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    Clinical Trial Results:
    A Multicenter, Randomized, Double-blinded Study Evaluating the Pharmacokinetics, Efficacy and Safety of Multiple Switches Between Ustekinumab and ABP 654 Compared with Continued Use of Ustekinumab in Subjects with Moderate to Severe Plaque Psoriasis

    Summary
    EudraCT number
    		 2020-005205-42
    Trial protocol
    		 DE   HU   LV   EE   ES  
    Global end of trial date
    28 Feb 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Dec 2023
    First version publication date
    28 Dec 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    20200417
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04761627
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Amgen inc.
    Sponsor organisation address
    One Amgen Center Drive, Thousand Oaks, CA, United States,
    Public contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
    Scientific contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.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
    28 Feb 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Feb 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to demonstrate similarity of pharmacokinetics (PK) in participants with multiple switches between ustekinumab RP and ABP 654 compared to participants receiving continued use of ustekinumab RP.
    Protection of trial subjects
    This study was conducted in accordance with International Council for Harmonisation Good Clinical Practice Guideline E6 (R1)/Integrated Addendum E6 (R2); 21 Code of Federal Regulations Parts 50, 56, and 312; requirements for the conduct of clinical studies as provided in the European Union Directive 2001/20/EC; the consensus ethical principles derived from international guidelines, including the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines; and all applicable laws and regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Mar 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 88
    Country: Number of subjects enrolled
    Estonia: 14
    Country: Number of subjects enrolled
    Georgia: 6
    Country: Number of subjects enrolled
    Germany: 64
    Country: Number of subjects enrolled
    Hungary: 29
    Country: Number of subjects enrolled
    Latvia: 12
    Country: Number of subjects enrolled
    Poland: 121
    Country: Number of subjects enrolled
    United States: 160
    Worldwide total number of subjects
    494
    EEA total number of subjects
    240
    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)
    431
    From 65 to 84 years
    63
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at 87 study centers in 8 countries, including Canada, Estonia, Georgia, Germany, Hungary, Latvia, Poland, and the United States, and participated from 24 March 2021 to 28 February 2023.

    Pre-assignment
    Screening details
    		 Participants with plaque psoriasis were randomized at week 28 to 1 of 2 treatment groups following a run-in period. Randomization was stratified by prior biologic use for psoriasis at baseline, geographic region, and body weight group at baseline. Dosage was weight-based to ensure similar concentration by body weight received.

    Period 1
    Period 1 title
    Run-in Period
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer

    Arms
    Arm title
    		 Run-in: Ustekinumab Reference Product (RP)
    Arm description
    		 Participants received ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight > 100 kg) on day 1 (week 0), week 4, and week 16. At week 28, eligible participants with a 50% improvement in Psoriasis Area and Severity Index (PASI 50) response or better were randomized to the continued-use group (ustekinumab RP) or the switching group (ustekinumab RP and ABP 654).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab RP
    Investigational medicinal product code
    Other name
    Stelara®
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight > 100 kg) on day 1 (week 0), week 4, and week 16 in the run-in period.

    Number of subjects in period 1
    		Run-in: Ustekinumab Reference Product (RP)
    Started
    494
    Completed
    453
    Not completed
    41
         Adverse event, serious fatal
    1
         Consent withdrawn by subject
    7
         Abnormal liver function
    1
         Study site closure
    2
         Adverse event, non-fatal
    6
         Pregnancy
    2
         Did not meet PASI 50
    15
         Lost to follow-up
    2
         Required alternative therapy
    2
         Protocol deviation
    3
    Period 2
    Period 2 title
    Post-randomization Period
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Post-randomization Switching: Ustekinumab RP and ABP 654
    Arm description
    		 At week 28, eligible participants with a PASI 50 response or better were randomized to the switching group and received ABP 654 at week 28, ustekinumab RP at week 40, and ABP 654 at week 52. Ustekinumab RP and ABP 654 (45 mg [baseline body weight ≤ 100 kg] or 90 mg [baseline body weight > 100 kg]) were administered by SC injection using a pre-filled syringe.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABP 654
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received ABP 654 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight > 100 kg) at weeks 28 and 52 in the post-randomization period.

    Investigational medicinal product name
    Ustekinumab RP
    Investigational medicinal product code
    Other name
    Stelara®
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight > 100 kg) at week 40 in the post-randomization period.

