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    Clinical Trial Results:
    A Phase 4, Multicenter Study to Evaluate Discontinuation and Re-Treatment in Subjects With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With Pexidartinib

    Summary
    EudraCT number
    		 2020-000192-20
    Trial protocol
    		 HU   NL   IT  
    Global end of trial date
    07 Jul 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Oct 2024
    First version publication date
    27 Oct 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PL3397-A-U4003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04526704
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Daiichi Sankyo, Inc.
    Sponsor organisation address
    211 Mount Airy Road, Basking Ridge, United States, 07920
    Public contact
    Contact for Clinical Trial Information, Daiichi Sankyo, Inc., +1 908-992-6400, CTRinfo@dsi.com
    Scientific contact
    Contact for Clinical Trial Information, Daiichi Sankyo, Inc., +1 908-992-6400, CTRinfo@dsi.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
    07 Jul 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jul 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the trial was to determine the proportion of patients who remained treatment-free. Secondary objectives in the Treatment-free Period was change from baseline in PROs and safety and in the Re-Treatment Period it was change from baseline in PROs, tumor assessment , and safety.
    Protection of trial subjects
    The study was conducted in compliance with ethical principles that have their origin in the Declarations of Helsinki and in accordance with guidelines. The study protocol, amendments, the informed consent/assent form(s), and information sheets were approved by the appropriate and applicable Independent Ethics Committees (IECs) or Institutional Review Boards (IRBs).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Oct 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Hungary: 2
    Country: Number of subjects enrolled
    Australia: 3
    Country: Number of subjects enrolled
    Italy: 7
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Spain: 6
    Country: Number of subjects enrolled
    Taiwan: 2
    Country: Number of subjects enrolled
    United States: 11
    Worldwide total number of subjects
    32
    EEA total number of subjects
    16
    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)
    28
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 32 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study.

    Pre-assignment
    Screening details
    		 As specified in the protocol, the study analysis was conducted based on 2 cohorts: Treatment Continuation Cohort and Treatment-Free/Re-Treatment Cohort. Patient disposition, efficacy and safety endpoints were assessed based on these 2 cohorts, not according to the sequential nature of the arm/group assignment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Treatment Continuation Cohort
    Arm description
    		 Previously-treated participants with TGCT who continued their current dose of pexidartinib treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pexidartinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg capsules administered orally twice daily on an empty stomach (at least 1 hour before or at least 2 hours after a meal or snack)

    Arm title
    		 Treatment-Free/Re-Treatment Cohort
    Arm description
    		 Previously-treated participants with TGCT who discontinued pexidartinib treatment (Treatment-Free Period) and had the option to resume pexidartinib treatment at dose of completion of prior study (Re-Treatment Period).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pexidartinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg capsules administered orally twice daily on an empty stomach (at least 1 hour before or at least 2 hours after a meal or snack)

    Number of subjects in period 1
    		Treatment Continuation Cohort Treatment-Free/Re-Treatment Cohort
    Started
    21
    11
    Completed
    17
    11
    Not completed
    4
    0
         Physician decision
    1
    -
         Consent withdrawn by subject
    2
    -
         Adverse event, non-fatal
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Continuation Cohort
    Reporting group description
    		 Previously-treated participants with TGCT who continued their current dose of pexidartinib treatment.

    Reporting group title
    Treatment-Free/Re-Treatment Cohort
    Reporting group description
    		 Previously-treated participants with TGCT who discontinued pexidartinib treatment (Treatment-Free Period) and had the option to resume pexidartinib treatment at dose of completion of prior study (Re-Treatment Period).

    Reporting group values
    		 Treatment Continuation Cohort Treatment-Free/Re-Treatment Cohort Total
    Number of subjects
    		 21 11 32
    Age categorical
    Units: participants
        18 to 40 years
    		 7 1 8
        41 to 64 years
    		 12 8 20
        65 to 74 years
    		 1 1 2
        75 to 84 years
    		 1 1 2
        ≥ 85 years
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.2 ( 15.7 ) 51.9 ( 15.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 12 4 16
        Male
    		 9 7 16
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 1 1 2
        White
    		 19 8 27
        Not collected per local regulations
    		 1 2 3

    End points

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    End points reporting groups
    Reporting group title
    Treatment Continuation Cohort
    Reporting group description
    		 Previously-treated participants with TGCT who continued their current dose of pexidartinib treatment.

