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    Clinical Trial Results:
    A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients with Moderate to Severe Plaque Psoriasis

    Summary
    EudraCT number
    		 2020-001045-39
    Trial protocol
    		 EE  
    Global end of trial date
    12 May 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 May 2023
    First version publication date
    19 May 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CT-P43_3.1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04673786
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Celltrion, Inc.
    Sponsor organisation address
    23, Academy-ro, Incheon, Korea, Republic of,
    Public contact
    Youn Jeong Choi, Celltrion, Inc., 82 32 850 5767, YounJeong.choi@celltrion.com
    Scientific contact
    Yun Ju Bae, Celltrion, Inc., 82 32 850 4160, YunJu.Bae@celltrion.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
    12 May 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 May 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to demonstrate that CT-P43 is equivalent to EU-Stelara, in terms of efficacy as determined by the mean percent improvement from baseline in Psoriasis Area and Severity Index (PASI) score at Week 12.
    Protection of trial subjects
    Hypersensitivity reactions will be assessed prior to the study drug administration and 1 hour (±10 minutes) after the end of the study drug administration by additional vital sign measurements including BP, pulse and respiratory rates, and body temperature. If patients have signs and symptoms of hypersensitivity/allergic reactions at home (hives, difficulty breathing, or swelling of face, eyes, lips, or mouth or any symptoms of cardiac origin), patients or caregivers should be advised to call the study center or get immediate help. In addition, hypersensitivity will be monitored by routine continuous clinical monitoring including patient-reported signs and symptoms. In case of hypersensitivity, emergency medication and equipment, such as adrenaline, antihistamines, corticosteroids, and respiratory support including inhalational therapy, oxygen, and artificial ventilation must be available and any types of ECG can be performed. For patients who experience or develop life-threatening treatment-related anaphylactic reactions, study drug must be stopped immediately and succeeding doses need to be discontinued.
    Background therapy
    		 -
    Evidence for comparator
    		 CT-P43 has been developed as a proposed biosimilar product to Stelara (ustekinumab), a human IgG1қ monoclonal antibody that binds with high affinity and specificity to the p40 protein subunit used by both the interleukin (IL)-12 and IL-23 cytokines. The purpose of this study is to show that there are no clinical meaningful differences between the two products.
    Actual start date of recruitment
    14 Dec 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 377
    Country: Number of subjects enrolled
    Estonia: 11
    Country: Number of subjects enrolled
    Korea, Republic of: 48
    Country: Number of subjects enrolled
    Ukraine: 73
    Worldwide total number of subjects
    509
    EEA total number of subjects
    388
    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)
    483
    From 65 to 84 years
    26
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The first patient randomly assigned to study drug: 11 January 2021. The study was conducted at 34 study centers in Estonia, Korea, Poland and Ukraine.

    Pre-assignment
    Screening details
    		 Male or female patient aged 18-80 years with moderate to severe chronic plaque psoriasis (with or without psoriatic arthritis [PsA]) for at least 24 weeks

    Pre-assignment period milestones
    Number of subjects started
    		 574 [1]
    Number of subjects completed
    		 509

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 14
    Reason: Number of subjects
    		 Other: 2
    Reason: Number of subjects
    		 Inclusion/Exclusion criteria not met: 49
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The 'Number of subjects reported to have started the pre-assignment period' means subjects who consented to participate in this trial through the Screening procedure. If these subjects meet Inclusion and Exclusion criteria defined by the protocol, they can be randomized which will have study drug administration. For this reason, 574 patients were screened and of these 509 patients were met Inclusion and Exclusion criteria and randomized to each arm.
    Period 1
    Period 1 title
    Treatment Period I
    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, patients, and other predefined personnel from the sponsor and CRO teams remained blinded until the EOS.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CT-P43
    Arm description
    		 CT-P43 45mg or 90mg at Weeks 0 and 4
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT-P43
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients who were initially randomly assigned to CT-P43 45 mg (who weighed ≤100 kg) or 90 mg (who weighed >100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight.

