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    Clinical Trial Results:
    A Multicenter, Randomized, Double-Blind, Parallel-Arm, Phase 3 Study to Compare Efficacy and Safety of BAT2306 with Cosentyx® in Patients with Moderate to Severe Plaque Psoriasis

    Summary
    EudraCT number
    2022-001770-59
    Trial protocol
    HU  
    Global end of trial date
    24 May 2024

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

    Trial information

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    Trial identification
    Sponsor protocol code
    BAT-2306-002-CR
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT05377944
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    China IND: CXSL2000344
    Sponsors
    Sponsor organisation name
    Bio-Thera Solutions, Ltd.
    Sponsor organisation address
    Floor 5, Building A6 Science Enterprise Accelerator 11 Kaiyuan Avenue, Science City Huangpu District, Guangzhou, China, 510530
    Public contact
    Xiaolei Yang, Bio-Thera Solutions, Ltd., +86 13538941739, xlyang@bio-thera.com
    Scientific contact
    Xiaolei Yang, Bio-Thera Solutions, Ltd., +86 13538941739, xlyang@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
    05 Jul 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Jul 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    24 May 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate equivalent efficacy of BAT2306 and Cosentyx® in patients with moderate to severe plaque psoriasis.
    Protection of trial subjects
    This study was conducted in accordance with the accepted version of the Declaration of Helsinki in compliance with ICH GCP guidelines, and according to the appropriate regulatory requirements in the countries where the study was conducted. 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.
    Background therapy
    -
    Evidence for comparator
    Secukinumab (Cosentyx®) is a human IgG1 monoclonal antibody developed by Novartis. Secukinumab can inhibit IL-17 receptor via selectively binding to IL-17A, to inhibit its interaction with the IL-17 receptor and thus inhibiting the release of pro-inflammatory cytokines and chemokines. Cosentyx® has been marketed overseas in 2014 with approved indications such as moderate to severe plaque psoriasis (in adults who are candidates for systemic therapy or phototherapy [EU label for candidates of systematic therapy only]), psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis. Secukinumab has been marketed in China in March 2019 under the trade name of Cosentyx, and its approved indications are psoriasis and ankylosing spondylitis
    Actual start date of recruitment
    13 Oct 2022
    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: 112
    Country: Number of subjects enrolled
    Hungary: 65
    Country: Number of subjects enrolled
    China: 265
    Country: Number of subjects enrolled
    Japan: 60
    Worldwide total number of subjects
    502
    EEA total number of subjects
    177
    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)
    451
    From 65 to 84 years
    51
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects were screened from 2022.Oct.13 to 2023.May.15. First patient was randomized on 2022.Oct.26 and Last patient was randomized on 2023.May.31 Subjects were recruited from Poland, Hungary, China and Japan.

    Pre-assignment
    Screening details
    Patients should have moderate to severe plaque-type psoriasis as defined at screening and baseline by: a. PASI ≥ 12, b. IGA ≥ 3 (based on a scale of 0-4), and c. BSA affected by chronic plaque-type psoriasis ≥ 10%

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    BAT2306
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    BAT2306 Injection
    Investigational medicinal product code
    BAT2306
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg (2 injections of 150 mg/1 ml) of BAT2306 or Cosentyx via PFS will be subcutaneously administered at weeks 0, 1, 2, 3, and 4 followed by dosing every 4 weeks, thereafter up to Week 40.

    Arm title
    Cosentyx
    Arm description
    -
    Arm type
    Active comparator

    Investigational medicinal product name
    EU-approved Cosentyx
    Investigational medicinal product code
    Cosentyx
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg (2 injections of 150 mg/1 ml) of BAT2306 or Cosentyx via PFS will be subcutaneously administered at weeks 0, 1, 2, 3, and 4 followed by dosing every 4 weeks, thereafter up to Week 40.