    Arm title
    		 Post-randomization Continued-use: Ustekinumab RP
    Arm description
    		 At week 28, eligible participants with a PASI 50 response or better were randomized to the continued-use group to receive ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight > 100 kg) at weeks 28, 40, and 52. Ustekinumab RP was administered by SC injection using a pre-filled syringe.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab RP
    Investigational medicinal product code
    Other name
    Stelara®
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight > 100 kg) at weeks 28, 40, and 52 in the post-randomization period.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: In Period 2, eligible participants were randomized to treatment and this was considered the baseline period.
    Number of subjects in period 2 [2]
    		Post-randomization Switching: Ustekinumab RP and ABP 654 Post-randomization Continued-use: Ustekinumab RP
    Started
    228
    225
    Full analysis set
    228
    225
    Safety analysis set
    228
    224
    Completed
    209
    209
    Not completed
    19
    16
         Consent withdrawn by subject
    7
    6
         Study site closure
    -
    1
         Adverse event, non-fatal
    4
    2
         Family planning
    1
    -
         Military service
    1
    -
         Pregnancy
    -
    1
         Lost to follow-up
    6
    6
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of participants included in the worldwide number enrolled aligns with the number of participants who entered the run-in period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Post-randomization Switching: Ustekinumab RP and ABP 654
    Reporting group description
    		 At week 28, eligible participants with a PASI 50 response or better were randomized to the switching group and received ABP 654 at week 28, ustekinumab RP at week 40, and ABP 654 at week 52. Ustekinumab RP and ABP 654 (45 mg [baseline body weight ≤ 100 kg] or 90 mg [baseline body weight > 100 kg]) were administered by SC injection using a pre-filled syringe.

    Reporting group title
    Post-randomization Continued-use: Ustekinumab RP
    Reporting group description
    		 At week 28, eligible participants with a PASI 50 response or better were randomized to the continued-use group to receive ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight > 100 kg) at weeks 28, 40, and 52. Ustekinumab RP was administered by SC injection using a pre-filled syringe.

    Reporting group values
    		 Post-randomization Switching: Ustekinumab RP and ABP 654 Post-randomization Continued-use: Ustekinumab RP Total
    Number of subjects
    		 228 225 453
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational 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
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 203 190 393
        From 65-84 years
    		 25 35 60
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.9 ( 13.36 ) 48.1 ( 13.48 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 64 83 147
        Male
    		 164 142 306
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 26 23 49
        Not Hispanic or Latino
    		 202 201 403
        Unknown or Not Reported
    		 0 1 1
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 207 214 421
        Asian
    		 9 3 12
        Black or African American
    		 7 1 8
        Other
    		 3 2 5
        American Indian or Alaska Native
    		 1 2 3
        Native Hawaiian or other Pacific Islander
    		 1 2 3
        Not allowed to collect
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Run-in: Ustekinumab Reference Product (RP)
    Reporting group description
    		 Participants received ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight > 100 kg) on day 1 (week 0), week 4, and week 16. At week 28, eligible participants with a 50% improvement in Psoriasis Area and Severity Index (PASI 50) response or better were randomized to the continued-use group (ustekinumab RP) or the switching group (ustekinumab RP and ABP 654).
    Reporting group title
    Post-randomization Switching: Ustekinumab RP and ABP 654
    Reporting group description
    		 At week 28, eligible participants with a PASI 50 response or better were randomized to the switching group and received ABP 654 at week 28, ustekinumab RP at week 40, and ABP 654 at week 52. Ustekinumab RP and ABP 654 (45 mg [baseline body weight ≤ 100 kg] or 90 mg [baseline body weight > 100 kg]) were administered by SC injection using a pre-filled syringe.

    Reporting group title
    Post-randomization Continued-use: Ustekinumab RP
    Reporting group description
    		 At week 28, eligible participants with a PASI 50 response or better were randomized to the continued-use group to receive ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight > 100 kg) at weeks 28, 40, and 52. Ustekinumab RP was administered by SC injection using a pre-filled syringe.

    Subject analysis set title
    Switching: Ustekinumab RP and ABP 654
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants were randomized to the switching group at week 28 and completed all planned doses of ABP 654 and ustekinumab RP up to week 52, including ABP 654 at week 28, ustekinumab RP at week 40, and ABP 654 at week 52.

    Subject analysis set title
    Continued-use: Ustekinumab RP
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants were randomized to the continued-use group at week 28 and completed all planned doses of ustekinumab RP up to week 52, including 3 doses at weeks 28, 40, and 52.

    Subject analysis set title
    Switching: ABP 654/Ustekinumab RP/Missing
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and ustekinumab RP at week 40 but did not receive the planned dose of ABP 654 at week 52.

    Subject analysis set title
    Continued-use: Ustekinumab RP/Ustekinumab RP/Missing
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 and week 40 but did not receive the planned dose of ustekinumab RP at week 52.

    Subject analysis set title
    Switching: ABP 654/Missing/Missing
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and did not receive the planned doses of ustekinumab RP at week 40 and ABP 654 at week 52.

