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    Clinical Trial Results:
    A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VTX958 in Participants With Moderate to Severe Psoriasis

    Summary
    EudraCT number
    		 2022-002887-59
    Trial protocol
    		 PL  
    Global end of trial date
    20 Dec 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Sep 2026
    First version publication date
    27 Sep 2026
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    VTX958-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05655299
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ventyx Biosciences, Inc.
    Sponsor organisation address
    662 Encinitas Boulevard, Suite 250, Encinitas, United States, CA 92024
    Public contact
    Ventyx Clinical Trial Contact, Ventyx Biosciences, Inc., +1 888-411-5176108, ClinicalTrials@ventyxbio.com
    Scientific contact
    Ventyx Clinical Trial Contact, Ventyx Biosciences, Inc., +1 888-411-5176108, ClinicalTrials@ventyxbio.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
    20 Dec 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Dec 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine the efficacy of VTX958 after treatment for 16 weeks in participants with moderate to severe psoriasis. To evaluate the safety and tolerability of VTX958 during the placebo controlled treatment period in participants with moderate to severe psoriasis.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (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
    17 Nov 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
    Poland: 74
    Country: Number of subjects enrolled
    Canada: 42
    Country: Number of subjects enrolled
    United States: 106
    Worldwide total number of subjects
    222
    EEA total number of subjects
    74
    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)
    201
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 222 participants were enrolled and randomized with 220 participants receiving at least 1 dose of study treatment; 2 randomized participants withdrew consent prior to receiving their first dose of study treatment.

    Pre-assignment
    Screening details
    		 Participants were randomized to VTX958 (300 mg BID, 225 mg BID, 300 mg QD, or 50 mg BID) or placebo. Participants achieving PASI-75 by the end of period 1 continued their assigned VTX958 dose during the LTE period, whereas participants not achieving PASI-75 by the end of period 1 and participants assigned to placebo received VTX958 300 mg BID.

    Period 1
    Period 1 title
    Period 1: Placebo Controlled (PC)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 VTX958 300 mg BID (PC)
    Arm description
    		 Participants received VTX958 300 milligram (mg) administered orally twice daily (BID) to maintain the blind in Period 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    VTX958
    Investigational medicinal product code
    VTX958
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received VTX958 300 mg BID, administered as 2 tablets of VTX958 125 mg and 1 tablet of VTX958 50 mg.

    Arm title
    		 VTX958 225 mg BID (PC)
    Arm description
    		 Participants received VTX958 225 mg administered orally BID to maintain the blind in Period 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    VTX958
    Investigational medicinal product code
    VTX958
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received VTX958 225 mg BID, administered as 1 tablet of VTX958 125 mg and 2 tablets of VTX958 50 mg.

    Arm title
    		 VTX958 300 mg QD (PC)
    Arm description
    		 Participants received VTX958 300 mg administered orally once daily (QD), and matching placebo tablets administered orally QD to maintain the blind in Period 1
    Arm type
    		 Experimental

    Investigational medicinal product name
    VTX958
    Investigational medicinal product code
    VTX958
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received VTX958 300 mg QD, administered as 2 tablets of VTX958 125 mg and 1 tablet of VTX958 50 mg.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 3 matching placebo tablets QD.

    Arm title
    		 VTX958 50 mg BID (PC)
    Arm description
    		 Participants received VTX958 50 mg and matching placebo tablets administered orally BID to maintain the blind in Period 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    VTX958
    Investigational medicinal product code
    VTX958
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received VTX958 50 mg BID, administered as 1 tablet of VTX958 50 mg.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 2 placebo tablets BID.

    Arm title
    		 Placebo BID (PC)
    Arm description
    		 Participants received placebo tablets matched to VTX958 administered BID to maintain the blind in Period 1.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 3 matching placebo tablets QD.

    Number of subjects in period 1
    		VTX958 300 mg BID (PC) VTX958 225 mg BID (PC) VTX958 300 mg QD (PC) VTX958 50 mg BID (PC) Placebo BID (PC)
    Started
    44
    45
    44
    45
    44
    Safety Population
    43
    45
    44
    45
    43
    Completed
    34
    35
    38
    40
    36
    Not completed
    10
    10
    6
    5
    8
         Adverse event, non-fatal
    5
    5
    2
    1
    1
         Lost to follow-up
    1
    3
    2
    1
    3
         Withdrawal by subject
    4
    2
    2
    3
    3
         Lack of efficacy
    -
    -
    -
    -
    1
    Period 2
    Period 2 title
    Period 2: Long Term Extension (LTE)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Long Term Extension Period (LTE): VTX958 300 mg BID
    Arm description
    		 Participants who received VTX958 300 mg dose administered orally BID in Period 2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    VTX958
    Investigational medicinal product code
    VTX958
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received VTX958 300mg BID, administered as 2 tablets of VTX958 125 mg and 1 tablet of VTX958 50 mg..