    Arm title
    		 EU-Stelara
    Arm description
    		 EU-Stelara 45mg or 90mg at Weeks 0 and 4
    Arm type
    		 Active comparator

    Investigational medicinal product name
    EU-Stelara
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients who were initially randomly assigned to EU-Stelara 45 mg (who weighed ≤100 kg) or 90 mg (who weighed >100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight.

    Number of subjects in period 1
    		CT-P43 EU-Stelara
    Started
    256
    253
    Completed
    253
    249
    Not completed
    3
    4
         Consent withdrawn by subject
    3
    3
         Lost to follow-up
    -
    1
    Period 2
    Period 2 title
    Treatment Period II
    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, patients, and other predefined personnel from the sponsor and CRO teams remained blinded until the EOS.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CT-P43 Maintenance
    Arm description
    		 All patients who received CT-P43 during Treatment Period I and continued to receive CT-P43 in Treatment Period II (at Weeks 16, 28 and 40).
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT-P43
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients administered 45 mg (who weighed ≤100 kg) or 90 mg (who weighed >100 kg) of CT-P43 subcutaneously at Weeks 16, 28 and 40.

    Arm title
    		 EU-Stelara maintenance
    Arm description
    		 Patients who were initially randomly assigned to EU-Stelara at Day 1 (Week 0) were to continue to receive EU-Stelara in Treatment Period II (at Weeks 16, 28 and 40).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    EU-Stelara
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients administered 45 mg (who weighed ≤100 kg) or 90 mg (who weighed >100 kg) of EU-Stelara subcutaneously at Weeks 16, 28 and 40.

    Arm title
    		 Switched to CT-P43
    Arm description
    		 Patients who received EU-Stelara during Treatment Period I and re-randomized to receive CT-P43 in Treatment Period II (at Weeks 16, 28 and 40).
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT-P43
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients were switched to administer 45 mg (who weighed ≤100 kg) or 90 mg (who weighed >100 kg) of CT-P43 subcutaneously at Weeks 16, 28 and 40.

    Number of subjects in period 2
    		CT-P43 Maintenance EU-Stelara maintenance Switched to CT-P43
    Started
    253
    125
    124
    Completed
    239
    122
    122
    Not completed
    14
    3
    2
         Consent withdrawn by subject
    9
    3
    1
         Adverse event, non-fatal
    2
    -
    1
         Death
    1
    -
    -
         Lost to follow-up
    2
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CT-P43
    Reporting group description
    		 CT-P43 45mg or 90mg at Weeks 0 and 4

    Reporting group title
    EU-Stelara
    Reporting group description
    		 EU-Stelara 45mg or 90mg at Weeks 0 and 4

    Reporting group values
    		 CT-P43 EU-Stelara Total
    Number of subjects
    		 256 253 509
    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)
    		 242 241 483
        From 65-84 years
    		 14 12 26
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 41 (18 to 74) 41 (18 to 77) -
    Gender categorical
    Units: Subjects
        Female
    		 95 80 175
        Male
    		 161 173 334
    Presence of Psoriasis Arthritis at Screening
    Units: Subjects
        Yes
    		 80 83 163
        No
    		 176 170 346
    Time since Plaque-type Psoriasis Diagnosis
    Units: year
        arithmetic mean (standard deviation)
    		 17.81 ( 12.144 ) 15.56 ( 11.560 ) -

    End points

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    End points reporting groups
    Reporting group title
    CT-P43
    Reporting group description
    		 CT-P43 45mg or 90mg at Weeks 0 and 4

    Reporting group title
    EU-Stelara
    Reporting group description
    		 EU-Stelara 45mg or 90mg at Weeks 0 and 4
    Reporting group title
    CT-P43 Maintenance
    Reporting group description
    		 All patients who received CT-P43 during Treatment Period I and continued to receive CT-P43 in Treatment Period II (at Weeks 16, 28 and 40).

