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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Efficacy and Safety of ABP 654 Compared with Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis

    Summary
    EudraCT number
    		 2020-003184-25
    Trial protocol
    		 DE   LT   EE   BG   HU   SK   LV  
    Global end of trial date
    03 Jun 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Apr 2023
    First version publication date
    14 Apr 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    20190232
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04607980
    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
    Study Director, Amgen Inc., +1 8665726436, medinfo@amgen.com
    Scientific contact
    Study Director, Amgen Inc., +1 8665726436, medinfo@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
    03 Jun 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jun 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to compare the efficacy of ABP 654 with ustekinumab in participants with moderate to severe plaque psoriasis (Ps).
    Protection of trial subjects
    This study was conducted in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) regulations/guidelines. Essential documents will be retained in accordance with ICH GCP.
    Background therapy
    		 -
    Evidence for comparator
    		 Ustekinumab belongs to the pharmacologic class of interleukin (IL)-23 and IL-12 antagonists. In the United States and the European Union, ustekinumab is approved for subcutaneous (SC) administration in the treatment of moderate to severe Ps in adults and pediatric patients (6 years or older).
    Actual start date of recruitment
    11 Nov 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
    Poland: 170
    Country: Number of subjects enrolled
    Germany: 26
    Country: Number of subjects enrolled
    Estonia: 22
    Country: Number of subjects enrolled
    Latvia: 20
    Country: Number of subjects enrolled
    Lithuania: 18
    Country: Number of subjects enrolled
    Hungary: 15
    Country: Number of subjects enrolled
    Canada: 158
    Country: Number of subjects enrolled
    United States: 134
    Worldwide total number of subjects
    563
    EEA total number of subjects
    271
    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)
    518
    From 65 to 84 years
    45
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 84 centers in Canada, Estonia, Germany, Hungary, Latvia, Lithuania, Poland, and the United States between 11 November 2020 and 03 June 2022.

    Pre-assignment
    Screening details
    		 Of the 648 participants screened, 563 participants were enrolled.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment Group A (ABP 654)
    Arm description
    		 Participants received SC injection of ABP 654, 45 mg (Baseline body weight [BW] less than or equal to [<=] 100 kg) or 90 mg (Baseline BW greater than [>] 100 kg) at Weeks 0, 4, and 16. From Week 28 participants received ABP 654 (same dose) every 12 weeks (Q12W) at Weeks 28 and 40 or depending on Psoriasis Area and Severity Index (PASI) score, received dose intensification every 8 weeks (Q8W) at Weeks 28, 36, and 44 (as per protocol).
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABP 654
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received SC injection of ABP 654.

    Arm title
    		 Treatment Group B (Ustekinumab)
    Arm description
    		 Participants received SC injection of ustekinumab, 45 mg (Baseline BW <= 100 kg) or 90 mg (Baseline BW > 100 kg) at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue receiving ustekinumab (Treatment group B1), or to receive ABP 654 (Treatment group B2) at Weeks 28 and 40. Depending on PASI score, some participants were not re-randomized and received dose intensification with ustekinumab Q8W at Weeks 28, 36, and 44 (as per protocol).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Stelara®
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received SC injection of ustekinumab.

    Investigational medicinal product name
    ABP 654
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received SC injection of ABP 654.

    Number of subjects in period 1
    		Treatment Group A (ABP 654) Treatment Group B (Ustekinumab)
    Started
    281
    282
    Treated
    280
    282
    Re-randomized at Week 28
    247 [1]
    233 [2]
    Completed at Week 28
    2 [3]
    3 [4]
    Completed
    269
    261
    Not completed
    12
    21
         Consent withdrawn by subject
    2
    5
         Death
    -
    1
         Adverse event
    3
    4
         Unspecified
    3
    -
         Lost to follow-up
    4
    8
         Protocol deviation
    -
    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: PASI 50 non-responders were not re-randomized and were considered completed at Week 28 as per protocol.
    [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: PASI 50 non-responders were not re-randomized and were considered completed at Week 28 as per protocol.
    [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: PASI 50 non-responders were not re-randomized and were considered completed at Week 28 as per protocol.
    [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: PASI 50 non-responders were not re-randomized and were considered completed at Week 28 as per protocol.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Group A (ABP 654)
    Reporting group description
    		 Participants received SC injection of ABP 654, 45 mg (Baseline body weight [BW] less than or equal to [<=] 100 kg) or 90 mg (Baseline BW greater than [>] 100 kg) at Weeks 0, 4, and 16. From Week 28 participants received ABP 654 (same dose) every 12 weeks (Q12W) at Weeks 28 and 40 or depending on Psoriasis Area and Severity Index (PASI) score, received dose intensification every 8 weeks (Q8W) at Weeks 28, 36, and 44 (as per protocol).

    Reporting group title
    Treatment Group B (Ustekinumab)
    Reporting group description
    		 Participants received SC injection of ustekinumab, 45 mg (Baseline BW <= 100 kg) or 90 mg (Baseline BW > 100 kg) at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue receiving ustekinumab (Treatment group B1), or to receive ABP 654 (Treatment group B2) at Weeks 28 and 40. Depending on PASI score, some participants were not re-randomized and received dose intensification with ustekinumab Q8W at Weeks 28, 36, and 44 (as per protocol).

    Reporting group values
    		 Treatment Group A (ABP 654) Treatment Group B (Ustekinumab) Total
    Number of subjects
    		 281 282 563
    Age Categorical
    Units: Participants
        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)
    		 257 261 518
        From 65-84 years
    		 24 21 45
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 43.7 ( 14.15 ) 45.0 ( 12.58 ) -
    Gender Categorical
    Units: Participants
        Female
    		 104 91 195
        Male
    		 177 191 368
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 1 2 3
        Asian
    		 20 25 45
        Black or African American
    		 4 2 6
        Native Hawaiian or other Pacific Islander
    		 0 1 1
        White
    		 250 247 497
        Multiple
    		 1 0 1
        Not allowed to collect
    		 1 0 1
        Other
    		 4 5 9
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 32 28 60
        Not Hispanic or Latino
    		 248 252 500
        Not allowed to collect
    		 1 0 1
        Unknown
    		 0 2 2
    Static Physician Global Assessment of Psoriasis (sPGA)
    The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response was defined as a sPGA value of clear (score 0) or almost clear (score 1). Higher scores represent worse symptom severity.
    Units: Subjects
        Score 0 (clear)
    		 0 0 0
        Score 1 (almost clear)
    		 0 0 0
        Score 2 (mild)
    		 0 0 0
        Score 3 (moderate)
    		 130 154 284
        Score 4 (severe)
    		 132 114 246
        Score 5 (very severe)
    		 19 14 33
    PASI
    The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling; each graded on a 0-4 scale [0 = clear; 1-4 = increasing severity]) of the lesions, weighted by the area of involvement in the four main body areas (i.e., head, arms, trunk to groin, and legs to top of buttocks). The PASI score ranges from 0 to 72. Higher scores represent worse symptom severity.
    Units: Score on a scale
        arithmetic mean (standard deviation)
    		 21.50 ( 8.855 ) 20.35 ( 7.850 ) -
    Psoriasis Body Surface Area (BSA)
    The percentage of BSA affected was estimated by assuming that the participant's palm, excluding the fingers and thumb, represents roughly 1% of the body's surface.
    Units: Percentage of BSA
        arithmetic mean (standard deviation)
    		 26.5 ( 15.25 ) 24.9 ( 15.05 ) -