    Arm title
    		 LTE: VTX958 225 mg BID (PC)/ VTX958 225 mg BID
    Arm description
    		 Participants who received VTX958 225 mg at Period 1 continued to receive VTX958 225 mg dose administered orally BID in Period 2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    VTX958
    Investigational medicinal product code
    VTX958
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received VTX958 225 mg BID, administered as 1 tablet of VTX958 125 mg and 2 tablets of VTX958 50 mg.

    Arm title
    		 LTE: VTX958 300 mg QD (PC)/ VTX958 300 mg QD
    Arm description
    		 Participants who received VTX958300 mg at Period 1 continued to receive VTX958 300 mg dose administered orally QD in Period 2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    VTX958
    Investigational medicinal product code
    VTX958
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received VTX958 300 mg QD, administered as 2 tablets of VTX958 125 mg and 1 tablet of VTX958 50 mg.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 3 tablets of placebo QD.

    Arm title
    		 LTE: VTX958 50 mg BID (PC)/ VTX958 50 mg BID
    Arm description
    		 Participants who received VTX958 50 mg at Period 1 continued to receive VTX958 50 mg dose administered orally BID in Period 2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    VTX958
    Investigational medicinal product code
    VTX958
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received VTX958 50 mg BID, administered as 1 tablet of VTX958 50 mg.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 2 tablets of placebo BID

    Number of subjects in period 2 [1]
    		Long Term Extension Period (LTE): VTX958 300 mg BID LTE: VTX958 225 mg BID (PC)/ VTX958 225 mg BID LTE: VTX958 300 mg QD (PC)/ VTX958 300 mg QD LTE: VTX958 50 mg BID (PC)/ VTX958 50 mg BID
    Started
    134
    20
    14
    11
    Completed
    23
    1
    3
    1
    Not completed
    111
    19
    11
    10
         Physician decision
    2
    -
    -
    -
         Adverse event, non-fatal
    1
    -
    -
    -
         Pregnancy
    1
    -
    -
    -
         Study terminated by sponsor
    95
    19
    10
    8
         Lost to follow-up
    3
    -
    -
    -
         Withdrawal by subject
    7
    -
    -
    1
         Lack of efficacy
    2
    -
    1
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 4 participants declined to continue into the LTE period, which is why fewer participants entered the LTE period than completed the Placebo-controlled period.
    Period 3
    Period 3 title
    Period 3: Open Label Extension (OLE)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Arm title
    		 Open Label Extension (OLE): VTX958 300 mg BID
    Arm description
    		 Participants received VTX958 300 mg dose administered orally BID in Period 3.
    Arm type
    		 Experimental

    Investigational medicinal product name
    VTX958
    Investigational medicinal product code
    VTX958
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received VTX958 300 mg BID, administered as 2 tablets of VTX958 125 mg and 1 tablet of VTX958 50 mg.

    Number of subjects in period 3 [2]
    		Open Label Extension (OLE): VTX958 300 mg BID
    Started
    27
    Completed
    0
    Not completed
    27
         Study terminated by sponsor
    26
         Withdrawal by subject
    1
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 1 participant declined to continue into the OLE period, which is why fewer participants entered the OLE period than completed the LTE period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    VTX958 300 mg BID (PC)
    Reporting group description
    		 Participants received VTX958 300 milligram (mg) administered orally twice daily (BID) to maintain the blind in Period 1.

    Reporting group title
    VTX958 225 mg BID (PC)
    Reporting group description
    		 Participants received VTX958 225 mg administered orally BID to maintain the blind in Period 1.

    Reporting group title
    VTX958 300 mg QD (PC)
    Reporting group description
    		 Participants received VTX958 300 mg administered orally once daily (QD), and matching placebo tablets administered orally QD to maintain the blind in Period 1

    Reporting group title
    VTX958 50 mg BID (PC)
    Reporting group description
    		 Participants received VTX958 50 mg and matching placebo tablets administered orally BID to maintain the blind in Period 1.

