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    Clinical Trial Results:
    A Proof-of-Concept Study of Guselkumab in the Treatment of Subjects with New-onset or Relapsing Giant Cell Arteritis

    Summary
    EudraCT number
    		 2020-000622-26
    Trial protocol
    		 FR   DE   PL   BE   IT  
    Global end of trial date
    22 May 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jun 2025
    First version publication date
    04 Jun 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CNTO1959GCA2001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04633447
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International NV
    Sponsor organisation address
    Turnhoutseweg 30, B-2340 Beerse, Belgium, 2170
    Public contact
    Clinical Registry group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.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
    22 May 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 May 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to evaluate the efficacy of guselkumab compared to placebo, in combination with a 26-week glucocorticoid (GC) taper regimen, in adult subjects with new-onset or relapsing giant cell arteritis (GCA).
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Oct 2020
    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
    Israel: 4
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Italy: 10
    Country: Number of subjects enrolled
    Poland: 2
    Country: Number of subjects enrolled
    Spain: 13
    Country: Number of subjects enrolled
    Canada: 12
    Worldwide total number of subjects
    53
    EEA total number of subjects
    37
    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)
    9
    From 65 to 84 years
    43
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 53 subjects were enrolled and randomised in this study, of these 35 subjects were randomised to guselkumab treatment arm and 18 to the placebo arm.

    Period 1
    Period 1 title
    Main study (from Week 0 Up to Week 60)
    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
    		 Main Study: Guselkumab
    Arm description
    		 Initially, subjects received 3 intravenous (IV) induction doses of Guselkumab 400 milligrams (mg) every 4 weeks starting from Week 0 up to Week 8 followed by a subcutaneous (SC) maintenance regimen of Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study  along with a protocol defined 26-week Glucocorticoid (GC) taper regimen. Subjects were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and subjects enrolled from that point onwards received Guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Subjects who did not enter LTE continued in the main study till Week 60.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    Other name
    CNTO1959
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received 3 intravenous (IV) induction doses of Guselkumab 400 mg every 4 weeks starting from Week 0 until Week 8.

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    CNTO1959
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received Guselkumab 200 mg injection every 4 weeks starting from Week 12 until Week 48.

    Arm title
    		 Main Study: Placebo
    Arm description
    		 Initially, subjects received 3 IV induction doses of Placebo matching to Guselkumab 400 mg every 4 weeks starting from Week 0 up to Week 8 followed by a SC maintenance regimen of placebo matching to Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week GC taper regimen. Subjects were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and subjects enrolled from that point onwards received placebo matching to guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Subjects who did not enter LTE continued in the main study till Week 60.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo matching to Guselkumab 200 mg injection every 4 weeks starting from Week 12 until Week 48.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received 3 IV induction doses of Placebo matching to Guselkumab 400 mg every 4 weeks starting from Week 0 until Week 8.

    Number of subjects in period 1
    		Main Study: Guselkumab Main Study: Placebo
    Started
    35
    18
    Treated post PA5 by Week 0 (W0): PBO
    0 [1]
    11 [2]
    Treated post PA5 by W0:Gus 200 mg
    19 [3]
    0 [4]
    Completed
    22
    12
    Not completed
    13
    6
         Consent withdrawn by subject
    2
    -
         Physician decision
    -
    1
         Adverse event, non-fatal
    8
    2
         Study Terminated by Sponsor
    3
    3
    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: Only reported subjects were planned to be included in this milestone.
    [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: Only reported subjects were planned to be included in this milestone.
    [3] - 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: Only reported subjects were planned to be included in this milestone.
    [4] - 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: Only reported subjects were planned to be included in this milestone.
    Period 2
    Period 2 title
    LTE Period (Week 52 up to Week 112)
    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
    		 LTE Period: Guselkumab
    Arm description
    		 At Week 48, subjects from main study who were in GC-free remission and consented for the long term extension (LTE) period, continued to receive Guselkumab 200 mg subcutaneously every 4 weeks starting from Week 52 (LTE Week 0) until Week 100 (LTE Week 48). Subjects were then followed up for safety for 12 weeks after the last dose (up to Week 112).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    CNTO1959
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received Guselkumab 200 mg injection every 4 weeks starting from Week 52 (LTE Week 0) until Week 100 (LTE Week 48) in LTE period.

    Arm title
    		 LTE Period: Placebo
    Arm description
    		 At Week 48, subjects from main study who were in GC-free remission and consented for the LTE period, continued to receive placebo matching to guselkumab 200 mg subcutaneously every 4 weeks starting from Week 52 (LTE Week 0) until Week 100 (LTE Week 48). Subjects were then followed up for safety for 12 weeks after the last dose (up to Week 112).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo matching to Guselkumab 200 mg injection every 4 weeks starting from Week 52 (LTE Week 0) until Week 100 (LTE Week 48) in LTE period.