    End points

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    End points reporting groups
    Reporting group title
    Treatment Group A (ABP 654)
    Reporting group description
    		 Participants received SC injection of ABP 654, 45 mg (Baseline body weight [BW] less than or equal to [<=] 100 kg) or 90 mg (Baseline BW greater than [>] 100 kg) at Weeks 0, 4, and 16. From Week 28 participants received ABP 654 (same dose) every 12 weeks (Q12W) at Weeks 28 and 40 or depending on Psoriasis Area and Severity Index (PASI) score, received dose intensification every 8 weeks (Q8W) at Weeks 28, 36, and 44 (as per protocol).

    Reporting group title
    Treatment Group B (Ustekinumab)
    Reporting group description
    		 Participants received SC injection of ustekinumab, 45 mg (Baseline BW <= 100 kg) or 90 mg (Baseline BW > 100 kg) at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue receiving ustekinumab (Treatment group B1), or to receive ABP 654 (Treatment group B2) at Weeks 28 and 40. Depending on PASI score, some participants were not re-randomized and received dose intensification with ustekinumab Q8W at Weeks 28, 36, and 44 (as per protocol).

    Subject analysis set title
    Through Week 28: ABP 654
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All participants who were randomized to receive SC injection of ABP 654, 45 mg (Baseline BW <= 100 kg) or 90 mg (Baseline BW > 100 kg) at Weeks 0, 4, and 16.

    Subject analysis set title
    Through Week 28: Ustekinumab
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All participants who were randomized to receive SC injection of ustekinumab, 45 mg (Baseline BW <= 100 kg) or 90 mg (Baseline BW > 100 kg) at Weeks 0, 4, and 16.

    Subject analysis set title
    Post Week 28: ABP 654/ ABP 654
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16, followed by ABP 654 (same dose) Q12W at Weeks 28 and 40.

    Subject analysis set title
    Post Week 28: Ustekinumab/ ABP 654
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to receive ABP 654 (Treatment group B2) at Weeks 28 and 40.

    Subject analysis set title
    Post Week 28: Ustekinumab/ Ustekinumab
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue on ustekinumab (Treatment group B1) at Weeks 28 and 40.

    Subject analysis set title
    Post Week 28: ABP 654 Dose Intensification
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ABP 654 dose intensification every 8 weeks (Q8W) at Weeks 28, 36, and 44.

    Subject analysis set title
    Post Week 28: Ustekinumab Dose Intensification
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ustekinumab dose intensification Q8W at Weeks 28, 36, and 44.

    Primary: PASI Percent Change From Baseline to Week 12

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    End point title
    		 PASI Percent Change From Baseline to Week 12
    End point description
    The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling; each graded on a 0-4 scale [0 = clear; 1-4 = increasing severity]) of the lesions, weighted by the area of involvement in the four main body areas (i.e., head, arms, trunk to groin, and legs to top of buttocks). The PASI score ranges from 0 to 72. Higher scores represent worse symptom severity. Results are presented for the Full Analysis Set (FAS) with available data; observed data was used for summary statistics.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1 [Week 0]) and Week 12
    End point values
    		 Treatment Group A (ABP 654) Treatment Group B (Ustekinumab)
    Number of subjects analysed
    272
    276
    Units: Percent Change in PASI score
        arithmetic mean (standard deviation)
    81.92 ( 19.872 )
    81.91 ( 19.611 )
    Statistical analysis title
    		 Treatment Group A versus Treatment Group B
    Statistical analysis description
    Clinical equivalence of the primary endpoint was evaluated by comparing the 2-sided 95% confidence interval (CI) of the mean difference of PASI percent improvement from Baseline to Week 12 between ABP 654 versus (vs) ustekinumab with an equivalence margin of (-15, +15). Multiple imputation was applied for the point estimate and CI of the mean difference between the 2 groups.
    Comparison groups
    Treatment Group A (ABP 654) v Treatment Group B (Ustekinumab)
    Number of subjects included in analysis
    548
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.16
         upper limit
    		 3.43