    Subject analysis set title
    Continued-use: Ustekinumab RP/Missing/Missing
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 but did not receive the planned doses of ustekinumab RP at week 40 and week 52.

    Primary: Area Under the Plasma Concentration Time Curve (AUC) Over the Dosing Interval (AUCtau) Between Week 52 and Week 64

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    End point title
    		 Area Under the Plasma Concentration Time Curve (AUC) Over the Dosing Interval (AUCtau) Between Week 52 and Week 64
    End point description
    AUCtau from time 0 (week 52) over the dosing interval up to week 64 is presented. PK parameters are based on ABP 654 in the switching group and on ustekinumab in the continued use group. The PK parameter analysis set consisted of all randomized participants who received all 3 doses of the assigned investigational product (IP) between week 28 and week 52 and who had an evaluable ABP 654 or ustekinumab serum concentration-time profile between week 52 and week 64. Participants with data available are presented.
    End point type
    Primary
    End point timeframe
    Blood samples were taken pre-dose week 52; and at 2 days, 7 days, 10 days, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the week 52 dose
    End point values
    		 Post-randomization Switching: Ustekinumab RP and ABP 654 Post-randomization Continued-use: Ustekinumab RP
    Number of subjects analysed
    199
    204
    Units: hour*mcg/mL
        geometric mean (geometric coefficient of variation)
    5144.40 ( 45.3 )
    5768.45 ( 50.4 )
    Statistical analysis title
    		 AUCtau: Switching group versus Continued-use group
    Statistical analysis description
    The geometric least squares (LS) mean, ratio of geometric LS means, and 90% confidence intervals (CIs) were estimated using the analysis of covariance (ANCOVA) model adjusted for the actual stratification factors if prior biologic use for psoriasis, baseline body weight group, geographic region, and PK trough concentration at week 28.
    Comparison groups
    Post-randomization Continued-use: Ustekinumab RP v Post-randomization Switching: Ustekinumab RP and ABP 654
    Number of subjects included in analysis
    403
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    Method
    Parameter type
    		 Geometric LS mean ratio
    Point estimate
    0.9325
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.8874
         upper limit
    		 0.9799
    Notes
    [1] - The prespecified similarity margin was 0.8 to 1.25.

    Primary: Maximum Observed Serum Concentration (Cmax) Between Week 52 and Week 64

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    End point title
    		 Maximum Observed Serum Concentration (Cmax) Between Week 52 and Week 64
    End point description
    Cmax between week 52 and week 64 is presented. PK parameters are based on ABP 654 in the switching group and on ustekinumab in the continued use group. The PK parameter analysis set consisted of all randomized participants who received all 3 doses of the assigned IP between week 28 and week 52 and who had an evaluable ABP 654 or ustekinumab serum concentration-time profile between week 52 and week 64. Participants with data available are presented.
    End point type
    Primary
    End point timeframe
    Blood samples were taken pre-dose week 52; and at 2 days, 7 days, 10 days, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the week 52 dose
    End point values
    		 Post-randomization Switching: Ustekinumab RP and ABP 654 Post-randomization Continued-use: Ustekinumab RP
    Number of subjects analysed
    204
    205
    Units: mcg/mL
        geometric mean (geometric coefficient of variation)
    5.78 ( 41.4 )
    6.31 ( 46.8 )
    Statistical analysis title
    		 Cmax: Switching group versus Continued-use group
    Statistical analysis description
    The geometric LS mean, ratio of geometric LS means, and 90% CIs were estimated using the ANCOVA model adjusted for the actual stratification factors if prior biologic use for psoriasis, baseline body weight group, geographic region, and PK trough concentration at week 28.
    Comparison groups
    Post-randomization Switching: Ustekinumab RP and ABP 654 v Post-randomization Continued-use: Ustekinumab RP
    Number of subjects included in analysis
    409
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [2]
    Method
    Parameter type
    		 Geometric LS mean ratio
    Point estimate
    0.9483
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.8977
         upper limit
    		 1.0018
    Notes
    [2] - The prespecified similarity margin was 0.8 to 1.25.

    Secondary: Time of Maximum Serum Concentration (tmax) Between Week 52 and Week 64

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    End point title
    		 Time of Maximum Serum Concentration (tmax) Between Week 52 and Week 64
    End point description
    Tmax between week 52 and week 64 is presented. PK parameters are based on ABP 654 in the switching group and on ustekinumab in the continued-use group. The PK parameter analysis set consisted of all randomized participants who received all 3 doses of the assigned IP between week 28 and week 52 and who had an evaluable ABP 654 or ustekinumab serum concentration-time profile between week 52 and week 64. Participants with data available are presented.
    End point type
    Secondary
    End point timeframe
    Blood samples were taken pre-dose week 52; and at 2 days, 7 days, 10 days, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the week 52 dose
    End point values
    		 Post-randomization Switching: Ustekinumab RP and ABP 654 Post-randomization Continued-use: Ustekinumab RP
    Number of subjects analysed
    204
    205
    Units: hours
        median (full range (min-max))
    167.80 (41.4 to 355.2)
    168.93 (43.6 to 407.6)
    No statistical analyses for this end point