    Number of subjects in period 2 [5]
    		LTE Period: Guselkumab LTE Period: Placebo
    Started
    9
    6
    Completed
    5
    3
    Not completed
    4
    3
         Adverse event, non-fatal
    1
    1
         Study Terminated by Sponsor
    3
    2
    Notes
    [5] - 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: Only reported subjects were planned to be included in this period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Main Study: Guselkumab
    Reporting group description
    		 Initially, subjects received 3 intravenous (IV) induction doses of Guselkumab 400 milligrams (mg) every 4 weeks starting from Week 0 up to Week 8 followed by a subcutaneous (SC) maintenance regimen of Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study  along with a protocol defined 26-week Glucocorticoid (GC) taper regimen. Subjects were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and subjects enrolled from that point onwards received Guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Subjects who did not enter LTE continued in the main study till Week 60.

    Reporting group title
    Main Study: Placebo
    Reporting group description
    		 Initially, subjects received 3 IV induction doses of Placebo matching to Guselkumab 400 mg every 4 weeks starting from Week 0 up to Week 8 followed by a SC maintenance regimen of placebo matching to Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week GC taper regimen. Subjects were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and subjects enrolled from that point onwards received placebo matching to guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Subjects who did not enter LTE continued in the main study till Week 60.

    Reporting group values
    		 Main Study: Guselkumab Main Study: Placebo Total
    Number of subjects
    		 35 18 53
    Age categorical
    Units: Subjects
        In Utero
    		 0 0 0
        Preterm newborn infants (gestional age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days - 23 months)
    		 0 0 0
        Children (2 - 11 years)
    		 0 0 0
        12 - 17 years
    		 0 0 0
        Adults (18 - 64 years)
    		 6 3 9
        From 65 - 84 years
    		 28 15 43
        85 years and over
    		 1 0 1
    Age continuous
    years
    Units: years
        arithmetic mean (standard deviation)
    		 71.9 ( 7.65 ) 70.8 ( 7.14 ) -
    Gender categorical
    Units: Subjects
        Male
    		 10 6 16
        Female
    		 25 12 37

    End points

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    End points reporting groups
    Reporting group title
    Main Study: Guselkumab
    Reporting group description
    		 Initially, subjects received 3 intravenous (IV) induction doses of Guselkumab 400 milligrams (mg) every 4 weeks starting from Week 0 up to Week 8 followed by a subcutaneous (SC) maintenance regimen of Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study  along with a protocol defined 26-week Glucocorticoid (GC) taper regimen. Subjects were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and subjects enrolled from that point onwards received Guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Subjects who did not enter LTE continued in the main study till Week 60.

    Reporting group title
    Main Study: Placebo
    Reporting group description
    		 Initially, subjects received 3 IV induction doses of Placebo matching to Guselkumab 400 mg every 4 weeks starting from Week 0 up to Week 8 followed by a SC maintenance regimen of placebo matching to Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week GC taper regimen. Subjects were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and subjects enrolled from that point onwards received placebo matching to guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Subjects who did not enter LTE continued in the main study till Week 60.
    Reporting group title
    LTE Period: Guselkumab
    Reporting group description
    		 At Week 48, subjects from main study who were in GC-free remission and consented for the long term extension (LTE) period, continued to receive Guselkumab 200 mg subcutaneously every 4 weeks starting from Week 52 (LTE Week 0) until Week 100 (LTE Week 48). Subjects were then followed up for safety for 12 weeks after the last dose (up to Week 112).

    Reporting group title
    LTE Period: Placebo
    Reporting group description
    		 At Week 48, subjects from main study who were in GC-free remission and consented for the LTE period, continued to receive placebo matching to guselkumab 200 mg subcutaneously every 4 weeks starting from Week 52 (LTE Week 0) until Week 100 (LTE Week 48). Subjects were then followed up for safety for 12 weeks after the last dose (up to Week 112).