    Secondary: PASI Percent Change at Other Timepoints

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    End point title
    		 PASI Percent Change at Other Timepoints
    End point description
    The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling; each graded on a 0-4 scale [0 = clear; 1-4 = increasing severity]) of the lesions, weighted by the area of involvement in the four main body areas (i.e., head, arms, trunk to groin, and legs to top of buttocks). The PASI score ranges from 0 to 72. Higher scores represent worse symptom severity. 999999 = analysis was not pre-specified for this timepoint; N=0. Through Week 28 results are presented for the FAS with available data; last observation carried forward (LOCF) imputation was used. Post Week 28 results are presented for dose intensification participants with available observed data and re-randomized FAS participants with available data (LOCF imputation was used).
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1 [Week 0]), Weeks 4, 16, 28, 36, 40 (re-randomized FAS only), 44 and Week 52 (End of Study [EOS])
    End point values
    		 Treatment Group A (ABP 654) Treatment Group B (Ustekinumab) Post Week 28: ABP 654/ ABP 654 Post Week 28: Ustekinumab/ ABP 654 Post Week 28: Ustekinumab/ Ustekinumab
    Number of subjects analysed
    280
    281
    247
    117
    116
    Units: Percent Change in PASI score
    arithmetic mean (standard deviation)
        Week 4 (N = 280; 281; 0; 0; 0)
    44.15 ( 23.587 )
    42.40 ( 24.536 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Week 16 (N = 280; 281; 0; 0; 0)
    85.88 ( 18.704 )
    85.86 ( 19.953 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Week 28 (N = 280; 281; 0; 0; 0)
    89.41 ( 14.228 )
    88.18 ( 18.771 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Week 36 (N = 25; 34; 0; 0; 0)
    75.53 ( 11.038 )
    74.12 ( 13.826 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Week 40 (N = 0; 0; 247; 117; 116)
    999999 ( 999999 )
    999999 ( 999999 )
    93.60 ( 9.738 )
    94.22 ( 8.296 )
    95.10 ( 8.529 )
        Week 44 (N = 25; 34; 0; 0; 0)
    75.33 ( 15.563 )
    78.42 ( 14.733 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Week 52 (N = 25; 34; 247; 117; 116)
    77.80 ( 14.760 )
    77.46 ( 18.109 )
    92.54 ( 11.808 )
    93.90 ( 8.987 )
    93.23 ( 16.029 )
    Statistical analysis title
    		 Week 4: Treatment Group A vs Treatment Group B
    Statistical analysis description
    The mean differences and 95% CIs of PASI percent improvement between the initial randomized groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using analysis of covariance (ANCOVA) model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. LOCF imputation was used.
    Comparison groups
    Treatment Group A (ABP 654) v Treatment Group B (Ustekinumab)
    Number of subjects included in analysis
    561
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.05
         upper limit
    		 5.94
    Statistical analysis title
    		 Week 28: Treatment Group A vs Treatment Group B
    Statistical analysis description
    The mean differences and 95% CIs of PASI percent improvement between the initial randomized groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. LOCF imputation was used.
    Comparison groups
    Treatment Group A (ABP 654) v Treatment Group B (Ustekinumab)
    Number of subjects included in analysis
    561
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.39
         upper limit
    		 4.07
    Statistical analysis title
    		 Week 36: Treatment Group A vs Treatment Group B
    Statistical analysis description
    The mean differences and 95% CIs of PASI percent improvement between the dose intensification groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. Observed data was used.
    Comparison groups
    Treatment Group A (ABP 654) v Treatment Group B (Ustekinumab)
    Number of subjects included in analysis
    561
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.46
         upper limit
    		 7.98
    Statistical analysis title
    		 Week 52: ABP 654/Ustekinumab vs Ustekinumab
    Statistical analysis description
    The differences for the mean percent change from baseline and the corresponding CIs were for ABP 654/ustekinumab minus ustekinumab/ustekinumab. Estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. LOCF imputation was used.
    Comparison groups
    Post Week 28: Ustekinumab/ ABP 654 v Post Week 28: Ustekinumab/ Ustekinumab
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.46
         upper limit
    		 3.86
    Statistical analysis title
    		 Week 52: Treatment Group A vs Treatment Group B
    Statistical analysis description
    The mean differences and 95% CIs of PASI percent improvement between the dose intensification groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. Observed data was used.
    Comparison groups
    Treatment Group A (ABP 654) v Treatment Group B (Ustekinumab)
    Number of subjects included in analysis
    561
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.45
         upper limit
    		 7.13
    Statistical analysis title
    		 Week 40: ABP 654 vs Ustekinumab
    Statistical analysis description
    The differences for the mean percent change from baseline and the corresponding CIs were for ABP 654/ABP 654 minus ustekinumab/ustekinumab. Estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. LOCF imputation was used.
    Comparison groups
    Post Week 28: ABP 654/ ABP 654 v Post Week 28: Ustekinumab/ Ustekinumab
    Number of subjects included in analysis
    363
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.42
         upper limit
    		 0.59
    Statistical analysis title
    		 Week 40: ABP 654/Ustekinumab vs Ustekinumab
    Statistical analysis description
    The differences for the mean percent change from baseline and the corresponding CIs were for ABP 654/ustekinumab minus ustekinumab/ustekinumab. Estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. LOCF imputation was used.
    Comparison groups
    Post Week 28: Ustekinumab/ ABP 654 v Post Week 28: Ustekinumab/ Ustekinumab
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.17
         upper limit
    		 1.48
    Statistical analysis title
    		 Week 52: ABP 654 vs Ustekinumab
    Statistical analysis description
    The differences for the mean percent change from baseline and the corresponding CIs were for ABP 654/ABP 654 minus ustekinumab/ustekinumab. Estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. LOCF imputation was used.
    Comparison groups
    Post Week 28: ABP 654/ ABP 654 v Post Week 28: Ustekinumab/ Ustekinumab
    Number of subjects included in analysis
    363
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.29
         upper limit
    		 2.17
    Statistical analysis title
    		 Week 16: Treatment Group A vs Treatment Group B
    Statistical analysis description
    The mean differences and 95% CIs of PASI percent improvement between the initial randomized groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. LOCF imputation was used.
    Comparison groups
    Treatment Group A (ABP 654) v Treatment Group B (Ustekinumab)
    Number of subjects included in analysis
    561
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.97
         upper limit
    		 3.31
    Statistical analysis title
    		 Week 44: Treatment Group A vs Treatment Group B
    Statistical analysis description
    The mean differences and 95% CIs of PASI percent improvement between the dose intensification groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. Observed data was used.
    Comparison groups
    Treatment Group A (ABP 654) v Treatment Group B (Ustekinumab)
    Number of subjects included in analysis
    561
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.71
         upper limit
    		 3.28