    Reporting group title
    Placebo BID (PC)
    Reporting group description
    		 Participants received placebo tablets matched to VTX958 administered BID to maintain the blind in Period 1.

    Reporting group values
    		 VTX958 300 mg BID (PC) VTX958 225 mg BID (PC) VTX958 300 mg QD (PC) VTX958 50 mg BID (PC) Placebo BID (PC) Total
    Number of subjects
    		 44 45 44 45 44 222
    Age categorical
    2 randomized participants withdrew consent prior to receiving their first dose of study treatment.
    Units: Subjects
        In utero
    		 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0
        Adults (18-64 years)
    		 39 40 39 42 41 201
        From 65-84 years
    		 5 5 5 3 3 21
        85 years and over
    		 0 0 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 15 13 14 17 15 74
        Male
    		 29 32 30 28 29 148
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 6 12 10 7 4 39
        Not Hispanic or Latino
    		 38 33 34 38 40 183
        Unknown or Not Reported
    		 0 0 0 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0 0
        Asian
    		 2 1 3 4 2 12
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 1 1
        Black or African American
    		 2 3 2 1 6 14
        White
    		 40 41 38 40 33 192
        More than one race
    		 0 0 1 0 2 3
        Unknown or Not Reported
    		 0 0 0 0 0 0
    Region of Enrollment
    Units: Subjects
        Canada
    		 6 11 8 10 7 42
        Poland
    		 23 11 11 12 17 74
        United States
    		 15 23 25 23 20 106

    End points

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    End points reporting groups
    Reporting group title
    VTX958 300 mg BID (PC)
    Reporting group description
    		 Participants received VTX958 300 milligram (mg) administered orally twice daily (BID) to maintain the blind in Period 1.

    Reporting group title
    VTX958 225 mg BID (PC)
    Reporting group description
    		 Participants received VTX958 225 mg administered orally BID to maintain the blind in Period 1.

    Reporting group title
    VTX958 300 mg QD (PC)
    Reporting group description
    		 Participants received VTX958 300 mg administered orally once daily (QD), and matching placebo tablets administered orally QD to maintain the blind in Period 1

    Reporting group title
    VTX958 50 mg BID (PC)
    Reporting group description
    		 Participants received VTX958 50 mg and matching placebo tablets administered orally BID to maintain the blind in Period 1.

    Reporting group title
    Placebo BID (PC)
    Reporting group description
    		 Participants received placebo tablets matched to VTX958 administered BID to maintain the blind in Period 1.
    Reporting group title
    Long Term Extension Period (LTE): VTX958 300 mg BID
    Reporting group description
    		 Participants who received VTX958 300 mg dose administered orally BID in Period 2.

    Reporting group title
    LTE: VTX958 225 mg BID (PC)/ VTX958 225 mg BID
    Reporting group description
    		 Participants who received VTX958 225 mg at Period 1 continued to receive VTX958 225 mg dose administered orally BID in Period 2.

    Reporting group title
    LTE: VTX958 300 mg QD (PC)/ VTX958 300 mg QD
    Reporting group description
    		 Participants who received VTX958300 mg at Period 1 continued to receive VTX958 300 mg dose administered orally QD in Period 2.

    Reporting group title
    LTE: VTX958 50 mg BID (PC)/ VTX958 50 mg BID
    Reporting group description
    		 Participants who received VTX958 50 mg at Period 1 continued to receive VTX958 50 mg dose administered orally BID in Period 2.
    Reporting group title
    Open Label Extension (OLE): VTX958 300 mg BID
    Reporting group description
    		 Participants received VTX958 300 mg dose administered orally BID in Period 3.