    Primary: Main study: Percentage of Subjects Achieving Glucocorticoid (GC)-Free Remission at Week 28

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    End point title
    		 Main study: Percentage of Subjects Achieving Glucocorticoid (GC)-Free Remission at Week 28
    End point description
    GC free remission at Week 28 was defined as (1) no signs or symptoms of active Giant cell arteritis (GCA) at Week 28; (2) absence of GCA flare from first dose of the study drug through Week 28; and (3) adherence to the protocol specified 26-week GC taper regimen. GCA flare was defined as the recurrence of signs and symptoms of active GCA, with or without elevation of inflammatory markers, and with the necessity for an increase in GC dose for GCA. Full analysis set (FAS) included all randomised subjects who received at least 1 administration of study intervention.
    End point type
    Primary
    End point timeframe
    Week 28
    End point values
    		 Main Study: Guselkumab Main Study: Placebo
    Number of subjects analysed
    35
    18
    Units: Percentage of subjects
        number (not applicable)
    40.0
    33.3
    Statistical analysis title
    		 Guselkumab Vs Placebo
    Comparison groups
    Main Study: Guselkumab v Main Study: Placebo
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.638
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentage
    Point estimate
    6.6
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -14.7
         upper limit
    		 27.9

    Secondary: Main study: Percentage of Subjects Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52

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    End point title
    		 Main study: Percentage of Subjects Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52
    End point description
    GC free remission was defined as (1) no signs or symptoms of active GCA at Weeks 28, 32, 36, 40, 44, 48 and 52 respectively; (2) absence of GCA flare from first dose of the study drug through Weeks 28, 32, 36, 40, 44, 48 and 52; (3) adherence to the protocol specified 26-week GC taper regimen. GCA flare was defined as the recurrence of signs and symptoms of active GCA, with or without elevation of inflammatory markers, and with the necessity for an increase in GC dose for GCA. FAS included all randomised subjects who received at least 1 administration of study intervention.
    End point type
    Secondary
    End point timeframe
    Weeks 28, 32, 36, 40, 44, 48 and 52
    End point values
    		 Main Study: Guselkumab Main Study: Placebo
    Number of subjects analysed
    35
    18
    Units: Percentage of subjects
    number (not applicable)
        At Week 28
    40.0
    33.3
        At Week 32
    34.3
    33.3
        At Week 36
    34.3
    33.3
        At Week 40
    34.3
    33.3
        At Week 44
    34.3
    33.3
        At Week 48
    31.4
    27.8
        At Week 52
    25.7
    27.8
    No statistical analyses for this end point

    Secondary: Main study: Percentage of Subjects Achieving Both GC-Free Remission and Normalization of Erythrocyte Sedimentation Rate (ESR) at Weeks 28, 32, 36, 40, 44, 48 and 52

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    End point title
    		 Main study: Percentage of Subjects Achieving Both GC-Free Remission and Normalization of Erythrocyte Sedimentation Rate (ESR) at Weeks 28, 32, 36, 40, 44, 48 and 52
    End point description
    GC-free remission at Weeks 28, 32, 36, 40, 44, 48 and 52 was defined as (1) no signs or symptoms of active GCA at Weeks 28, 32, 36, 40, 44, 48 and 52 respectively; (2) absence of GCA flare from first dose of the study drug through Weeks 28, 32, 36, 40, 44, 48; and 52 (3) adherence to the protocol specified 26-week GC taper regimen. Normalization of ESR was defined as ESR less than (<) 30 millimeter per hour (mm/hr) at Weeks 28, 32, 36, 40, 44, 48 and 52. GCA flare was defined as the recurrence of signs and symptoms of active GCA, with or without elevation of inflammatory markers, and with the necessity for an increase in GC dose for GCA. FAS included all randomised subjects who received at least 1 administration of study intervention.
    End point type
    Secondary
    End point timeframe
    Weeks 28, 32, 36, 40, 44, 48 and 52
    End point values
    		 Main Study: Guselkumab Main Study: Placebo
    Number of subjects analysed
    35
    18
    Units: Percentage of Subjects
    number (not applicable)
        At Week 28
    22.9
    5.6
        At Week 32
    22.9
    11.1
        At Week 36
    22.9
    16.7
        At Week 40
    25.7
    16.7
        At Week 44
    22.9
    11.1
        At Week 48
    20.0
    22.2
        At Week 52
    22.9
    16.7
    No statistical analyses for this end point

    Secondary: Main study: Percentage of Subjects Achieving Both GC-Free Remission and Normalization of C-Reactive Protein (CRP)

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    End point title
    		 Main study: Percentage of Subjects Achieving Both GC-Free Remission and Normalization of C-Reactive Protein (CRP)
    End point description
    GC-free remission at Weeks 28, 32, 36, 40, 44, 48 and 52 was defined as (1) no signs or symptoms of active Giant cell arteritis (GCA) at Weeks 28, 32, 36, 40, 44, 48 and 52 respectively; (2) absence of GCA flare from first dose of the study drug through Weeks 28, 32, 36, 40, 44, 48 and 52; (3) adherence to the protocol specified 26-week GC taper regimen. Normalization of CRP was defined as CRP <10 milligrams per liter (mg/L) or <1 milligrams per deciliter (mg/dL). GCA flare was defined as the recurrence of signs and symptoms of active GCA, with or without elevation of inflammatory markers, and with the necessity for an increase in GC dose for GCA. FAS included all randomised subjects who received at least 1 administration of study intervention.
    End point type
    Secondary
    End point timeframe
    Weeks 28, 32, 36, 40, 44, 48 and 52
    End point values
    		 Main Study: Guselkumab Main Study: Placebo
    Number of subjects analysed
    35
    18
    Units: Percentage of Subjects
    number (not applicable)
        At Week 28
    22.9
    16.7
        At Week 32
    20.0
    16.7
        At Week 36
    25.7
    22.2
        At Week 40
    28.6
    33.3
        At Week 44
    25.7
    27.8
        At Week 48
    20.0
    27.8
        At Week 52
    17.1
    22.2
    No statistical analyses for this end point