    Secondary: Percentage of Participants with PASI 75 Response Throughout the Study

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    End point title
    		 Percentage of Participants with PASI 75 Response Throughout the Study
    End point description
    Reduction in disease was measured by PASI score. The PASI 75 response is a 75% or greater improvement (reduction in disease [PASI 75]) from baseline in PASI score. The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling; each graded on a 0-4 scale [0 = clear; 1-4 = increasing severity]) of the lesions, weighted by the area of involvement in the four main body areas (i.e., head, arms, trunk to groin, and legs to top of buttocks). The PASI score ranges from 0 to 72. Higher scores represent worse symptom severity. 999999 = analysis was not pre-specified for this timepoint; N=0. Through Week 28 FAS results are presented for the FAS with available data; non-responder imputation (NRI) was used. Post Week 28 results are presented for dose intensification participants with available observed data and re-randomized FAS participants with available data (NRI was used).
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1 [Week 0]), Weeks 4, 16, 28, 36, 40 (re-randomized FAS only), 44 and Week 52 (End of Study [EOS])
    End point values
    		 Treatment Group A (ABP 654) Treatment Group B (Ustekinumab) Post Week 28: ABP 654/ ABP 654 Post Week 28: Ustekinumab/ ABP 654 Post Week 28: Ustekinumab/ Ustekinumab
    Number of subjects analysed
    281
    282
    247
    117
    116
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4 (N = 281; 282; 0; 0; 0)
    11.4 (7.67 to 15.10)
    10.3 (6.74 to 13.83)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
        Week 12 (N = 281; 282; 0; 0; 0)
    69.8 (64.38 to 75.12)
    70.2 (64.88 to 75.55)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
        Week 16 (N = 281; 282; 0; 0; 0)
    80.8 (76.18 to 85.39)
    80.1 (75.49 to 84.80)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
        Week 28 (N = 281; 282; 0; 0; 0)
    85.8 (81.68 to 89.85)
    82.3 (77.81 to 86.73)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
        Week 36 (N = 25; 34; 0; 0; 0)
    52.0 (32.42 to 71.58)
    55.9 (39.19 to 72.57)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
        Week 40 (N = 0; 0; 247; 117; 116)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
    94.7 (91.95 to 97.52)
    95.7 (92.06 to 99.39)
    94.0 (89.63 to 98.30)
        Week 44 (N = 25; 34; 0; 0; 0)
    48.0 (28.42 to 67.58)
    64.7 (48.64 to 80.77)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
        Week 52 (N = 25; 34; 247; 117; 116)
    64.0 (45.18 to 82.82)
    58.8 (42.28 to 75.37)
    89.5 (85.65 to 93.30)
    92.3 (87.48 to 97.14)
    92.2 (87.37 to 97.11)
    Statistical analysis title
    		 Week 4: Treatment Group A vs Treatment Group B
    Statistical analysis description
    Response difference (ABP 654 – ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. NRI was used.
    Comparison groups
    Treatment Group A (ABP 654) v Treatment Group B (Ustekinumab)
    Number of subjects included in analysis
    563
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Response difference
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.02
         upper limit
    		 6.42
    Statistical analysis title
    		 Week 12: Treatment Group A vs Treatment Group B
    Statistical analysis description
    Response difference (ABP 654 – ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. NRI was used.
    Comparison groups
    Treatment Group A (ABP 654) v Treatment Group B (Ustekinumab)
    Number of subjects included in analysis
    563
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Response difference
    Point estimate
    -0.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.87
         upper limit
    		 7.23
    Statistical analysis title
    		 Week 16: Treatment Group A vs Treatment Group B
    Statistical analysis description
    Response difference (ABP 654 – ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. NRI was used.
    Comparison groups
    Treatment Group A (ABP 654) v Treatment Group B (Ustekinumab)
    Number of subjects included in analysis
    563
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Response difference
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.75
         upper limit
    		 7.37
    Statistical analysis title
    		 Week 28: Treatment Group A vs Treatment Group B
    Statistical analysis description
    Response difference (ABP 654 – ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. NRI was used.
    Comparison groups
    Treatment Group A (ABP 654) v Treatment Group B (Ustekinumab)
    Number of subjects included in analysis
    563
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Response difference
    Point estimate
    3.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.37
         upper limit
    		 9.84
    Statistical analysis title
    		 Week 36: Treatment Group A vs Treatment Group B
    Statistical analysis description
    Response difference in dose intensification participants (ABP 654 – ustekinumab) was estimated by the generalized linear model adjusted for the baseline PASI and the stratification factors with an identity link was used to obtain the point estimate and 95% CI for the risk difference of PASI 75 response rate at each scheduled timepoint. Observed data was used.
    Comparison groups
    Treatment Group A (ABP 654) v Treatment Group B (Ustekinumab)
    Number of subjects included in analysis
    563
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Response difference
    Point estimate
    -3.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.15
         upper limit
    		 21.76
    Statistical analysis title
    		 Week 44: Treatment Group A vs Treatment Group B
    Statistical analysis description
    Response difference in dose intensification participants (ABP 654 – ustekinumab) was estimated by the generalized linear model adjusted for the baseline PASI and the stratification factors with an identity link was used to obtain the point estimate and 95% CI for the risk difference of PASI 75 response rate at each scheduled timepoint. Observed data was used.
    Comparison groups
    Treatment Group A (ABP 654) v Treatment Group B (Ustekinumab)
    Number of subjects included in analysis
    563
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    Method
    Parameter type
    		 Response difference
    Point estimate
    9999
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9999
         upper limit
    		 9999
    Notes
    [1] - If there were less than 25 participants in any of the treatment groups at any visit or any other reason leading to model non-convergence after model check, no statistical modelling could be performed and the results were displayed as 9999.
    Statistical analysis title
    		 Week 40: ABP 654 vs Ustekinumab
    Statistical analysis description
    Response difference (ABP 654/ABP 654 – ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. NRI was used.
    Comparison groups
    Post Week 28: ABP 654/ ABP 654 v Post Week 28: Ustekinumab/ Ustekinumab
    Number of subjects included in analysis
    363
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Response difference
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.74
         upper limit
    		 7.54
    Statistical analysis title
    		 Week 52: Treatment Group A vs Treatment Group B
    Statistical analysis description
    Response difference in dose intensification participants (ABP 654 – ustekinumab) was estimated by the generalized linear model adjusted for the baseline PASI and the stratification factors with an identity link was used to obtain the point estimate and 95% CI for the risk difference of PASI 75 response rate at each scheduled timepoint. Observed data was used.
    Comparison groups
    Treatment Group A (ABP 654) v Treatment Group B (Ustekinumab)
    Number of subjects included in analysis
    563
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [2]
    Method
    Parameter type
    		 Response difference
    Point estimate
    9999
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9999
         upper limit
    		 9999
    Notes
    [2] - If there were less than 25 participants in any of the treatment groups at any visit or any other reason leading to model non-convergence after model check, no statistical modelling could be performed and the results were displayed as 9999.
    Statistical analysis title
    		 Week 52: ABP 654 vs Ustekinumab
    Statistical analysis description
    Response difference (ABP 654/ABP 654 – ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. NRI was used.
    Comparison groups
    Post Week 28: ABP 654/ ABP 654 v Post Week 28: Ustekinumab/ Ustekinumab
    Number of subjects included in analysis
    363
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Response difference
    Point estimate
    -2.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.61
         upper limit
    		 4.41
    Statistical analysis title
    		 Week 40: ABP 654/Ustekinumab vs Ustekinumab
    Statistical analysis description
    Response difference (ABP 654/ustekinumab – ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. NRI was used.
    Comparison groups
    Post Week 28: Ustekinumab/ ABP 654 v Post Week 28: Ustekinumab/ Ustekinumab
    Number of subjects included in analysis
    233
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Response difference
    Point estimate
    1.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.89
         upper limit
    		 8.39
    Statistical analysis title
    		 Week 52: ABP 654/Ustekinumab vs Ustekinumab
    Statistical analysis description
    Response difference (ABP 654/ustekinumab – ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. NRI was used.
    Comparison groups
    Post Week 28: Ustekinumab/ ABP 654 v Post Week 28: Ustekinumab/ Ustekinumab
    Number of subjects included in analysis
    233
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Response difference
    Point estimate
    0.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.32
         upper limit
    		 7.43

