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    Clinical Trial Results:
    A Multicenter, Randomized, Double-blind Study Evaluating the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Multiple Switches Between Humira (adalimumab [US]) and ABP 501 Compared With Continued Use of Adalimumab in Subjects With Moderate to Severe Plaque Psoriasis

    Summary
    EudraCT number
    		 2021-000542-18
    Trial protocol
    		 DE   LV  
    Global end of trial date
    19 Dec 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jan 2024
    First version publication date
    04 Jan 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    20200497
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    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
    19 Dec 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Dec 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study is to demonstrate similarity of pharmacokinetics (PK) in participants after multiple switches between adalimumab (Humira®) 100 mg/mL and ABP 501 100 mg/mL, compared to participants receiving continued use of adalimumab 100 mg/mL.
    Protection of trial subjects
    This study was conducted in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) 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 (EU) 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
    04 Oct 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
    Poland: 143
    Country: Number of subjects enrolled
    Germany: 38
    Country: Number of subjects enrolled
    Latvia: 14
    Country: Number of subjects enrolled
    Estonia: 9
    Country: Number of subjects enrolled
    United States: 151
    Country: Number of subjects enrolled
    Canada: 70
    Worldwide total number of subjects
    425
    EEA total number of subjects
    204
    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)
    384
    From 65 to 84 years
    41
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 425 participants were enrolled in the study at 83 centers across 6 countries (Canada, Estonia, Germany, Latvia, Poland, and the US) between October 2021 and December 2022.

    Pre-assignment
    Screening details
    		 Participants were enrolled into period 1 of the study (Lead-in Period) and received adalimumab subcutaneously (SC) during 12 week. Participants who responded to treatment during Period 1 (achieving PASI ≥ 50) were randomized to Period 2 to either the Continued-use Group or the Switching Group. Period 2 lasted 20 weeks from Week 12 to Week 32.

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

    Arms
    Arm title
    		 Period 1 (Lead-in period)
    Arm description
    		 Participants with plaque psoriasis (Ps) received adalimumab 100 mg/mL SC from Week 1 to Week 12 for a total of 6 doses (Week 1/Day 1 [80 mg], Week 2/Day 8 [40 mg], Week 4, Week 6, Week 8, and Week 10 [40 mg]) during the Lead-in Period.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Period 1 (Lead-in period)
    Started
    425
    Completed
    380
    Not completed
    45
         Adverse event, serious fatal
    1
         Consent withdrawn by subject
    6
         Adverse event, non-fatal
    6
         Not indicated
    1
         Lost to follow-up
    3
         Lack of efficacy
    23
         Protocol deviation
    5
    Period 2
    Period 2 title
    Period 2
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Period 2 (Switching Group)
    Arm description
    		 Participants with Ps who responded to treatment (achieving PASI ≥ 50) in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 [40 mg]), adalimumab Q2W (Week 16 and Week 18 [40 mg]), and again ABP 501 Q2W (Week 20, Week 22, Week 24, Week 26, Week 28 [40 mg]).
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABP 501
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    40 mg Q2W at Week 12, Week 14, Week 20, Week 22, Week 24, Week 26, and Week 28

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Humira
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    40 mg Q2W at Week 16 and Week 18

    Arm title
    		 Period 2 (Continued-use Group)
    Arm description
    		 Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Humira
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    40 mg Q2W from Week 12 to Week 28

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Baseline characteristics are presented for participants who responded to treatment during Period 1 (achieving PASI ≥ 50) and were randomized in Period 2.
    Number of subjects in period 2 [2]
    		Period 2 (Switching Group) Period 2 (Continued-use Group)
    Started
    186
    194
    Completed
    174
    173
    Not completed
    12
    21
         Consent withdrawn by subject
    4
    9
         Adverse event, non-fatal
    3
    6
         Lost to follow-up
    5
    5
         Protocol deviation
    -
    1
    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: Baseline characteristics are presented for participants who responded to treatment during Period 1 (achieving PASI ≥ 50) and were randomized in Period 2. The worldwide number enrolled in the study includes participants in the Lead-in Period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Period 2 (Switching Group)
    Reporting group description
    		 Participants with Ps who responded to treatment (achieving PASI ≥ 50) in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 [40 mg]), adalimumab Q2W (Week 16 and Week 18 [40 mg]), and again ABP 501 Q2W (Week 20, Week 22, Week 24, Week 26, Week 28 [40 mg]).

    Reporting group title
    Period 2 (Continued-use Group)
    Reporting group description
    		 Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.