    Secondary: Main study: Percentage of Subjects Achieving Both GC-Free Remission and Normalization of Both ESR and CRP

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    End point title
    		 Main study: Percentage of Subjects Achieving Both GC-Free Remission and Normalization of Both ESR and CRP
    End point description
    GC-free remission at Weeks 28, 32, 36, 40, 44, 48 and 52 was defined as (1) no signs or symptoms of active Giant cell arteritis (GCA) at Weeks 28, 32, 36, 40, 44, 48 and 52 respectively; (2) absence of GCA flare from first dose of the study drug through Weeks 28, 32, 36, 40, 44, 48 and 52; (3) adherence to the protocol specified 26-week GC taper regimen. normalization of ESR is defined as ESR < 30 mm/hr at Weeks 28, 32, 36, 40, 44, 48 and 52. (5) Normalization of CRP was defined as CRP <10 mg/L or <1 mg/dL. GCA flare was defined as the recurrence of signs and symptoms of active GCA, with or without elevation of inflammatory markers, and with the necessity for an increase in GC dose for GCA. FAS included all randomised subjects who received at least 1 administration of study intervention.
    End point type
    Secondary
    End point timeframe
    Weeks 28, 32, 36, 40, 44, 48 and 52
    End point values
    		 Main Study: Guselkumab Main Study: Placebo
    Number of subjects analysed
    35
    18
    Units: Percentage of Subjects
    number (not applicable)
        At Week 28
    14.3
    5.6
        At Week 32
    17.1
    11.1
        At Week 36
    20.0
    16.7
        At Week 40
    22.9
    16.7
        At Week 44
    17.1
    11.1
        At Week 48
    14.3
    22.2
        At Week 52
    17.1
    16.7
    No statistical analyses for this end point

    Secondary: Main study: Cumulative Glucocorticoid (GC) Dose

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    End point title
    		 Main study: Cumulative Glucocorticoid (GC) Dose
    End point description
    Total cumulative GC dose administered included GCA taper, GC rescue therapy as well as for all other indications (any oral GC) from baseline (Day 1) up to Weeks 28 and 52 . FAS included all randomised subjects who received at least 1 administration of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) up to Weeks 28 and 52
    End point values
    		 Main Study: Guselkumab Main Study: Placebo
    Number of subjects analysed
    35
    18
    Units: Milligrams (mg)
    median (full range (min-max))
        Baseline (Day 1) up to Week 28
    2231.0 (1315 to 4146)
    2205.0 (1736 to 6010)
        Baseline (Day 1) up to Week 52
    2418.5 (1315 to 4319)
    2902.1 (1736 to 7345)
    No statistical analyses for this end point

    Secondary: Main study: Time to First GCA Disease Flare or Discontinuation of Study Intervention Due to Adverse Event (AE) of Worsening of GCA

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    End point title
    		 Main study: Time to First GCA Disease Flare or Discontinuation of Study Intervention Due to Adverse Event (AE) of Worsening of GCA
    End point description
    Time to occurrence of GCA disease flare was defined as the time from first dose of the study agent to the occurrence of the first observation of GCA disease flare or discontinuation due to AE of worsening of GCA. GCA flare was defined as the recurrence of signs and symptoms of active GCA, with or without elevation of inflammatory markers, and with the necessity for an increase in GC dose for GCA. FAS included all randomised subjects who received at least 1 administration of study intervention. "99999" indicated that median and upper limit of 90% confidence interval (CI) could not be estimated due to low number of subjects with events. Here, N (Number of Subjects analyzed) signifies subjects with at least 1 disease flare or discontinuation of study intervention due to AE of Worsening of GCA.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) up to Weeks 28 and 52
    End point values
    		 Main Study: Guselkumab Main Study: Placebo
    Number of subjects analysed
    35
    18
    Units: Weeks
    median (confidence interval 90%)
        Baseline (Day 1) up to Week 28
    99999 (27.71 to 99999)
    29.71 (20.14 to 99999)
        Baseline (Day 1) up to Week 52
    99999 (27.71 to 99999)
    30.07 (20.14 to 99999)
    No statistical analyses for this end point

