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    Clinical Trial Results:
    An Open Label, Long-Term Extension Study to Investigate the Safety of PF-06823859 Administered to Adult Participants >=18 and <=80 With Active Dermatomyositis

    Summary
    EudraCT number
    		 2021-004787-10
    Trial protocol
    		 HU   PL   ES   DE  
    Global end of trial date
    20 Nov 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Nov 2024
    First version publication date
    29 Nov 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C0251008
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05192200
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.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
    03 Jun 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Nov 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the long-term safety and tolerability of PF-06823859.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Dec 2021
    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
    Spain: 1
    Country: Number of subjects enrolled
    Poland: 4
    Country: Number of subjects enrolled
    United States: 17
    Worldwide total number of subjects
    24
    EEA total number of subjects
    7
    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)
    20
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Eligible participants with moderate to severe dermatomyositis (DM) who completed treatment period of study C0251002 [NCT03181893] and had agreement from their study doctor to continue treatment were enrolled in this study.

    Pre-assignment
    Screening details
    		 Total of 24 participants (9 from skin cohort [Amended Stage 2] and 15 from muscle cohort [Stage 3]) of study C0251002 were enrolled in study. As planned, in subject disposition discontinuations were reported by treatment.

    Period 1
    Period 1 title
    Treatment Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 PF-06823859 600mg: All Participants
    Arm description
    		 Participants with DM received PF-06823859 600 milligrams (mg) intravenously (IV) once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06823859
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants with DM received PF-06823859 600 mg intravenously IV once every 4 weeks.

    Number of subjects in period 1
    		PF-06823859 600mg: All Participants
    Started
    24
    Safety Analysis Set
    24
    Skin Analysis Set
    9 [1]
    Muscle Analysis Set
    15 [2]
    Completed
    21
    Not completed
    3
         Consent withdrawn by subject
    1
         Unspecified
    1
         Lack of efficacy
    1
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of participants in this milestone is as per the number of participants in the specified cohort.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of participants in this milestone is as per the number of participants in the specified cohort.
    Period 2
    Period 2 title
    Follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 PF-06823859 600mg: All Participants
    Arm description
    		 Participants with DM received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		PF-06823859 600mg: All Participants
    Started
    21
    Completed
    21
    Not completed
    1
         Consent withdrawn by subject
    1
    Joined
    1
         For Follow-up
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PF-06823859 600mg: All Participants
    Reporting group description
    		 Participants with DM received PF-06823859 600 milligrams (mg) intravenously (IV) once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).

    Reporting group values
    		 PF-06823859 600mg: All Participants Total
    Number of subjects
    		 24 24
    Age categorical
    Units: Participants
        Adults (18-64 years)
    		 20 20
        From 65-84 years
    		 4 4
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 49.79 ( 12.73 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 20 20
        Male
    		 4 4
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 0 0
        White
    		 24 24
        More than one race
    		 0 0
        Unknown or Not Reported
    		 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 5 5
        Not Hispanic or Latino
    		 19 19
        Unknown or Not Reported
    		 0 0
    Subject analysis sets

    Subject analysis set title
    PF-06823859 600mg: Skin Cohort
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants with skin predominant DM entering from amended stage 2 of study C0251002 [NCT03181893] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).

    Subject analysis set title
    PF-06823859 600mg: Muscle Cohort
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants with muscle predominant DM entering from stage 3 of study C0251002 [NCT03181893] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).

    Subject analysis sets values
    		 PF-06823859 600mg: Skin Cohort PF-06823859 600mg: Muscle Cohort
    Number of subjects
    9
    15
    Age categorical
    Units: Participants
        Adults (18-64 years)
    8
    12
        From 65-84 years
    1
    3
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    51.78 ( 10.32 )
    48.60 ( 14.19 )
    Sex: Female, Male
    Units: Participants
        Female
    9
    11
        Male
    0
    4
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0
    0
        Asian
    0
    0
        Native Hawaiian or Other Pacific Islander
    0
    0
        Black or African American
    0
    0
        White
    9
    15
        More than one race
    0
    0
        Unknown or Not Reported
    0
    0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    1
    4
        Not Hispanic or Latino
    8
    11
        Unknown or Not Reported
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    PF-06823859 600mg: All Participants
    Reporting group description
    		 Participants with DM received PF-06823859 600 milligrams (mg) intravenously (IV) once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
    Reporting group title
    PF-06823859 600mg: All Participants
    Reporting group description
    		 Participants with DM received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).