    Primary: Period 1: Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI‑75) at Week 16

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    End point title
    		 Period 1: Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI‑75) at Week 16
    End point description
    Participants achieving a ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI) score (PASI 75) at Week 16 were considered responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity. All randomised participants who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 VTX958 300 mg BID (PC) VTX958 225 mg BID (PC) VTX958 300 mg QD (PC) VTX958 50 mg BID (PC) Placebo BID (PC)
    Number of subjects analysed
    43
    45
    44
    45
    43
    Units: Percentage of participants
        number (not applicable)
    48.8
    48.9
    31.8
    24.4
    14.0
    Statistical analysis title
    		 VTX958 300 mg BID (PC), Placebo BID (PC)
    Comparison groups
    VTX958 300 mg BID (PC) v Placebo BID (PC)
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    5.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.013
         upper limit
    		 16.531
    Statistical analysis title
    		 VTX958 225 mg BID (PC), Placebo BID (PC)
    Comparison groups
    VTX958 225 mg BID (PC) v Placebo BID (PC)
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    6.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.086
         upper limit
    		 17.542
    Statistical analysis title
    		 VTX958 300 mg QD (PC), Placebo BID (PC)
    Comparison groups
    VTX958 300 mg QD (PC) v Placebo BID (PC)
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.045
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.002
         upper limit
    		 8.98
    Statistical analysis title
    		 VTX958 50 mg BID (PC), Placebo BID (PC)
    Comparison groups
    VTX958 50 mg BID (PC) v Placebo BID (PC)
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.673
         upper limit
    		 6.517

    Primary: Period 1: Number of Participants With Treatment emergent adverse events (TEAEs) and Serious adverse events (SAEs) Observed During the Study of VTX958

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    End point title
    		 Period 1: Number of Participants With Treatment emergent adverse events (TEAEs) and Serious adverse events (SAEs) Observed During the Study of VTX958 [1]
    End point description
    The number of participants with TEAEs and SAEs observed during the study of VTX958. A TEAE is any condition that was not present prior to treatment with the study product but appeared following treatment, was present at treatment initiation but worsened during treatment, or was present at treatment initiation but resolved and then reappeared while the individual was on treatment (regardless of the intensity of the AE when the treatment was initiated). An SAE or reaction is any untoward medical occurrence that, at any dose has any of the following consequences: - Results in death - Is life-threatening - Requires in-patient hospitalization or prolongation of existing hospitalization - Results in persistent or significant disability/incapacity - Is a congenital anomaly/birth defect All randomised participants who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    Baseline up to week 16
    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: This endpoint was analyzed descriptively only. Results are presented as counts and percentages of participants with TEAEs and SAEs. No statistical inferences were prespecified in the SAP. Therefore, no formal statistical analysis was performed.
    End point values
    		 VTX958 300 mg BID (PC) VTX958 225 mg BID (PC) VTX958 300 mg QD (PC) VTX958 50 mg BID (PC) Placebo BID (PC)
    Number of subjects analysed
    43
    45
    44
    45
    43
    Units: participants
        TEAE's
    25
    28
    20
    17
    18
        SAE's
    1
    0
    1
    1
    1
    No statistical analyses for this end point

    Secondary: Period 1: Percentage of Participants Achieving a static Physician's Global Assessment(sPGA) Score of 0 (Clear) or 1 (Almost Clear) With ≥2 Grade Improvement From Baseline at Week 16

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    End point title
    		 Period 1: Percentage of Participants Achieving a static Physician's Global Assessment(sPGA) Score of 0 (Clear) or 1 (Almost Clear) With ≥2 Grade Improvement From Baseline at Week 16
    End point description
    Percentage of participants achieving a sPGA score of 0 (clear) or 1 (almost clear) with ≥2‑grade improvement from baseline at Week 16. The investigator assessed psoriasis severity on a 5-point scale from 0 (clear) to 4 (severe): 0 = Clear: No signs of psoriasis; post-inflammatory hyperpigmentation may occur = Almost clear: Normal to pink lesions; no thickening; no or minimal focal scaling = Mild: Pink to light red color; slight thickening; mainly fine scaling = Moderate: Dull bright red erythema; moderate thickening; moderate scaling = Severe: Bright to deep red; severe thickening with hard edges; coarse scaling covering most or all lesions All randomised participants who received at least one dose of the study intervention.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 VTX958 300 mg BID (PC) VTX958 225 mg BID (PC) VTX958 300 mg QD (PC) VTX958 50 mg BID (PC) Placebo BID (PC)
    Number of subjects analysed
    43
    45
    44
    45
    43
    Units: Percentage of participants
        number (not applicable)
    37.2
    40.0
    20.5
    13.3
    7.0
    No statistical analyses for this end point

