 7.2 μmol
    Reporting group description
    		 Participants randomised to this arm received TPM502 at the total dose of 7.2 μmol in two divided doses (3.6 μmol each). Each dose was prepared as a 30 mL solution for infusion.

    Reporting group title
    Placebo
    Reporting group description
    		 Ferinject solution diluted to 2 mg iron/ml was used as placebo and administered as 30 ml infusion. Ferinject, an iron preparation, was chosen as placebo in this study because of its visual characteristics (i.e., its colour), relevant to maintain the study blinding.

    Reporting group values
    		 TPM502 0.72 μmol TPM502 2.4 μmol TPM502 4.8 μmol TPM502 7.2 μmol Placebo Total
    Number of subjects
    		 8 6 6 6 12 38
    Age categorical
    Units: Subjects
    Age continuous
    Mean age (continuous)
    Units: years
        arithmetic mean (standard deviation)
    		 36.4 ( 13.69 ) 38.7 ( 17.07 ) 35.8 ( 18.54 ) 44.2 ( 23.61 ) 37.4 ( 13.94 ) -
    Gender categorical
    Gender
    Units: Subjects
        Female
    		 6 5 4 3 9 27
        Male
    		 2 1 2 3 3 11

    End points

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    End points reporting groups
    Reporting group title
    TPM502 0.72 μmol
    Reporting group description
    		 Participants randomised to this arm received TPM502 at the total dose of 0.72 μmol in two divided doses (0.36 μmol each). Each dose was prepared as a 30 mL solution for infusion.

    Reporting group title
    TPM502 2.4 μmol
    Reporting group description
    		 Participants randomised to this arm received TPM502 at the total dose of 2.4 μmol in two divided doses (1.2 μmol each). Each dose was prepared as a 30 mL solution for infusion.

    Reporting group title
    TPM502 4.8 μmol
    Reporting group description
    		 Participants in this arm received TPM502 at the total dose of 4.8 μmol in two divided doses (2.4 μmol each). Each dose was prepared as a 30 mL solution for infusion.

    Reporting group title
    TPM502 7.2 μmol
    Reporting group description
    		 Participants randomised to this arm received TPM502 at the total dose of 7.2 μmol in two divided doses (3.6 μmol each). Each dose was prepared as a 30 mL solution for infusion.

    Reporting group title
    Placebo
    Reporting group description
    		 Ferinject solution diluted to 2 mg iron/ml was used as placebo and administered as 30 ml infusion. Ferinject, an iron preparation, was chosen as placebo in this study because of its visual characteristics (i.e., its colour), relevant to maintain the study blinding.

    Primary: TEAE incidence

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    End point title
    		 TEAE incidence [1]
    End point description
    End point type
    Primary
    End point timeframe
    Throughout the study, on average 43 days
    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 were used in the evaluation of the safety and tolerability of escalating doses of TPM502 in CeD patients.
    End point values
    		 TPM502 0.72 μmol TPM502 2.4 μmol TPM502 4.8 μmol TPM502 7.2 μmol Placebo
    Number of subjects analysed
    8
    6
    6
    6
    12
    Units: events
    94
    58
    101
    75
    100
    No statistical analyses for this end point

    Primary: TEAE causality

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    End point title
    		 TEAE causality [2]
    End point description
    Number of TEAE events assessed to be related to IMP.
    End point type
    Primary
    End point timeframe
    Throughout the study, on average 43 days
    Notes
    [2] - 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 were used in the evaluation of the safety and tolerability of escalating doses of TPM502 in CeD patients.
    End point values
    		 TPM502 0.72 μmol TPM502 2.4 μmol TPM502 4.8 μmol TPM502 7.2 μmol Placebo
    Number of subjects analysed
    8
    6
    6
    6
    12
    Units: events
    41
    32
    53
    40
    24
    No statistical analyses for this end point

