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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of OCS-05 in patients with acute optic neuritis

    Summary
    EudraCT number
    		 2020-003147-29
    Trial protocol
    		 FR  
    Global end of trial date
    16 Sep 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Oct 2025
    First version publication date
    23 Oct 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OCS-05_P2_01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Oculis
    Sponsor organisation address
    Avenue de la Gare 39, Lausanne, Switzerland,
    Public contact
    Oculis, Oculis, info@oculis.com
    Scientific contact
    Oculis, Oculis , info@oculis.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
    15 Jul 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Sep 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Sep 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the safety and tolerability of OCS-05 in participants with optic neuritis.
    Protection of trial subjects
    This study was conducted in accordance with International Council on Harmonisation (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Feb 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
    France: 33
    Worldwide total number of subjects
    33
    EEA total number of subjects
    33
    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)
    33
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants who met all the inclusion and none of the exclusion criteria were enrolled in this study.

    Pre-assignment
    Screening details
    		 Informed consent, eligibility determination, blood sample, ophthalmology examinations, neurology examinations

    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
    		 Investigator, Monitor, Data analyst, Carer, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 OCS-05 3 mg/kg/day + Steroid
    Arm description
    		 FAS (full analysis set) randomized and treated
    Arm type
    		 Experimental

    Investigational medicinal product name
    OCS-05 + IV methylprednisolone
    Investigational medicinal product code
    Other name
    Privosegtor
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    OCS-05 at 3 mg/kg/day for 5 days + IV methylprednisolone at 1g/day

    Arm title
    		 OCS-05 2 mg/kg/day + Steroid
    Arm description
    		 FAS (full analysis set) randomized and treated
    Arm type
    		 Experimental

    Investigational medicinal product name
    OCS-05 + IV methylprednisolone
    Investigational medicinal product code
    Other name
    Privosegtor
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    OCS-05 2 mg/kg/day for 5 days + IV methylprednisolone at 1g/day

    Arm title
    		 Placebo + Steroid
    Arm description
    		 FAS (full analysis set) randomized and treated
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo + IV methylprednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.9% sodium chloride sterile saline solution (NaCl) + IV methylprednisolone at 1g/day

    Number of subjects in period 1
    		OCS-05 3 mg/kg/day + Steroid OCS-05 2 mg/kg/day + Steroid Placebo + Steroid
    Started
    15
    4
    14
    Completed
    15
    4
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    OCS-05 3 mg/kg/day + Steroid
    Reporting group description
    		 FAS (full analysis set) randomized and treated

    Reporting group title
    OCS-05 2 mg/kg/day + Steroid
    Reporting group description
    		 FAS (full analysis set) randomized and treated

    Reporting group title
    Placebo + Steroid
    Reporting group description
    		 FAS (full analysis set) randomized and treated

    Reporting group values
    		 OCS-05 3 mg/kg/day + Steroid OCS-05 2 mg/kg/day + Steroid Placebo + Steroid Total
    Number of subjects
    		 15 4 14 33
    Age categorical
    Units: Subjects
        <30
    		 6 0 6 12
        [30, 40]
    		 5 1 5 11
        >=40
    		 4 3 3 10
    Gender categorical
    Units: Subjects
        Female
    		 9 4 10 23
        Male
    		 6 0 4 10

    End points

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    End points reporting groups
    Reporting group title
    OCS-05 3 mg/kg/day + Steroid
    Reporting group description
    		 FAS (full analysis set) randomized and treated

    Reporting group title
    OCS-05 2 mg/kg/day + Steroid
    Reporting group description
    		 FAS (full analysis set) randomized and treated

    Reporting group title
    Placebo + Steroid
    Reporting group description
    		 FAS (full analysis set) randomized and treated

    Primary: Percentage of subjects with shift from normal (baseline) to abnormal in any ECG parameter