    Secondary: Serum Trough Concentration at Steady-state (Ctrough,ss) at Week 28, Week 40, and Week 52

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    End point title
    		 Serum Trough Concentration at Steady-state (Ctrough,ss) at Week 28, Week 40, and Week 52
    End point description
    Ctrough,ss at weeks 28, 40, and 52 are presented. PK parameters are based on ABP 654 in the switching group and on ustekinumab in the continued-use group. The PK parameter analysis set consisted of all randomized participants who received all 3 doses of the assigned IP between week 28 and week 52 and who had an evaluable ABP 654 or ustekinumab serum concentration-time profile between week 52 and week 64. Participants with data available are presented.
    End point type
    Secondary
    End point timeframe
    Blood samples were taken pre-dose week 28, week 40, and week 52
    End point values
    		 Post-randomization Switching: Ustekinumab RP and ABP 654 Post-randomization Continued-use: Ustekinumab RP
    Number of subjects analysed
    204
    205
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Week 28 (n=194, 198)
    570.46 ( 105.9 )
    595.86 ( 110.0 )
        Week 40 (n=193, 200)
    537.52 ( 96.4 )
    590.61 ( 103.9 )
        Week 52 (n=196, 201)
    562.51 ( 114.0 )
    599.11 ( 108.5 )
    Statistical analysis title
    		 Week 28 Ctrough,ss: Switching versus Continued-use
    Statistical analysis description
    Geometric LS means, ratio of Geometric LS means, and 90% CIs for Ctrough,ss at week 28 were estimated based on an ANCOVA model adjusted for the actual stratification factors of prior biologic use for psoriasis, baseline body weight group, and geographic region.
    Comparison groups
    Post-randomization Switching: Ustekinumab RP and ABP 654 v Post-randomization Continued-use: Ustekinumab RP
    Number of subjects included in analysis
    409
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [3]
    Method
    Parameter type
    		 Geometric LS mean ratio
    Point estimate
    0.9617
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.8319
         upper limit
    		 1.1119
    Notes
    [3] - At week 28 a total of 392 participants were included in this analysis. The prespecified similarity margin was 0.8 to 1.25.
    Statistical analysis title
    		 Week 52 Ctrough,ss: Switching versus Continued-use
    Statistical analysis description
    Geometric LS means, ratio of geometric LS means, and 90% CIs for Ctrough,ss at week 40 and week 52 between the 2 treatment groups were estimated using an ANCOVA model adjusting for stratification factors and PK trough concentration at week 28.
    Comparison groups
    Post-randomization Switching: Ustekinumab RP and ABP 654 v Post-randomization Continued-use: Ustekinumab RP
    Number of subjects included in analysis
    409
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [4]
    Method
    Parameter type
    		 Geometric LS mean ratio
    Point estimate
    0.9806
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.8916
         upper limit
    		 1.0785
    Notes
    [4] - At week 52 a total of 397 participants were included in this analysis. The prespecified similarity margin was 0.8 to 1.25.
    Statistical analysis title
    		 Week 40 Ctrough,ss: Switching versus Continued-use
    Statistical analysis description
    Geometric LS means, ratio of geometric LS means, and 90% CIs for Ctrough,ss at week 40 and week 52 between the 2 treatment groups were estimated using an ANCOVA model adjusting for stratification factors and PK trough concentration at week 28.
    Comparison groups
    Post-randomization Switching: Ustekinumab RP and ABP 654 v Post-randomization Continued-use: Ustekinumab RP
    Number of subjects included in analysis
    409
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [5]
    Method
    Parameter type
    		 Geometric LS mean ratio
    Point estimate
    0.9662
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.8879
         upper limit
    		 1.0515
    Notes
    [5] - At week 40 a total of 393 participants were included in this analysis. The prespecified similarity margin was 0.8 to 1.25.

