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    Clinical Trial Results:
    A Multicenter, Double-blind, Randomized, Parallel-group Study to Compare the Efficacy and Safety of BAT2506 Versus Simponi® in Participants with Active Psoriatic Arthritis

    Summary
    EudraCT number
    		 2020-002004-39
    Trial protocol
    		 CZ   BG  
    Global end of trial date
    06 Oct 2023

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

    Trial information

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    Trial identification
    Sponsor protocol code
    BAT-2506-002-CR
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05046431
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bio-Thera Solutions, Ltd.
    Sponsor organisation address
    Floor 5, Building A6, 11 Kai-Yuan Blvd, Huangpu District,, Guangzhou, China, 510530
    Public contact
    Clinical Development Department, Bio-Thera Solutions, Ltd., +86 17665187738, CT_Registration@bio-thera.com
    Scientific contact
    Clinical Development Department, Bio-Thera Solutions, Ltd., +86 17665187738, CT_Registration@bio-thera.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
    17 Jan 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Oct 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Oct 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to demonstrate the equivalence of BAT2506 and Simponi® on the efficacy parameter, American College of Rheumatology (ACR) 20 response, in participants with active PsA.
    Protection of trial subjects
    The clinical study protocol, protocol amendments, informed consent forms (ICFs), and any other appropriate study-related documents were reviewed and approved by independent ethics committees (IECs) and institutional review boards (IRBs) for each study center. Before entering the study, the investigator (or designee) explained to each subject (or their legally acceptable representatives, if applicable) the nature of the study, its purpose, procedures, expected duration, alternative therapy available, and the benefits and risks involved in study participation. Subjects were given written information about the study, and, before any study procedures were performed, each subject voluntarily signed and dated the ICF. This was to be done during the Screening Period (Days -1 to -28). The master ICF and country-specific and site-specific versions are available upon request.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Apr 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 425
    Country: Number of subjects enrolled
    Bulgaria: 38
    Country: Number of subjects enrolled
    Czechia: 137
    Country: Number of subjects enrolled
    China: 92
    Country: Number of subjects enrolled
    Ukraine: 12
    Worldwide total number of subjects
    704
    EEA total number of subjects
    600
    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)
    664
    From 65 to 84 years
    40
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 852 subjects were screened, and 704 subjects were enrolled by 11 Aug 2022, with 38 subjects enrolled in Bulgaria, 425 subjects in Poland, 137 subjects in Czech Republic, 12 subjects in Ukraine, and 92 subjects in China.

    Pre-assignment
    Screening details
    		 Subjects with active PsA were screened in this study. A total of 852 subjects were screened and 704 subjects were randomized. Investigators completed the protocol defined screening procedures during ≤28-day screening period.

    Period 1
    Period 1 title
    Treatment period 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The investigators, site staff assessing the safety and efficacy, other related study staff (including contract research organization and sponsor), all subjects, and central laboratories would remain blinded to the study treatment assignment throughout this study. The unblinded site staff who were not involved in any study assessment were responsible for IMP storage, transfer and administration.The treatment assignment was not disclosed to any blinded personnel during the study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BAT2506 Arm
    Arm description
    		 Subjects randomized to the BAT2506 Arm at baseline received 13 doses of BAT2506 during the study (6 doses in treatment period 1 and 7 doses in treatment period 2).
    Arm type
    		 Experimental

    Investigational medicinal product name
    BAT2506
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Study treatment was administered at the study site, 50mg SC injection every 4 weeks.

    Arm title
    		 Simponi Arm
    Arm description
    		 Subjects randomized to Simponi Arm at baseline received 6 doses of Simponi in treatment period 1, followed by either 7 doses of Simponi or 7 doses of BAT2506 in treatment period 2.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Simponi
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Study treatment was administered at the study site, 50mg SC injection every 4 weeks.

