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    Clinical Trial Results:
    Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of norucholic acid tablets with placebo in the treatment of primary biliary cholangitis in patients with an inadequate response to ursodeoxycholic acid

    Summary
    EudraCT number
    		 2021-001431-56
    Trial protocol
    		 DE   AT   FI   BE   FR   NO   NL   DK  
    Global end of trial date
    12 Dec 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Mar 2026
    First version publication date
    07 Mar 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NUT-2/PBC
    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 Clinic. Res. & Development, Dr. Falk Pharma GmbH, +49 76115140, zentrale@drfalkpharma.de
    Scientific contact
    Dept. of Clinic. Res. & Development, Dr. Falk Pharma GmbH, +49 76115140, zentrale@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
    14 Jan 2026
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Dec 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Dec 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of two doses of norucholic acid vs. placebo for the treatment of primary biliary cholangitis (PBC) in patients with an inadequate response to ursodeoxycholic acid (UDCA).
    Protection of trial subjects
    Close supervision of subjects by implementing interim visits every 14 days for the first 4 weeks and every 4 weeks up to week 12 and one follow up visit 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. Additionally, an IDMC was implemented to evaluate the safety data of the clinical study.
    Background therapy
    		 All patients were to continue their pre-trial dose of UDCA throughout trial participation without changing the dosing regimen.
    Evidence for comparator
    		 As all patients will continue standard care treatment with UDCA, a placebo arm will be included as control due to regulatory recommendations to evaluate dose-related benefits and adverse effects in randomised, double-blind, placebo controlled studies.
    Actual start date of recruitment
    03 Jan 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
    Netherlands: 4
    Country: Number of subjects enrolled
    Norway: 1
    Country: Number of subjects enrolled
    Poland: 8
    Country: Number of subjects enrolled
    Austria: 11
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Denmark: 8
    Country: Number of subjects enrolled
    Finland: 4
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Germany: 15
    Country: Number of subjects enrolled
    Switzerland: 10
    Country: Number of subjects enrolled
    United Kingdom: 11
    Worldwide total number of subjects
    77
    EEA total number of subjects
    56
    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)
    63
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 In total 77 patients were included in Austria, Belgium, Switzerland, Germany, Denmark, Finland, France, United Kingdom, the Netherlands, Norway and Poland from September 2022 to July 2024.

    Pre-assignment
    Screening details
    		 A total of 99 patients were screened for the trial, 20 of whom were screening failures. A total of 79 patients were randomized. 77 were treated and included in the full analysis set.

    Period 1
    Period 1 title
    Treatment Phase (overall trial/period) (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
    Blinding implementation details
    Blinding was achieved by the application of the same number of tablets (verum and/or placebo) to each participant, i.e., each participant received a total of 3 tablets per day. Placebo tablets corresponded to verum tablets in size, taste and appearance.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 NCA high
    Arm description
    		 NCA 1500 mg once daily, 3 NCA tablets of 500 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    NCA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    NCA 1500 mg once daily 3 tablets à 500 mg NCA to be taken orally once daily

    Arm title
    		 NCA low
    Arm description
    		 NCA 1000 mg once daily, 2 NCA tablets of 500 mg and 1 Placebo tablet
    Arm type
    		 Experimental

    Investigational medicinal product name
    NCA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1000 mg NCA once daily 2 tablets à 500 mg NCA + 1 tablet Placebo to be taken orally once daily

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo for NCA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo for NCA once daily 3 tablets of Placebo to be taken orally once daily

    Number of subjects in period 1
    		NCA high NCA low Placebo
    Started
    26
    26
    25
    Completed
    25
    24
    23
    Not completed
    1
    2
    2
         Consent withdrawn by subject
    -
    -
    1
         Adverse event, non-fatal
    -
    2
    -
         Lack of compliance
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Phase (overall trial/period)
    Reporting group description
    		 79 patients were randomized. 2 patients have been randomized but not treated. Baseline characteristics are only reported for the 77 patients having received treatment.