    Secondary: PASI Percent Improvement From Baseline at Week 64

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    End point title
    		 PASI Percent Improvement From Baseline at Week 64
    End point description
    The PASI is a measure of the average redness, thickness, and scaliness, each graded on a 0 to 4 scale, weighted by the area of involvement. PASI combines the assessment of the severity and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). PASI percent improvement is defined as 100 x (value at baseline - value at post-baseline visit)/value at baseline. A positive value indicates PASI improvement. Baseline data were derived based on observed data and at week 64 were derived based on multiple imputation (MI) data. Baseline was the last non-missing assessment prior to the first dose of IP. The per-protocol efficacy analysis set included all participants who were randomized and received all 3 doses of the assigned IP between week 28 and week 52 and did not experience an important protocol deviation that could affect the evaluation of the efficacy endpoints. The participants analyzed includes those imputed by MI as well as those with observed data.
    End point type
    Secondary
    End point timeframe
    Baseline (day 1) and week 64
    End point values
    		 Post-randomization Switching: Ustekinumab RP and ABP 654 Post-randomization Continued-use: Ustekinumab RP
    Number of subjects analysed
    216
    215
    Units: Percentage change
        arithmetic mean (standard deviation)
    88.80 ( 18.066 )
    88.72 ( 16.128 )
    Statistical analysis title
    		 Mean difference PASI Percent Improvement
    Statistical analysis description
    Switching group - Continued-use group. Multiple imputation was applied for the point estimate and CI of the mean difference between the switching and continued-use groups. Missing PASI scores at the week 64 visit were imputed by MI.
    Comparison groups
    Post-randomization Switching: Ustekinumab RP and ABP 654 v Post-randomization Continued-use: Ustekinumab RP
    Number of subjects included in analysis
    431
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [6]
    Method
    Parameter type
    		 Mean difference
    Point estimate
    0.07
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.62
         upper limit
    		 2.77
    Notes
    [6] - The prespecified similarity margin was 0.8 to 1.25.

    Secondary: PASI 75 Response at Week 64

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    End point title
    		 PASI 75 Response at Week 64
    End point description
    The PASI is a measure of the average redness, thickness, and scaliness, each graded on a 0 to 4 scale, weighted by the area of involvement. PASI combines the assessment of the severity and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). PASI response was defined as a participant meeting/surpassing a pre-specified threshold for percent improvement in PASI score compared to baseline. A participant with ≥75% improvement was a PASI 75 responder. Missing PASI 75 responses at week 64 were imputed by non-responder imputation (NRI). Baseline was the last non-missing assessment prior to first dose of IP. The per-protocol efficacy analysis set included all participants who were randomized and received all 3 doses of the assigned IP between week 28 and week 52 and did not experience an important protocol deviation that could affect the evaluation of the efficacy endpoints. The participants analyzed include those imputed by NRI and those with observed.
    End point type
    Secondary
    End point timeframe
    Baseline (day 1) and week 64
    End point values
    		 Post-randomization Switching: Ustekinumab RP and ABP 654 Post-randomization Continued-use: Ustekinumab RP
    Number of subjects analysed
    216
    215
    Units: Percentage of responders
        number (confidence interval 95%)
    83.3 (78.4 to 88.3)
    82.8 (77.8 to 87.8)
    Statistical analysis title
    		 Difference in PASI 75 Response at Week 64
    Statistical analysis description
    Switching group - Continued-use group. Response difference was estimated by the Mantel-Haenszel estimate, and the 90% CIs were estimated by the stratified Newcombe confidence limits, adjusting for the prior biologic use of psoriasis, baseline body weight group, geographic region. Missing post-baseline binary response data were imputed by NRI.
    Comparison groups
    Post-randomization Switching: Ustekinumab RP and ABP 654 v Post-randomization Continued-use: Ustekinumab RP
    Number of subjects included in analysis
    431
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [7]
    Method
    Parameter type
    		 Response difference
    Point estimate
    0.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -5.7
         upper limit
    		 6.2
    Notes
    [7] - The prespecified similarity margin was 0.8 to 1.25.

    Secondary: PASI 100 Response at Week 64

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    End point title
    		 PASI 100 Response at Week 64
    End point description
    The PASI is a measure of the average redness, thickness, and scaliness, each graded on a 0 to 4 scale, weighted by area of involvement. PASI combines assessment of the severity and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). PASI response was defined as a participant meeting/surpassing a pre-specified threshold for percent improvement in PASI score compared to baseline. A participant with ≥ 100% improvement was a PASI 100 responder. Missing PASI 100 responses at week 64 were imputed by NRI. Baseline was the last non-missing assessment taken prior to the first dose of IP. The per-protocol efficacy analysis set included all participants who were randomized and received all 3 doses of assigned IP between week 28 and week 52 and who did not experience an important protocol deviation during the study that could affect the evaluation of the efficacy endpoints. The participants analyzed include those imputed by NRI and those with observed data.
    End point type
    Secondary
    End point timeframe
    Baseline (day 1) and week 64
    End point values
    		 Post-randomization Switching: Ustekinumab RP and ABP 654 Post-randomization Continued-use: Ustekinumab RP
    Number of subjects analysed
    216
    215
    Units: Percentage of responders
        number (confidence interval 95%)
    36.1 (29.7 to 42.5)
    35.8 (29.4 to 42.2)
    Statistical analysis title
    		 Difference in PASI 100 Response at Week 64
    Statistical analysis description
    Switching group - Continued-use group. Response difference was estimated by the Mantel-Haenszel estimate, and the 90% CIs were estimated by the stratified Newcombe confidence limits, adjusting for the prior biologic use of psoriasis, baseline body weight group, geographic region. Missing post-baseline binary response data were imputed by NRI.
    Comparison groups
    Post-randomization Switching: Ustekinumab RP and ABP 654 v Post-randomization Continued-use: Ustekinumab RP
    Number of subjects included in analysis
    431
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [8]
    Method
    Parameter type
    		 Response difference
    Point estimate
    0.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -7.4
         upper limit
    		 7.8
    Notes
    [8] - The prespecified similarity margin was 0.8 to 1.25.