    Secondary: Main study: Number of Subjects With GCA Disease Flares or Discontinuation of Study Intervention Due to AE of Worsening of GCA

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    End point title
    		 Main study: Number of Subjects With GCA Disease Flares or Discontinuation of Study Intervention Due to AE of Worsening of GCA
    End point description
    Number of subjects with GCA disease flares or discontinuation of study intervention due to AE of worsening of GCA was reported. GCA flare was defined as the recurrence of signs and symptoms of active GCA, with or without elevation of inflammatory markers, and with the necessity for an increase in GC dose for GCA. FAS included all randomised subjects who received at least 1 administration of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) up to Weeks 28 and 52
    End point values
    		 Main Study: Guselkumab Main Study: Placebo
    Number of subjects analysed
    35
    18
    Units: Subjects
        Baseline (Day 1) up to Week 28: 1 Flare
    10
    8
        Baseline (Day 1) up to Week 28: 2 Flare
    0
    0
        Baseline (Day 1) up to Week 28: >3 Flare
    0
    0
        Baseline up to Week 52: 1 Flare
    13
    7
        Baseline up to Week 52: 2 Flares
    3
    3
        Baseline up to Week 52: >=3 Flares
    0
    0
    No statistical analyses for this end point

    Secondary: Main study: Number of Subjects With Treatment-emergent Adverse Events (TEAEs)

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    End point title
    		 Main study: Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
    End point description
    Number of subjects with TEAEs (including serious and non-serious AEs) were reported. An adverse event (AE) was any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. Any AE occurring at or after the initial administration of study intervention through the end of the main study was considered to be treatment emergent. Safety analysis set included all subjects who received at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) up to Week 60
    End point values
    		 Main Study: Guselkumab Main Study: Placebo
    Number of subjects analysed
    35
    17
    Units: Subjects
    34
    17
    No statistical analyses for this end point

    Secondary: Main study: Number of Subjects With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More

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    End point title
    		 Main study: Number of Subjects With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More
    End point description
    Number of subjects with TEAEs (including serious and non-serious AEs) by SOC with a frequency threshold of 5 percent (%) or more were reported. An adverse event (AE) was any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Any AE occurring at or after the initial administration of study intervention through the end of the main study was considered to be treatment emergent. Safety analysis set included all subjects who received at least 1 dose of study intervention. Neoplasms benign, malignant (N B and M)
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) up to Week 60
    End point values
    		 Main Study: Guselkumab Main Study: Placebo
    Number of subjects analysed
    35
    18
    Units: Subjects
        Infections and infestations
    21
    11
        Musculoskeletal and connective tissue disorders
    19
    5
        Vascular disorders
    18
    11
        Gastrointestinal disorders
    10
    2
        General disorder & administration site conditions
    10
    6
        Nervous system disorders
    9
    9
        Eye disorders
    8
    3
        Respiratory, thoracic and mediastinal disorders
    8
    4
        Skin and subcutaneous tissue disorders
    8
    1
        Injury, poisoning and procedural complications
    7
    2
        Investigations
    6
    0
        Endocrine disorders
    5
    0
        Psychiatric disorders
    4
    1
        Metabolism and nutrition disorders
    3
    1
        N B and M and unspecified(incl cysts and polyps)
    3
    1
        Cardiac disorders
    2
    2
        Renal and urinary disorders
    2
    1
        Reproductive system and breast disorders
    1
    1
    No statistical analyses for this end point

    Secondary: Main study: Number of Subjects With Treatment-emergent Serious Adverse Event (SAEs)

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    End point title
    		 Main study: Number of Subjects With Treatment-emergent Serious Adverse Event (SAEs)
    End point description
    Number of subjects with treatment emergent SAEs were reported. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurred at or after the initial administration of study intervention through the end of the main study was considered to be treatment emergent. Safety analysis set included all subjects who received at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) up to Week 60
    End point values
    		 Main Study: Guselkumab Main Study: Placebo
    Number of subjects analysed
    35
    18
    Units: Subjects
    6
    0
    No statistical analyses for this end point

    Secondary: Main study: Number of Subjects With Clinically Significant Abnormalities in Vital Signs