    Subject analysis set title
    PF-06823859 600mg: Skin Cohort
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants with skin predominant DM entering from amended stage 2 of study C0251002 [NCT03181893] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).

    Subject analysis set title
    PF-06823859 600mg: Muscle Cohort
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants with muscle predominant DM entering from stage 3 of study C0251002 [NCT03181893] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).

    Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Participants With Treatment Emergent Adverse Events (TEAEs) [1]
    End point description
    AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. SAE: any untoward medical occurrence at any dose that: resulted in death, was life threatening, required hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or considered to be important medical event. AE considered treatment emergent relative to given treatment if event occurred for first time during effective duration of treatment & was not seen prior to the start of treatment, or event was seen prior to the start of treatment but increased severity during treatment. AEs included both SAEs & all non-SAEs. Safety analysis set was evaluated. In this endpoint, data planned to be reported for skin cohort/analysis set, muscle cohort/analysis set & all participants/safety analysis set.
    End point type
    Primary
    End point timeframe
    From Day 1 of dosing maximum up to Week 68
    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: Only descriptive data was planned for this endpoint.
    End point values
    		 PF-06823859 600mg: All Participants PF-06823859 600mg: Skin Cohort PF-06823859 600mg: Muscle Cohort
    Number of subjects analysed
    24
    9
    15
    Units: Participants
    20
    7
    13
    No statistical analyses for this end point

    Primary: Number of Participants With Laboratory Abnormalities

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    End point title
    		 Number of Participants With Laboratory Abnormalities [2]
    End point description
    Hematology laboratory parameters: hemoglobin (g/dL); haematocrit (%); lymphocytes (10^3/millimetre[mm]^3); lymphocytes/leukocytes (%); neutrophils (10^3/mm^3)<0.8*lower limit of normal (LLN), leukocytes (10^3/mm^3)<0.6*LLN, neutrophils (10^3/mm^3); basophils (10^3/mm^3); basophils/leukocytes (%); monocytes/leukocytes (%); activated partial thromboplastin time (seconds [sec]); prothrombin time (sec)>1.2*upper limit of normal (ULN). Clinical chemistry: potassium (mEq/L); bicarbonate (mEq/L)<0.9*LLN, creatine kinase (units per liter [U/L])>2.0*ULN, glucose (mg/dl); glucose-fasting (mg/dl)>1.5*ULN. Urinalysis: Urine glucose; ketones; urine protein; urine hemoglobin; nitrite; leukocyte esterase; hyaline casts (1/per leukocytosis promoting factor (>= 1, urine erythrocytes (scalar); urine leukocytes (scalar)>=20. Safety analysis set evaluated. In this endpoint, data was planned to be reported for skin cohort/analysis set, muscle cohort/analysis set and all participants/safety analysis set.
    End point type
    Primary
    End point timeframe
    From Day 1 of dosing maximum up to Week 68
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned for this endpoint.
    End point values
    		 PF-06823859 600mg: All Participants PF-06823859 600mg: Skin Cohort PF-06823859 600mg: Muscle Cohort
    Number of subjects analysed
    24
    9
    15
    Units: Participants
    22
    8
    14
    No statistical analyses for this end point

    Primary: Number of Participants According to Categorisation of Changes in Vital Signs