    Reporting group values
    		 Period 2 (Switching Group) Period 2 (Continued-use Group) Total
    Number of subjects
    		 186 194 380
    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)
    		 171 173 344
        From 65-84 years
    		 15 21 36
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.9 ± 13.27 44.3 ± 13.91 -
    Sex: Female, Male
    Units: Participants
        Female
    		 56 63 119
        Male
    		 130 131 261
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 2 2 4
        Asian
    		 14 10 24
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 4 4 8
        White
    		 162 172 334
        More than one race
    		 1 0 1
        Unknown or Not Reported
    		 3 6 9
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 27 36 63
        Not Hispanic or Latino
    		 158 158 316
        Unknown or Not Reported
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Period 1 (Lead-in period)
    Reporting group description
    		 Participants with plaque psoriasis (Ps) received adalimumab 100 mg/mL SC from Week 1 to Week 12 for a total of 6 doses (Week 1/Day 1 [80 mg], Week 2/Day 8 [40 mg], Week 4, Week 6, Week 8, and Week 10 [40 mg]) during the Lead-in Period.
    Reporting group title
    Period 2 (Switching Group)
    Reporting group description
    		 Participants with Ps who responded to treatment (achieving PASI ≥ 50) in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 [40 mg]), adalimumab Q2W (Week 16 and Week 18 [40 mg]), and again ABP 501 Q2W (Week 20, Week 22, Week 24, Week 26, Week 28 [40 mg]).

    Reporting group title
    Period 2 (Continued-use Group)
    Reporting group description
    		 Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.

    Primary: Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)

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    End point title
    		 Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)
    End point description
    Data collected from the PK Parameter Analysis Set which consisted of all randomized participants who receive at least one dose post-randomization and who have an evaluable ABP 501 or adalimumab serum concentration-time profile between weeks 28 and 30. This analysis set was used for the primary analysis of the primary and secondary PK endpoints and was analyzed according to actual treatment received.
    End point type
    Primary
    End point timeframe
    Week 28 pre-dose and 1hour, 1 day, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose
    End point values
    		 Period 2 (Switching Group) Period 2 (Continued-use Group)
    Number of subjects analysed
    146
    145
    Units: hr*μg/mL
        geometric mean (geometric coefficient of variation)
    1458.03 ± 156.6
    1472.68 ± 174.9
    Statistical analysis title
    		 AUCtau
    Comparison groups
    Period 2 (Continued-use Group) v Period 2 (Switching Group)
    Number of subjects included in analysis
    291
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    Method
    Parameter type
    		 Ratio Geometric Least Square Mean (GMR)
    Point estimate
    1.0516
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.901
         upper limit
    		 1.2273
    Notes
    [1] - The pre-specified similarity margin was 0.8 to 1.25.

    Primary: Maximum Serum Concentration (Cmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)

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    End point title
    		 Maximum Serum Concentration (Cmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)
    End point description
    Data collected from the PK Parameter Analysis Set which consisted of all randomized participants who receive at least one dose post-randomization and who have an evaluable ABP 501 or adalimumab serum concentration-time profile between weeks 28 and 30. This analysis set was used for the primary analysis of the primary and secondary PK endpoints and was analyzed according to actual treatment received.
    End point type
    Primary
    End point timeframe
    Week 28 pre-dose and 1hour, 1 day, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose
    End point values
    		 Period 2 (Switching Group) Period 2 (Continued-use Group)
    Number of subjects analysed
    153
    153
    Units: μg/mL
        geometric mean (geometric coefficient of variation)
    4.91 ± 153.6
    5.01 ± 160.4
    Statistical analysis title
    		 Cmax
    Comparison groups
    Period 2 (Switching Group) v Period 2 (Continued-use Group)
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [2]
    Method
    Parameter type
    		 GMR
    Point estimate
    1.0044
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.8717
         upper limit
    		 1.1574
    Notes
    [2] - The pre-specified similarity margin was 0.8 to 1.25.