    Reporting group values
    		 Treatment Phase (overall trial/period) Total
    Number of subjects
    		 77 77
    Age categorical
    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)
    		 63 63
        From 65-84 years
    		 14 14
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 55 (21 to 74) -
    Gender categorical
    Units: Subjects
        Female
    		 71 71
        Male
    		 6 6

    End points

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    End points reporting groups
    Reporting group title
    NCA high
    Reporting group description
    		 NCA 1500 mg once daily, 3 NCA tablets of 500 mg

    Reporting group title
    NCA low
    Reporting group description
    		 NCA 1000 mg once daily, 2 NCA tablets of 500 mg and 1 Placebo tablet

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Primary: Mean relative change (%) in ALP between the baseline visit and the EOT visit

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    End point title
    		 Mean relative change (%) in ALP between the baseline visit and the EOT visit
    End point description
    End point type
    Primary
    End point timeframe
    12 weeks treatment: from Baseline to end of treatment, LOCF (last ovservation carried forward)
    End point values
    		 NCA high NCA low Placebo
    Number of subjects analysed
    26
    26
    25
    Units: %
        arithmetic mean (confidence interval 95%)
    -4.998 (-16.3653 to 6.3699)
    1.548 (-7.9182 to 11.0135)
    -6.652 (-13.5321 to 0.2273)
    Statistical analysis title
    		 NCA high vs. Placebo
    Comparison groups
    NCA high v Placebo
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Median difference (final values)
    Point estimate
    -1.91
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -11.11
         upper limit
    		 7.28
    Statistical analysis title
    		 NCA low vs. Placebo
    Comparison groups
    NCA low v Placebo
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Median difference (final values)
    Point estimate
    8.62
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -2.26
         upper limit
    		 19.49

    Secondary: Mean relative change (%) in ALP between the baseline visit and the EOT visit

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    End point title
    		 Mean relative change (%) in ALP between the baseline visit and the EOT visit [1]
    End point description
    End point type
    Secondary
    End point timeframe
    12 week treatment: from Baseline to end of treatment, LOCF (last observation carried forward)
    Notes
    [1] - 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: The comparison of the other arms are reported in the primary endpoint. In this secondary endpoint the additional comparison between NCA high and NCA low is analyzed and reported.
    End point values
    		 NCA high NCA low
    Number of subjects analysed
    26
    26
    Units: %
        arithmetic mean (confidence interval 95%)
    -4.998 (-16.3653 to 6.3699)
    1.548 (-7.9182 to 11.0135)
    Statistical analysis title
    		 NCA high vs. NCA low
    Comparison groups
    NCA high v NCA low
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Median difference (final values)
    Point estimate
    -11.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.93
         upper limit
    		 -2.27

    Secondary: Partial normalization of serum alkaline phosphatase (ALP)

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    End point title
    		 Partial normalization of serum alkaline phosphatase (ALP)
    End point description
    Partial normalization of ALP [U/L] (<1.5x ULN) at any Visit during the treatment phase
    End point type
    Secondary
    End point timeframe
    12 weeks treatment: from Baseline to end of treatment, LOCF (last observation carried forward)
    End point values
    		 NCA high NCA low Placebo
    Number of subjects analysed
    26
    26
    25
    Units: Patients
    6
    2
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were assessed at V1 (Baseline visit), V2, V3, V4, V5 (End of Treatment visit) and V6 (Follow-Up Visit).
    Adverse event reporting additional description
    Treatment emergent adverse events
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    NCA high
    Reporting group description
    		 -