    Number of subjects in period 1
    BAT2306 Cosentyx
    Started
    252
    250
    Completed
    234
    223
    Not completed
    18
    27
         Physician decision
    1
    2
         Consent withdrawn by subject
    12
    17
         Adverse event, non-fatal
    -
    3
         Pregnancy
    1
    -
         Imprisoned
    -
    1
         Poor patient compliance
    -
    1
         Lost to follow-up
    3
    3
         Lack of efficacy
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BAT2306
    Reporting group description
    -

    Reporting group title
    Cosentyx
    Reporting group description
    -

    Reporting group values
    BAT2306 Cosentyx Total
    Number of subjects
    252 250 502
    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)
    228 223 451
        From 65-84 years
    24 27 51
        85 years and over
    0 0 0
    Gender categorical
    Units: Subjects
        Female
    70 73 143
        Male
    182 177 359

    End points

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    End points reporting groups
    Reporting group title
    BAT2306
    Reporting group description
    -

    Reporting group title
    Cosentyx
    Reporting group description
    -

    Subject analysis set title
    BAT2306 TP1
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    The ITT Set will consist of all patients randomized into TP1. Patients will be analyzed under the treatment group as randomized. The ITT Set will be used for the primary analyses of efficacy.

    Subject analysis set title
    Cosentyx TP1
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    The ITT Set will consist of all patients randomized into TP1. Patients will be analyzed under the treatment group as randomized. The ITT Set will be used for the primary analyses of efficacy.

    Subject analysis set title
    BAT2306 - BAT2306 TP2
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    The ITT2 will consist of all patients rerandomized into TP2 at Week 24. Patients from the ITT2 will be analyzed under the treatment group as randomized. The ITT2 will be used for the analyses of efficacy during TP2.

    Subject analysis set title
    Cosentyx - Cosentyx TP2
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    The ITT2 will consist of all patients rerandomized into TP2 at Week 24. Patients from the ITT2 will be analyzed under the treatment group as randomized. The ITT2 will be used for the analyses of efficacy during TP2.

    Subject analysis set title
    Cosentyx - BAT2306 TP2
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    The ITT2 will consist of all patients rerandomized into TP2 at Week 24. Patients from the ITT2 will be analyzed under the treatment group as randomized. The ITT2 will be used for the analyses of efficacy during TP2.

    Primary: EMA, PMDA, and Agencies other than the FDA and NMPA: Percent change from baseline in Psoriasis Area and Severity Index (PASI) score to Week 8

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    End point title
    EMA, PMDA, and Agencies other than the FDA and NMPA: Percent change from baseline in Psoriasis Area and Severity Index (PASI) score to Week 8
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to Week 8
    End point values
    BAT2306 Cosentyx
    Number of subjects analysed
    252
    250
    Units: Percent change in PASI Score
        least squares mean (standard error)
    -88.906 ( 1.2595 )
    -90.454 ( 1.2469 )
    Statistical analysis title
    Treatment Group :BAT2306 and Cosentyx
    Comparison groups
    BAT2306 v Cosentyx
    Number of subjects included in analysis
    502
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    1.549
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.954
         upper limit
    4.051

    Primary: Psoriasis Area and Severity Index Score at Week 12 (FDA and NMPA)

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    End point title
    Psoriasis Area and Severity Index Score at Week 12 (FDA and NMPA)
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to Week 12
    End point values
    BAT2306 Cosentyx
    Number of subjects analysed
    252
    250
    Units: Percent change in PASl Score
        least squares mean (standard error)
    -93.405 ( 1.1135 )
    -93.056 ( 1.0978 )
    Statistical analysis title
    Treatment Group :BAT2306 and Cosentyx
    Comparison groups
    BAT2306 v Cosentyx
    Number of subjects included in analysis
    502
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.349
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.579
         upper limit
    1.881

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    For the purposes of this study, the period of observation for collection of AEs extends from the time immediately after obtaining the informed consent until the EOS visit on Week 52
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    BAT2306 TP1
    Reporting group description
    -

    Reporting group title
    Cosentyx TP1
    Reporting group description
    -

    Reporting group title
    BAT2306 - BAT2306 TP2
    Reporting group description
    -

    Reporting group title
    Cosentyx - Cosentyx TP2
    Reporting group description
    -

    Reporting group title
    Cosentyx - BAT2306 TP2
    Reporting group description
    -