    Secondary: Time to Reach Maximum Serum Concentration (tmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)

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    End point title
    		 Time to Reach Maximum Serum Concentration (tmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)
    End point description
    Data collected from the PK Parameter Analysis Set which consisted of all randomized participants who receive at least one dose post-randomization and who have an evaluable ABP 501 or adalimumab serum concentration-time profile between weeks 28 and 30. This analysis set was used for the primary analysis of the primary and secondary PK endpoints and was analyzed according to actual treatment received.
    End point type
    Secondary
    End point timeframe
    Week 28 pre-dose and 1hour, 1 day, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose
    End point values
    		 Period 2 (Switching Group) Period 2 (Continued-use Group)
    Number of subjects analysed
    162
    160
    Units: Hours
        median (full range (min-max))
    72.30 (0 to 266.5)
    72.35 (0 to 334.9)
    No statistical analyses for this end point

    Secondary: Trough Concentration (Ctrough) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)

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    End point title
    		 Trough Concentration (Ctrough) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)
    End point description
    Data collected between Week 14 and Week 28
    End point type
    Secondary
    End point timeframe
    Week 12, Week 16, Week 20 and Week 28
    End point values
    		 Period 2 (Switching Group) Period 2 (Continued-use Group)
    Number of subjects analysed
    162
    160
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Week 12
    4528.7316 ± 88.9
    4072.5556 ± 119.0
        Week 16
    4046.3069 ± 144.1
    3682.0016 ± 188.1
        Week 20
    4113.0839 ± 160.8
    4332.1272 ± 148.9
        Week 28
    3736.9917 ± 182.1
    4014.4980 ± 193.5
    No statistical analyses for this end point

    Secondary: PASI Percent Improvement From Baseline (Day 1) to Week 30

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    End point title
    		 PASI Percent Improvement From Baseline (Day 1) to Week 30
    End point description
    The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. Percent improvement from baseline was calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline). Results are presented for the per-protocol efficacy analysis set as observed, which consisted of all participants who were randomized and received all assigned doses post randomization and who had not experienced an important protocol deviation that could affect the efficacy endpoints.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 30
    End point values
    		 Period 2 (Switching Group) Period 2 (Continued-use Group)
    Number of subjects analysed
    151
    151
    Units: Percentage change
        arithmetic mean (confidence interval 95%)
    88.56 (86.07 to 91.05)
    91.01 (88.76 to 93.26)
    Statistical analysis title
    		 PASI Percentage Change
    Comparison groups
    Period 2 (Switching Group) v Period 2 (Continued-use Group)
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [3]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.47
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -5.23
         upper limit
    		 0.29
    Notes
    [3] - The pre-specified similarity margin was 0.8 to 1.25.

    Secondary: Number of Participants Achieving PASI 75 Response at Week 30

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    End point title
    		 Number of Participants Achieving PASI 75 Response at Week 30
    End point description
    A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. Results are presented for the per-protocol efficacy analysis set, which consisted of all participants who were randomized and received all assigned doses post randomization and who had not experienced an important protocol deviation that could affect the efficacy endpoints.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 30
    End point values
    		 Period 2 (Switching Group) Period 2 (Continued-use Group)
    Number of subjects analysed
    151
    151
    Units: Participants
    131
    134
    No statistical analyses for this end point

    Secondary: Number of Participants Achieving PASI 100 Response at Week 30

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    End point title
    		 Number of Participants Achieving PASI 100 Response at Week 30
    End point description
    A PASI 100 response is a 100% improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. Results are presented for the per-protocol efficacy analysis set, which consisted of all participants who were randomized and received all assigned doses post randomization and who had not experienced an important protocol deviation that could affect the efficacy endpoints.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 30
    End point values
    		 Period 2 (Switching Group) Period 2 (Continued-use Group)
    Number of subjects analysed
    151
    151
    Units: Participants
    52
    61
    No statistical analyses for this end point

    Secondary: Number of Participants Achieving PASI 90 Response at Week 30

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    End point title
    		 Number of Participants Achieving PASI 90 Response at Week 30
    End point description
    A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. Results are presented for the per-protocol efficacy analysis set, which consisted of all participants who were randomized and received all assigned doses post randomization and who had not experienced an important protocol deviation that could affect the efficacy endpoints.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 30
    End point values
    		 Period 2 (Switching Group) Period 2 (Continued-use Group)
    Number of subjects analysed
    151
    151
    Units: Participants
    92
    108
    No statistical analyses for this end point

    Secondary: Number of Participants Experiencing Events of Interest (EOI)

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    End point title
    		 Number of Participants Experiencing Events of Interest (EOI)
    End point description
    An EOI is defined as a noteworthy event for a particular product or class of products that a sponsor may wish to monitor carefully. It could be serious or non-serious and could include events that might be potential precursors or prodromes for more serious medical conditions in susceptible individuals.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 32
    End point values
    		 Period 2 (Switching Group) Period 2 (Continued-use Group)
    Number of subjects analysed
    186
    194
    Units: Participants
    13
    17
    No statistical analyses for this end point

    Secondary: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)