    Reporting group title
    Treatment-Free/Re-Treatment Cohort
    Reporting group description
    		 Previously-treated participants with TGCT who discontinued pexidartinib treatment (Treatment-Free Period) and had the option to resume pexidartinib treatment at dose of completion of prior study (Re-Treatment Period).

    Primary: Number of Treatment-Free Participants at 12 Months In The Treatment-free/Re-treatment Cohort

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    End point title
    		 Number of Treatment-Free Participants at 12 Months In The Treatment-free/Re-treatment Cohort [1] [2]
    End point description
    Participants who were not remaining treatment-free were defined as either participants who resumed pexidartinib treatment, death (any cause) or who were receiving systemic therapy or undergoing surgery for the treatment of TGCT, whichever occurs first. The number of participants who remained treatment-free at Month 12 is reported.
    End point type
    Primary
    End point timeframe
    Baseline up to 12 months after last participant enrolled in Cohort
    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 to assess this outcome.
    [2] - 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 to assess this outcome.
    End point values
    		 Treatment-Free/Re-Treatment Cohort
    Number of subjects analysed
    11
    Units: participants
    8
    No statistical analyses for this end point

    Primary: Number of Treatment-Free Participants at 24 Months In The Treatment-free/Re-treatment Cohort

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    End point title
    		 Number of Treatment-Free Participants at 24 Months In The Treatment-free/Re-treatment Cohort [3] [4]
    End point description
    Participants who were not remaining treatment-free were defined as either participants who resumed pexidartinib treatment, death (any cause) or who were receiving systemic therapy or undergoing surgery for the treatment of TGCT, whichever occurs first. The number of participants who remained treatment-free at Month 24 is reported.
    End point type
    Primary
    End point timeframe
    Baseline up to 24 months after last participant enrolled in Cohort
    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 to assess this outcome.
    [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 to assess this outcome.
    End point values
    		 Treatment-Free/Re-Treatment Cohort
    Number of subjects analysed
    11
    Units: participants
    8
    No statistical analyses for this end point

    Secondary: Change From Baseline in PROMIS Physical Function Total Overall Score In The Treatment Continuation and Treatment-free/Re-Treatment Cohorts

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    End point title
    		 Change From Baseline in PROMIS Physical Function Total Overall Score In The Treatment Continuation and Treatment-free/Re-Treatment Cohorts
    End point description
    The PROMIS Physical Function Total Overall Score (includes 11 upper extremity questions and 13 lower extremity questions) ranges from 24 to 120, with each individual question being rated on a 5-point rating scale (where 1 is unable to do and 5 is without any difficulty). Higher PROMIS Physical Function Total Overall Scores indicate a better health state. The change from baseline in PROMIS Physical Function Total Overall Scores is being reported.
    End point type
    Secondary
    End point timeframe
    Baseline up to Month 24
    End point values
    		 Treatment Continuation Cohort Treatment-Free/Re-Treatment Cohort
    Number of subjects analysed
    16
    7
    Units: score on a scale
        arithmetic mean (standard deviation)
    -2.78 ( 6.42 )
    -1.93 ( 4.80 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in EQ-5D-5L Scale Score In The Treatment Continuation and Treatment-free/Re-Treatment Cohorts

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    End point title
    		 Change From Baseline in EQ-5D-5L Scale Score In The Treatment Continuation and Treatment-free/Re-Treatment Cohorts
    End point description
    The EQ-5D-5L questionnaire assessed a participant's mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The overall health is rated on a scale from 0 to 100, where 0 is worst health you can imagine and 100 is best health you can imagine. The change from baseline in EQ-5D-5L Scale Score is being reported.
    End point type
    Secondary
    End point timeframe
    Baseline up to Month 24
    End point values
    		 Treatment Continuation Cohort Treatment-Free/Re-Treatment Cohort
    Number of subjects analysed
    16
    7
    Units: score on a scale
        arithmetic mean (standard deviation)
    -2.4 ( 13.53 )
    3.4 ( 7.59 )
    No statistical analyses for this end point

    Secondary: Number of Participants Who Reported Treatment-Emergent Adverse Events (TEAEs) In The Treatment Continuation Cohort