    Number of subjects in period 1
    		BAT2506 Arm Simponi Arm
    Started
    351
    353
    Completed
    347
    341
    Not completed
    4
    12
         Consent withdrawn by subject
    2
    6
         Adverse event, non-fatal
    1
    5
         due to other reason
    1
    1
    Period 2
    Period 2 title
    Treatment period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The investigators, site staff assessing the safety and efficacy, other related study staff (including contract research organization and sponsor), all subjects, and central laboratories would remain blinded to the study treatment assignment throughout this study. The unblinded site staff who were not involved in any study assessment were responsible for IMP storage, transfer and administration. The treatment assignment was not disclosed to any blinded personnel during study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BAT2506 Arm
    Arm description
    		 Subjects randomized to the BAT2506 Arm at baseline received 13 doses of BAT2506 during the study (6 doses in treatment period 1 and 7 doses in treatment period 2).
    Arm type
    		 Experimental

    Investigational medicinal product name
    BAT2506
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Study treatment was administered at the study site, 50mg SC injection every 4 weeks.

    Arm title
    		 Simponi Arm
    Arm description
    		 Subjects randomized to Simponi Arm at baseline received 6 doses of Simponi in treatment period 1, followed by 7 doses of Simponi in treatment period 2.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Simponi
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Study treatment was administered at the study site, 50mg SC injection every 4 weeks.

    Arm title
    		 Simponi→ BAT2506 Arm
    Arm description
    		 Subjects randomized to RoActemra Arm at baseline received 6 doses of Sinponi in treatment period 1, followed by 7 doses of BAT2506 in treatment period 2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Simponi
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Study treatment was administered at the study site, 50mg SC injection every 4 weeks.

    Number of subjects in period 2 [1]
    		BAT2506 Arm Simponi Arm Simponi→ BAT2506 Arm
    Started
    341
    172
    166
    Completed
    315
    159
    154
    Not completed
    26
    13
    12
         Adverse event, serious fatal
    -
    1
    -
         Consent withdrawn by subject
    8
    5
    4
         Adverse event, non-fatal
    2
    1
    -
         due to other reason
    2
    -
    2
         did not complete the safety follow-up visit
    11
    5
    6
         Lost to follow-up
    -
    1
    -
         Lack of efficacy
    1
    -
    -
         Protocol deviation
    2
    -
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: A subject completed TP1 was defined as those who received study drug administration at or after week 20. A subject entered TP2 was defined as those who received the study drug administration at or after week 24. In this study, there are some subjects – 9 subjects in total - who completed TP1 but did not enter in TP2 (subjects didn't receive dose at week 24 and early terminated at week 24).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BAT2506 Arm
    Reporting group description
    		 Subjects randomized to the BAT2506 Arm at baseline received 13 doses of BAT2506 during the study (6 doses in treatment period 1 and 7 doses in treatment period 2).

    Reporting group title
    Simponi Arm
    Reporting group description
    		 Subjects randomized to Simponi Arm at baseline received 6 doses of Simponi in treatment period 1, followed by either 7 doses of Simponi or 7 doses of BAT2506 in treatment period 2.

    Reporting group values
    		 BAT2506 Arm Simponi Arm Total
    Number of subjects
    		 351 353 704
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 328 336 664
        From 65-84 years
    		 23 17 40
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.6 ( 11.8 ) 45 ( 12.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 171 175 346
        Male
    		 180 178 358
    Region
    Units: Subjects
        Asia
    		 44 48 92
        Europe
    		 307 305 612
    Concomitant use of MTX
    Units: Subjects
        Concomitant use of MTX(yes)
    		 155 156 311
        Concomitant use of MTX(no)
    		 196 197 393
    Plaque Psoriatic Involvement
    Units: Subjects
        Mild (<12)
    		 287 296 583
        Moderate and Severe (≥12)
    		 64 57 121
    Body Weight Group
    Units: Subjects
        ≤84 kg
    		 204 205 409
        >84 kg
    		 147 148 295
    Body Weight
    Units: Kg
        arithmetic mean (standard deviation)
    		 81.92 ( 17.01 ) 81.60 ( 19.06 ) -
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 171.1 ( 9.8 ) 170.5 ( 9.0 ) -
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 27.8794 ( 4.9330 ) 27.9943 ( 5.8360 ) -
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set for TP1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set 1 comprised all subjects randomized to a study treatment arm.

    Subject analysis set title
    Safety Analysis Set for TP1 (SAF1)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The SAF1 comprised all subjects in the FAS1 who received at least one dose of study drug during TP1.

