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    Clinical Trial Results:
    A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis

    Summary
    EudraCT number
    		 2019-003849-15
    Trial protocol
    		 FR   AT   BG   ES   CZ   PL   GR   HR   IT  
    Global end of trial date
    11 Jul 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Mar 2024
    First version publication date
    08 Mar 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CT-P13_3.7
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04205643
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Celltrion, Inc.
    Sponsor organisation address
    23, Academy-ro, Yeonsu-gu, Incheon, 22014, Korea, Republic of,
    Public contact
    Yun Ju Bae, Celltrion, Inc., 82 328504160, yunju.bae@celltrion.com
    Scientific contact
    Yun Ju Bae, Celltrion, Inc., 82 328504160, 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
    03 Jan 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Dec 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jul 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate superiority of CT-P13 SC over Placebo SC based on clinical remission at Week 54
    Protection of trial subjects
    Hypersensitivity monitoring (including delayed hypersensitivity) was assessed by vital signs (including blood pressure, heart and respiratory rates, and body temperature) at the following time points at each visit specified in the schedule of events. - Prior to the beginning of study drug administration - Within 15 minutes after the end of study drug administration - 1 hour (+10 minutes) after the end of study drug administration If patients had signs and symptoms of hypersensitivity at home (such as but not limited to skin rash, hives, difficulty breathing, or swelling of face, lips, or mouth, or swelling of the hands, feet, or ankles), patients or caregivers were advised to call the study center or get immediate help. In addition, hypersensitivity was monitored by routine continuous clinical monitoring including patient-reported signs and symptoms. In case of hypersensitivity, emergency equipment, such as adrenaline, antihistamines, corticosteroids, and respiratory support including inhalational therapy, oxygen, and artificial ventilation, were available; in addition, any type of ECG could have been performed. For patients who experienced or developed life-threatening treatment-related anaphylactic reactions, study drug was stopped immediately, and the patient was withdrawn from the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Jul 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: 247
    Country: Number of subjects enrolled
    Croatia: 14
    Country: Number of subjects enrolled
    Bulgaria: 8
    Country: Number of subjects enrolled
    Czechia: 14
    Country: Number of subjects enrolled
    Italy: 25
    Country: Number of subjects enrolled
    Latvia: 7
    Country: Number of subjects enrolled
    Belarus: 3
    Country: Number of subjects enrolled
    Israel: 5
    Country: Number of subjects enrolled
    Mexico: 16
    Country: Number of subjects enrolled
    Russian Federation: 94
    Country: Number of subjects enrolled
    Serbia: 25
    Country: Number of subjects enrolled
    South Africa: 4
    Country: Number of subjects enrolled
    Türkiye: 15
    Country: Number of subjects enrolled
    Ukraine: 71
    Worldwide total number of subjects
    548
    EEA total number of subjects
    315
    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)
    529
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 800 patients from 104 study centers in 15 countries were screened and 548 patients from 92 study centers in 14 countries were enrolled in this study.

    Pre-assignment
    Screening details
    		 Key Inclusion Criteria -Age of 18 to 75 years patients -UC patients with a modified Mayo score of 5-9 points with endoscopic subscore of >=2 points at Screening -Patients with failure of conventional therapy including corticosteroids and/or immunosuppressants -Patients who previously received less than 2 biologic agents and/or JAK inhibitors

    Period 1
    Period 1 title
    Induction Phase
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 CT-P13 IV 5 mg/kg
    Arm description
    		 Patient treated with CT-P13 (5 mg/kg, IV) for Week 0, Week 2, and Week 6.
    Arm type
    		 Induction medication