    Secondary: Period 1: Change From Baseline in PASI Score at Week 16

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    End point title
    		 Period 1: Change From Baseline in PASI Score at Week 16
    End point description
    Least square mean was determined with mixed model repeated measures (MMRM) using an unstructured covariance matrix, including treatment, visit, treatment-by-visit interaction, baseline PASI score, prior biologic therapy (Yes/No), and geographic region as fixed effects. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity. All randomised participants who received at least 1 dose of the study intervention and had evaluable efficacy data for this outcome at the specified timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 VTX958 300 mg BID (PC) VTX958 225 mg BID (PC) VTX958 300 mg QD (PC) VTX958 50 mg BID (PC) Placebo BID (PC)
    Number of subjects analysed
    35
    37
    39
    40
    38
    Units: score on a scale
        least squares mean (standard error)
    -13.58 ( 1.160 )
    -13.20 ( 1.144 )
    -9.79 ( 1.123 )
    -7.88 ( 1.115 )
    -5.81 ( 1.162 )
    No statistical analyses for this end point

    Secondary: Period 1: Percent Change From Baseline in PASI Score at Week 16

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    End point title
    		 Period 1: Percent Change From Baseline in PASI Score at Week 16
    End point description
    Least square mean was determined with mixed model repeated measures (MMRM) using an unstructured covariance matrix, including treatment, visit, treatment-by-visit interaction, baseline PASI score, prior biologic therapy (Yes/No), and geographic region as fixed effects. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity. All randomised participants who received at least 1 dose of the study intervention and had evaluable efficacy data for this outcome at the specified timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 VTX958 300 mg BID (PC) VTX958 225 mg BID (PC) VTX958 300 mg QD (PC) VTX958 50 mg BID (PC) Placebo BID (PC)
    Number of subjects analysed
    35
    37
    39
    40
    38
    Units: Percent change
        least squares mean (standard error)
    -74.94 ( 5.365 )
    -72.18 ( 5.290 )
    -54.82 ( 5.186 )
    -45.22 ( 5.155 )
    -33.44 ( 5.356 )
    No statistical analyses for this end point

    Secondary: Period 1: Percentage of Participants Achieving ≥90% Reduction From Baseline in PASI 90 at Week 16

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    End point title
    		 Period 1: Percentage of Participants Achieving ≥90% Reduction From Baseline in PASI 90 at Week 16
    End point description
    Percentage of participants achieving ≥90% reduction from baseline in PASI‑90 at Week 16. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity. All randomised participants who received at least 1 dose of the study intervention.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 VTX958 300 mg BID (PC) VTX958 225 mg BID (PC) VTX958 300 mg QD (PC) VTX958 50 mg BID (PC) Placebo BID (PC)
    Number of subjects analysed
    43
    45
    44
    45
    43
    Units: Percentage of participants
        number (not applicable)
    41.9
    37.8
    15.9
    11.1
    4.7
    No statistical analyses for this end point

    Secondary: Period 1: Percentage of Participants Achieving ≥100% Reduction From Baseline in PASI 100 at Week 16

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    End point title
    		 Period 1: Percentage of Participants Achieving ≥100% Reduction From Baseline in PASI 100 at Week 16
    End point description
    Percentage of participants achieving ≥100% reduction from baseline in PASI‑100 at Week 16. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity. All randomised participants who received at least 1 dose of the study intervention.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 VTX958 300 mg BID (PC) VTX958 225 mg BID (PC) VTX958 300 mg QD (PC) VTX958 50 mg BID (PC) Placebo BID (PC)
    Number of subjects analysed
    43
    45
    44
    45
    43
    Units: Percentage of participants
        number (not applicable)
    14.0
    15.6
    2.3
    4.4
    0
    No statistical analyses for this end point

    Secondary: Period 1: Change From Baseline in Dermatology Life Quality Index (DLQI) at 16 Weeks

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    End point title
    		 Period 1: Change From Baseline in Dermatology Life Quality Index (DLQI) at 16 Weeks
    End point description
    The DLQI is a simple 10-question validated questionnaire where, except for question 7, each question is rated from 0 (Not at all) to 3 (Very much). If question 7 is answered 'yes', this question is assigned a score of 3. If question 7 is answered 'No' or 'Not Relevant', this question is assigned a score 0, except if either 'a lot' or 'a little' is ticked. If so, this question is assigned a score of 2 or 1, respectively. Then, the DLQI total score is the sum of the 10 questions and ranges from 0 to 30, where higher scores indicate worst disease severity. All randomised participants who received at least 1 dose of the study intervention and had evaluable efficacy sample for this outcome at the specified timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 VTX958 300 mg BID (PC) VTX958 225 mg BID (PC) VTX958 300 mg QD (PC) VTX958 50 mg BID (PC) Placebo BID (PC)
    Number of subjects analysed
    35
    37
    39
    40
    38
    Units: score on a scale
        least squares mean (standard error)
    -7.2 ( 0.90 )
    -8.1 ( 0.88 )
    -5.4 ( 0.86 )
    -4.4 ( 0.86 )
    -3.1 ( 0.89 )
    No statistical analyses for this end point