    Subject analysis set title
    Per PK Analysis Set for TP1 (PKS1)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The PKS1 consisted of all subjects in the SAF who had at least one quantifiable PK concentration during TP1, excluding observations after relevant ICEs that might impact PK evaluations. Subjects in the PKS1 were analyzed under the treatment as actually received. The PKS1 was used for analyses of PK during TP1.

    Subject analysis sets values
    		 Full Analysis Set for TP1 Safety Analysis Set for TP1 (SAF1) Per PK Analysis Set for TP1 (PKS1)
    Number of subjects
    704
    704
    704
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    664
    664
    664
        From 65-84 years
    40
    40
    40
        85 years and over
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    45.8 ( 12.1 )
    45.8 ( 12.1 )
    45.8 ( 12.1 )
    Gender categorical
    Units: Subjects
        Female
    346
    346
    346
        Male
    358
    358
    358
    Region
    Units: Subjects
        Asia
    92
    92
    92
        Europe
    612
    612
    612
    Concomitant use of MTX
    Units: Subjects
        Concomitant use of MTX(yes)
    311
    311
    311
        Concomitant use of MTX(no)
    393
    393
    393
    Plaque Psoriatic Involvement
    Units: Subjects
        Mild (<12)
    583
    583
    583
        Moderate and Severe (≥12)
    121
    121
    121
    Body Weight Group
    Units: Subjects
        ≤84 kg
    409
    409
    409
        >84 kg
    295
    295
    295
    Body Weight
    Units: Kg
        arithmetic mean (standard deviation)
    81.76 ( 18.05 )
    81.76 ( 18.05 )
    81.76 ( 18.05 )
    Height
    Units: cm
        arithmetic mean (standard deviation)
    170.8 ( 9.4 )
    170.8 ( 9.4 )
    170.8 ( 9.4 )
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    27.9369 ( 5.4005 )
    27.9369 ( 5.4005 )
    27.9369 ( 5.4005 )

    End points

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    End points reporting groups
    Reporting group title
    BAT2506 Arm
    Reporting group description
    		 Subjects randomized to the BAT2506 Arm at baseline received 13 doses of BAT2506 during the study (6 doses in treatment period 1 and 7 doses in treatment period 2).

    Reporting group title
    Simponi Arm
    Reporting group description
    		 Subjects randomized to Simponi Arm at baseline received 6 doses of Simponi in treatment period 1, followed by either 7 doses of Simponi or 7 doses of BAT2506 in treatment period 2.
    Reporting group title
    BAT2506 Arm
    Reporting group description
    		 Subjects randomized to the BAT2506 Arm at baseline received 13 doses of BAT2506 during the study (6 doses in treatment period 1 and 7 doses in treatment period 2).

    Reporting group title
    Simponi Arm
    Reporting group description
    		 Subjects randomized to Simponi Arm at baseline received 6 doses of Simponi in treatment period 1, followed by 7 doses of Simponi in treatment period 2.

    Reporting group title
    Simponi→ BAT2506 Arm
    Reporting group description
    		 Subjects randomized to RoActemra Arm at baseline received 6 doses of Sinponi in treatment period 1, followed by 7 doses of BAT2506 in treatment period 2.

    Subject analysis set title
    Full Analysis Set for TP1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set 1 comprised all subjects randomized to a study treatment arm.

    Subject analysis set title
    Safety Analysis Set for TP1 (SAF1)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The SAF1 comprised all subjects in the FAS1 who received at least one dose of study drug during TP1.

    Subject analysis set title
    Per PK Analysis Set for TP1 (PKS1)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The PKS1 consisted of all subjects in the SAF who had at least one quantifiable PK concentration during TP1, excluding observations after relevant ICEs that might impact PK evaluations. Subjects in the PKS1 were analyzed under the treatment as actually received. The PKS1 was used for analyses of PK during TP1.