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    End point title
    		 Number of Participants Who Reported Treatment-Emergent Adverse Events (TEAEs) In The Treatment Continuation Cohort [5]
    End point description
    Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) or pre-existing conditions that worsen in CTCAE grade after the first dose of study drug and up to 30 days after last dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline up to 30 days after the start of re-treatment or end of study (whichever occurs first), up to 24 months
    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 to assess this outcome.
    End point values
    		 Treatment Continuation Cohort
    Number of subjects analysed
    21
    Units: participants
        TEAE
    19
    No statistical analyses for this end point

    Secondary: Number of Participants With and Without Progressive Disease

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    End point title
    		 Number of Participants With and Without Progressive Disease
    End point description
    Tumors were assessed based on the RECIST criteria. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; ≥30% increase in volume relative to lowest score during the study whether at baseline or some other visit.
    End point type
    Secondary
    End point timeframe
    Month 18 (Re-treatment Period of the Treatment-free/Re-treatment Cohort), Month 24 (Treatment Continuation Cohort)
    End point values
    		 Treatment Continuation Cohort Treatment-Free/Re-Treatment Cohort
    Number of subjects analysed
    16
    3
    Units: participants
        Not progressive
    16
    0
        Progressive disease
    0
    1
        Not evaluable
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants Who Reported Treatment-Emergent Adverse Events (TEAEs) In The Re-Treatment Period of the Treatment-free/Re-Treatment Cohort

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    End point title
    		 Number of Participants Who Reported Treatment-Emergent Adverse Events (TEAEs) In The Re-Treatment Period of the Treatment-free/Re-Treatment Cohort [6]
    End point description
    Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) or pre-existing conditions that worsen in CTCAE grade after the first dose of study drug and up to 30 days after last dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline up to 30 days after the start of re-treatment or end of study (whichever occurs first), up to 24 months
    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 to assess this outcome.
    End point values
    		 Treatment-Free/Re-Treatment Cohort
    Number of subjects analysed
    3
    Units: participants
        TEAE
    3
    No statistical analyses for this end point

    Secondary: Number of Patients Reporting AEs (Treatment-free)

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    End point title
    		 Number of Patients Reporting AEs (Treatment-free) [7]
    End point description
    Adverse events (AEs) were defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product and that does not necessarily have to have a causal relationship with this treatment.
    End point type
    Secondary
    End point timeframe
    Baseline up to 30 days after the start of re-treatment or end of study (whichever occurs first), up to 24 months
    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 to assess this outcome.
    End point values
    		 Treatment-Free/Re-Treatment Cohort
    Number of subjects analysed
    11
    Units: participants
        Any Grade AE
    7
        Any Grade Musculoskeletal/Tissue Disorders
    6
        Any Grade Arthralgia
    2
        Any Grade Back pain
    2
        Any Grade Intervertebral disc protrusion
    1
        Any Grade Joint swelling
    1
        Any Grade Musculoskeletal pain
    1
        Any Grade Pain in extremity
    1
        Any Grade Metabolism and Nutrition Disorders
    3
        Any Grade Hypercholesterolaemia
    2
        Any Grade Hypertriglyceridaemia
    2
        Any Grade General Disorders & Site Conditions
    2
        Any Grade Asthenia
    1
        Any Grade Oedema peripheral
    1
        Any Grade Infections and Infestations
    2
        Any Grade Cellulitis
    1
        Any Grade COVID-19
    1
        Any Grade investigations
    2
        Any Gr Blood creatinine phosphokinase increased
    2
        Any Grade Blood uric acid increased
    1
        Any Renal and Urinary Disorders
    2
        Any Renal colic
    1
        Any Grade Urinary retention
    1
        Any Grade Injury, Poisoning & Procedural Issues
    1
        Any Grade Animal bite
    1
        Any Grade Neoplasms Benign, Malignant & Other
    1
        Any Grade Lipoma
    1
        Any Grade Nervous System Disorders
    1
        Any Grade Sciatica
    1
        Any Grade Skin and Subcutaneous Tissue Disorders
    1
        Any Grade Urticaria
    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 were collected from baseline up to 30 days after the start of re-treatment or end of study (whichever occurs first), up to 24 months.
    Adverse event reporting additional description
    TEAEs observed in the Treatment Continuation Cohort and the Re-Treatment Period of the Treatment-free/Re-Treatment Cohort are reported. AEs from the Treatment-free Period of the Treatment-free/Re-Treatment Cohort were captured and are reported as well.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26
    Reporting groups
    Reporting group title
    Treatment Continuation Cohort
    Reporting group description
    		 Previously-treated participants with TGCT who continued their current dose of pexidartinib treatment.