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		CT-P13 IV 5 mg/kg
    Started
    548
    Completed
    438
    Not completed
    110
         Consent withdrawn by subject
    15
         Physician decision
    5
         Other
    1
         Adverse event
    13
         Lost to follow-up
    2
         Progressive disease
    6
         Non-responder at Week 10
    65
         Protocol deviation
    3
    Period 2
    Period 2 title
    Maintenance Phase
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    This study had a double blind maintenance phase, the treatment assignment for the maintenance phase was blinded to the investigators, patients, and predefined CELLTRION, Inc. and CRO blinded teams until the final CSR was generated. The blind could be broken only if specific emergency treatment would be dictated by knowing the study drug assignment was required for medical management.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CT-P13 SC 120 mg
    Arm description
    		 Patients who were classified as clinical responder at Week 10 received CT-P13 120mg subcutaneously every 2 weeks from Week 10 to Week 54. From Week 22, patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection [2 shots] of CT-P13 SC 120 mg) every 2 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT-P13 SC 120 mg
    Investigational medicinal product code
    Other name
    Remsima SC, Zymfentra
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients who were classified as clinical responder at Week 10 received CT-P13 120mg subcutaneously every 2 weeks from Week 10 to Week 54. From Week 22, patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection [2 shots] of CT-P13 SC 120 mg) every 2 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Patients who were classified as clinical responder at Week 10 received placebo-matching subcutaneously every 2 weeks from Week 10 to Week 54. From Week 22, patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection [2 shots] of CT-P13 SC 120 mg) every 2 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients who were classified as clinical responder at Week 10 received placebo-matching subcutaneously every 2 weeks from Week 10 to Week 54. From Week 22, patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection [2 shots] of CT-P13 SC 120 mg) every 2 weeks.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Only for patients in Period 2 were considered as baseline as per objective of this study was to demonstrate superiority of CT-P13 SC over Placebo.
    Number of subjects in period 2 [2]
    		CT-P13 SC 120 mg Placebo
    Started
    294
    144
    Completed
    237
    111
    Not completed
    57
    33
         Physician decision
    4
    2
         Consent withdrawn by subject
    24
    12
         Other
    2
    1
         Adverse event
    11
    9
         Progressive disease
    13
    9
         Non-responder at Week 10
    1
    -
         Lost to follow-up
    2
    -
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Only for patients in Period 2 were considered as baseline as per objective of this study was to demonstrate superiority of CT-P13 SC over Placebo.
    Period 3
    Period 3 title
    Extension Phase
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CT-P13 SC 120 mg
    Arm description
    		 In the open-label extension phase, all patients who completed the maintenance phase up to Week 54 and may benefit from continued treatment, in the opinion of the investigator, received active treatment with CT-P13 SC 120 mg via PFS from Week 56. The patients who received the adjusted dose of CT-P13 SC 240 mg in the Maintenance Phase continued receiving the same doses of CT-P13 SC for the study treatment in the Extension Phase. Patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection [2 shots] of CT-P13 SC 120 mg) every 2 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT-P13 SC 120 mg
    Investigational medicinal product code
    Other name
    Remsima SC, Zymfentra
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients who completed the Maintenance Phase CT-P13 SC treatment up to Week 54 and may benefit from continued treatment, in the opinion of the investigator, received active treatment with CT-P13 SC 120 mg via PFS from Week 56 to Week 102. The patients who received the adjusted dose of CT-P13 SC 240 mg in the Maintenance Phase continued receiving the same doses of CT-P13 SC for the study treatment in the Extension Phase. Patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection [2 shots] of CT-P13 SC 120 mg) every 2 weeks.

    Arm title
    		 Placebo
    Arm description
    		 In the open-label extension phase, all patients who completed the maintenance phase up to Week 54 and may benefit from continued treatment, in the opinion of the investigator, received active treatment with CT-P13 SC 120 mg via PFS from Week 56. The patients who received the adjusted dose of CT-P13 SC 240 mg in the Maintenance Phase continued receiving the same doses of CT-P13 SC for the study treatment in the Extension Phase. Patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection [2 shots] of CT-P13 SC 120 mg) every 2 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    CT-P13 SC 120 mg
    Investigational medicinal product code
    Other name
    Remsima SC, Zymfentra
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients who completed the Maintenance Phase Placebo SC treatment up to Week 54 and may benefit from continued treatment, in the opinion of the investigator, received active treatment with CT-P13 SC 120 mg via PFS from Week 56 to Week 102. The patients who received the adjusted dose of CT-P13 SC 240 mg in the Maintenance Phase continued receiving the same doses of CT-P13 SC for the study treatment in the Extension Phase. Patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection [2 shots] of CT-P13 SC 120 mg) every 2 weeks.