    Primary: Percentage of subjects achieving ACR 20 response at Week 8

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    End point title
    		 Percentage of subjects achieving ACR 20 response at Week 8
    End point description
    End point type
    Primary
    End point timeframe
    baseline to week 8
    End point values
    		 BAT2506 Arm Simponi Arm Full Analysis Set for TP1
    Number of subjects analysed
    351
    353
    704
    Units: Proportion of Subjects
        number (not applicable)
    74.53
    63.41
    68.95
    Statistical analysis title
    		 ACR20 analysis for week 8 (Full Analysis Set 1)
    Comparison groups
    BAT2506 Arm v Simponi Arm v Full Analysis Set for TP1
    Number of subjects included in analysis
    1408
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    11.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.4
         upper limit
    		 18.25

    Primary: Percentage of subjects achieving ACR 20 response at Week 14

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    End point title
    		 Percentage of subjects achieving ACR 20 response at Week 14
    End point description
    End point type
    Primary
    End point timeframe
    baseline to week 14
    End point values
    		 BAT2506 Arm Simponi Arm Full Analysis Set for TP1
    Number of subjects analysed
    351
    353
    704
    Units: Proportion of subjects
        number (not applicable)
    79.26
    77.08
    78.17
    Statistical analysis title
    		 ACR20 analysis for week 14 (Full Analysis Set 1)
    Comparison groups
    BAT2506 Arm v Simponi Arm
    Number of subjects included in analysis
    704
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    2.36
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.91
         upper limit
    		 7.63
    Statistical analysis title
    		 ACR20 analysis for week 14 (Full Analysis Set 1)
    Comparison groups
    BAT2506 Arm v Simponi Arm
    Number of subjects included in analysis
    704
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    2.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.92
         upper limit
    		 8.64

    Secondary: Percentage of subjects achieving ACR 50 response at Week 8

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    End point title
    		 Percentage of subjects achieving ACR 50 response at Week 8
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to week 8
    End point values
    		 BAT2506 Arm Simponi Arm Full Analysis Set for TP1
    Number of subjects analysed
    351
    353
    704
    Units: Proportion of Subjects
        number (not applicable)
    36.03
    34.05
    35.04
    Statistical analysis title
    		 ACR50 analysis for Week 8 (Full Analysis Set 1)
    Comparison groups
    BAT2506 Arm v Simponi Arm
    Number of subjects included in analysis
    704
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    2.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.98
         upper limit
    		 9.35

    Secondary: Percentage of subjects achieving ACR 50 response at Week 14

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    End point title
    		 Percentage of subjects achieving ACR 50 response at Week 14
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to week 14
    End point values
    		 BAT2506 Arm Simponi Arm Full Analysis Set for TP1
    Number of subjects analysed
    351
    353
    704
    Units: Percentage of subjects
        number (not applicable)
    49.29
    50.10
    49.70
    Statistical analysis title
    		 ACR50 analysis for Week 14 (Full Analysis Set 1)
    Comparison groups
    BAT2506 Arm v Simponi Arm
    Number of subjects included in analysis
    704
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -7.02
         upper limit
    		 5.62
    Statistical analysis title
    		 ACR50 analysis for Week 14 (Full Analysis Set 1)
    Comparison groups
    BAT2506 Arm v Simponi Arm
    Number of subjects included in analysis
    704
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.23
         upper limit
    		 6.84

    Secondary: Percentage of subjects achieving ACR 70 response at Week 8

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    End point title
    		 Percentage of subjects achieving ACR 70 response at Week 8
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to week 8
    End point values
    		 BAT2506 Arm Simponi Arm Full Analysis Set for TP1
    Number of subjects analysed
    351
    353
    704
    Units: Proportion of Subjects
        number (not applicable)
    16.21
    14.67
    15.44
    Statistical analysis title
    		 ACR70 analysis at Week 8 (Full Analysis Set 1)
    Comparison groups
    BAT2506 Arm v Simponi Arm
    Number of subjects included in analysis
    704
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    1.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.61
         upper limit
    		 7.13

    Secondary: Percentage of subjects achieving ACR 70 response at Week 14

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    End point title
    		 Percentage of subjects achieving ACR 70 response at Week 14
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to week 14
    End point values
    		 BAT2506 Arm Simponi Arm Full Analysis Set for TP1
    Number of subjects analysed
    351
    353
    704
    Units: Proportion of Subjects
        number (not applicable)
    29.06
    23.13
    26.09
    Statistical analysis title
    		 ACR70 analysis at Week 14 (Full Analysis Set 1)
    Comparison groups
    BAT2506 Arm v Simponi Arm
    Number of subjects included in analysis
    704
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    6.08
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 11.59
    Statistical analysis title
    		 ACR70 analysis at Week 14 (Full Analysis Set 1)
    Comparison groups
    BAT2506 Arm v Simponi Arm
    Number of subjects included in analysis
    704
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    6.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.48
         upper limit
    		 12.64