    Secondary: Number of Participants with Treatment-emergent Adverse Events (TEAEs): Post-randomization Period

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    End point title
    		 Number of Participants with Treatment-emergent Adverse Events (TEAEs): Post-randomization Period
    End point description
    TEAEs during the post-randomization period were defined as AEs that started on or after the first dose of investigational product post-randomization and prior to the end of study. The number of participants who experienced any TEAE, and who experienced a serious TEAE are presented. A serious TEAE was defined as any untoward medical occurrence that meets at least 1 of the following serious criteria: resulted in death (fatal), was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly/birth defect, or other medically important serious event. Participants in the safety analysis set who completed all planned doses of investigational product in the post-randomization period up to week 52. The safety analysis set included all randomized participant who received at least 1 dose of investigational product post randomization.
    End point type
    Secondary
    End point timeframe
    Week 28 to week 64
    End point values
    		 Switching: Ustekinumab RP and ABP 654 Continued-use: Ustekinumab RP Switching: ABP 654/Ustekinumab RP/Missing Continued-use: Ustekinumab RP/Ustekinumab RP/Missing Switching: ABP 654/Missing/Missing Continued-use: Ustekinumab RP/Missing/Missing
    Number of subjects analysed
    217
    216
    8
    5
    3
    3
    Units: participants
        Any TEAE
    97
    108
    4
    1
    3
    0
        Any serious TEAE
    3
    2
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants with Events of Interest (EOI): Post-randomization Period

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    End point title
    		 Number of Participants with Events of Interest (EOI): Post-randomization Period
    End point description
    The treatment-emergent EOIs prespecified for this study included serious systemic hypersensitivity reactions, facial palsy, pustular psoriasis, erythrodermic psoriasis, serious infections (including mycobacterial and salmonella infections), malignancy, cardiovascular events, reversible posterior leukoencephalopathy syndrome (RPLS), serious depression including suicidality, and venous thromboembolism. The safety analysis set included all randomized participant who received at least 1 dose of investigational product post randomization.
    End point type
    Secondary
    End point timeframe
    Week 28 to week 64
    End point values
    		 Switching: Ustekinumab RP and ABP 654 Continued-use: Ustekinumab RP
    Number of subjects analysed
    217
    216
    Units: participants
        Any EOI
    6
    7
        Cardiovascular events
    2
    3
        RPLS
    2
    0
        Serious infections
    1
    2
        Malignancy
    1
    1
        Serious depression
    0
    1
        Serious systemic hypersensitivity reactions
    0
    0
        Facial palsy
    0
    0
        Pustular psoriasis
    0
    0
        Erythrodermic psoriasis
    0
    0
        Venous thromboembolism
    0
    0
    Statistical analysis title
    		 Risk difference for any EOI
    Statistical analysis description
    Switching group - Continued-use group. Risk difference and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n < 25 for either treatment.
    Comparison groups
    Switching: Ustekinumab RP and ABP 654 v Continued-use: Ustekinumab RP
    Number of subjects included in analysis
    433
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [9]
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.17
         upper limit
    		 3.1
    Notes
    [9] - The prespecified similarity margin was 0.8 to 1.25.

    Secondary: Number of Participants with Antidrug Antibodies (ADAs): Post-randomization Period