    Secondary: Period 1: Change From Baseline in the Percentage of Body Surface Area (BSA) Affected at Week 16

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    End point title
    		 Period 1: Change From Baseline in the Percentage of Body Surface Area (BSA) Affected at Week 16
    End point description
    Least square mean was determined with MMRM using an unstructured covariance matrix, including treatment, visit, treatment-by-visit interaction, prior biologic treatment for psoriasis (Yes/No), and baseline score as a covariate, with participant as a random effect baseline is the last non-missing pre-dose value. BSA is a measurement of the affected skin area. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). The overall BSA affected by psoriasis plaques is estimated based on the palm area of the participant hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total BSA. Negative change from baseline indicates improvement. All randomised participants who received at least 1 dose of the study intervention and had evaluable efficacy data for this given outcome at the specified timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 VTX958 300 mg BID (PC) VTX958 225 mg BID (PC) VTX958 300 mg QD (PC) VTX958 50 mg BID (PC) Placebo BID (PC)
    Number of subjects analysed
    35
    37
    39
    40
    38
    Units: Percentage of BSA
        least squares mean (standard error)
    -13.48 ( 1.797 )
    -13.82 ( 1.771 )
    -9.56 ( 1.739 )
    -4.94 ( 1.725 )
    -3.82 ( 1.800 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 76 weeks
    Adverse event reporting additional description
    All randomised participants who received at least 1 dose of the study intervention.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    VTX958 300 mg BID (PC)
    Reporting group description
    		 Participants received one 300 mg VTX958 tablet administered orally twice daily (BID) to maintain the blind in Period 1.

    Reporting group title
    VTX958 225 mg BID (PC)
    Reporting group description
    		 Participants received one 225 mg VTX958 tablet administered orally BID to maintain the blind in Period 1.

    Reporting group title
    VTX958 300 mg QD (PC)
    Reporting group description
    		 Participants received 300 mg VTX958 tablet administered orally QD, and matching placebo tablets administered orally QD to maintain the blind in Period 1

    Reporting group title
    VTX958 50 mg BID (PC)
    Reporting group description
    		 Participants received 50 mg VTX958 tablet administered orally BID to maintain the blind in Period 1.

    Reporting group title
    Placebo BID (PC)
    Reporting group description
    		 Participants received placebo tablets matched to VTX958 administered BID to maintain the blind in Period 1.

    Reporting group title
    Long Term Extension Period (LTE): VTX958 300 mg BID
    Reporting group description
    		 Participants who received receive 300 mg VTX958 dose administered orally BID in Period 2.

    Reporting group title
    LTE: VTX958 225 mg BID (PC)/ VTX958 225 mg BID
    Reporting group description
    		 Participants who received 225 mg VTX958 at Period 1 continued to receive 225 mg VTX958 dose administered orally BID in Period 2.

    Reporting group title
    LTE: VTX958 300 mg QD (PC)/ VTX958 300 mg QD
    Reporting group description
    		 Participants who received 300 mg VTX958 at Period 1 continued to receive 300 mg VTX958 dose administered orally QD in Period 2.

    Reporting group title
    LTE: VTX958 50 mg BID (PC)/ VTX958 50 mg BID
    Reporting group description
    		 Participants who received 50 mg VTX958 at Period 1 continued to receive 50 mg VTX958 dose administered orally BID in Period 2.

    Reporting group title
    Open Label Extension (OLE): VTX958 300 mg BID
    Reporting group description
    		 Participants who received receive 300 mg VTX958 dose administered orally BID in Period 3.