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All AEs occuring during the study (from the time of receiving written informed consent to 12 weeks after the last dose of IMP) must be collected and documented on the relevant eCRF pages.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    BAT2506 Arm
    Reporting group description
    		 -

    Reporting group title
    Simponi Arm
    Reporting group description
    		 -

    Reporting group title
    Simponi →BAT2506 Arm
    Reporting group description
    		 -

    Serious adverse events
    		 BAT2506 Arm Simponi Arm Simponi →BAT2506 Arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    19 / 351 (5.41%)
    8 / 187 (4.28%)
    5 / 166 (3.01%)
         number of deaths (all causes)
    0
    1
    0
         number of deaths resulting from adverse events
    0
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    1 / 351 (0.28%)
    0 / 187 (0.00%)
    0 / 166 (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
    Uterine leiomyoma
         subjects affected / exposed
    2 / 351 (0.57%)
    0 / 187 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    0 / 351 (0.00%)
    1 / 187 (0.53%)
    0 / 166 (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
    Intraductal proliferative breast lesion
         subjects affected / exposed
    0 / 351 (0.00%)
    1 / 187 (0.53%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    1 / 351 (0.28%)
    0 / 187 (0.00%)
    0 / 166 (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
    Foetal growth restriction
         subjects affected / exposed
    0 / 351 (0.00%)
    1 / 187 (0.53%)
    0 / 166 (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
    General disorders and administration site conditions
    Sudden death
         subjects affected / exposed
    0 / 351 (0.00%)
    1 / 187 (0.53%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Reproductive system and breast disorders
    Endometrial hyperplasia
         subjects affected / exposed
    0 / 351 (0.00%)
    1 / 187 (0.53%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervical polyp
         subjects affected / exposed
    1 / 351 (0.28%)
    0 / 187 (0.00%)
    0 / 166 (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
    Respiratory, thoracic and mediastinal disorders
    Adenoidal hypertrophy
         subjects affected / exposed
    1 / 351 (0.28%)
    0 / 187 (0.00%)
    0 / 166 (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
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    1 / 351 (0.28%)
    0 / 187 (0.00%)
    0 / 166 (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
    Tendon rupture
         subjects affected / exposed
    1 / 351 (0.28%)
    1 / 187 (0.53%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    1 / 351 (0.28%)
    0 / 187 (0.00%)
    0 / 166 (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
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 351 (0.28%)
    0 / 187 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal fissure
         subjects affected / exposed
    0 / 351 (0.00%)
    0 / 187 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Ureterolithiasis
         subjects affected / exposed
    1 / 351 (0.28%)
    0 / 187 (0.00%)
    0 / 166 (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
    Musculoskeletal and connective tissue disorders
    Osteonecrosis
         subjects affected / exposed
    1 / 351 (0.28%)
    0 / 187 (0.00%)
    0 / 166 (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
    Synovitis
         subjects affected / exposed
    1 / 351 (0.28%)
    0 / 187 (0.00%)
    0 / 166 (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
    Arthralgia
         subjects affected / exposed
    0 / 351 (0.00%)
    1 / 187 (0.53%)
    0 / 166 (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
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 351 (0.28%)
    0 / 187 (0.00%)
    0 / 166 (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
    COVID-19
         subjects affected / exposed
    1 / 351 (0.28%)
    0 / 187 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 351 (0.28%)
    0 / 187 (0.00%)
    0 / 166 (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
    Pneumonia
         subjects affected / exposed
    1 / 351 (0.28%)
    0 / 187 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 351 (0.00%)