    Serious adverse events
    BAT2306 TP1 Cosentyx TP1 BAT2306 - BAT2306 TP2 Cosentyx - Cosentyx TP2 Cosentyx - BAT2306 TP2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 252 (1.59%)
    14 / 250 (5.60%)
    5 / 243 (2.06%)
    3 / 118 (2.54%)
    2 / 113 (1.77%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Rectal adenocarcinoma
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 250 (0.00%)
    1 / 243 (0.41%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    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
    Thyroid adenoma
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 250 (0.00%)
    1 / 243 (0.41%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    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
    Psychiatric disorders
    Behaviour disorder
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 250 (0.40%)
    0 / 243 (0.00%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    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
    Mental disorder
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 250 (0.40%)
    0 / 243 (0.00%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    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
    Affective disorder
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 250 (0.00%)
    0 / 243 (0.00%)
    1 / 118 (0.85%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    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
    Injury, poisoning and procedural complications
    Compression fracture
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 250 (0.40%)
    0 / 243 (0.00%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    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
    Ligament rupture
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 250 (0.40%)
    0 / 243 (0.00%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    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
    Meniscus injury
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 250 (0.40%)
    0 / 243 (0.00%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    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
    Cataract traumatic
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 250 (0.00%)
    0 / 243 (0.00%)
    1 / 118 (0.85%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    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
    Clavicle fracture
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 250 (0.00%)
    0 / 243 (0.00%)
    0 / 118 (0.00%)
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 250 (0.40%)
    0 / 243 (0.00%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    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
    Arteriosclerosis coronary artery
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 250 (0.40%)
    0 / 243 (0.00%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    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
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 250 (0.40%)
    0 / 243 (0.00%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    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
    Carotid artery stenosis
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 250 (0.00%)
    1 / 243 (0.41%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    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
    Ear and labyrinth disorders
    Deafness neurosensory
         subjects affected / exposed
    1 / 252 (0.40%)
    0 / 250 (0.00%)
    0 / 243 (0.00%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    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
    Eye disorders
    Lens dislocation
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 250 (0.00%)
    0 / 243 (0.00%)
    1 / 118 (0.85%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    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
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 250 (0.40%)
    0 / 243 (0.00%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal ulcer
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 250 (0.40%)
    0 / 243 (0.00%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 250 (0.40%)
    0 / 243 (0.00%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Drug eruption
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 250 (0.40%)
    0 / 243 (0.00%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyshidrotic eczema
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 250 (0.40%)