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    End point title
    		 Main study: Number of Subjects With Clinically Significant Abnormalities in Vital Signs
    End point description
    Clinically significant abnormal vital signs criteria: Pulse rate (PR) : <50 beats per minutes (bpm) and with greater than (>) 20 bpm decrease from baseline, >115 bpm and with >30 bpm increase from baseline; Systolic blood pressure (SBP): <90 millimeters of mercury [mmHg] and with >30 mmHg decrease from baseline, >150 mmHg and with >40 mmHg increase from baseline; Diastolic blood pressure (DBP): <50 mmHg and with >20 mmHg decrease from baseline, >95 mmHg and with >30 mmHg increase from baseline; Interarm blood pressure: Interarm blood pressure difference greater than or equal to (>=) 15 mmHg in systolic blood pressure at 3 consecutive visits; Temperature (Temp): >38.4 Degree Celsius (C) and with >=1 C increase from baseline; Weight (kilogram [kg]): decrease 10 percent (%) from baseline, increase 10% from baseline; Respiratory Rate: >20 breaths per minute. Safety analysis set included all subjects who received at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) up to Week 60
    End point values
    		 Main Study: Guselkumab Main Study: Placebo
    Number of subjects analysed
    35
    18
    Units: Subjects
        PR: <50 bpm and with >20 bpm decrease(n=35, 18)
    1
    0
        PR: >115 bpm and with >30 bpm increase(n=35, 18)
    0
    0
        SBP: <90 mmHg and >30 mmHg decrease(n=35, 18)
    2
    0
        SBP: >150 mmHg and >40 mmHg increase(n=35, 18)
    0
    2
        DBP: <50 mmHg and >20 mmHg decrease(n=35, 18)
    2
    0
        DBP: >95 mmHg and >30 mmHg increase(n=35, 18)
    1
    1
        Interarm BP:BP difference >=15 mmHg SBP(n=35,18)
    2
    2
        Temp:>38.4 & >=1C increase from baseline(n=35,18)
    0
    0
        Weight: Decrease 10% from baseline (n=30, 18)
    0
    1
        Weight: Increase 10% from baseline (n=30, 18)
    6
    2
        Respiratory Rate:>20 breaths per minute(n=35,18)
    1
    4
    No statistical analyses for this end point

    Secondary: Main study: Number of Subjects With Clinically Significant Abnormalities in Laboratory Parameters

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    End point title
    		 Main study: Number of Subjects With Clinically Significant Abnormalities in Laboratory Parameters
    End point description
    Number of subjects National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade 3 or 4 abnormalities in clinical laboratory tests: hematology and chemistry were reported. Clinical laboratory abnormalities of living subjects were assessed as per NCI CTCAE version 5, grades (0-4), where Grade 0-Normal, Grade 1- Mild, Grade 2- Moderate, Grade 3- Severe or medically significant but not immediately life-threatening, Grade 4- Life-threatening consequences. Higher grades showed severe abnormality. As per the discretion of investigator, laboratory abnormalities with NCI CTCAE Grade 3 or 4 were considered clinically significant. Combined data of Grade 3 and 4 abnormalities are reported as planned. Only those categories in which at least 1 subject had data were reported. Safety analysis set included all subjects who received at least 1 dose of study intervention.”
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) up to Week 60
    End point values
    		 Main Study: Guselkumab Main Study: Placebo
    Number of subjects analysed
    35
    18
    Units: Subjects
        Chemistry: Creatinine Increased
    1
    0
        Chemistry: Alanine Aminotransferase Increased
    1
    0
        Hematology: Lymphocyte Count Decreased
    3
    3
    No statistical analyses for this end point

    Secondary: Main study: Serum Concentrations of Guselkumab

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    End point title
    		 Main study: Serum Concentrations of Guselkumab [1]
    End point description
    Serum concentrations of Guselkumab over time was reported. Pharmacokinetics (PK) analysis set included all subjects who received at least 1 administration of Guselkumab and had at least one valid post dose blood sample drawn for PK analysis. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint and "n" signifies number of subjects evaluable at specified timepoints. This endpoint was planned to be analyzed for Guselkumab arm only.
    End point type
    Secondary
    End point timeframe
    Pre-dose and 1 hour post dose on Week 0 (Day 1), Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84), Week 16 (Day 112), Week 28 (Day 196), Week 52 (Day 364)
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No inferential statistics was done. Only descriptive statistics was performed.
    End point values
    		 Main Study: Guselkumab
    Number of subjects analysed
    35
    Units: Microgram per milliliter (mcg/ mL)
    arithmetic mean (standard deviation)
        Pre dose on Week 0 (Day 1)(n=34)
    0.00 ( 0.000 )
        1 Hour Post Dose on Week 0 (Day 1) (n=15)
    130.93 ( 45.522 )
        Pre dose on Week 4 (Day 28) (n=32)
    11.21 ( 6.616 )
        1 Hour Post Dose on Week 4 (Day 28) (n=12)
    150.21 ( 34.952 )
        Pre dose on Week 8 (Day 56)(n=30)
    19.71 ( 23.002 )
        1 Hour Post Dose on Week 8 (Day 56) (n=9)
    127.14 ( 68.157 )
        Week 12 (Day 84) (n=31)
    19.16 ( 17.831 )
        Week 16 (Day 112) (n=29)
    15.81 ( 9.644 )
        Week 28 (Day 196) (n=25)
    12.63 ( 4.824 )
        Week 52 (Day 364) (n=19)
    12.55 ( 4.701 )
    No statistical analyses for this end point