    Serious adverse events
    		 VTX958 300 mg BID (PC) VTX958 225 mg BID (PC) VTX958 300 mg QD (PC) VTX958 50 mg BID (PC) Placebo BID (PC) Long Term Extension Period (LTE): VTX958 300 mg BID LTE: VTX958 225 mg BID (PC)/ VTX958 225 mg BID LTE: VTX958 300 mg QD (PC)/ VTX958 300 mg QD LTE: VTX958 50 mg BID (PC)/ VTX958 50 mg BID Open Label Extension (OLE): VTX958 300 mg BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 45 (0.00%)
    1 / 44 (2.27%)
    1 / 45 (2.22%)
    1 / 43 (2.33%)
    4 / 132 (3.03%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 45 (0.00%)
    1 / 44 (2.27%)
    0 / 45 (0.00%)
    0 / 43 (0.00%)
    0 / 132 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Clavicle fracture
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    0 / 43 (0.00%)
    1 / 132 (0.76%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary artery disease
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    1 / 43 (2.33%)
    1 / 132 (0.76%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    1 / 43 (2.33%)
    0 / 132 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Brain injury
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    0 / 43 (0.00%)
    0 / 132 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    0 / 43 (0.00%)
    1 / 132 (0.76%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    0 / 43 (0.00%)
    1 / 132 (0.76%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Cyclic vomiting syndrome
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    0 / 43 (0.00%)
    1 / 132 (0.76%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
    1 / 45 (2.22%)
    0 / 43 (0.00%)
    0 / 132 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    0 / 43 (0.00%)
    0 / 132 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 VTX958 300 mg BID (PC) VTX958 225 mg BID (PC) VTX958 300 mg QD (PC) VTX958 50 mg BID (PC) Placebo BID (PC) Long Term Extension Period (LTE): VTX958 300 mg BID LTE: VTX958 225 mg BID (PC)/ VTX958 225 mg BID LTE: VTX958 300 mg QD (PC)/ VTX958 300 mg QD LTE: VTX958 50 mg BID (PC)/ VTX958 50 mg BID Open Label Extension (OLE): VTX958 300 mg BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 43 (34.88%)
    10 / 45 (22.22%)
    8 / 44 (18.18%)
    5 / 45 (11.11%)
    5 / 43 (11.63%)
    24 / 132 (18.18%)
    3 / 21 (14.29%)
    4 / 15 (26.67%)
    1 / 11 (9.09%)
    2 / 27 (7.41%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    6 / 43 (13.95%)
    2 / 45 (4.44%)
    3 / 44 (6.82%)
    0 / 45 (0.00%)
    0 / 43 (0.00%)
    5 / 132 (3.79%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    7
    3
    4
    0
    0
    6
    0
    0
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    4 / 43 (9.30%)
    0 / 45 (0.00%)
    1 / 44 (2.27%)
    0 / 45 (0.00%)
    1 / 43 (2.33%)
    5 / 132 (3.79%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    5
    0
    2
    0
    1
    5
    0
    0
    0
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    2 / 43 (4.65%)
    4 / 132 (3.03%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    3
    0
    0
    0
    2
    4
    0
    0
    0
    0
    Blood creatine increased
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    0 / 43 (0.00%)
    0 / 132 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    0 / 43 (0.00%)
    0 / 132 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    0 / 43 (0.00%)
    0 / 132 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 45 (2.22%)
    0 / 44 (0.00%)
    3 / 45 (6.67%)
    0 / 43 (0.00%)
    1 / 132 (0.76%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    2
    1
    0
    3
    0
    1
    0
    0
    0
    0
    Reproductive system and breast disorders
    Prostatitis
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    0 / 43 (0.00%)
    0 / 132 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 43 (2.33%)
    3 / 45 (6.67%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    0 / 43 (0.00%)
    4 / 132 (3.03%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    3
    0
    0
    0
    4
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
    1 / 45 (2.22%)
    0 / 43 (0.00%)
    0 / 132 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 45 (2.22%)
    1 / 44 (2.27%)
    1 / 45 (2.22%)
    1 / 43 (2.33%)
    7 / 132 (5.30%)
    1 / 21 (4.76%)
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    2
    1
    1
    1
    1
    7
    1
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 43 (11.63%)
    3 / 45 (6.67%)
    3 / 44 (6.82%)
    1 / 45 (2.22%)
    1 / 43 (2.33%)
    5 / 132 (3.79%)
    2 / 21 (9.52%)
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    5
    3
    4
    1
    1
    5
    2
    1
    0
    1
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 45 (0.00%)
    1 / 44 (2.27%)
    0 / 45 (0.00%)
    0 / 43 (0.00%)
    0 / 132 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    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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    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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