    Primary: TEAE severity

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    End point title
    		 TEAE severity [3]
    End point description
    All TEAEs, both IMP- and not IMP-related are described. The one Grade 4 AE was not IMP-related and had onset during the follow-up period of the study.
    End point type
    Primary
    End point timeframe
    Throughout the study, on average 43 days
    Notes
    [3] - 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 were used in the evaluation of the safety and tolerability of escalating doses of TPM502 in CeD patients.
    End point values
    		 TPM502 0.72 μmol TPM502 2.4 μmol TPM502 4.8 μmol TPM502 7.2 μmol Placebo
    Number of subjects analysed
    8
    6
    6
    6
    12
    Units: events
        Grade 1
    77
    51
    88
    37
    82
        Grade 2
    17
    7
    14
    29
    15
        Grade 3
    0
    0
    0
    8
    3
        Grade 4
    0
    0
    0
    1
    0
    No statistical analyses for this end point

    Secondary: IL-2 AUC

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    End point title
    		 IL-2 AUC
    End point description
    Change in the log of IL-2 AUC after gluten challenge (GC) post TPM502 treatment (Day 22) versus IL-2 after GC at screening (Day -28).
    End point type
    Secondary
    End point timeframe
    Day 22
    End point values
    		 TPM502 0.72 μmol TPM502 2.4 μmol TPM502 4.8 μmol TPM502 7.2 μmol Placebo
    Number of subjects analysed
    6
    6
    6
    6
    12
    Units: pg.h/ml
        arithmetic mean (standard deviation)
    0.023 ( 0.374 )
    -0.098 ( 0.151 )
    -0.258 ( 0.396 )
    -0.063 ( 0.271 )
    0.112 ( 0.485 )
    No statistical analyses for this end point

    Secondary: TPM502 Cmax (Day 1)

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    End point title
    		 TPM502 Cmax (Day 1) [4]
    End point description
    Maximum observed plasma concentration of the peptide components (i.e. TPCs) after dosing.
    End point type
    Secondary
    End point timeframe
    Day 1
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive statistics were used.
    End point values
    		 TPM502 0.72 μmol TPM502 2.4 μmol TPM502 4.8 μmol TPM502 7.2 μmol
    Number of subjects analysed
    6
    6
    6
    6
    Units: ng/ml
    median (full range (min-max))
        TPC0203
    12.8 (10.6 to 22.9)
    89.4 (47.6 to 116.0)
    191.0 (118.0 to 287.0)
    418.5 (211.0 to 578.0)
        TPC0205
    21.5 (13.0 to 49.1)
    166.0 (119.0 to 214.0)
    304.5 (246.0 to 413.0)
    641.0 (246.0 to 800.0)
        TPC0206
    14.1 (10.5 to 26.3)
    106.0 (69.4 to 125.0)
    216.0 (177.0 to 320.0)
    463.0 (182.0 to 612.0)
    No statistical analyses for this end point

    Secondary: TPM502 Cmax (Day 15)

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    End point title
    		 TPM502 Cmax (Day 15) [5]
    End point description
    Maximum observed plasma concentration of the peptide components (i.e. TPCs) after dosing.
    End point type
    Secondary
    End point timeframe
    Day 15
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive statistics were used.
    End point values
    		 TPM502 0.72 μmol TPM502 2.4 μmol TPM502 4.8 μmol TPM502 7.2 μmol
    Number of subjects analysed
    6
    6
    6
    6
    Units: ng/ml
    median (full range (min-max))
        TPC0203
    14.1 (10.4 to 17.6)
    81.9 (68.4 to 120.0)
    175.0 (114.0 to 347.0)
    447.5 (261.0 to 701.0)
        TPC0205
    16.2 (13.9 to 37.5)
    161.0 (147.0 to 212.0)
    252.5 (222.0 to 430.0)
    653.0 (338.0 to 912.0)
        TPC0206
    17.4 (10.8 to 21.5)
    89.2 (81.2 to 135.0)
    89.2 (81.2 to 135.0)
    466.5 (269.0 to 582.0)
    No statistical analyses for this end point

    Secondary: TPM502 AUC (0-last) (Day 1)