    Secondary: Main study: Number of Subjects With Antibodies to Guselkumab

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    End point title
    		 Main study: Number of Subjects With Antibodies to Guselkumab [2]
    End point description
    Number of subjects with antibodies to Guselkumab were reported. Immunogenicity analysis set included all subjects who received at least 1 administration of guselkumab and have at least one post-dose sample collection. This endpoint was planned to be analyzed for Guselkumab arm only.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) up to Weeks 28 and 52
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No inferential statistics was done. Only descriptive statistics was performed.
    End point values
    		 Main Study: Guselkumab
    Number of subjects analysed
    35
    Units: Subjects
        Baseline (Day 1) up to Week 28
    1
        Baseline (Day 1) up to Week 52
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Main study: All-Cause Mortality: From Screening (-6 weeks) up to Week 60; SAEs & Other AEs: Baseline (Day 1) up to Week 60. LTE Period: From Week 52 (LTE Week 0) up to Week 112 (LTE Week 48)
    Adverse event reporting additional description
    Safety analysis set included all subjects who received at least 1 dose of study intervention.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Main Study: Guselkumab
    Reporting group description
    		 Initially, subjects received 3 intravenous (IV) induction doses of Guselkumab 400 milligrams (mg) every 4 weeks starting from Week 0 up to Week 8 followed by a subcutaneous (SC) maintenance regimen of Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study  along with a protocol defined 26-week Glucocorticoid (GC) taper regimen. Subjects were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and subjects enrolled from that point onwards received Guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Subjects who did not enter LTE continued in the main study till Week 60.

    Reporting group title
    LTE Period: Placebo
    Reporting group description
    		 At Week 48, subjects from main study who were in GC-free remission and consented for the LTE period, continued to receive placebo matching to guselkumab 200 mg subcutaneously every 4 weeks starting from Week 52 (LTE Week 0) until Week 100 (LTE Week 48). Subjects were then followed up for safety for 12 weeks after the last dose (up to Week 112).

    Reporting group title
    LTE Period: Guselkumab
    Reporting group description
    		 At Week 48, subjects from main study who were in GC-free remission and consented for the long term extension (LTE) period, continued to receive Guselkumab 200 mg subcutaneously every 4 weeks starting from Week 52 (LTE Week 0) until Week 100 (LTE Week 48). Subjects were then followed up for safety for 12 weeks after the last dose (up to Week 112).

    Reporting group title
    Main Study: Placebo
    Reporting group description
    		 Initially, subjects received 3 IV induction doses of Placebo matching to Guselkumab 400 mg every 4 weeks starting from Week 0 up to Week 8 followed by a SC maintenance regimen of placebo matching to Guselkumab 200 mg every 4 weeks starting from Week 12 until Week 48 in the main study along with a protocol defined 26-week GC taper regimen. Subjects were then followed up for safety for 12 weeks until Week 60. With protocol amendment 5, IV induction was discontinued, and subjects enrolled from that point onwards received placebo matching to guselkumab 200 mg subcutaneously every 4 weeks from Week 0 until Week 48 (end of treatment). Subjects who did not enter LTE continued in the main study till Week 60.