    1 / 187 (0.53%)
    0 / 166 (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
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 351 (0.28%)
    0 / 187 (0.00%)
    0 / 166 (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
    Osteoarthritis
         subjects affected / exposed
    1 / 351 (0.28%)
    0 / 187 (0.00%)
    0 / 166 (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
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 BAT2506 Arm Simponi Arm Simponi →BAT2506 Arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    291 / 351 (82.91%)
    152 / 187 (81.28%)
    134 / 166 (80.72%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    28 / 351 (7.98%)
    12 / 187 (6.42%)
    12 / 166 (7.23%)
         occurrences all number
    43
    16
    18
    Aspartate aminotransferase increased
         subjects affected / exposed
    16 / 351 (4.56%)
    4 / 187 (2.14%)
    12 / 166 (7.23%)
         occurrences all number
    21
    4
    16
    Low density lipoprotein increased
         subjects affected / exposed
    9 / 351 (2.56%)
    2 / 187 (1.07%)
    9 / 166 (5.42%)
         occurrences all number
    16
    4
    18
    Weight increased
         subjects affected / exposed
    7 / 351 (1.99%)
    0 / 187 (0.00%)
    3 / 166 (1.81%)
         occurrences all number
    9
    0
    3
    Blood cholesterol increased
         subjects affected / exposed
    6 / 351 (1.71%)
    3 / 187 (1.60%)
    6 / 166 (3.61%)
         occurrences all number
    8
    4
    8
    Blood alkaline phosphatase increased
         subjects affected / exposed
    4 / 351 (1.14%)
    0 / 187 (0.00%)
    6 / 166 (3.61%)
         occurrences all number
    5
    0
    7
    SARS-CoV-2 test positive
         subjects affected / exposed
    3 / 351 (0.85%)
    5 / 187 (2.67%)
    2 / 166 (1.20%)
         occurrences all number
    3
    5
    2
    Vascular disorders
    Hypertension
         subjects affected / exposed
    18 / 351 (5.13%)
    3 / 187 (1.60%)
    3 / 166 (1.81%)
         occurrences all number
    19
    3
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    15 / 351 (4.27%)
    12 / 187 (6.42%)
    8 / 166 (4.82%)
         occurrences all number
    17
    13
    8
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    4 / 351 (1.14%)
    1 / 187 (0.53%)
    4 / 166 (2.41%)
         occurrences all number
    7
    1
    8
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 351 (1.14%)
    4 / 187 (2.14%)
    2 / 166 (1.20%)
         occurrences all number
    5
    4
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    17 / 351 (4.84%)
    12 / 187 (6.42%)
    10 / 166 (6.02%)
         occurrences all number
    17
    12
    11
    Nausea
         subjects affected / exposed
    5 / 351 (1.42%)
    4 / 187 (2.14%)
    1 / 166 (0.60%)
         occurrences all number
    5
    4
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 351 (1.99%)
    6 / 187 (3.21%)
    1 / 166 (0.60%)
         occurrences all number
    7
    6
    1
    Rhinorrhoea
         subjects affected / exposed
    4 / 351 (1.14%)
    2 / 187 (1.07%)
    4 / 166 (2.41%)
         occurrences all number
    4
    2
    4
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    11 / 351 (3.13%)
    5 / 187 (2.67%)
    3 / 166 (1.81%)
         occurrences all number
    13
    5
    4
    Musculoskeletal and connective tissue disorders
    Psoriatic arthropathy
         subjects affected / exposed
    27 / 351 (7.69%)
    7 / 187 (3.74%)
    7 / 166 (4.22%)
         occurrences all number
    40
    8
    8
    Arthralgia
         subjects affected / exposed
    5 / 351 (1.42%)
    2 / 187 (1.07%)
    4 / 166 (2.41%)
         occurrences all number
    6
    2
    4
    Back pain
         subjects affected / exposed
    5 / 351 (1.42%)
    5 / 187 (2.67%)
    3 / 166 (1.81%)
         occurrences all number
    5
    5
    3
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    61 / 351 (17.38%)
    29 / 187 (15.51%)
    43 / 166 (25.90%)
         occurrences all number
    78
    40
    52
    Nasopharyngitis
         subjects affected / exposed
    56 / 351 (15.95%)
    27 / 187 (14.44%)
    25 / 166 (15.06%)
         occurrences all number
    71
    37
    32
    COVID-19
         subjects affected / exposed
    49 / 351 (13.96%)