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    End point title
    		 TPM502 AUC (0-last) (Day 1) [6]
    End point description
    Area under the plasma concentration-time curve from time zero to the time of the last quantifiable PK sample.
    End point type
    Secondary
    End point timeframe
    Day 1
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive statistics were used.
    End point values
    		 TPM502 0.72 μmol TPM502 2.4 μmol TPM502 4.8 μmol TPM502 7.2 μmol
    Number of subjects analysed
    6
    6
    6
    6
    Units: h.ng/ml
    median (full range (min-max))
        TPC0203
    3.9 (1.5 to 7.5)
    36.4 (17.0 to 49.1)
    105.1 (71.6 to 154.7)
    231.4 (114.8 to 644.3)
        TPC0205
    5.9 (1.8 to 24.1)
    106.4 (67.0 to 162.8)
    257.7 (148.4 to 317.6)
    523.0 (265.8 to 901.4)
        TPC0206
    3.7 (1.1 to 41.2)
    350.8 (145.3 to 536.7)
    797.0 (726.3 to 1050.0)
    1213.3 (587.0 to 2056.7)
    No statistical analyses for this end point

    Secondary: TPM502 AUC (0-last) (Day 15)

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    End point title
    		 TPM502 AUC (0-last) (Day 15) [7]
    End point description
    Area under the plasma concentration-time curve from time zero to the time of the last quantifiable PK sample.
    End point type
    Secondary
    End point timeframe
    Day 15
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive statistics were used.
    End point values
    		 TPM502 0.72 μmol TPM502 2.4 μmol TPM502 4.8 μmol TPM502 7.2 μmol
    Number of subjects analysed
    6
    6
    6
    6
    Units: h.ng/ml
    median (full range (min-max))
        TPC0203
    4.3 (1.3 to 5.9)
    36.8 (24.2 to 67.5)
    99.6 (62.8 to 199.6)
    288.8 (113.2 to 746.4)
        TPC0205
    4.6 (4.2 to 18.0)
    120.0 (95.3 to 157.0)
    252.8 (143.4 to 293.8)
    540.9 (241.9 to 1227.8)
        TPC0206
    3.8 (1.1 to 6.3)
    273.9 (93.3 to 589.5)
    273.9 (93.3 to 589.5)
    1265.0 (596.3 to 2122.3)
    No statistical analyses for this end point

    Secondary: CeD PRO - COMPGI2

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    End point title
    		 CeD PRO - COMPGI2
    End point description
    COMPGI2 is a composite score including the nausea and vomiting items of the CeD PRO. Results represent the mean and SD of the change between Day 22 (post treatment gluten challenge) and Day -28 (screening gluten challenge) AUCs (calculated over a period of 6 hours).
    End point type
    Secondary
    End point timeframe
    Day 22
    End point values
    		 TPM502 0.72 μmol TPM502 2.4 μmol TPM502 4.8 μmol TPM502 7.2 μmol Placebo
    Number of subjects analysed
    6
    6
    6
    6
    12
    Units: unitless score
        arithmetic mean (standard deviation)
    0.003 ( 4.41 )
    -2.04 ( 2.32 )
    4.87 ( 15.8 )
    -5.43 ( 10.7 )
    5.27 ( 12.0 )
    No statistical analyses for this end point

    Secondary: CeD PRO - COMPGI7

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    End point title
    		 CeD PRO - COMPGI7
    End point description
    COMPGI7 is a composite score including all gastrointestinal symptom items of the CeD PRO. Results represent the mean and SD of the change between Day 22 (post treatment gluten challenge) and Day -28 (screening gluten challenge) AUCs (calculated over a period of 6 hours).
    End point type
    Secondary
    End point timeframe
    Day 22
    End point values
    		 TPM502 0.72 μmol TPM502 2.4 μmol TPM502 4.8 μmol TPM502 7.2 μmol Placebo
    Number of subjects analysed
    6
    6
    6
    6
    12
    Units: unitless score
        arithmetic mean (standard deviation)
    0.530 ( 15.2 )
    -8.40 ( 20.4 )
    -2.84 ( 30.9 )
    -36.6 ( 35.3 )
    11.3 ( 48.5 )
    No statistical analyses for this end point