    Serious adverse events
    		 Main Study: Guselkumab LTE Period: Placebo LTE Period: Guselkumab Main Study: Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 35 (17.14%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         number of deaths (all causes)
    1
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fractured Sacrum
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral Artery Stenosis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary Embolism
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute Kidney Injury
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal Sepsis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Main Study: Guselkumab LTE Period: Placebo LTE Period: Guselkumab Main Study: Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 35 (88.57%)
    5 / 6 (83.33%)
    6 / 9 (66.67%)
    17 / 18 (94.44%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lipoma
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Arteriosclerosis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Giant Cell Arteritis
         subjects affected / exposed
    17 / 35 (48.57%)
    1 / 6 (16.67%)
    0 / 9 (0.00%)
    10 / 18 (55.56%)
         occurrences all number
    20
    1
    0
    14
    Haematoma
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Hot Flush
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    0
    General disorders and administration site conditions
    Influenza Like Illness
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Fatigue
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Complication Associated with Device
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Chest Pain
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    0
    1
    Malaise
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    1
    0
    0
    2
    Pyrexia
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    2
    0
    0
    1
    Peripheral Swelling
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    4
    0
    0
    0
    Oedema Peripheral
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    2
    0
    0
    1
    Non-Cardiac Chest Pain
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Reproductive system and breast disorders
    Vulvovaginal Discomfort
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Tonsillar Hypertrophy
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Sleep Apnoea Syndrome
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Oropharyngeal Pain
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    1
    Nasal Polyps
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nasal Congestion
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Dyspnoea
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Dysphonia
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Cough
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 6 (16.67%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    0
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    0
    1
    Investigations
    C-Reactive Protein Increased
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Weight Increased
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Injury, poisoning and procedural complications
    Foot Fracture
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Fall
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 6 (16.67%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    5
    1
    0
    1
    Limb Injury
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tendon Rupture
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Cardiac disorders
    Myocarditis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Ventricular Extrasystoles
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Ventricular Tachycardia
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Nervous system disorders
    Paraesthesia
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Brain Fog
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Cognitive Disorder
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Dizziness Postural
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Headache
         subjects affected / exposed
    6 / 35 (17.14%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    7 / 18 (38.89%)
         occurrences all number
    8
    0
    0
    11
    Hypotonia
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Somnolence
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Sciatica
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Eye disorders
    Cataract Nuclear
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Myopia
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Visual Field Defect
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Blepharitis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Cataract
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    2
    0
    0
    1
    Macular Degeneration
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorders
    Abdominal Mass
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Abdominal Pain
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Abdominal Pain Upper
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Nausea
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    4
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    2
    0
    0
    2
    Anal Fistula
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Skin Fragility
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Ecchymosis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Eczema
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 6 (16.67%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Erythema
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Pruritus
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Renal and urinary disorders
    Haemorrhage Urinary Tract
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Endocrine disorders
    Cushingoid
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 35 (17.14%)
    1 / 6 (16.67%)
    1 / 9 (11.11%)
    0 / 18 (0.00%)
         occurrences all number
    9
    1
    1
    0
    Back Pain
         subjects affected / exposed
    4 / 35 (11.43%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    4
    0
    0
    1
    Bursitis
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Greater Trochanteric Pain Syndrome
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Joint Swelling
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Muscle Spasms
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    4
    0
    0
    0
    Osteoarthritis
         subjects affected / exposed
    5 / 35 (14.29%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    5
    0
    0
    0
    Musculoskeletal Pain
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Muscular Weakness
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Osteoporosis
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 6 (16.67%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    0
    1
    Polymyalgia Rheumatica
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    2
    Rotator Cuff Syndrome
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Spinal Osteoarthritis
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Myalgia
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    3
    0
    0
    1
    Infections and infestations
    Covid-19
         subjects affected / exposed
    8 / 35 (22.86%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    5 / 18 (27.78%)
         occurrences all number
    8
    0
    0
    5
    Bronchitis
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    2 / 18 (11.11%)
         occurrences all number
    3
    0
    1
    3
    Acute Sinusitis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    0
    0
    0
    2
    Gastroenteritis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    2 / 18 (11.11%)
         occurrences all number
    0
    0
    1
    2
    Influenza
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    4 / 35 (11.43%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    4
    0
    0
    1
    Oral Herpes
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    1 / 18 (5.56%)
         occurrences all number
    6
    0
    1
    1
    Pharyngitis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    2 / 18 (11.11%)
         occurrences all number
    0
    0
    1
    2
    Pneumonia
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Urinary Tract Infection
         subjects affected / exposed
    4 / 35 (11.43%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    6
    0
    0
    3
    Upper Respiratory Tract Infection
         subjects affected / exposed
    4 / 35 (11.43%)
    2 / 6 (33.33%)
    2 / 9 (22.22%)
    1 / 18 (5.56%)
         occurrences all number
    7
    2
    2
    1
    Tonsillitis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tinea Pedis
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 6 (16.67%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Sinusitis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    1 / 18 (5.56%)
         occurrences all number
    2
    0
    1
    1
    Respiratory Tract Infection
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    0
    1
    Metabolism and nutrition disorders
    Diabetes Mellitus
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Dyslipidaemia
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 6 (16.67%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 May 2022
    The sponsor decided to no longer pursue a treatment regimen that included IV induction doses. Newly enrolled subjects were to be treated with a full subcutaneous (SC) dosing regimen. Sample size reduced while maintaining sufficient statistical power. Updated inclusion/exclusion criteria.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    24 Mar 2022
    An urgent safety measure triggered by 2 venous thromboembolism (VTE) events lead to pausing the enrollment and after additional investigation, VTEs were shown to be unrelated to drug, study was resumed.
    03 Jun 2022

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

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