    Number of subjects in period 3
    		CT-P13 SC 120 mg Placebo
    Started
    237
    111
    Completed
    208
    95
    Not completed
    29
    16
         Physician decision
    2
    3
         Consent withdrawn by subject
    11
    5
         Other
    1
    -
         Pregnancy
    1
    -
         Adverse event
    5
    1
         Progressive disease
    5
    4
         Lost to follow-up
    4
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CT-P13 SC 120 mg
    Reporting group description
    		 Patients who were classified as clinical responder at Week 10 received CT-P13 120mg subcutaneously every 2 weeks from Week 10 to Week 54. From Week 22, patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection [2 shots] of CT-P13 SC 120 mg) every 2 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Patients who were classified as clinical responder at Week 10 received placebo-matching subcutaneously every 2 weeks from Week 10 to Week 54. From Week 22, patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection [2 shots] of CT-P13 SC 120 mg) every 2 weeks.

    Reporting group values
    		 CT-P13 SC 120 mg Placebo Total
    Number of subjects
    		 294 144 438
    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)
    		 286 138 424
        From 65-84 years
    		 8 6 14
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.2 ( 12.78 ) 40.4 ( 13.49 ) -
    Gender categorical
    Units: Subjects
        Female
    		 131 61 192
        Male
    		 163 83 246
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 6 4 10
        Asian
    		 0 0 0
        Black or African American
    		 0 0 0
        Native Hawaiian or other Pacific Islander
    		 0 0 0
        White
    		 288 140 428
        Not allowed by investigator country regulations
    		 0 0 0
        Other
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    CT-P13 IV 5 mg/kg
    Reporting group description
    		 Patient treated with CT-P13 (5 mg/kg, IV) for Week 0, Week 2, and Week 6.
    Reporting group title
    CT-P13 SC 120 mg
    Reporting group description
    		 Patients who were classified as clinical responder at Week 10 received CT-P13 120mg subcutaneously every 2 weeks from Week 10 to Week 54. From Week 22, patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection [2 shots] of CT-P13 SC 120 mg) every 2 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Patients who were classified as clinical responder at Week 10 received placebo-matching subcutaneously every 2 weeks from Week 10 to Week 54. From Week 22, patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection [2 shots] of CT-P13 SC 120 mg) every 2 weeks.
    Reporting group title
    CT-P13 SC 120 mg
    Reporting group description
    		 In the open-label extension phase, all patients who completed the maintenance phase up to Week 54 and may benefit from continued treatment, in the opinion of the investigator, received active treatment with CT-P13 SC 120 mg via PFS from Week 56. The patients who received the adjusted dose of CT-P13 SC 240 mg in the Maintenance Phase continued receiving the same doses of CT-P13 SC for the study treatment in the Extension Phase. Patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection [2 shots] of CT-P13 SC 120 mg) every 2 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 In the open-label extension phase, all patients who completed the maintenance phase up to Week 54 and may benefit from continued treatment, in the opinion of the investigator, received active treatment with CT-P13 SC 120 mg via PFS from Week 56. The patients who received the adjusted dose of CT-P13 SC 240 mg in the Maintenance Phase continued receiving the same doses of CT-P13 SC for the study treatment in the Extension Phase. Patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection [2 shots] of CT-P13 SC 120 mg) every 2 weeks.

    Primary: Number of Patients Achieving Clinical Remission at Week 54

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    End point title
    		 Number of Patients Achieving Clinical Remission at Week 54
    End point description
    Clinical remission defined by modified Mayo score (ranges from 0 to 9, including Stool frequency subscore, Rectal bleeding subscore and Endoscopic subscore), stool frequency subscore of 0 or 1 point, and rectal bleeding subscore of 0 point, and an endoscopic subscore of 0 or 1 point. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.
    End point type
    Primary
    End point timeframe
    Week 54
    End point values
    		 CT-P13 SC 120 mg Placebo
    Number of subjects analysed
    294
    144
    Units: number of patients
    127
    30
    Statistical analysis title
    		 Clinical Remission
    Comparison groups
    CT-P13 SC 120 mg v Placebo
    Number of subjects included in analysis
    438
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference estimated using CMH weights
    Point estimate
    21.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.8
         upper limit
    		 29.3