    Secondary: CeD PRO - COMPGI10

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    End point title
    		 CeD PRO - COMPGI10
    End point description
    COMPGI10 is a composite score including all ten symptom items of the CeD PRO. Results represent the mean and SD of the change between Day 22 (post treatment gluten challenge) and Day -28 (screening gluten challenge) AUCs (calculated over a period of 6 hours).
    End point type
    Secondary
    End point timeframe
    Day 22
    End point values
    		 TPM502 0.72 μmol TPM502 2.4 μmol TPM502 4.8 μmol TPM502 7.2 μmol Placebo
    Number of subjects analysed
    6
    6
    6
    6
    12
    Units: unitless score
        arithmetic mean (standard deviation)
    -18.1 ( 38.4 )
    -16.2 ( 34.0 )
    -15.6 ( 33.4 )
    -52.1 ( 47.5 )
    -1.20 ( 66.3 )
    No statistical analyses for this end point

    Secondary: GloSS PRO

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    End point title
    		 GloSS PRO
    End point description
    Results represent the mean and SD of the change between Day 22 (post treatment gluten challenge) and Day -28 (screening gluten challenge) AUCs (calculated over a period of 6 hours) of the GloSS patient-reported outcome.
    End point type
    Secondary
    End point timeframe
    Day 22
    End point values
    		 TPM502 0.72 μmol TPM502 2.4 μmol TPM502 4.8 μmol TPM502 7.2 μmol Placebo
    Number of subjects analysed
    6
    6
    6
    6
    12
    Units: unitless score
        arithmetic mean (standard deviation)
    -4.88 ( 7.71 )
    -0.976 ( 3.83 )
    -4.11 ( 2.49 )
    -2.96 ( 11.2 )
    2.49 ( 10.1 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment emergent adverse events are reported here (from Day -1 to Day 43/end of trial).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    TPM502 0.72 μmol
    Reporting group description
    		 Participants randomised to this arm received TPM502 at the total dose of 0.72 μmol in two divided doses (0.36 μmol each). Each dose was prepared as a 30 mL solution for infusion.

    Reporting group title
    TPM502 2.4 μmol
    Reporting group description
    		 Participants randomised to this arm received TPM502 at the total dose of 2.4 μmol in two divided doses (1.2 μmol each). Each dose was prepared as a 30 mL solution for infusion.

    Reporting group title
    TPM502 4.8 μmol
    Reporting group description
    		 Participants in this arm received TPM502 at the total dose of 4.8 μmol in two divided doses (2.4 μmol each). Each dose was prepared as a 30 mL solution for infusion.

    Reporting group title
    TPM502 7.2 μmol
    Reporting group description
    		 Participants randomised to this arm received TPM502 at the total dose of 7.2 μmol in two divided doses (3.6 μmol each). Each dose was prepared as a 30 mL solution for infusion.

    Reporting group title
    Placebo
    Reporting group description
    		 Ferinject solution diluted to 2 mg iron/ml was used as placebo and administered as 30 mL infusion. Ferinject, an iron preparation, was chosen as placebo in this study because of its visual characteristics (i.e., its colour), relevant to maintain the study blinding.