    Reporting group title
    EU-Stelara maintenance
    Reporting group description
    		 Patients who were initially randomly assigned to EU-Stelara at Day 1 (Week 0) were to continue to receive EU-Stelara in Treatment Period II (at Weeks 16, 28 and 40).

    Reporting group title
    Switched to CT-P43
    Reporting group description
    		 Patients who received EU-Stelara during Treatment Period I and re-randomized to receive CT-P43 in Treatment Period II (at Weeks 16, 28 and 40).

    Primary: The Mean Percent Improvement From Baseline in PASI Score at Week 12

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    End point title
    		 The Mean Percent Improvement From Baseline in PASI Score at Week 12
    End point description
    The mean percent improvement from baseline in Psoriasis Area and Severity Index (PASI) score at Week 12. PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).
    End point type
    Primary
    End point timeframe
    From baseline to Week 12
    End point values
    		 CT-P43 EU-Stelara
    Number of subjects analysed
    198 [1]
    194 [2]
    Units: percent
        least squares mean (standard error)
    78.26 ( 2.054 )
    77.33 ( 2.049 )
    Notes
    [1] - The equivalence test was conducted with patients administered 45 mg only in Treatment Period I.
    [2] - The equivalence test was conducted with patients administered 45 mg only in Treatment Period I.
    Statistical analysis title
    		 Primary efficacy analysis
    Statistical analysis description
    The equivalence test consisted of patients who are administered at least one 45 mg of study drug and had never received 90 mg of study drug in Treatment Period I. The primary efficacy analysis was conducted on the FAS using an analysis of covariance (ANCOVA) model considering the treatment as a fixed effect and country, baseline body weight, prior biologic use approved for psoriasis treatment and baseline PASI score as covariates.
    Comparison groups
    CT-P43 v EU-Stelara
    Number of subjects included in analysis
    392
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [3]
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference (%) and 95% CI
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.29
         upper limit
    		 4.16
    Notes
    [3] - Predefined equivalence margin: -15% to 15%

    Secondary: The PASI score at Week 12

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    End point title
    		 The PASI score at Week 12
    End point description
    The percent improvement from baseline in Psoriasis Area and Severity Index (PASI) score at Week 12. PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 CT-P43 EU-Stelara
    Number of subjects analysed
    256
    248
    Units: score
        arithmetic mean (standard deviation)
    2.98 ( 3.412 )
    3.44 ( 4.362 )
    No statistical analyses for this end point

    Secondary: The Mean Percent Improvement From Baseline in PASI Score Through Week 52

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    End point title
    		 The Mean Percent Improvement From Baseline in PASI Score Through Week 52
    End point description
    The Psoriasis Area and Severity Index (PASI) score through Week 52. PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).
    End point type
    Secondary
    End point timeframe
    Through Week 52
    End point values
    		 CT-P43 Maintenance EU-Stelara maintenance Switched to CT-P43
    Number of subjects analysed
    242
    122
    123
    Units: percent
        arithmetic mean (standard deviation)
    93.79 ( 11.794 )
    93.39 ( 14.947 )
    91.58 ( 13.264 )
    No statistical analyses for this end point

    Secondary: The Number of Patients Achieving PASI 50/75/90/100 Responses at Week 12

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    End point title
    		 The Number of Patients Achieving PASI 50/75/90/100 Responses at Week 12
    End point description
    The number of participants achieving at least 50%/75%/90%/100% improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12. PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 CT-P43 EU-Stelara
    Number of subjects analysed
    256
    253
    Units: Responder
        PASI50
    247
    240
        PASI75
    212
    187
        PASI90
    129
    127
        PASI100
    47
    48
    No statistical analyses for this end point

    Secondary: The Number of Patients With sPGA Score of Clear (0) or Almost Clear (1) at Week 12