    Reporting group title
    NCA low
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 NCA high NCA low Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 26 (7.69%)
    1 / 25 (4.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Surgical and medical procedures
    Gastrectomy
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Mental disorder
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 NCA high NCA low Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 26 (88.46%)
    21 / 26 (80.77%)
    19 / 25 (76.00%)
    Vascular disorders
    Aortic arteriosclerosis
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Hypertension
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Surgical and medical procedures
    Salpingectomy
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Skin lesion removal
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Chest pain
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    1
    0
    2
    Fatigue
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
    3 / 25 (12.00%)
         occurrences all number
    2
    2
    4
    Influenza like illness
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    2
    1
    0
    Swelling face
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    Immune system disorders
    Contrast media reaction
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Hypersensitivity
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    2
    0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Anxiety
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    Emotional disorder
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 26 (7.69%)
    0 / 25 (0.00%)
         occurrences all number
    0
    2
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Blood folate decreased
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Coagulation test abnormal
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Electrocardiogram abnormal
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Ankle fracture
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Post procedural haematoma
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Skin wound
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    Mitral valve incompetence
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Palpitations
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    Sinus bradycardia
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Tachycardia
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Cerebral disorder
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    Dizziness
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    1
    0
    2
    Head discomfort
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    Headache
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 26 (7.69%)
    3 / 25 (12.00%)
         occurrences all number
    1
    3
    3
    Migraine
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    1
    0
    1
    Nerve compression
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Sciatica
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    1
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Microcytic anaemia
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    Vertigo
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    1
    0
    1
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    Eye pain
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    Eye swelling
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    Retinal detachment
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    0
    2
    Abdominal distension
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    1
    Abdominal pain
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    2 / 25 (8.00%)
         occurrences all number
    0
    1
    2
    Abdominal pain lower
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    0
    2
    Abdominal pain upper
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    2 / 25 (8.00%)
         occurrences all number
    0
    1
    2
    Abdominal tenderness
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    Breath odour
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Change of bowel habit
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    Constipation
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 26 (7.69%)
    0 / 25 (0.00%)
         occurrences all number
    0
    2
    0
    Diarrhoea
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 26 (7.69%)
    6 / 25 (24.00%)
         occurrences all number
    1
    3
    7
    Dry mouth
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    1
    1
    0
    Dyspepsia
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    2
    1
    0
    Dysphagia
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Faeces discoloured
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Food poisoning
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Frequent bowel movements
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 26 (7.69%)
    1 / 25 (4.00%)
         occurrences all number
    0
    2
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    2 / 25 (8.00%)
         occurrences all number
    0
    1
    2
    Haemorrhoids
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Nausea
         subjects affected / exposed
    1 / 26 (3.85%)
    3 / 26 (11.54%)
    1 / 25 (4.00%)
         occurrences all number
    3
    3
    1
    Tooth impacted
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    1
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    Hepatic cirrhosis
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    0
    2
    Hepatic fibrosis
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatitis cholestatic
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Jaundice
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Liver disorder
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Ocular icterus
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Alopecia
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    2
    1
    0
    Dry skin
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    1
    2
    0
    Erythema
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    Pruritus
         subjects affected / exposed
    3 / 26 (11.54%)
    9 / 26 (34.62%)
    2 / 25 (8.00%)
         occurrences all number
    6
    9
    2
    Psoriasis
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    1
    0
    1
    Purpura
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Rash
         subjects affected / exposed
    3 / 26 (11.54%)
    2 / 26 (7.69%)
    2 / 25 (8.00%)
         occurrences all number
    3
    2
    2
    Rash maculo-papular
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Skin burning sensation
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Skin discolouration
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Skin irritation
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    Telangiectasia
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 26 (11.54%)
    2 / 26 (7.69%)
    2 / 25 (8.00%)
         occurrences all number
    3
    2
    2
    Arthritis
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    Back pain
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Bone pain
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    Joint swelling
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    Muscle spasms
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Scoliosis
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Adenovirus infection
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchitis
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    COVID-19
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    2
    0
    1
    Coronavirus infection
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Cystitis
         subjects affected / exposed
    1 / 26 (3.85%)
    4 / 26 (15.38%)
    0 / 25 (0.00%)
         occurrences all number
    1
    5
    0
    Erysipelas
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    1
    1
    0
    Genital infection fungal
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Gingivitis
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Influenza
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Nail infection
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    2
    0
    Nasopharyngitis
         subjects affected / exposed
    5 / 26 (19.23%)
    5 / 26 (19.23%)
    3 / 25 (12.00%)
         occurrences all number
    5
    5
    3
    Sinusitis
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    2 / 25 (8.00%)
         occurrences all number
    0
    1
    2
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    0
    3
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    Increased appetite
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Vitamin B12 deficiency
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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