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    End point title
    		 Number of Participants with Antidrug Antibodies (ADAs): Post-randomization Period
    End point description
    The number of participants developing binding or neutralizing ADAs during the post-randomization period is defined as the number of participants in the safety analysis set who had a positive result post-randomization and had never tested positive (i.e., negative or no results) prior to the first dose of post-randomization investigational product and who had at least one ADA result post-randomization. A transient antibody result was defined as a positive result during the post-randomization period with a negative result at the participant's last visit tested within the respective study period. Baseline was defined as the last non-missing assessment taken prior to the first dose of IP for the study. The safety analysis set included all randomized participants who received at least 1 dose of IP post randomization. PB=post-baseline; PR=post-randomization; bAb= binding antibody; nAb=neutralizing antibody; t= transient; +ve=positive; -ve=negative
    End point type
    Secondary
    End point timeframe
    Baseline (pre-dose day 1), week 4, week 16, week 28, week 40, week 52 and week 64
    End point values
    		 Switching: Ustekinumab RP and ABP 654 Continued-use: Ustekinumab RP Switching: ABP 654/Ustekinumab RP/Missing Continued-use: Ustekinumab RP/Ustekinumab RP/Missing Switching: ABP 654/Missing/Missing Continued-use: Ustekinumab RP/Missing/Missing
    Number of subjects analysed
    217
    216
    8
    5
    3
    3
    Units: participants
        Participants with PB result PR
    217
    216
    8
    5
    3
    1
        BAb -ve/no result prior first dose PR
    136
    134
    5
    4
    3
    1
        BAb +ve PR; -ve/no result prior to first dose PR
    7
    11
    0
    1
    1
    0
        T bAb +ve PR; -ve/no result prior first dose PR
    4
    5
    0
    0
    0
    0
        NAb -ve/no result prior to first dose PR
    190
    188
    6
    5
    3
    1
        Nab +ve PR; -ve/no results prior to first dose PR
    8
    6
    0
    1
    0
    0
        T nAb +ve PR; -ve/no result prior first dose PR
    6
    1
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality was collected from enrollment to the end of study visit, up to approximately 68 weeks. Adverse events were collected from Day 1 to end of study, up to 64 weeks.
    Adverse event reporting additional description
    All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Run-in: Ustekinumab RP
    Reporting group description
    		 Participants received ustekinumab RP 45 mg (baseline body weight ≤ 100 kg) or 90 mg (baseline body weight > 100 kg) on day 1 (week 0), week 4, and week 16.

    Reporting group title
    Switching: Ustekinumab RP and ABP 654
    Reporting group description
    		 Participants were randomized to the switching group at week 28 and completed all planned doses of ABP 654 and ustekinumab RP up to week 52, including ABP 654 at week 28, ustekinumab RP at week 40, and ABP 654 at week 52.

    Reporting group title
    Continued-use: Ustekinumab RP
    Reporting group description
    		 Participants were randomized to the continued-use group at week 28 and completed all planned doses of ustekinumab RP up to week 52, including 3 doses at weeks 28, 40, and 52.

    Reporting group title
    Continued-use: Ustekinumab RP/Missing/Missing
    Reporting group description
    		 Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 but did not receive the planned doses of ustekinumab RP at week 40 and week 52.

    Reporting group title
    Continued-use: Ustekinumab RP/Ustekinumab RP/Missing
    Reporting group description
    		 Participants were randomized to the continued-use group at week 28 and received ustekinumab RP at week 28 and week 40 but did not receive the planned dose of ustekinumab RP at week 52.

    Reporting group title
    Switching: ABP 654/Missing/Missing
    Reporting group description
    		 Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and did not receive the planned doses of ustekinumab RP at week 40 and ABP 654 at week 52.

    Reporting group title
    Switching: ABP 654/Ustekinumab RP/Missing
    Reporting group description
    		 Participants were randomized to the switching group at week 28 and received ABP 654 at week 28 and ustekinumab RP at week 40 but did not receive the planned dose of ABP 654 at week 52.