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    End point title
    		 The Number of Patients With sPGA Score of Clear (0) or Almost Clear (1) at Week 12
    End point description
    The sPGA is a 5-point score ranging from 0 to 4, based on the physician’s assessment of the erythema, average thickness, and scaling of all psoriatic lesions at a given time point. The sum of the 3 scales will be divided by 3 to obtain a final sPGA score.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 CT-P43 EU-Stelara
    Number of subjects analysed
    256
    253
    Units: Responder
    219
    201
    No statistical analyses for this end point

    Secondary: The Change From Baseline in Dermatology Life Quality Index (DLQI) Through Week 52

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    End point title
    		 The Change From Baseline in Dermatology Life Quality Index (DLQI) Through Week 52
    End point description
    This DLQI is a 10-item patient-reported outcome questionnaire that, in addition to evaluating overall QoL, can be used to assess 6 different aspects that may affect QoL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Total scores range from 0 to 30 (less to more impairment).
    End point type
    Secondary
    End point timeframe
    Through Week 52
    End point values
    		 CT-P43 Maintenance EU-Stelara maintenance Switched to CT-P43
    Number of subjects analysed
    242
    122
    123
    Units: Score
        arithmetic mean (standard deviation)
    -10.5 ( 7.24 )
    -8.5 ( 7.17 )
    -9.2 ( 6.93 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Through Week 52
    Adverse event reporting additional description
    Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Treatment Period I: CT-P43
    Reporting group description
    		 CT-P43 45mg or 90mg at Weeks 0 and 4

    Reporting group title
    Treatment Period I: EU-Stelara
    Reporting group description
    		 EU-Stelara 45mg or 90mg at Weeks 0 and 4

    Reporting group title
    Treatment Period II: CT-P43 maintenance
    Reporting group description
    		 All patients who received CT-P43 during Treatment Period I and continued to receive CT-P43 in Treatment Period II (at Weeks 16, 28 and 40).

    Reporting group title
    Treatment Period II: EU-Stelara maintenance
    Reporting group description
    		 Patients who were initially randomly assigned to EU-Stelara at Day 1 (Week 0) were to continue to receive EU-Stelara in Treatment Period II (at Weeks 16, 28 and 40).

    Reporting group title
    Treatment Period II: Switched to CT-P43
    Reporting group description
    		 Patients who received EU-Stelara during Treatment Period I and re-randomized to receive CT-P43 in Treatment Period II (at Weeks 16, 28 and 40).