    Secondary: Number of Patients Achieving Clinical Response at Week 54

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    End point title
    		 Number of Patients Achieving Clinical Response at Week 54
    End point description
    Clinical response defined by decrease in modified Mayo score from baseline of at least 2 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1 point. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder.
    End point type
    Secondary
    End point timeframe
    Week 54
    End point values
    		 CT-P13 SC 120 mg Placebo
    Number of subjects analysed
    294
    144
    Units: number of patients
    158
    45
    No statistical analyses for this end point

    Secondary: Number of Patients Achieving Endoscopic-Histologic Mucosal Improvement at Week 54

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    End point title
    		 Number of Patients Achieving Endoscopic-Histologic Mucosal Improvement at Week 54
    End point description
    Endoscopic-histologic mucosal improvement defined as an absolute endoscopic subscore of 0 or 1 point from modified Mayo score and an absolute RHI score of 3 points or less with an accompanying lamina propria neutrophils and neutrophils in epithelium subscore of 0 point. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as endoscopic-histologic mucosal improvement not achieved.
    End point type
    Secondary
    End point timeframe
    Week 54
    End point values
    		 CT-P13 SC 120 mg Placebo
    Number of subjects analysed
    294
    144
    Units: number of patients
    105
    24
    No statistical analyses for this end point

    Secondary: Number of Patients Achieving Corticosteroid-Free Remission at Week 54

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    End point title
    		 Number of Patients Achieving Corticosteroid-Free Remission at Week 54
    End point description
    Corticosteroid-free remission defined as being in clinical remission by modified Mayo score in addition to not requiring any treatment with corticosteroid for at least 8 weeks at Week 54, among the patients who used oral corticosteroids at baseline. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.
    End point type
    Secondary
    End point timeframe
    Week 54
    End point values
    		 CT-P13 SC 120 mg Placebo
    Number of subjects analysed
    120
    61
    Units: number of patients
    44
    11
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-Emergent Adverse Events for CT-P13 IV 5 mg/kg group during induction phase (Week 0 to 10), CT-P13 SC 120 mg and placebo groups during the maintenance phase (from Week 10 to Week 54) and extension phase (From Week 56 to Week 102) were reported.
    Adverse event reporting additional description
    Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5 mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC 120 mg and Placebo groups, the safety analyses were performed in the safety population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    CT-P13 IV 5 mg/kg - Induction
    Reporting group description
    		 Patients who administered CT-P13 IV 5mg/kg at Week 0, 2, and 6.

    Reporting group title
    CT-P13 SC 120 mg - Maintenance
    Reporting group description
    		 Patients who administered CT-P13 SC 120 mg every 2 weeks from W10 to Week 54. For patients with dose adjustment, only data before initiation of dose adjustment are included.

    Reporting group title
    Placebo - Maintenance
    Reporting group description
    		 Patients who administered Placebo every 2 weeks from W10 to Week 54. For patients with dose adjustment, only data before initiation of dose adjustment are included.

    Reporting group title
    CT-P13 SC 120 mg - Extension
    Reporting group description
    		 Patients who administered CT-P13 SC 120 mg every 2 weeks from Maintenacne Phase to Week 102. Patients who received adjusted dose of CT-P13 SC 240mg which is allowed from Week 22 are also included.

    Reporting group title
    Placebo - Extension
    Reporting group description
    		 Patients who administered Placebo SC every 2 weeks from Maintenance and switched to CT-P13 SC 120 mg from Week 56. Patients who received adjusted dose of CT-P13 SC 240mg which is allowed from Week 22 are also included.