    Secondary: Percentage of Participants with PASI 100 Response Throughout the Study

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    End point title
    		 Percentage of Participants with PASI 100 Response Throughout the Study
    End point description
    Reduction in disease was measured by PASI score. The PASI 100 response is a 100% improvement (reduction in disease [PASI 100]) from baseline in PASI score. The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling; each graded on a 0-4 scale [0 = clear; 1-4 = increasing severity]) of the lesions, weighted by the area of involvement in the four main body areas (i.e., head, arms, trunk to groin, and legs to top of buttocks). The PASI score ranges from 0 to 72. Higher scores represent worse symptom severity. -99999 and 99999 = results are not estimable as there were not enough PASI responses. 999999 = analysis was not pre-specified for this timepoint; N=0. Through Week 28 FAS results are presented for the FAS with available data; NRI was used. Post Week 28 results are presented for dose intensification participants with available observed data and re-randomized FAS participants with available data (NRI was used).
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1 [Week 0]), Weeks 4, 12, 16, 28, 36, 40 (re-randomized FAS only), 44 and Week 52 (EOS)
    End point values
    		 Treatment Group A (ABP 654) Treatment Group B (Ustekinumab) Post Week 28: ABP 654/ ABP 654 Post Week 28: Ustekinumab/ ABP 654 Post Week 28: Ustekinumab/ Ustekinumab
    Number of subjects analysed
    281
    282
    247
    117
    116
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4 (N = 281; 282; 0; 0; 0)
    0.4 (0.00 to 1.05)
    0.7 (0.00 to 1.69)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
        Week 12 (N = 281; 282; 0; 0; 0)
    20.6 (15.91 to 25.37)
    19.1 (14.56 to 23.74)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
        Week 16 (N = 281; 282; 0; 0; 0)
    29.9 (24.54 to 35.25)
    26.2 (21.11 to 31.38)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
        Week 28 (N = 281; 282; 0; 0; 0)
    34.5 (28.96 to 40.08)
    31.6 (26.14 to 36.98)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
        Week 36 (N = 25; 34; 0; 0; 0)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
        Week 40 (N = 0; 0; 247; 117; 116)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
    44.5 (38.34 to 50.73)
    41.9 (32.94 to 50.82)
    46.6 (37.47 to 55.63)
        Week 44 (N = 25; 34; 0; 0; 0)
    4.0 (0.00 to 11.68)
    2.9 (0.00 to 8.62)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
        Week 52 (N = 25; 34; 247; 117; 116)
    4.0 (0.00 to 11.68)
    14.7 (2.80 to 26.61)
    47.0 (40.74 to 53.19)
    42.7 (33.77 to 51.70)
    44.8 (35.78 to 53.88)
    Statistical analysis title
    		 Week 36: Treatment Group A vs Treatment Group B
    Statistical analysis description
    Response difference in dose intensification participants (ABP 654 – ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. Observed data was used.
    Comparison groups
    Treatment Group A (ABP 654) v Treatment Group B (Ustekinumab)
    Number of subjects included in analysis
    563
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence [3]
    Method
    Parameter type
    		 Response difference
    Point estimate
    99999
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 99999
         upper limit
    		 99999
    Notes
    [3] - 99999 = results are not estimable as there were not enough PASI responses.
    Statistical analysis title
    		 Week 28: Treatment Group A vs Treatment Group B
    Statistical analysis description
    Response difference (ABP 654 – ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. NRI was used.
    Comparison groups
    Treatment Group A (ABP 654) v Treatment Group B (Ustekinumab)
    Number of subjects included in analysis
    563
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Response difference
    Point estimate
    3.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.68
         upper limit
    		 10.78
    Statistical analysis title
    		 Week 16: Treatment Group A vs Treatment Group B
    Statistical analysis description
    Response difference (ABP 654 – ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. NRI was used.
    Comparison groups
    Treatment Group A (ABP 654) v Treatment Group B (Ustekinumab)
    Number of subjects included in analysis
    563
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Response difference
    Point estimate
    3.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.62
         upper limit
    		 11.17
    Statistical analysis title
    		 Week 12: Treatment Group A vs Treatment Group B
    Statistical analysis description
    Response difference (ABP 654 – ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. NRI was used.
    Comparison groups
    Treatment Group A (ABP 654) v Treatment Group B (Ustekinumab)
    Number of subjects included in analysis
    563
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Response difference
    Point estimate
    1.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.03
         upper limit
    		 8.18
    Statistical analysis title
    		 Week 4: Treatment Group A vs Treatment Group B
    Statistical analysis description
    Response difference (ABP 654 – ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. NRI was used.
    Comparison groups
    Treatment Group A (ABP 654) v Treatment Group B (Ustekinumab)
    Number of subjects included in analysis
    563
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Response difference
    Point estimate
    -0.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.16
         upper limit
    		 3.21
    Statistical analysis title
    		 Week 52: ABP 654 vs Ustekinumab
    Statistical analysis description
    Response difference (ABP 654/ABP 654 – ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. NRI was used.
    Comparison groups
    Post Week 28: ABP 654/ ABP 654 v Post Week 28: Ustekinumab/ Ustekinumab
    Number of subjects included in analysis
    363
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Response difference
    Point estimate
    2.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.42
         upper limit
    		 13.3
    Statistical analysis title
    		 Week 40: ABP 654/Ustekinumab vs Ustekinumab
    Statistical analysis description
    Response difference (ABP 654/ustekinumab - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. NRI was used.
    Comparison groups
    Post Week 28: Ustekinumab/ ABP 654 v Post Week 28: Ustekinumab/ Ustekinumab
    Number of subjects included in analysis
    233
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Response difference
    Point estimate
    -4.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.39
         upper limit
    		 7.73
    Statistical analysis title
    		 Week 40: ABP 654 vs Ustekinumab
    Statistical analysis description
    Response difference (ABP 654/ABP 654 – ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. NRI was used.
    Comparison groups
    Post Week 28: ABP 654/ ABP 654 v Post Week 28: Ustekinumab/ Ustekinumab
    Number of subjects included in analysis
    363
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Response difference
    Point estimate
    -1.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.85
         upper limit
    		 8.89
    Statistical analysis title
    		 Week 52: Treatment Group A vs Treatment Group B
    Statistical analysis description
    Response difference in dose intensification participants (ABP 654 – ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. Observed data was used.
    Comparison groups
    Treatment Group A (ABP 654) v Treatment Group B (Ustekinumab)
    Number of subjects included in analysis
    563
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence [4]
    Method
    Parameter type
    		 Response difference
    Point estimate
    99999
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 99999
         upper limit
    		 99999
    Notes
    [4] - 99999 = results are not estimable as there were not enough PASI responses.
    Statistical analysis title
    		 Week 52: ABP 654/Ustekinumab vs Ustekinumab
    Statistical analysis description
    Response difference (ABP 654/ustekinumab – ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. NRI was used.
    Comparison groups
    Post Week 28: Ustekinumab/ ABP 654 v Post Week 28: Ustekinumab/ Ustekinumab
    Number of subjects included in analysis
    233
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Response difference
    Point estimate
    -2.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.91
         upper limit
    		 10.19
    Statistical analysis title
    		 Week 44: Treatment Group A vs Treatment Group B
    Statistical analysis description
    Response difference in dose intensification participants (ABP 654 – ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. Observed data was used.
    Comparison groups
    Treatment Group A (ABP 654) v Treatment Group B (Ustekinumab)
    Number of subjects included in analysis
    563
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence [5]
    Method
    Parameter type
    		 Response difference
    Point estimate
    99999
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 99999
         upper limit
    		 99999
    Notes
    [5] - 99999 = results are not estimable as there were not enough PASI responses.