    0 / 243 (0.00%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pustular psoriasis
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 250 (0.40%)
    0 / 243 (0.00%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 252 (0.40%)
    0 / 250 (0.00%)
    0 / 243 (0.00%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    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
    Glomerulonephritis chronic
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 250 (0.40%)
    0 / 243 (0.00%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    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
    Ureterolithiasis
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 250 (0.00%)
    0 / 243 (0.00%)
    1 / 118 (0.85%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    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
    Musculoskeletal and connective tissue disorders
    Intervertebral disc
         subjects affected / exposed
    1 / 252 (0.40%)
    0 / 250 (0.00%)
    0 / 243 (0.00%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    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
    Rhabdomyolysis
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 250 (0.00%)
    0 / 243 (0.00%)
    0 / 118 (0.00%)
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Anal fistula infection
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 250 (0.40%)
    0 / 243 (0.00%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 250 (0.40%)
    0 / 243 (0.00%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 250 (0.40%)
    0 / 243 (0.00%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    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
    Chronic tonsillitis
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 250 (0.00%)
    1 / 243 (0.41%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 252 (0.40%)
    0 / 250 (0.00%)
    0 / 243 (0.00%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    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
    Diabetes mellitus
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 250 (0.00%)
    1 / 243 (0.41%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    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
    Frequency threshold for reporting non-serious adverse events: 1.5%
    Non-serious adverse events
    BAT2306 TP1 Cosentyx TP1 BAT2306 - BAT2306 TP2 Cosentyx - Cosentyx TP2 Cosentyx - BAT2306 TP2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    144 / 252 (57.14%)
    158 / 250 (63.20%)
    129 / 243 (53.09%)
    67 / 118 (56.78%)
    69 / 113 (61.06%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    8 / 252 (3.17%)
    6 / 250 (2.40%)
    2 / 243 (0.82%)
    1 / 118 (0.85%)
    3 / 113 (2.65%)
         occurrences all number
    9
    6
    2
    1
    3
    Blood glucose increased
         subjects affected / exposed
    3 / 252 (1.19%)
    6 / 250 (2.40%)
    3 / 243 (1.23%)
    3 / 118 (2.54%)
    2 / 113 (1.77%)
         occurrences all number
    4
    6
    3
    4
    3
    Blood uric acid increased
         subjects affected / exposed
    8 / 252 (3.17%)
    3 / 250 (1.20%)
    4 / 243 (1.65%)
    2 / 118 (1.69%)
    0 / 113 (0.00%)
         occurrences all number
    12
    3
    4
    2
    0
    Blood bilirubin increased
         subjects affected / exposed
    8 / 252 (3.17%)
    5 / 250 (2.00%)
    4 / 243 (1.65%)
    2 / 118 (1.69%)
    0 / 113 (0.00%)
         occurrences all number
    9
    6
    4
    2
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    3 / 252 (1.19%)
    7 / 250 (2.80%)
    4 / 243 (1.65%)
    2 / 118 (1.69%)
    0 / 113 (0.00%)
         occurrences all number
    3
    8
    4
    2
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    6 / 252 (2.38%)
    2 / 250 (0.80%)
    2 / 243 (0.82%)
    0 / 118 (0.00%)
    3 / 113 (2.65%)
         occurrences all number
    6
    2
    2
    0
    3
    Protein urine present
         subjects affected / exposed
    4 / 252 (1.59%)
    5 / 250 (2.00%)
    2 / 243 (0.82%)
    2 / 118 (1.69%)
    1 / 113 (0.88%)
         occurrences all number
    4
    6
    2
    3
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    4 / 252 (1.59%)
    3 / 250 (1.20%)
    3 / 243 (1.23%)
    1 / 118 (0.85%)
    1 / 113 (0.88%)
         occurrences all number
    4
    3
    4
    1
    1
    Urinary occult blood positive
         subjects affected / exposed
    4 / 252 (1.59%)
    2 / 250 (0.80%)