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    End point title
    		 Number of Participants According to Categorisation of Changes in Vital Signs [3]
    End point description
    Vital signs included the following parameters: sitting diastolic blood pressure (millimetres of mercury [mmHg]) change >=20 mmHg increase; sitting systolic blood pressure (mmHg) change >=30 mmHg increase, sitting diastolic blood pressure (mmHg) change >=20 mmHg decrease and sitting systolic blood pressure (mmHg) change >=30 mmHg decrease. Safety analysis set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this endpoint, data was planned to be reported for skin cohort/analysis set, muscle cohort/analysis set and all participants/safety analysis set. Here, Increase= Inc. and Decrease= Dec.
    End point type
    Primary
    End point timeframe
    From Day 1 of dosing maximum up to Week 68
    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: Only descriptive data was planned for this endpoint.
    End point values
    		 PF-06823859 600mg: All Participants PF-06823859 600mg: Skin Cohort PF-06823859 600mg: Muscle Cohort
    Number of subjects analysed
    24
    9
    15
    Units: Participants
        Inc.: sitting diastolic blood pressure (mmHg)
    8
    4
    4
        Inc.: sitting systolic blood pressure (mmHg)
    6
    4
    2
        Dec.: sitting diastolic blood pressure (mmHg)
    5
    1
    4
        Dec.: sitting systolic blood pressure (mmHg)
    4
    1
    3
    No statistical analyses for this end point

    Primary: Number of Participants According to Categorisation of Electrocardiogram (ECG) Findings

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    End point title
    		 Number of Participants According to Categorisation of Electrocardiogram (ECG) Findings [4]
    End point description
    ECG parameters evaluated were: PR interval value >=300 milliseconds (msec); QRS duration value >=200 msec; QT interval value >=500 msec; corrected QT Interval using Fridericia's formula (QTCF) 450 <= value<480 msec; 480 <=value<500 msec and value>=500 msec. Safety analysis set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this endpoint, data was planned to be reported for skin cohort/analysis set, muscle cohort/analysis set and all participants/safety analysis set.
    End point type
    Primary
    End point timeframe
    From Day 1 of dosing maximum up to Week 68
    Notes
    [4] - 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: Only descriptive data was planned for this endpoint.
    End point values
    		 PF-06823859 600mg: All Participants PF-06823859 600mg: Skin Cohort PF-06823859 600mg: Muscle Cohort
    Number of subjects analysed
    24
    9
    15
    Units: Participants
        PR interval: value >=300 msec
    0
    0
    0
        QRS duration: value >=200 msec
    0
    0
    0
        QT interval: >=500 msec
    0
    0
    0
        QTCF: 450<=value<480 msec
    3
    2
    1
        QTCF: 480<=value<500 msec
    0
    0
    0
        QTCF: value>=500 msec
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Change From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 52

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    End point title
    		 Change From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 52
    End point description
    CDASI is a validated DM-specific instrument designed to systematically quantify the extent of cutaneous disease. Disease involvement in 15 different anatomical locations was rated using three activity (erythema, scale, erosion/ulceration) and two damage (poikiloderma, calcinosis) measures. The presence and severity of Gottron's papules, periungual changes and alopecia were also captured. Total CDASI activity score was based on the physician's evaluation of three activities (erythema, scale, erosion/ulceration), presence and severity of Gottron's papules, periungual changes and alopecia. Total CDASI activity score ranged from 0 to 100, where higher scores indicated higher levels of disability. Safety analysis set was evaluated. In this endpoint, data was planned to be reported for skin cohort/analysis set and muscle cohort/analysis set. Here, ‘Number of Participants Analysed’ signifies number evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline (before dose on Day 1), Week 52
    End point values
    		 PF-06823859 600mg: Skin Cohort PF-06823859 600mg: Muscle Cohort
    Number of subjects analysed
    9
    12
    Units: Units on a scale
        least squares mean (confidence interval 90%)
    -4.67 (-7.41 to -1.92)
    -2.51 (-3.40 to -1.62)
    No statistical analyses for this end point

    Secondary: Change From Baseline in CDASI Activity Score at Weeks 12, 24, 36, and 48