    Secondary: Percentage of Participants With sPGA Responses (0/1) at Week 12 and Week 52

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    End point title
    		 Percentage of Participants With sPGA Responses (0/1) at Week 12 and Week 52
    End point description
    The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response was defined as a sPGA value of clear (score 0) or almost clear (score 1). Higher scores represent worse symptom severity. 999999 = analysis was not pre-specified for this timepoint; N=0. Week 12 results are presented for the FAS with available data; NRI was used. Week 52 results are presented for dose intensification participants with available data and re-randomized FAS participants with available data (NRI was used).
    End point type
    Secondary
    End point timeframe
    Week 12 and Week 52 (EOS)
    End point values
    		 Treatment Group A (ABP 654) Treatment Group B (Ustekinumab) Post Week 28: ABP 654/ ABP 654 Post Week 28: Ustekinumab/ ABP 654 Post Week 28: Ustekinumab/ Ustekinumab
    Number of subjects analysed
    281
    282
    247
    117
    116
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 12 (N = 281; 282; 0; 0; 0)
    55.2 (49.35 to 60.98)
    52.8 (47.01 to 58.66)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
    999999 (999999 to 999999)
        Week 52 (N = 25; 34; 247; 117; 116)
    24.0 (7.26 to 40.74)
    35.3 (19.23 to 51.36)
    71.3 (65.61 to 76.90)
    70.9 (62.71 to 79.17)
    78.4 (70.97 to 85.93)
    Statistical analysis title
    		 Week 12: Treatment Group A vs Treatment Group B
    Statistical analysis description
    Response difference (ABP 654 – ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. NRI was used.
    Comparison groups
    Treatment Group A (ABP 654) v Treatment Group B (Ustekinumab)
    Number of subjects included in analysis
    563
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Response difference
    Point estimate
    2.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.65
         upper limit
    		 10.71
    Statistical analysis title
    		 Week 52: Treatment Group A vs Treatment Group B
    Statistical analysis description
    Generalized linear model adjusted for the baseline sPGA and the stratification factors with an identity link was used to obtain the point estimate and 95% CI for the risk difference of sPGA response rate at each scheduled timepoint in dose intensification participants. Observed data was used.
    Comparison groups
    Treatment Group A (ABP 654) v Treatment Group B (Ustekinumab)
    Number of subjects included in analysis
    563
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence [6]
    Method
    Parameter type
    		 Response difference
    Point estimate
    9999
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9999
         upper limit
    		 9999
    Notes
    [6] - If there were less than 25 participants in any of the treatment groups at any visit or any other reason leading to model non-convergence after model check, no statistical modelling could be performed and the results were displayed as 9999.
    Statistical analysis title
    		 Week 52: ABP 654 vs Ustekinumab
    Statistical analysis description
    Response difference (ABP 654/ABP 654 – ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. NRI was used.
    Comparison groups
    Post Week 28: ABP 654/ ABP 654 v Post Week 28: Ustekinumab/ Ustekinumab
    Number of subjects included in analysis
    363
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Response difference
    Point estimate
    -6.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.41
         upper limit
    		 3.29
    Statistical analysis title
    		 Week 52: ABP 654/Ustekinumab vs Ustekinumab
    Statistical analysis description
    Response difference (ABP 654/ustekinumab – ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. NRI was used.
    Comparison groups
    Post Week 28: Ustekinumab/ ABP 654 v Post Week 28: Ustekinumab/ Ustekinumab
    Number of subjects included in analysis
    233
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Response difference
    Point estimate
    -7.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.41
         upper limit
    		 3.74

    Secondary: Change From Baseline in Percentage of BSA Affected with Psoriasis at Week 12 and Week 52