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    End point title
    		 Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)
    End point description
    TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 32
    End point values
    		 Period 2 (Switching Group) Period 2 (Continued-use Group)
    Number of subjects analysed
    186
    194
    Units: Participants
        TEAE
    97
    106
        Serious TEAE
    3
    4
    No statistical analyses for this end point

    Secondary: Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization

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    End point title
    		 Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization
    End point description
    Ab = antibody Trans = transient
    End point type
    Secondary
    End point timeframe
    Week 16, Week 20, Week 28, Week 30, and Week 32
    End point values
    		 Period 2 (Switching Group) Period 2 (Continued-use Group)
    Number of subjects analysed
    186
    194
    Units: Participants
        Subjects with a post-randomization result
    186
    194
        Binding Ab negative or no result
    25
    18
        Binding Ab positive post randomization
    16
    10
        Trans binding Ab positive post randomization
    3
    2
        Neutralizing Ab negative or no result
    174
    182
        Neutralizing Ab positive
    21
    27
        Trans neutralizing Ab positive post randomization
    2
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    32 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
    Period 1 (Lead-in period)
    Reporting group description
    		 Participants with Ps received adalimumab 100 mg/mL SC from Week 1 to Week 12 for a total of 6 doses (Week 1/D1 [80 mg], Week 2/D8 [40 mg], Week 4, Week 6, Week 8, and Week 10 [40 mg]) during the Lead-in Period.

    Reporting group title
    Period 2 (Switching Group)
    Reporting group description
    		 Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 [40 mg]), adalimumab Q2W (Week 16 and Week 18 [40 mg]), and again ABP 501 Q2W (Week 20, Week 22, Week 24, Week 26, Week 28 [40 mg]).

    Reporting group title
    Period 2 (Continued-use Group)
    Reporting group description
    		 Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomized to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.

    Serious adverse events
    		 Period 1 (Lead-in period) Period 2 (Switching Group) Period 2 (Continued-use Group)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 425 (1.18%)
    3 / 186 (1.61%)
    4 / 194 (2.06%)
         number of deaths (all causes)
    1
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to lymph nodes
         subjects affected / exposed
    1 / 425 (0.24%)
    0 / 186 (0.00%)
    0 / 194 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 425 (0.24%)
    0 / 186 (0.00%)
    0 / 194 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Trigeminal nerve disorder
         subjects affected / exposed
    1 / 425 (0.24%)
    0 / 186 (0.00%)
    0 / 194 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Facial paralysis
         subjects affected / exposed
    1 / 425 (0.24%)
    0 / 186 (0.00%)
    0 / 194 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Central nervous system lesion
         subjects affected / exposed
    1 / 425 (0.24%)
    0 / 186 (0.00%)
    0 / 194 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 425 (0.00%)
    0 / 186 (0.00%)
    1 / 194 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 425 (0.24%)
    0 / 186 (0.00%)
    0 / 194 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Alcoholic pancreatitis
         subjects affected / exposed
    0 / 425 (0.00%)
    1 / 186 (0.54%)
    0 / 194 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 425 (0.24%)
    0 / 186 (0.00%)
    0 / 194 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 425 (0.00%)
    0 / 186 (0.00%)
    1 / 194 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Diabetic foot
         subjects affected / exposed
    0 / 425 (0.00%)
    1 / 186 (0.54%)
    0 / 194 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 425 (0.24%)
    0 / 186 (0.00%)
    0 / 194 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Tuberculosis
         subjects affected / exposed
    0 / 425 (0.00%)
    0 / 186 (0.00%)
    1 / 194 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis intestinal perforated
         subjects affected / exposed
    0 / 425 (0.00%)
    0 / 186 (0.00%)
    1 / 194 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 425 (0.00%)
    1 / 186 (0.54%)
    0 / 194 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Period 1 (Lead-in period) Period 2 (Switching Group) Period 2 (Continued-use Group)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 425 (8.94%)
    26 / 186 (13.98%)
    28 / 194 (14.43%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    16 / 425 (3.76%)
    4 / 186 (2.15%)
    13 / 194 (6.70%)
         occurrences all number
    19
    4
    15
    Infections and infestations
    COVID-19
         subjects affected / exposed
    14 / 425 (3.29%)
    13 / 186 (6.99%)
    7 / 194 (3.61%)
         occurrences all number
    14
    13
    7
    Nasopharyngitis
         subjects affected / exposed
    12 / 425 (2.82%)
    13 / 186 (6.99%)
    11 / 194 (5.67%)
         occurrences all number
    13
    14
    16

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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