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    End point title
    		 Percentage of subjects with shift from normal (baseline) to abnormal in any ECG parameter
    End point description
    Percentage of subjects with shift from normal (baseline) to abnormal in any ECG parameter
    End point type
    Primary
    End point timeframe
    Baseline (V3-t1 before IMP or V1) to V3-t1 after IMP to V4 (Primary endpoint)
    End point values
    		 OCS-05 3 mg/kg/day + Steroid OCS-05 2 mg/kg/day + Steroid Placebo + Steroid
    Number of subjects analysed
    14
    2
    8
    Units: subjects
        Heart Rate
    1
    0
    1
        PR Interval
    0
    0
    0
        QRS duration
    1
    0
    0
        QTcB Interval
    0
    0
    0
        QTcF Interval
    1
    0
    0
        Overall
    2
    0
    1
    Statistical analysis title
    		 Shift From Normal to Abnormal in Any ECG Parameter
    Comparison groups
    OCS-05 3 mg/kg/day + Steroid v OCS-05 2 mg/kg/day + Steroid v Placebo + Steroid
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    1.8
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -31.2
         upper limit
    		 29.3
    Notes
    [1] - Between group comparison based on risk differences with 90% exact confidence interval for the difference.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The period of observation for collection of AEs extended from the time the subject gave informed consent until the last study visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    OCS-05 3 mg/kg/day + Steroid
    Reporting group description
    		 -

    Reporting group title
    OCS-05 2 mg/kg/day + Steroid
    Reporting group description
    		 -

    Reporting group title
    Placebo + Steroid
    Reporting group description
    		 -

    Serious adverse events
    		 OCS-05 3 mg/kg/day + Steroid OCS-05 2 mg/kg/day + Steroid Placebo + Steroid
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Nervous system disorders
    MYELITIS
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    MULTIPLE SCLEROSIS RELAPSE
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 14 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 OCS-05 3 mg/kg/day + Steroid OCS-05 2 mg/kg/day + Steroid Placebo + Steroid
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 15 (80.00%)
    4 / 4 (100.00%)
    14 / 14 (100.00%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Phlebitis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Pain
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    0
    1
    Catheter site pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    Chest discomfort
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    Discomfort
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Infusion site phlebitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    Puncture site pain
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    Gait disturbance
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 4 (25.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Anxiety
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    Depression
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    Euphoric mood
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    Mixed anxiety and depressive disorder
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    0
    1
    Electrocardiogram QRS complex prolonged
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    2
    Biopsy
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Transaminases increased
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Weight decreased
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Post lumbar puncture syndrome
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    Procedural headache
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    Procedural pain
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    Road traffic accident
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 15 (26.67%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    4
    0
    1
    Paraesthesia
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 4 (25.00%)
    1 / 14 (7.14%)
         occurrences all number
    2
    1
    1
    Optic neuritis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    1
    0
    3
    Uhthoff's phenomenon
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    0
    1
    Dizziness
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    Dizziness postural
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    Electric shock sensation
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Hypoaesthesia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    Motor dysfunction
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Presyncope
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Sensory disturbance
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Sensory loss
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Tremor
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Vertigo
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    2
    0
    1
    Neutrophilia
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 4 (25.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    1
    Hyperleukocytosis
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 4 (25.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Anaemia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Monocytopenia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Hypochromic anaemia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    Eye disorders
    DIPLOPIA
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Dry eye
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    Ocular hyperaemia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    Retinal tear
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    0
    0
    4
    Abdominal pain
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 4 (25.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Constipation
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    0
    0
    2
    Nausea
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    Segmental diverticular colitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Hepatobiliary disorders
    HEPATIC CYTOLYSIS
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 4 (25.00%)
    1 / 14 (7.14%)
         occurrences all number
    2
    1
    1
    Rash pruritic
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    2
    Dermatitis acneiform
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    Dry skin
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Papule
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    Rash
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Rosacea
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Urticaria
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    Pruritus
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    Renal and urinary disorders
    Leukocyturia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    Renal colic
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 4 (25.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    1
    Myalgia
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 4 (25.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    2
    0
    NECK PAIN
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 4 (25.00%)
    3 / 14 (21.43%)
         occurrences all number
    2
    1
    3
    Influenza
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 4 (25.00%)
    0 / 14 (0.00%)
         occurrences all number
    2
    1
    0
    Pharyngitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    0
    Bronchitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Genital infection fungal
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Gingivitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Rash pustular
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Sinusitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Diabetic metabolic decompensation
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Hypokalaemia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 14 (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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