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    End point title
    		 Change From Baseline in CDASI Activity Score at Weeks 12, 24, 36, and 48
    End point description
    CDASI is a validated DM-specific instrument designed to systematically quantify the extent of cutaneous disease. Disease involvement in 15 different anatomical locations was rated using three activity (erythema, scale, erosion/ulceration) and two damage (poikiloderma, calcinosis) measures. The presence and severity of Gottron's papules, periungual changes and alopecia were also captured. Total CDASI activity score was based on the physician's evaluation of three activities (erythema, scale, erosion/ulceration), presence and severity of Gottron's papules, periungual changes and alopecia. Total CDASI activity score ranged from 0 to 100, where higher scores indicated higher levels of disability. Safety analysis set was evaluated. In this endpoint, data was planned to be reported for skin cohort/analysis set and muscle cohort/analysis set. Here, ‘Number Analysed (n)’ signifies number evaluable for specified rows.
    End point type
    Secondary
    End point timeframe
    Baseline (before dose on Day 1), Weeks 12, 24, 36 and 48
    End point values
    		 PF-06823859 600mg: Skin Cohort PF-06823859 600mg: Muscle Cohort
    Number of subjects analysed
    9
    15
    Units: Units on a scale
    least squares mean (confidence interval 90%)
        Change at Week 12 (n=8,15)
    -5.28 (-7.67 to -2.90)
    -0.87 (-1.98 to 0.25)
        Change at Week 24 (n=9,15)
    -4.11 (-6.47 to -1.75)
    -0.67 (-2.09 to 0.75)
        Change at Week 36 (n=8,15)
    -4.51 (-7.90 to -1.11)
    -1.40 (-2.40 to -0.40)
        Change at Week 48 (n=9,12)
    -4.56 (-7.27 to -1.84)
    -1.70 (-2.70 to -0.70)
    No statistical analyses for this end point

    Secondary: Absolute Values of CDASI Activity Score at Weeks 12, 24, 36, 48, and 52

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    End point title
    		 Absolute Values of CDASI Activity Score at Weeks 12, 24, 36, 48, and 52
    End point description
    CDASI is a validated DM-specific instrument designed to systematically quantify the extent of cutaneous disease. Disease involvement in 15 different anatomical locations was rated using three activity (erythema, scale, erosion/ulceration) and two damage (poikiloderma, calcinosis) measures. The presence and severity of Gottron's papules, periungual changes and alopecia were also captured. Total CDASI activity score was based on the physician's evaluation of three activities (erythema, scale, erosion/ulceration), presence and severity of Gottron's papules, periungual changes and alopecia. Total CDASI activity score ranged from 0 to 100, where higher scores indicated higher levels of disability. Safety analysis set was evaluated. In this endpoint, data was planned to be reported for skin cohort/analysis set and muscle cohort/analysis set. Here, ‘n’ signifies number evaluable for specified rows.
    End point type
    Secondary
    End point timeframe
    Weeks 12, 24, 36, 48 and 52
    End point values
    		 PF-06823859 600mg: Skin Cohort PF-06823859 600mg: Muscle Cohort
    Number of subjects analysed
    9
    15
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=8,15)
    4.4 ( 2.45 )
    4.4 ( 3.44 )
        Week 24 (n=9,15)
    5.0 ( 3.71 )
    4.6 ( 3.81 )
        Week 36 (n=8,15)
    5.5 ( 5.13 )
    3.9 ( 3.27 )
        Week 48 (n=9,12)
    4.6 ( 4.45 )
    3.1 ( 3.03 )
        Week 52 (n=9,12)
    4.4 ( 4.85 )
    2.2 ( 2.52 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in CDASI Damage Score at Weeks 12, 24, 36, 48, and 52