    Serious adverse events
    		 TPM502 0.72 μmol TPM502 2.4 μmol TPM502 4.8 μmol TPM502 7.2 μmol Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Subdural heamatoma
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 TPM502 0.72 μmol TPM502 2.4 μmol TPM502 4.8 μmol TPM502 7.2 μmol Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 8 (100.00%)
    6 / 6 (100.00%)
    6 / 6 (100.00%)
    6 / 6 (100.00%)
    12 / 12 (100.00%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Pallor
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    General disorders and administration site conditions
    Administration site haematoma
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    Catheter site pain
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Chest pain
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Chills
         subjects affected / exposed
    2 / 8 (25.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    1 / 12 (8.33%)
         occurrences all number
    3
    1
    1
    2
    1
    Fatigue
         subjects affected / exposed
    6 / 8 (75.00%)
    2 / 6 (33.33%)
    4 / 6 (66.67%)
    3 / 6 (50.00%)
    7 / 12 (58.33%)
         occurrences all number
    16
    7
    8
    5
    10
    Feeling hot
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    Injection site reaction
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    Injection site swelling
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Malaise
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    1
    0
    0
    0
    1
    Oedema
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    Pain
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    0
    0
    1
    Sensation of foreign body
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Thirst
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    0
    0
    0
    3
    Respiratory, thoracic and mediastinal disorders
    Hiccups
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    1
    0
    1
    0
    1
    Throat irritation
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Psychiatric disorders
    Alcoholic hangover
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Depressed mood
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Investigations
    Blood fibrinogen increased
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Blood pressure systolic decreased
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Body temperature increased
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    C-reactive protein increased
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 12 (0.00%)
         occurrences all number
    1
    2
    0
    3
    0
    Complement factor C3 increased
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Head injury
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Skin injury
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Subdural haematoma
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 6 (0.00%)
    4 / 6 (66.67%)
    1 / 6 (16.67%)
    4 / 12 (33.33%)
         occurrences all number
    2
    0
    5
    1
    4
    Dysgeusia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    Headache
         subjects affected / exposed
    3 / 8 (37.50%)
    2 / 6 (33.33%)
    3 / 6 (50.00%)
    2 / 6 (33.33%)
    9 / 12 (75.00%)
         occurrences all number
    8
    2
    7
    3
    19
    Paraesthesia
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    1
    2
    0
    0
    Presyncope
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Syncope
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Tremor
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Eye inflammation
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Photopsia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Abdominal distension
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 6 (16.67%)
    2 / 6 (33.33%)
    1 / 6 (16.67%)
    4 / 12 (33.33%)
         occurrences all number
    1
    4
    5
    2
    4
    Abdominal pain
         subjects affected / exposed
    3 / 8 (37.50%)
    2 / 6 (33.33%)
    4 / 6 (66.67%)
    3 / 6 (50.00%)
    1 / 12 (8.33%)
         occurrences all number
    8
    4
    9
    3
    2
    Abdominal pain upper
         subjects affected / exposed
    0 / 8 (0.00%)
    3 / 6 (50.00%)
    1 / 6 (16.67%)
    2 / 6 (33.33%)
    3 / 12 (25.00%)
         occurrences all number
    0
    3
    1
    4
    3
    Constipation
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    5 / 8 (62.50%)
    2 / 6 (33.33%)
    3 / 6 (50.00%)
    5 / 6 (83.33%)
    4 / 12 (33.33%)
         occurrences all number
    6
    6
    9
    6
    9
    Faeces hard
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Faeces soft
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Flatulence
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 6 (33.33%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    1 / 12 (8.33%)
         occurrences all number
    1
    4
    0
    2
    1
    Gastrointestinal sounds abnormal
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Gastroesophageal reflux disease
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    2
    0
    1
    Nausea
         subjects affected / exposed
    5 / 8 (62.50%)
    5 / 6 (83.33%)
    5 / 6 (83.33%)
    5 / 6 (83.33%)
    11 / 12 (91.67%)
         occurrences all number
    14
    8
    21
    13
    15
    Vomiting
         subjects affected / exposed
    6 / 8 (75.00%)
    3 / 6 (50.00%)
    5 / 6 (83.33%)
    5 / 6 (83.33%)
    10 / 12 (83.33%)
         occurrences all number
    11
    4
    13
    10
    10
    Skin and subcutaneous tissue disorders
    Blister
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    0
    0
    1
    Dermatitis contact
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Erythema
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    0
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    Rash
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Rash pruritic
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    3
    Urticaria
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    2
    1
    Renal and urinary disorders
    Micturition urgency
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Back pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Muscle spasms
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Infections and infestations
    Gastroenteritis viral
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    2 / 6 (33.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    1
    2
    0
    Oral herpes
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Otitis media acute
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    2
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Jan 2024
    The substantial amendment was implemented to align with current standard of care regarding Covid infection (i.e. full Covid vaccination no longer a requirement), to ensure the eligibility criteria allow inclusion of “average” celiac patients (i.e. qualifying BMI range slightly modified) and to ensure adequate safety and pharmacodynamic monitoring in light of the knowledge acquired to date (CRP measurement introduced at Day 8 and 22). Given the proposed changes (i.e. specifically, the modification of the eligibility criteria, namely the BMI and Covid vaccination requirements), this amendment was regarded as substantial, even though the proposed changes had no impact on the scientific value of the trial nor on the safety monitoring and risk minimization approach of the clinical study.

    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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