    Serious adverse events
    		 CT-P13 IV 5 mg/kg - Induction CT-P13 SC 120 mg - Maintenance Placebo - Maintenance CT-P13 SC 120 mg - Extension Placebo - Extension
    Total subjects affected by serious adverse events
         subjects affected / exposed
    23 / 548 (4.20%)
    15 / 296 (5.07%)
    4 / 140 (2.86%)
    12 / 296 (4.05%)
    5 / 140 (3.57%)
         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)
    Colorectal adenoma
         subjects affected / exposed
    0 / 548 (0.00%)
    1 / 296 (0.34%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (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
    Uterine leiomyoma
         subjects affected / exposed
    0 / 548 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    1 / 140 (0.71%)
         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
    Injury, poisoning and procedural complications
    Anastomotic leak
         subjects affected / exposed
    1 / 548 (0.18%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (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
    Clavicle fracture
         subjects affected / exposed
    0 / 548 (0.00%)
    1 / 296 (0.34%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (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
    Infusion related reaction
         subjects affected / exposed
    3 / 548 (0.55%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 548 (0.00%)
    0 / 296 (0.00%)
    1 / 140 (0.71%)
    0 / 296 (0.00%)
    0 / 140 (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
    Cardiac disorders
    Aortic valve incompetence
         subjects affected / exposed
    0 / 548 (0.00%)
    1 / 296 (0.34%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (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
    Cardiac failure
         subjects affected / exposed
    0 / 548 (0.00%)
    1 / 296 (0.34%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (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
    Myocardial infarction
         subjects affected / exposed
    0 / 548 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
    1 / 296 (0.34%)
    0 / 140 (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
    Nervous system disorders
    Neuromyopathy
         subjects affected / exposed
    0 / 548 (0.00%)
    0 / 296 (0.00%)
    1 / 140 (0.71%)
    0 / 296 (0.00%)
    0 / 140 (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
    Cerebral infarction
         subjects affected / exposed
    0 / 548 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
    1 / 296 (0.34%)
    0 / 140 (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
    Syncope
         subjects affected / exposed
    0 / 548 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
    1 / 296 (0.34%)
    0 / 140 (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
    Transient ischaemic attack
         subjects affected / exposed
    0 / 548 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
    1 / 296 (0.34%)
    0 / 140 (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
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 548 (0.55%)
    1 / 296 (0.34%)
    0 / 140 (0.00%)
    1 / 296 (0.34%)
    0 / 140 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    2 / 548 (0.36%)
    1 / 296 (0.34%)
    0 / 140 (0.00%)
    1 / 296 (0.34%)
    0 / 140 (0.00%)
         occurrences causally related to treatment / all
    0 / 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
    Lymphadenopathy
         subjects affected / exposed
    0 / 548 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    1 / 140 (0.71%)
         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
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    3 / 548 (0.55%)
    2 / 296 (0.68%)
    1 / 140 (0.71%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    1 / 548 (0.18%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (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
    Duodenal ulcer perforation
         subjects affected / exposed
    0 / 548 (0.00%)
    1 / 296 (0.34%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (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
    Intestinal obstruction
         subjects affected / exposed
    1 / 548 (0.18%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (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
    Intestinal strangulation
         subjects affected / exposed
    1 / 548 (0.18%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (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
    Large intestine perforation
         subjects affected / exposed
    1 / 548 (0.18%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (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
    1 / 548 (0.18%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
         occurrences causally related to treatment / all
    1 / 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
    Rectal haemorrhage
         subjects affected / exposed
    0 / 548 (0.00%)
    0 / 296 (0.00%)
    1 / 140 (0.71%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Cervical dysplasia
         subjects affected / exposed
    1 / 548 (0.18%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (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
    Cystocele
         subjects affected / exposed
    0 / 548 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    1 / 140 (0.71%)
         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
    Menstruation irregular
         subjects affected / exposed
    0 / 548 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
    1 / 296 (0.34%)
    0 / 140 (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
    Ovarian cyst
         subjects affected / exposed
    0 / 548 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
    1 / 296 (0.34%)
    0 / 140 (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
    Renal and urinary disorders
    Ureterolithiasis
         subjects affected / exposed
    1 / 548 (0.18%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (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
    Calculus urinary