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    End point title
    		 Change From Baseline in CDASI Damage Score at Weeks 12, 24, 36, 48, and 52
    End point description
    CDASI is a validated DM-specific instrument designed to systematically quantify the extent of cutaneous disease. Disease involvement in 15 different anatomical locations was rated using three activity (erythema, scale, erosion/ulceration) and two damage (poikiloderma, calcinosis) measures. The presence and severity of Gottron's papules, periungual changes and alopecia were also captured. Total CDASI damage score was based on the physician's evaluation of two damage (poikiloderma, calcinosis) measures, and presence and severity of Gottron's papules. Total CDASI damage score ranged from 0 to 32, where higher scores indicated higher level of skin damage. Safety analysis set: all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this endpoint, data was planned to be reported for skin cohort/analysis set and muscle cohort/analysis set. n= Number of participants evaluable for specified rows.
    End point type
    Secondary
    End point timeframe
    Baseline (before dose on Day 1), Weeks 12, 24, 36, 48 and 52
    End point values
    		 PF-06823859 600mg: Skin Cohort PF-06823859 600mg: Muscle Cohort
    Number of subjects analysed
    9
    15
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Change at Week 12 (n=8,15)
    -2.4 ( 2.77 )
    -0.8 ( 1.15 )
        Change at Week 24 (n=9,15)
    -1.8 ( 2.33 )
    -0.5 ( 1.19 )
        Change at Week 36 (n=8,15)
    -2.3 ( 2.25 )
    -0.5 ( 1.06 )
        Change at Week 48 (n=9,12)
    -2.0 ( 2.00 )
    -0.9 ( 1.24 )
        Change at Week 52 (n=9,12)
    -2.1 ( 2.09 )
    -0.9 ( 1.08 )
    No statistical analyses for this end point

    Secondary: Absolute Values of CDASI Damage Score at Weeks 12, 24, 36, 48, and 52

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    End point title
    		 Absolute Values of CDASI Damage Score at Weeks 12, 24, 36, 48, and 52
    End point description
    CDASI is a validated DM-specific instrument designed to systematically quantify the extent of cutaneous disease. Disease involvement in 15 different anatomical locations was rated using three activity (erythema, scale, erosion/ulceration) and two damage (poikiloderma, calcinosis) measures. The presence and severity of Gottron's papules, periungual changes and alopecia were also captured. Total CDASI damage score was based on the physician's evaluation of two damage (poikiloderma, calcinosis) measures, and presence and severity of Gottron's papules. Total CDASI damage score ranged from 0 to 32, where higher scores indicated higher level of skin damage. Safety analysis set: all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this endpoint, data was planned to be reported for skin cohort/analysis set and muscle cohort/analysis set. n= Number of participants evaluable for specified rows.
    End point type
    Secondary
    End point timeframe
    Weeks 12, 24, 36, 48 and 52
    End point values
    		 PF-06823859 600mg: Skin Cohort PF-06823859 600mg: Muscle Cohort
    Number of subjects analysed
    9
    15
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=8,15)
    0.9 ( 1.25 )
    1.6 ( 3.07 )
        Week 24 (n=9,15)
    1.9 ( 2.26 )
    1.9 ( 3.41 )
        Week 36 (n=8,15)
    1.4 ( 2.33 )
    1.9 ( 3.43 )
        Week 48 (n=9,12)
    1.7 ( 2.12 )
    1.3 ( 2.83 )
        Week 52 (n=9,12)
    1.6 ( 1.59 )
    1.3 ( 3.19 )
    No statistical analyses for this end point

    Secondary: Total Improvement Score (TIS) at Weeks 12, 24, 36, 48 and 52: Muscle Cohort