    Serious adverse events
    		 Treatment Period I: CT-P43 Treatment Period I: EU-Stelara Treatment Period II: CT-P43 maintenance Treatment Period II: EU-Stelara maintenance Treatment Period II: Switched to CT-P43
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 256 (1.56%)
    4 / 253 (1.58%)
    5 / 253 (1.98%)
    3 / 125 (2.40%)
    2 / 124 (1.61%)
         number of deaths (all causes)
    0
    0
    1
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon adenoma
         subjects affected / exposed
    0 / 256 (0.00%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
    0 / 125 (0.00%)
    0 / 124 (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
    Tubular breast carcinoma
         subjects affected / exposed
    0 / 256 (0.00%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
    0 / 125 (0.00%)
    0 / 124 (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
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 256 (0.00%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
    0 / 125 (0.00%)
    0 / 124 (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 / 1
    0 / 0
    0 / 0
    Nervous system disorders
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 256 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
    0 / 125 (0.00%)
    0 / 124 (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
    Guillain-Barre syndrome
         subjects affected / exposed
    0 / 256 (0.00%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
    1 / 125 (0.80%)
    0 / 124 (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
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 256 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
    0 / 125 (0.00%)
    0 / 124 (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
    Gastrointestinal disorders
    Gastrointestinal inflammation
         subjects affected / exposed
    1 / 256 (0.39%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
    0 / 125 (0.00%)
    0 / 124 (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
    Pancreatitis acute
         subjects affected / exposed
    0 / 256 (0.00%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
    0 / 125 (0.00%)
    0 / 124 (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
    Reproductive system and breast disorders
    Menstrual disorder
         subjects affected / exposed
    0 / 256 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
    0 / 125 (0.00%)
    0 / 124 (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
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    0 / 256 (0.00%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
    0 / 125 (0.00%)
    1 / 124 (0.81%)
         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
    Psychiatric disorders
    Bipolar disorder
         subjects affected / exposed
    1 / 256 (0.39%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
    0 / 125 (0.00%)
    0 / 124 (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
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 256 (0.00%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
    0 / 125 (0.00%)
    1 / 124 (0.81%)
         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
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    2 / 256 (0.78%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
    1 / 125 (0.80%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 256 (0.00%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
    1 / 125 (0.80%)
    0 / 124 (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
    Tooth abscess
         subjects affected / exposed
    0 / 256 (0.00%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
    0 / 125 (0.00%)
    0 / 124 (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: 3%
    Non-serious adverse events
    		 Treatment Period I: CT-P43 Treatment Period I: EU-Stelara Treatment Period II: CT-P43 maintenance Treatment Period II: EU-Stelara maintenance Treatment Period II: Switched to CT-P43
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 256 (5.47%)
    20 / 253 (7.91%)
    35 / 253 (13.83%)
    25 / 125 (20.00%)
    28 / 124 (22.58%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 256 (0.00%)
    0 / 253 (0.00%)
    3 / 253 (1.19%)
    3 / 125 (2.40%)
    6 / 124 (4.84%)
         occurrences all number
    0
    0
    3
    3
    6
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 256 (0.00%)
    0 / 253 (0.00%)
    2 / 253 (0.79%)
    3 / 125 (2.40%)
    4 / 124 (3.23%)
         occurrences all number
    0
    0
    2
    3
    4
    Infections and infestations
    COVID-19
         subjects affected / exposed
    11 / 256 (4.30%)
    12 / 253 (4.74%)
    13 / 253 (5.14%)
    11 / 125 (8.80%)
    7 / 124 (5.65%)
         occurrences all number
    11
    12
    13
    11
    8
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 256 (1.17%)
    8 / 253 (3.16%)
    10 / 253 (3.95%)
    4 / 125 (3.20%)
    7 / 124 (5.65%)
         occurrences all number
    3
    8
    10
    4
    8
    Latent tuberculosis
         subjects affected / exposed
    0 / 256 (0.00%)
    0 / 253 (0.00%)
    7 / 253 (2.77%)
    4 / 125 (3.20%)
    4 / 124 (3.23%)
         occurrences all number
    0
    0
    7
    4
    4
    Nasopharyngitis
         subjects affected / exposed
    0 / 256 (0.00%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
    1 / 125 (0.80%)
    4 / 124 (3.23%)
         occurrences all number
    0
    0
    1
    1
    4
    Metabolism and nutrition disorders
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 256 (0.00%)
    0 / 253 (0.00%)
    4 / 253 (1.58%)
    1 / 125 (0.80%)
    4 / 124 (3.23%)
         occurrences all number
    0
    0
    4
    1
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Jul 2021
    Summary of significant changes included the following: • Changed the number of study center and countries. • Added the specific information on Inclusion/Exclusion Criterions for clarifying. • Revised the number of planned enrolled patients as actual number of enrolled patients were exceeded expectations. • Deleted the category of covariate of body weight on the primary efficacy analysis. • Added the plan for statistical test for secondary efficacy endpoints. • Supplemented the definition of major deviations. •Other editorial changes.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Due to the conflict in Ukraine, sponsor provided guideline for exceptional allowance regarding visit window and study assessments (only EOS visit was affected) in order to ensure patients’ safety and the robustness and integrity of data.
    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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