    16 / 187 (8.56%)
    19 / 166 (11.45%)
         occurrences all number
    51
    16
    20
    Tonsillitis
         subjects affected / exposed
    18 / 351 (5.13%)
    5 / 187 (2.67%)
    6 / 166 (3.61%)
         occurrences all number
    19
    5
    6
    Pharyngitis
         subjects affected / exposed
    17 / 351 (4.84%)
    7 / 187 (3.74%)
    7 / 166 (4.22%)
         occurrences all number
    18
    9
    7
    Urinary tract infection
         subjects affected / exposed
    16 / 351 (4.56%)
    12 / 187 (6.42%)
    8 / 166 (4.82%)
         occurrences all number
    19
    13
    11
    Sinusitis
         subjects affected / exposed
    11 / 351 (3.13%)
    7 / 187 (3.74%)
    3 / 166 (1.81%)
         occurrences all number
    14
    8
    3
    Bronchitis
         subjects affected / exposed
    9 / 351 (2.56%)
    4 / 187 (2.14%)
    5 / 166 (3.01%)
         occurrences all number
    10
    4
    7
    Oral herpes
         subjects affected / exposed
    8 / 351 (2.28%)
    4 / 187 (2.14%)
    5 / 166 (3.01%)
         occurrences all number
    11
    4
    5
    Respiratory tract infection
         subjects affected / exposed
    8 / 351 (2.28%)
    5 / 187 (2.67%)
    7 / 166 (4.22%)
         occurrences all number
    10
    5
    7
    Gastroenteritis
         subjects affected / exposed
    7 / 351 (1.99%)
    7 / 187 (3.74%)
    1 / 166 (0.60%)
         occurrences all number
    7
    7
    1
    Rhinitis
         subjects affected / exposed
    6 / 351 (1.71%)
    6 / 187 (3.21%)
    2 / 166 (1.20%)
         occurrences all number
    10
    6
    2
    Acute sinusitis
         subjects affected / exposed
    3 / 351 (0.85%)
    4 / 187 (2.14%)
    0 / 166 (0.00%)
         occurrences all number
    3
    4
    0
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    20 / 351 (5.70%)
    7 / 187 (3.74%)
    12 / 166 (7.23%)
         occurrences all number
    30
    9
    20
    Hypertriglyceridaemia
         subjects affected / exposed
    14 / 351 (3.99%)
    4 / 187 (2.14%)
    8 / 166 (4.82%)
         occurrences all number
    24
    8
    16
    Hyperlipidaemia
         subjects affected / exposed
    7 / 351 (1.99%)
    10 / 187 (5.35%)
    4 / 166 (2.41%)
         occurrences all number
    8
    14
    5
    Hyperuricaemia
         subjects affected / exposed
    7 / 351 (1.99%)
    4 / 187 (2.14%)
    4 / 166 (2.41%)
         occurrences all number
    16
    9
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Nov 2020
    1)Update primary endpoint to percentage of participants achieving ACR 20 response at Week 8 for studies conducted under the EMA and at Week 14 for studies conducted under other regulatory agencies. Delete key secondary endpoint. Add study data from GO-REVEAL study in Appendix 8. 2) Update protocol to clarify what concomitant medications are prohibited during the study. Add section regarding the use of rescue medicine. 3)Add plaque psoriatic involvement as stratification factor for randomization. Add that the percentage of participants using MTX concomitantly should not exceed 60%. 4)Include 3 additional PK sampling time points and added more parameters to be assessed for other secondary endpoints. 5)Update equivalence margin from 15% to 13.8%. 6)Delete % Reticulocytes as parameters for hematology assessment. 7)Minor administrative updates.
    15 Nov 2021
    1)Update the statistical analyses with estimand framework. 2)Update that the percentage of participants using MTX concomitantly should not exceed 50%. 3)Add one more Safety Follow up Visit ( SFU2) to Week60. Include 1 additional PK and 2 additional ADA sampling time points. 4)Update the follow up period for participants who discontinue the study treatment early: they will be followed till W24 or 12 weeks post last dose (following the longer period)if they withdraw before dosing of W24, or they will be followed till W60. 5)Update sample size to 700. Update equivalence margin for FDA to [-12.6, +15%]. 6)Update the interim Analyses to Week36. 7)Adding Urea and Urine leukocyte/other indicatiors for Urine white cell detection. Change “Nonfasting Glucose ” to “ Glucose”. 8)Minor administrative updates.

    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.
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
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