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    End point title
    		 Total Improvement Score (TIS) at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
    End point description
    TIS: 1) PhGA (from the MDAAT, 0-100 mm or 0-10 cm on a visual analogue scale [VAS], higher scores = worse health status); 2) PtGA (0-100 mm or 0-10 cm on VAS, higher scores = worse status); 3) MMT-8 designated muscle groups (0-80, lower scores = higher level of disability); 4) HAQ-DI (0-3, higher scores = worse status); 5) Global Extramuscular Disease Activity (from MDAAT, 0-10 cm on VAS, higher scores = higher level of disability); 6) Participant’s most elevated muscle enzymes. TIS was sum of all 6 improvement scores associated with change in each core set measure. TIS range: 0-100; where TIS>=20 shows minimal improvement, TIS >=40 shows moderate improvement & TIS >= 60 shows major improvement. Safety analysis set: All participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. Data was planned to be reported for muscle cohort/analysis set. n= Number of participants evaluable for specified rows.
    End point type
    Secondary
    End point timeframe
    Weeks 12, 24, 36, 48 and 52
    End point values
    		 PF-06823859 600mg: Muscle Cohort
    Number of subjects analysed
    15
    Units: Units on a scale
    least squares mean (confidence interval 90%)
        Week 12 (n=14)
    15.03 (8.36 to 21.70)
        Week 24 (n=15)
    15.67 (8.96 to 22.37)
        Week 36 (n=15)
    18.17 (10.84 to 25.49)
        Week 48 (n=12)
    19.61 (10.58 to 28.63)
        Week 52 (n=12)
    23.66 (14.05 to 33.28)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Physician Global Assessment (PhGA) Score at Week 12, 24, 36, 48 and 52: Muscle Cohort

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    End point title
    		 Change From Baseline in Physician Global Assessment (PhGA) Score at Week 12, 24, 36, 48 and 52: Muscle Cohort
    End point description
    PhGA: investigator was asked to evaluate the participant’s overall disease activity on a VAS of 0 (very good) to 10 (very poor) centimetre (cm), higher scores indicated worse health status. Safety analysis set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this endpoint, data was planned to be reported for muscle cohort/analysis set. Here, ‘n’ signifies number of participants evaluable for specified rows.
    End point type
    Secondary
    End point timeframe
    Baseline (before dose on Day 1), Weeks 12, 24, 36, 48 and 52
    End point values
    		 PF-06823859 600mg: Muscle Cohort
    Number of subjects analysed
    15
    Units: Centimetre
    least squares mean (confidence interval 90%)
        Change at Week 12 (n=14)
    0.17 (-0.54 to 0.87)
        Change at Week 24 (n=15)
    0.29 (-0.39 to 0.98)
        Change at Week 36 (n=15)
    -0.18 (-0.59 to 0.23)
        Change at Week 48 (n=12)
    -0.48 (-0.85 to -0.10)
        Change at Week 52 (n=12)
    -0.60 (-0.97 to -0.23)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Patient Global Assessment (PtGA) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort

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    End point title
    		 Change From Baseline in Patient Global Assessment (PtGA) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
    End point description
    PtGA was the assessment of the severity of disease by the participant/participant's guardian, using a VAS from 0 mm (no evidence of disease activity) to 100 mm (extremely active or severe disease activity). Higher score indicated worse status. Safety analysis set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this endpoint, data was planned to be reported for muscle cohort/analysis set. Here, ‘n’ signifies number of participants evaluable for specified rows.
    End point type
    Secondary
    End point timeframe
    Baseline (before dose on Day 1), Weeks 12, 24, 36, 48 and 52
    End point values
    		 PF-06823859 600mg: Muscle Cohort
    Number of subjects analysed
    15
    Units: Millimetre
    least squares mean (confidence interval 90%)
        Change at Week 12 (n=15)
    3.70 (-6.55 to 13.95)
        Change at Week 24 (n=15)
    -9.63 (-18.18 to -1.08)
        Change at Week 36 (n=15)
    -9.10 (-16.47 to -1.73)
        Change at Week 48 (n=12)
    -8.36 (-14.74 to -1.97)
        Change at Week 52 (n=12)
    -6.28 (-16.79 to 4.22)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Manual Muscle Testing-8 Designated Muscle Groups (MMT-8) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort

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    End point title
    		 Change From Baseline in Manual Muscle Testing-8 Designated Muscle Groups (MMT-8) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
    End point description
    MMT-8 is a tool that assesses muscle strength using manual muscle testing. Eight designated muscles are tested unilaterally with a total potential summed score of 0-80. Lower scores indicated a higher level of disability. Safety analysis set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this endpoint, data was planned to be reported for muscle cohort/analysis set. Here ‘n’ signifies number of participants evaluable for specified rows.
    End point type
    Secondary
    End point timeframe
    Baseline (before dose on Day 1), Weeks 12, 24, 36, 48 and 52
    End point values
    		 PF-06823859 600mg: Muscle Cohort
    Number of subjects analysed
    15
    Units: Units on a scale
    least squares mean (confidence interval 90%)
        Change at Week 12 (n=14)
    -0.06 (-5.93 to 5.82)
        Change at Week 24 (n=15)
    1.85 (-3.11 to 6.81)
        Change at Week 36 (n=15)
    4.92 (0.61 to 9.22)
        Change at Week 48 (n=12)
    8.00 (5.69 to 10.30)
        Change at Week 52 (n=12)
    9.84 (7.38 to 12.31)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Health Assessment Questionnaire and Disease Index (HAQ-DI) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort

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    End point title
    		 Change From Baseline in Health Assessment Questionnaire and Disease Index (HAQ-DI) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
    End point description
    HAQ-DI consisted of eight sections (including dressing & grooming, arising, eating, walking, hygiene, grip, reach, and activities). Each section had multiple questions that the participant used to rank their functionality and ranged from 0 to 3 where 0 = without any difficulty and 3 = unable to do. For each participant, the average ranking was calculated for each of the eight sections. HAQ-DI had a score range of 0 to 3, where higher score reflected worse status. Safety analysis set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this endpoint, data was planned to be reported for muscle cohort/analysis set. Here ‘n’ signifies number of participants evaluable for specified rows.
    End point type
    Secondary
    End point timeframe
    Baseline (before dose on Day 1), Weeks 12, 24, 36, 48 and 52
    End point values
    		 PF-06823859 600mg: Muscle Cohort
    Number of subjects analysed
    15
    Units: Units on a scale
    least squares mean (confidence interval 90%)
        Change at Week 12 (n=15)
    0.00 (-0.13 to 0.13)
        Change at Week 24 (n=15)
    -0.10 (-0.21 to 0.01)
        Change at Week 36 (n=15)
    -0.07 (-0.23 to 0.08)
        Change at Week 48 (n=12)
    -0.12 (-0.24 to 0.00)
        Change at Week 52 (n=12)
    -0.18 (-0.32 to -0.04)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Creatine Kinase at Weeks 12, 24, 36, 48 and 52: Muscle Cohort

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    End point title
    		 Change From Baseline in Creatine Kinase at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
    End point description
    Creatine kinase is a muscle enzyme measured in units per liter (U/L). Safety analysis set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this endpoint, data was planned to be reported for muscle cohort/analysis set. Here, 'n' signifies number of participants evaluable for specified rows.
    End point type
    Secondary
    End point timeframe
    Baseline (before dose on Day 1), Weeks 12, 24, 36, 48 and 52
    End point values
    		 PF-06823859 600mg: Muscle Cohort
    Number of subjects analysed
    15
    Units: Units per litre
    least squares mean (confidence interval 90%)
        Change at Week 12 (n=15)
    -98.93 (-163.76 to -34.11)
        Change at Week 24 (n=15)
    -58.53 (-127.24 to 10.17)
        Change at Week 36 (n=14)
    -97.62 (-150.82 to -44.42)
        Change at Week 48 (n=12)
    -72.04 (-161.48 to 17.39)
        Change at Week 52 (n=12)
    -94.04 (-147.13 to -40.95)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Extramuscular Global Assessment From the Myositis Disease Activity Assessment Tool (MDAAT) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort