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    End point title
    		 Change From Baseline in Percentage of BSA Affected with Psoriasis at Week 12 and Week 52
    End point description
    The percentage of BSA affected was estimated by assuming that the participant's palm, excluding the fingers and thumb, represents roughly 1% of the body's surface. 999999 = analysis was not pre-specified for this timepoint; N=0. Week 12 results are presented for the FAS with available data; LOCF imputation was used. Week 52 results are presented for dose intensification participants with available observed data and re-randomized FAS participants with available data (LOCF imputation was used).
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1 [Week 0]), Week 12 and Week 52 (EOS)
    End point values
    		 Treatment Group A (ABP 654) Treatment Group B (Ustekinumab) Post Week 28: ABP 654/ ABP 654 Post Week 28: Ustekinumab/ ABP 654 Post Week 28: Ustekinumab/ Ustekinumab
    Number of subjects analysed
    280
    281
    247
    117
    116
    Units: Percentage of BSA
    arithmetic mean (standard deviation)
        Week 12 (N = 280; 281; 0; 0; 0)
    -17.8 ( 14.32 )
    -17.2 ( 14.51 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Week 52 (N = 25; 34; 247; 117; 116)
    -20.6 ( 14.72 )
    -21.6 ( 16.89 )
    -24.7 ( 14.81 )
    -22.8 ( 13.86 )
    -22.5 ( 14.11 )
    Statistical analysis title
    		 Week 12: Treatment Group A vs Treatment Group B
    Statistical analysis description
    Mean difference estimated for treatment group A and treatment group B using ANCOVA model adjusted for baseline BSA value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. LOCF imputation was used.
    Comparison groups
    Treatment Group A (ABP 654) v Treatment Group B (Ustekinumab)
    Number of subjects included in analysis
    561
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.15
         upper limit
    		 2.1
    Statistical analysis title
    		 Week 52: ABP 654/Ustekinumab vs Ustekinumab
    Statistical analysis description
    Mean difference estimated for ABP 654/ ustekinumab and ustekinumab/ ustekinumab using ANCOVA model adjusted for baseline BSA value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. LOCF imputation was used.
    Comparison groups
    Post Week 28: Ustekinumab/ ABP 654 v Post Week 28: Ustekinumab/ Ustekinumab
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 1.1
    Statistical analysis title
    		 Week 52: ABP 654 vs Ustekinumab
    Statistical analysis description
    Mean difference estimated for ABP 654/ ABP 654 and ustekinumab/ ustekinumab using ANCOVA model adjusted for baseline BSA value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. LOCF imputation was used.
    Comparison groups
    Post Week 28: ABP 654/ ABP 654 v Post Week 28: Ustekinumab/ Ustekinumab
    Number of subjects included in analysis
    363
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.99
         upper limit
    		 0.74
    Statistical analysis title
    		 Week 52: Treatment Group A vs Treatment Group B
    Statistical analysis description
    Mean difference estimated in dose intensification participants (treatment group A and treatment group B) using ANCOVA model adjusted for baseline BSA value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region. Observed data was used.
    Comparison groups
    Treatment Group A (ABP 654) v Treatment Group B (Ustekinumab)
    Number of subjects included in analysis
    561
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 3.67

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

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    End point title
    		 Number of Participants With Treatment Emergent Adverse Events (TEAEs)
    End point description
    TEAEs were summarized by actual treatment received. For each category, participants were included only once, even if they experienced multiple events in that category. Through Week 28 results are presented for the Safety Analysis Set. Post Week 28 results are presented for the re-randomized Safety Analysis Set and the dose intensification participants.
    End point type
    Secondary
    End point timeframe
    Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS)
    End point values
    		 Through Week 28: ABP 654 Through Week 28: Ustekinumab Post Week 28: ABP 654/ ABP 654 Post Week 28: Ustekinumab/ ABP 654 Post Week 28: Ustekinumab/ Ustekinumab Post Week 28: ABP 654 Dose Intensification Post Week 28: Ustekinumab Dose Intensification
    Number of subjects analysed
    280
    282
    247
    117
    116
    25
    34
    Units: Participants
        Any TEAE
    106
    99
    85
    44
    40
    12
    9
        Any Serious TEAE
    7
    5
    1
    1
    3
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Events of Interests (EOIs)

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    End point title
    		 Number of Participants With Events of Interests (EOIs)
    End point description
    The EOIs pre-specified 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, serious depression including suicidality, and venous thromboembolism. Through Week 28 results are presented for the Safety Analysis Set. Post Week 28 results are presented for the re-randomized Safety Analysis Set.
    End point type
    Secondary
    End point timeframe
    Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS)
    End point values
    		 Through Week 28: ABP 654 Through Week 28: Ustekinumab Post Week 28: ABP 654/ ABP 654 Post Week 28: Ustekinumab/ ABP 654 Post Week 28: Ustekinumab/ Ustekinumab
    Number of subjects analysed
    280
    282
    247
    117
    116
    Units: Participants
    5
    7
    3
    0
    4
    No statistical analyses for this end point

    Secondary: Number of Participants Developing Anti-drug Antibodies (ADAs) to ABP 654

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    End point title
    		 Number of Participants Developing Anti-drug Antibodies (ADAs) to ABP 654
    End point description
    A participant was considered to have developed ADAs if they: - had a positive post-baseline binding or neutralizing antibody result with a negative or no result at Baseline or - had a positive post-baseline binding or neutralizing antibody result with a negative or no result prior to the first dose in the post Week 28 study period. Through Week 28 results are presented for the Safety Analysis Set with available ADA data. Post Week 28 results are presented for the re-randomized Safety Analysis Set with available ADA data.
    End point type
    Secondary
    End point timeframe
    Baseline; Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS)
    End point values
    		 Through Week 28: ABP 654 Through Week 28: Ustekinumab Post Week 28: ABP 654/ ABP 654 Post Week 28: Ustekinumab/ ABP 654 Post Week 28: Ustekinumab/ Ustekinumab Post Week 28: ABP 654 Dose Intensification Post Week 28: Ustekinumab Dose Intensification
    Number of subjects analysed
    279
    280
    246
    116
    115
    25
    34
    Units: Participants
        Binding antibody
    52
    104
    11
    4
    2
    0
    2
        Neutralizing antibody
    24
    50
    5
    1
    1
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS)
    Adverse event reporting additional description
    Through Week 28: Safety Analysis Set. Post Week 28: Re-randomized Safety Analysis Set.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Through Week 28: ABP 654
    Reporting group description
    		 All participants who were randomized to receive SC injection of ABP 654, 45 mg (Baseline BW <= 100 kg) or 90 mg (Baseline BW > 100 kg) at Weeks 0, 4, and 16

    Reporting group title
    Through Week 28: Ustekinumab
    Reporting group description
    		 All participants who were randomized to receive SC injection of ustekinumab, 45 mg (Baseline BW <= 100 kg) or 90 mg (Baseline BW > 100 kg) at Weeks 0, 4, and 16.

    Reporting group title
    Post Week 28: ABP 654 / ABP 654
    Reporting group description
    		 All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16, followed by ABP 654 (same dose) Q12W at Weeks 28 and 40.