    4 / 243 (1.65%)
    2 / 118 (1.69%)
    0 / 113 (0.00%)
         occurrences all number
    4
    3
    4
    2
    0
    Blood triglycerides increased
         subjects affected / exposed
    1 / 252 (0.40%)
    3 / 250 (1.20%)
    4 / 243 (1.65%)
    1 / 118 (0.85%)
    0 / 113 (0.00%)
         occurrences all number
    1
    3
    4
    1
    0
    White blood cells urine positive
         subjects affected / exposed
    2 / 252 (0.79%)
    2 / 250 (0.80%)
    4 / 243 (1.65%)
    1 / 118 (0.85%)
    2 / 113 (1.77%)
         occurrences all number
    2
    2
    4
    1
    2
    White blood cell count increased
         subjects affected / exposed
    1 / 252 (0.40%)
    0 / 250 (0.00%)
    4 / 243 (1.65%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences all number
    1
    0
    4
    0
    0
    Weight increased
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 250 (0.00%)
    0 / 243 (0.00%)
    1 / 118 (0.85%)
    2 / 113 (1.77%)
         occurrences all number
    0
    0
    0
    1
    2
    Weight decreased
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 250 (0.00%)
    0 / 243 (0.00%)
    2 / 118 (1.69%)
    0 / 113 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Blood cholesterol increased
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 250 (0.00%)
    1 / 243 (0.41%)
    0 / 118 (0.00%)
    2 / 113 (1.77%)
         occurrences all number
    0
    0
    1
    0
    2
    Glucose urine present
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 250 (0.00%)
    0 / 243 (0.00%)
    2 / 118 (1.69%)
    0 / 113 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 252 (1.19%)
    5 / 250 (2.00%)
    3 / 243 (1.23%)
    1 / 118 (0.85%)
    0 / 113 (0.00%)
         occurrences all number
    3
    5
    3
    1
    0
    Cardiac disorders
    Sinus arrhythmia
         subjects affected / exposed
    2 / 252 (0.79%)
    4 / 250 (1.60%)
    3 / 243 (1.23%)
    0 / 118 (0.00%)
    0 / 113 (0.00%)
         occurrences all number
    2
    4
    3
    0
    0
    Sinus bradycardia
         subjects affected / exposed
    1 / 252 (0.40%)
    4 / 250 (1.60%)
    3 / 243 (1.23%)
    1 / 118 (0.85%)
    0 / 113 (0.00%)
         occurrences all number
    1
    4
    3
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 252 (0.79%)
    4 / 250 (1.60%)
    2 / 243 (0.82%)
    2 / 118 (1.69%)
    1 / 113 (0.88%)
         occurrences all number
    2
    4
    2
    2
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    7 / 252 (2.78%)
    3 / 250 (1.20%)
    1 / 243 (0.41%)
    1 / 118 (0.85%)
    2 / 113 (1.77%)
         occurrences all number
    8
    4
    1
    1
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 252 (0.79%)
    2 / 250 (0.80%)
    6 / 243 (2.47%)
    2 / 118 (1.69%)
    1 / 113 (0.88%)
         occurrences all number
    2
    2
    7
    2
    1
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    4 / 252 (1.59%)
    5 / 250 (2.00%)
    3 / 243 (1.23%)
    4 / 118 (3.39%)
    1 / 113 (0.88%)
         occurrences all number
    4
    5
    3
    4
    1
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    12 / 252 (4.76%)
    7 / 250 (2.80%)
    11 / 243 (4.53%)
    1 / 118 (0.85%)
    2 / 113 (1.77%)
         occurrences all number
    13
    8
    12
    1
    2
    Urticaria
         subjects affected / exposed
    5 / 252 (1.98%)
    8 / 250 (3.20%)
    1 / 243 (0.41%)
    2 / 118 (1.69%)
    1 / 113 (0.88%)
         occurrences all number
    5
    9
    1
    2
    1
    Dermatitis contact
         subjects affected / exposed
    1 / 252 (0.40%)
    3 / 250 (1.20%)
    2 / 243 (0.82%)
    1 / 118 (0.85%)
    2 / 113 (1.77%)
         occurrences all number
    2
    3
    2
    1
    2
    Acne
         subjects affected / exposed
    2 / 252 (0.79%)
    1 / 250 (0.40%)
    2 / 243 (0.82%)
    2 / 118 (1.69%)
    0 / 113 (0.00%)
         occurrences all number
    2
    1
    2
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 252 (2.38%)
    0 / 250 (0.00%)
    1 / 243 (0.41%)
    1 / 118 (0.85%)
    2 / 113 (1.77%)
         occurrences all number
    6
    0
    1
    1
    2
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    20 / 252 (7.94%)
    22 / 250 (8.80%)
    19 / 243 (7.82%)
    12 / 118 (10.17%)
    10 / 113 (8.85%)
         occurrences all number
    23
    26
    22
    17
    12
    Nasopharyngitis
         subjects affected / exposed
    14 / 252 (5.56%)
    13 / 250 (5.20%)