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    End point title
    		 Change From Baseline in Extramuscular Global Assessment From the Myositis Disease Activity Assessment Tool (MDAAT) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
    End point description
    MDAAT tool measures the degree of disease activity of extramuscular organ systems and muscle on a VAS of 0 to 10 centimetre (cm), higher scores indicated higher level of disability. Safety analysis set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this endpoint, data was planned to be reported for muscle cohort/analysis set. Here ‘n’ signifies number of participants evaluable for specified rows.
    End point type
    Secondary
    End point timeframe
    Baseline (before dose on Day 1), Weeks 12, 24, 36, 48 and 52
    End point values
    		 PF-06823859 600mg: Muscle Cohort
    Number of subjects analysed
    15
    Units: Centimetre
    least squares mean (confidence interval 90%)
        Change at Week 12 (n=14)
    0.05 (-0.40 to 0.50)
        Change at Week 24 (n=15)
    0.23 (-0.23 to 0.68)
        Change at Week 36 (n=15)
    0.01 (-0.51 to 0.53)
        Change at Week 48 (n=12)
    -0.16 (-0.91 to 0.59)
        Change at Week 52 (n=12)
    -0.56 (-1.07 to -0.06)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Day 1 of dosing maximum up to Week 68
    Adverse event reporting additional description
    Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorised as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was used.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    PF-06823859 600mg: Skin Cohort
    Reporting group description
    		 Participants with skin predominant DM entering from amended stage 2 of study C0251002 [NCT03181893] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).

    Reporting group title
    PF-06823859 600mg: All Participants
    Reporting group description
    		 Participants with DM received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).

    Reporting group title
    PF-06823859 600mg: Muscle Cohort
    Reporting group description
    		 Participants with muscle predominant DM entering from stage 3 of study C0251002 [NCT03181893] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).

    Serious adverse events
    		 PF-06823859 600mg: Skin Cohort PF-06823859 600mg: All Participants PF-06823859 600mg: Muscle Cohort
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 9 (11.11%)
    3 / 24 (12.50%)
    2 / 15 (13.33%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Lower limb fracture
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         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
    		 PF-06823859 600mg: Skin Cohort PF-06823859 600mg: All Participants PF-06823859 600mg: Muscle Cohort
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 9 (77.78%)
    20 / 24 (83.33%)
    13 / 15 (86.67%)
    Vascular disorders
    Peripheral venous disease
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Hypotension
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Lymphoedema
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    General disorders and administration site conditions
    Infusion site rash
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Infusion site extravasation
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Chest discomfort
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Calcinosis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Pyrexia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 9 (22.22%)
    2 / 24 (8.33%)
    0 / 15 (0.00%)
         occurrences all number
    2
    2
    0
    Dyspnoea
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Investigations
    Blood potassium decreased
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Blood pressure increased
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Crystal urine present
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Weight increased
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Sunburn
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Tooth fracture
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Nervous system disorders
    Presyncope
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Mental impairment
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Headache
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 24 (8.33%)
    2 / 15 (13.33%)
         occurrences all number
    0
    9
    9
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 24 (8.33%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    2
    Nausea
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Abdominal pain
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 24 (8.33%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    2
    Diarrhoea
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Faeces discoloured
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Skin and subcutaneous tissue disorders
    Nail pigmentation
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Erythema
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Dermatitis allergic
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Cutaneous calcification
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Urticaria
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 24 (8.33%)
    1 / 15 (6.67%)
         occurrences all number
    1
    3
    2
    Skin ulcer
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Pruritus
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Proteinuria
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Nephrolithiasis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Acute kidney injury
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 24 (8.33%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    1
    Bursitis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Compartment syndrome
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Plantar fasciitis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Myalgia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Myositis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Pain in extremity
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 24 (8.33%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    2
    Pain in jaw
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Periarthritis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Infections and infestations
    COVID-19
         subjects affected / exposed
    3 / 9 (33.33%)
    6 / 24 (25.00%)
    3 / 15 (20.00%)
         occurrences all number
    3
    6
    3
    Bronchitis
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 24 (8.33%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    1
    Herpes zoster
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Fungal infection
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Cystitis
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Influenza
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Laryngitis
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Pharyngitis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Pneumonia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Sinusitis
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 24 (8.33%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    1
    Tooth infection
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 9 (22.22%)
    2 / 24 (8.33%)
    0 / 15 (0.00%)
         occurrences all number
    2
    2
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 9 (11.11%)
    3 / 24 (12.50%)
    2 / 15 (13.33%)
         occurrences all number
    1
    3
    2
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    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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