    Serious adverse events
    		 Run-in: Ustekinumab RP Switching: Ustekinumab RP and ABP 654 Continued-use: Ustekinumab RP Continued-use: Ustekinumab RP/Missing/Missing Continued-use: Ustekinumab RP/Ustekinumab RP/Missing Switching: ABP 654/Missing/Missing Switching: ABP 654/Ustekinumab RP/Missing
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 494 (2.83%)
    3 / 217 (1.38%)
    2 / 216 (0.93%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    2
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Papillary thyroid cancer
         subjects affected / exposed
    0 / 494 (0.00%)
    0 / 217 (0.00%)
    1 / 216 (0.46%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    0 / 494 (0.00%)
    1 / 217 (0.46%)
    0 / 216 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    2 / 494 (0.40%)
    0 / 217 (0.00%)
    0 / 216 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Nasal turbinate hypertrophy
         subjects affected / exposed
    1 / 494 (0.20%)
    0 / 217 (0.00%)
    0 / 216 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasal septum deviation
         subjects affected / exposed
    1 / 494 (0.20%)
    0 / 217 (0.00%)
    0 / 216 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasal obstruction
         subjects affected / exposed
    1 / 494 (0.20%)
    0 / 217 (0.00%)
    0 / 216 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Dermatillomania
         subjects affected / exposed
    0 / 494 (0.00%)
    0 / 217 (0.00%)
    1 / 216 (0.46%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fibula fracture
         subjects affected / exposed
    1 / 494 (0.20%)
    0 / 217 (0.00%)
    0 / 216 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 494 (0.20%)
    0 / 217 (0.00%)
    0 / 216 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 494 (0.20%)
    0 / 217 (0.00%)
    0 / 216 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 494 (0.20%)
    0 / 217 (0.00%)
    0 / 216 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 494 (0.00%)
    1 / 217 (0.46%)
    0 / 216 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial paralysis
         subjects affected / exposed
    1 / 494 (0.20%)
    0 / 217 (0.00%)
    0 / 216 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    1 / 494 (0.20%)
    0 / 217 (0.00%)
    0 / 216 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis acute
         subjects affected / exposed
    1 / 494 (0.20%)
    1 / 217 (0.46%)
    0 / 216 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 494 (0.20%)
    0 / 217 (0.00%)
    0 / 216 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 494 (0.20%)
    0 / 217 (0.00%)
    0 / 216 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 494 (0.00%)
    1 / 217 (0.46%)
    0 / 216 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Erythrodermic psoriasis
         subjects affected / exposed
    1 / 494 (0.20%)
    0 / 217 (0.00%)
    0 / 216 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pustular psoriasis
         subjects affected / exposed
    1 / 494 (0.20%)
    0 / 217 (0.00%)
    0 / 216 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 494 (0.20%)
    0 / 217 (0.00%)
    0 / 216 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical spinal stenosis
         subjects affected / exposed
    1 / 494 (0.20%)
    0 / 217 (0.00%)
    0 / 216 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Otitis media chronic
         subjects affected / exposed
    1 / 494 (0.20%)
    0 / 217 (0.00%)
    0 / 216 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    1 / 494 (0.20%)
    0 / 217 (0.00%)
    0 / 216 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Run-in: Ustekinumab RP Switching: Ustekinumab RP and ABP 654 Continued-use: Ustekinumab RP Continued-use: Ustekinumab RP/Missing/Missing Continued-use: Ustekinumab RP/Ustekinumab RP/Missing Switching: ABP 654/Missing/Missing Switching: ABP 654/Ustekinumab RP/Missing
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    116 / 494 (23.48%)
    55 / 217 (25.35%)
    58 / 216 (26.85%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    3 / 3 (100.00%)
    4 / 8 (50.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Brain neoplasm benign
         subjects affected / exposed
    0 / 494 (0.00%)
    0 / 217 (0.00%)
    0 / 216 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Abdominal wall wound
         subjects affected / exposed
    0 / 494 (0.00%)
    0 / 217 (0.00%)
    0 / 216 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    9 / 494 (1.82%)
    5 / 217 (2.30%)
    1 / 216 (0.46%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    12
    6
    1
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Scleroedema
         subjects affected / exposed
    0 / 494 (0.00%)
    0 / 217 (0.00%)
    0 / 216 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Psoriatic arthropathy
         subjects affected / exposed
    1 / 494 (0.20%)
    1 / 217 (0.46%)
    2 / 216 (0.93%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    0 / 8 (0.00%)
         occurrences all number
    1
    1
    2
    0
    1
    1
    0
    Infections and infestations
    Sinusitis
         subjects affected / exposed
    6 / 494 (1.21%)
    1 / 217 (0.46%)
    3 / 216 (1.39%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    7
    1
    3
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    27 / 494 (5.47%)
    12 / 217 (5.53%)
    16 / 216 (7.41%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    28
    16
    19
    0
    0
    0
    0
    COVID-19
         subjects affected / exposed
    65 / 494 (13.16%)
    27 / 217 (12.44%)
    25 / 216 (11.57%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    2 / 3 (66.67%)
    2 / 8 (25.00%)
         occurrences all number
    65
    27
    25
    0
    0
    2
    2
    Upper respiratory tract infection
         subjects affected / exposed
    18 / 494 (3.64%)
    14 / 217 (6.45%)
    14 / 216 (6.48%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    20
    15
    15
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 494 (0.20%)
    2 / 217 (0.92%)
    2 / 216 (0.93%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    2
    2
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Jun 2021
    - change of sample size from 352 to 480 enrolled participants - updated verbiage of bioequivalence and PK equivalence to similarity and PK similarity - updated similarity margin from (0.77, 1.3) to (0.8, 1.25) - changed method for handling missing values for the PASI endpoint from last observation carried forward method to multiple imputation method - included PK and ADA samples at week 4 - clarified tolerance windows for PK sample collection times - included human immunodeficiency virus serology at screening and electrocardiogram at baseline and weeks 16, 28, 40, and 52 - updated inclusion/exclusion criteria - included electrocardiogram data analysis descriptive summary for the number of abnormal electrocardiograms - clarified that the concomitant medication for the run-in treated set was for the Run-in Period

    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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