    Reporting group title
    Post Week 28: Ustekinumab / ABP654
    Reporting group description
    		 All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to receive ABP 654 (Treatment group B2) at Weeks 28 and 40.

    Reporting group title
    Post Week 28: Ustekinumab / Ustekinumab
    Reporting group description
    		 All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16. At Week 28, participants were re-randomized to continue on ustekinumab (Treatment group B1) at Weeks 28 and 40.

    Reporting group title
    Post Week 28: ABP 654 Dose Intensification
    Reporting group description
    		 All participants who were randomized to receive SC injection of ABP 654 at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ABP 654 dose intensification Q8W at Weeks 28, 36, and 44.

    Reporting group title
    Post Week 28: Ustekinumab Dose Intensification
    Reporting group description
    		 All participants who were randomized to receive SC injection of ustekinumab at Weeks 0, 4, and 16 with PASI 50 response or better but less than PASI 75 response at Week 28 (as per protocol). Based on the Investigator's discretion, the participants received ustekinumab dose intensification Q8W at Weeks 28, 36, and 44.

    Serious adverse events
    		 Through Week 28: ABP 654 Through Week 28: Ustekinumab Post Week 28: ABP 654 / ABP 654 Post Week 28: Ustekinumab / ABP654 Post Week 28: Ustekinumab / Ustekinumab Post Week 28: ABP 654 Dose Intensification Post Week 28: Ustekinumab Dose Intensification
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 280 (2.50%)
    5 / 282 (1.77%)
    1 / 247 (0.40%)
    1 / 117 (0.85%)
    3 / 116 (2.59%)
    1 / 25 (4.00%)
    0 / 34 (0.00%)
         number of deaths (all causes)
    0
    1
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    1 / 280 (0.36%)
    0 / 282 (0.00%)
    0 / 247 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 25 (0.00%)
    0 / 34 (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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    0 / 280 (0.00%)
    1 / 282 (0.35%)
    0 / 247 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 25 (0.00%)
    0 / 34 (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
    Ovarian cancer
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 282 (0.00%)
    1 / 247 (0.40%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 25 (0.00%)
    0 / 34 (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
    Invasive lobular breast carcinoma
         subjects affected / exposed
    1 / 280 (0.36%)
    0 / 282 (0.00%)
    0 / 247 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 25 (0.00%)
    0 / 34 (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
    Clear cell renal cell carcinoma
         subjects affected / exposed
    0 / 280 (0.00%)
    1 / 282 (0.35%)
    0 / 247 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 25 (0.00%)
    0 / 34 (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
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    1 / 280 (0.36%)
    0 / 282 (0.00%)
    0 / 247 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 25 (0.00%)
    0 / 34 (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
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 280 (0.36%)
    0 / 282 (0.00%)
    0 / 247 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 25 (0.00%)
    0 / 34 (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
    Congenital, familial and genetic disorders
    Developmental hip dysplasia
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 282 (0.00%)
    0 / 247 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    1 / 25 (4.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 282 (0.00%)
    0 / 247 (0.00%)
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 25 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 280 (0.00%)
    1 / 282 (0.35%)
    0 / 247 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 25 (0.00%)
    0 / 34 (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
    Cardiac ventricular thrombosis
         subjects affected / exposed
    0 / 280 (0.00%)
    1 / 282 (0.35%)
    0 / 247 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 25 (0.00%)
    0 / 34 (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
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 280 (0.36%)
    0 / 282 (0.00%)
    0 / 247 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 25 (0.00%)
    0 / 34 (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
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 280 (0.36%)
    0 / 282 (0.00%)
    0 / 247 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 25 (0.00%)
    0 / 34 (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
    Bipolar I disorder
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 282 (0.00%)
    0 / 247 (0.00%)
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 25 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc disorder
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 282 (0.00%)
    0 / 247 (0.00%)
    1 / 117 (0.85%)
    0 / 116 (0.00%)
    0 / 25 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 280 (0.36%)
    0 / 282 (0.00%)
    0 / 247 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 25 (0.00%)
    0 / 34 (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
    COVID-19
         subjects affected / exposed
    0 / 280 (0.00%)
    1 / 282 (0.35%)
    0 / 247 (0.00%)
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 25 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 282 (0.00%)
    0 / 247 (0.00%)
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 25 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 282 (0.00%)
    0 / 247 (0.00%)
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 25 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected cyst
         subjects affected / exposed
    0 / 280 (0.00%)
    0 / 282 (0.00%)
    0 / 247 (0.00%)
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 25 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 280 (0.00%)
    1 / 282 (0.35%)
    0 / 247 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 25 (0.00%)
    0 / 34 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Through Week 28: ABP 654 Through Week 28: Ustekinumab Post Week 28: ABP 654 / ABP 654 Post Week 28: Ustekinumab / ABP654 Post Week 28: Ustekinumab / Ustekinumab Post Week 28: ABP 654 Dose Intensification Post Week 28: Ustekinumab Dose Intensification
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 280 (7.50%)
    15 / 282 (5.32%)
    36 / 247 (14.57%)
    22 / 117 (18.80%)
    17 / 116 (14.66%)
    9 / 25 (36.00%)
    2 / 34 (5.88%)
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    2 / 280 (0.71%)
    1 / 282 (0.35%)
    1 / 247 (0.40%)
    2 / 117 (1.71%)
    0 / 116 (0.00%)
    2 / 25 (8.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    1
    1
    2
    0
    2
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    6 / 280 (2.14%)
    4 / 282 (1.42%)
    23 / 247 (9.31%)
    15 / 117 (12.82%)
    10 / 116 (8.62%)
    5 / 25 (20.00%)
    1 / 34 (2.94%)
         occurrences all number
    6
    4
    23
    15
    10
    6
    1
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 280 (2.14%)
    7 / 282 (2.48%)
    6 / 247 (2.43%)
    6 / 117 (5.13%)
    3 / 116 (2.59%)
    0 / 25 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    6
    8
    6
    6
    3
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    7 / 280 (2.50%)
    3 / 282 (1.06%)
    9 / 247 (3.64%)
    1 / 117 (0.85%)
    7 / 116 (6.03%)
    2 / 25 (8.00%)
    0 / 34 (0.00%)
         occurrences all number
    7
    3
    9
    1
    7
    2
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Due to non-convergence of the generalized linear model used for pre-specified analyses, ad hoc analyses were conducted for efficacy endpoints of PASI 75 response, PASI 100 response, and sPGA response.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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