    14 / 243 (5.76%)
    6 / 118 (5.08%)
    7 / 113 (6.19%)
         occurrences all number
    15
    13
    17
    6
    7
    Pharyngitis
         subjects affected / exposed
    7 / 252 (2.78%)
    6 / 250 (2.40%)
    2 / 243 (0.82%)
    1 / 118 (0.85%)
    0 / 113 (0.00%)
         occurrences all number
    7
    6
    2
    1
    0
    COVID-19
         subjects affected / exposed
    6 / 252 (2.38%)
    1 / 250 (0.40%)
    4 / 243 (1.65%)
    2 / 118 (1.69%)
    2 / 113 (1.77%)
         occurrences all number
    6
    1
    4
    2
    2
    Otitis externa
         subjects affected / exposed
    5 / 252 (1.98%)
    3 / 250 (1.20%)
    2 / 243 (0.82%)
    5 / 118 (4.24%)
    0 / 113 (0.00%)
         occurrences all number
    4
    3
    2
    5
    0
    Tinea pedis
         subjects affected / exposed
    5 / 252 (1.98%)
    3 / 250 (1.20%)
    2 / 243 (0.82%)
    5 / 118 (4.24%)
    0 / 113 (0.00%)
         occurrences all number
    5
    3
    2
    5
    0
    Conjunctivitis
         subjects affected / exposed
    3 / 252 (1.19%)
    4 / 250 (1.60%)
    3 / 243 (1.23%)
    0 / 118 (0.00%)
    2 / 113 (1.77%)
         occurrences all number
    3
    4
    3
    0
    2
    Urinary tract infection
         subjects affected / exposed
    0 / 252 (0.00%)
    5 / 250 (2.00%)
    3 / 243 (1.23%)
    2 / 118 (1.69%)
    0 / 113 (0.00%)
         occurrences all number
    0
    6
    4
    2
    0
    Bronchitis
         subjects affected / exposed
    2 / 252 (0.79%)
    3 / 250 (1.20%)
    0 / 243 (0.00%)
    1 / 118 (0.85%)
    3 / 113 (2.65%)
         occurrences all number
    2
    3
    0
    1
    3
    Folliculitis
         subjects affected / exposed
    5 / 252 (1.98%)
    0 / 250 (0.00%)
    2 / 243 (0.82%)
    1 / 118 (0.85%)
    0 / 113 (0.00%)
         occurrences all number
    6
    0
    2
    2
    0
    Tonsillitis
         subjects affected / exposed
    0 / 252 (0.00%)
    3 / 250 (1.20%)
    2 / 243 (0.82%)
    2 / 118 (1.69%)
    1 / 113 (0.88%)
         occurrences all number
    0
    3
    2
    2
    2
    Pulpitis dental
         subjects affected / exposed
    0 / 252 (0.00%)
    2 / 250 (0.80%)
    3 / 243 (1.23%)
    0 / 118 (0.00%)
    2 / 113 (1.77%)
         occurrences all number
    0
    2
    3
    0
    2
    Pneumonia
         subjects affected / exposed
    1 / 252 (0.40%)
    2 / 250 (0.80%)
    2 / 243 (0.82%)
    1 / 118 (0.85%)
    0 / 113 (0.00%)
         occurrences all number
    1
    2
    3
    1
    0
    Influenza
         subjects affected / exposed
    0 / 252 (0.00%)
    2 / 250 (0.80%)
    1 / 243 (0.41%)
    0 / 118 (0.00%)
    2 / 113 (1.77%)
         occurrences all number
    0
    2
    1
    0
    4
    Fungal foot infection
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 250 (0.40%)
    0 / 243 (0.00%)
    0 / 118 (0.00%)
    2 / 113 (1.77%)
         occurrences all number
    0
    1
    0
    0
    2
    Asymptomatic bacteriuria
         subjects affected / exposed
    0 / 252 (0.00%)
    1 / 250 (0.40%)
    0 / 243 (0.00%)
    2 / 118 (1.69%)
    0 / 113 (0.00%)
         occurrences all number
    0
    1
    0
    2
    0
    Paronychia
         subjects affected / exposed
    0 / 252 (0.00%)
    0 / 250 (0.00%)
    0 / 243 (0.00%)
    0 / 118 (0.00%)
    2 / 113 (1.77%)
         occurrences all number
    0
    0
    0
    0
    2
    Metabolism and nutrition disorders
    Hyperlipidaemia
         subjects affected / exposed
    7 / 252 (2.78%)
    10 / 250 (4.00%)
    7 / 243 (2.88%)
    2 / 118 (1.69%)
    3 / 113 (2.65%)
         occurrences all number
    9
    10
    7
    2
    3
    Hyperuricaemia
         subjects affected / exposed
    6 / 252 (2.38%)
    9 / 250 (3.60%)
    6 / 243 (2.47%)
    2 / 118 (1.69%)
    4 / 113 (3.54%)
         occurrences all number
    7
    11
    6
    2
    5
    Hypokalaemia
         subjects affected / exposed
    0 / 252 (0.00%)
    2 / 250 (0.80%)
    0 / 243 (0.00%)
    0 / 118 (0.00%)
    2 / 113 (1.77%)
         occurrences all number
    0
    2
    0
    0
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Dec 2022
    • Patients not achieving a minimal clinically significant response (PASI-75) at the Week 24 assessment will be discontinued from the study treatment and followed up •FDA and NMPA: Percent change from baseline in PASI score to Week 12.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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