    Reporting group title
    Re-Treatment Period of Treatment- Free/Re-Treatment Cohort
    Reporting group description
    		 Previously-treated participants with TGCT who discontinued pexidartinib treatment (Treatment-Free Period) and had the option to resume pexidartinib treatment at dose of completion of prior study (Re-Treatment Period).

    Reporting group title
    Treatment-Free Period of Treatment- Free/Re-treatment Cohort
    Reporting group description
    		 Previously-treated participants with TGCT who discontinued pexidartinib treatment (Treatment-Free Period) and reported adverse events.

    Serious adverse events
    		 Treatment Continuation Cohort Re-Treatment Period of Treatment- Free/Re-Treatment Cohort Treatment-Free Period of Treatment- Free/Re-treatment Cohort
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 3 (0.00%)
    0 / 11 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Product issues
    Device dislocation
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 3 (0.00%)
    0 / 11 (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
    Infections and infestations
    Creutzfeldt-Jakob disease
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 3 (0.00%)
    0 / 11 (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
    		 Treatment Continuation Cohort Re-Treatment Period of Treatment- Free/Re-Treatment Cohort Treatment-Free Period of Treatment- Free/Re-treatment Cohort
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 21 (90.48%)
    3 / 3 (100.00%)
    7 / 11 (63.64%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lipoma
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 3 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 3 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 21 (14.29%)
    1 / 3 (33.33%)
    1 / 11 (9.09%)
         occurrences all number
    3
    1
    1
    Fatigue
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 3 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    3
    0
    0
    Generalised oedema
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 3 (33.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 3 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 3 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 3 (33.33%)
    0 / 11 (0.00%)
         occurrences all number
    2
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    5 / 21 (23.81%)
    1 / 3 (33.33%)
    0 / 11 (0.00%)
         occurrences all number
    5
    1
    0
    Blood creatinine phosphokinase increased
         subjects affected / exposed
    8 / 21 (38.10%)
    2 / 3 (66.67%)
    2 / 11 (18.18%)
         occurrences all number
    8
    2
    2
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 3 (33.33%)
    0 / 11 (0.00%)
         occurrences all number
    1
    1
    0
    SARS-CoV-2 test positive
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 3 (33.33%)
    0 / 11 (0.00%)
         occurrences all number
    1
    1
    0
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 3 (33.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    White blood cell count decreased
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 3 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    0
    Blood uric acid increased
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 3 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 3 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 3 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    0
    Headache
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 3 (33.33%)
    0 / 11 (0.00%)
         occurrences all number
    2
    1
    0
    Sciatica
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 3 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 3 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    0
    Anaemia
         subjects affected / exposed
    3 / 21 (14.29%)
    1 / 3 (33.33%)
    0 / 11 (0.00%)
         occurrences all number
    3
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 3 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    3
    0
    0
    Vomiting
         subjects affected / exposed
    4 / 21 (19.05%)
    0 / 3 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    4
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 3 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    0
    Diarrhoea
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 3 (33.33%)
    0 / 11 (0.00%)
         occurrences all number
    1
    1
    0
    Skin and subcutaneous tissue disorders
    Hair colour changes
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 3 (66.67%)
    0 / 11 (0.00%)
         occurrences all number
    1
    2
    0
    Pruritus
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 3 (66.67%)
    0 / 11 (0.00%)
         occurrences all number
    1
    2
    0
    Skin discolouration
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 3 (33.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Urticaria
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 3 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 3 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Urinary retention
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 3 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 3 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    0
    Arthralgia
         subjects affected / exposed
    4 / 21 (19.05%)
    0 / 3 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    4
    0
    2
    Back pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 3 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    1
    0
    2
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 3 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Joint swelling
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 3 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 3 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 3 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Sinusitis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 3 (33.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 21 (19.05%)
    0 / 3 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    4
    0
    0
    COVID-19
         subjects affected / exposed
    7 / 21 (33.33%)
    2 / 3 (66.67%)
    1 / 11 (9.09%)
         occurrences all number
    7
    2
    1
    Tooth infection
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 3 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    0
    Cellulitis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 3 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Hypertriglyceridaemia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 3 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    0
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 3 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    1
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Feb 2022
    Updated language regarding schedule of events, protocol synopsis, dose regimen, safety reporting and assessments.

    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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