         subjects affected / exposed
    0 / 548 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
    1 / 296 (0.34%)
    0 / 140 (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
    Endocrine disorders
    Thyroiditis
         subjects affected / exposed
    0 / 548 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
    1 / 296 (0.34%)
    0 / 140 (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
    Arthritis
         subjects affected / exposed
    0 / 548 (0.00%)
    1 / 296 (0.34%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (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
    Intervertebral disc degeneration
         subjects affected / exposed
    0 / 548 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
    1 / 296 (0.34%)
    0 / 140 (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
    Periarthritis
         subjects affected / exposed
    0 / 548 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    1 / 140 (0.71%)
         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
    Synovitis
         subjects affected / exposed
    0 / 548 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    1 / 140 (0.71%)
         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
    Appendicitis
         subjects affected / exposed
    1 / 548 (0.18%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
    1 / 296 (0.34%)
    0 / 140 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    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
    1 / 548 (0.18%)
    1 / 296 (0.34%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    2 / 548 (0.36%)
    2 / 296 (0.68%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 548 (0.18%)
    0 / 296 (0.00%)
    1 / 140 (0.71%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    0 / 548 (0.00%)
    1 / 296 (0.34%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (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
    Cytomegalovirus infection
         subjects affected / exposed
    2 / 548 (0.36%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 548 (0.18%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (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
    Pneumonia
         subjects affected / exposed
    0 / 548 (0.00%)
    1 / 296 (0.34%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (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
    Salpingitis
         subjects affected / exposed
    0 / 548 (0.00%)
    1 / 296 (0.34%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (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
    Urinary tract infection
         subjects affected / exposed
    0 / 548 (0.00%)
    1 / 296 (0.34%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (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
    Urosepsis
         subjects affected / exposed
    1 / 548 (0.18%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (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
    Anal abscess
         subjects affected / exposed
    0 / 548 (0.00%)
    0 / 296 (0.00%)
    0 / 140 (0.00%)
    1 / 296 (0.34%)
    0 / 140 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 CT-P13 IV 5 mg/kg - Induction CT-P13 SC 120 mg - Maintenance Placebo - Maintenance CT-P13 SC 120 mg - Extension Placebo - Extension
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    91 / 548 (16.61%)
    64 / 296 (21.62%)
    39 / 140 (27.86%)
    43 / 296 (14.53%)
    25 / 140 (17.86%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    30 / 548 (5.47%)
    15 / 296 (5.07%)
    7 / 140 (5.00%)
    5 / 296 (1.69%)
    2 / 140 (1.43%)
         occurrences all number
    46
    30
    8
    10
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    34 / 548 (6.20%)
    11 / 296 (3.72%)
    5 / 140 (3.57%)
    4 / 296 (1.35%)
    2 / 140 (1.43%)
         occurrences all number
    36
    12
    5
    4
    2
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    13 / 548 (2.37%)
    13 / 296 (4.39%)
    13 / 140 (9.29%)
    11 / 296 (3.72%)
    5 / 140 (3.57%)
         occurrences all number
    14
    14
    14
    14
    6
    Infections and infestations
    COVID-19
         subjects affected / exposed
    13 / 548 (2.37%)
    26 / 296 (8.78%)
    9 / 140 (6.43%)
    15 / 296 (5.07%)
    12 / 140 (8.57%)
         occurrences all number
    13
    27
    9
    16
    13
    Nasopharyngitis
         subjects affected / exposed
    9 / 548 (1.64%)
    5 / 296 (1.69%)
    7 / 140 (5.00%)
    4 / 296 (1.35%)
    3 / 140 (2.14%)
         occurrences all number
    9
    5
    7
    7
    3
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 548 (0.73%)
    6 / 296 (2.03%)
    3 / 140 (2.14%)
    11 / 296 (3.72%)
    8 / 140 (5.71%)
         occurrences all number
    4
    8
    5
    13
    11

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Jan 2020
    • Inclusion criteria was updated to be consistent with approved label of Infliximab. • Prohibited therapy section was updated according to the drug interaction description in the label of Remsima®. • Revised PD sampling to allow all sites to sample and handle the fecal calprotectin and updated the footnotes in the schedule of events tables since all sites were allowed to sample and handle the fecal calprotectin. • Analytical facilities table was updated due to a change in the analytical facilities. • Updated the Mayo scoring system to reflect FDA guideline. • Other administrative changes.
    18 Feb 2020
    • Exclusion criteria was revised in consideration of the potential risk of the infection. • Exclusion criteria was revised to clarify the patient who requires full colonoscopy at Screening. • Exclusion criteria were updated to specify the timeframe for current or history of drug or alcohol abuse. • Study design section was updated to clarify use of endoscopy and biopsy for the evaluation of Mayo score and mucosal healing at Week 10. • Updated the number of countries where the patients will be enrolled. • Corticosteroid tapering regimen was revised to allow local clinical practice for tapering regimen of Budesonide. • Update Mayo score diary collection method to reflect FDA guideline and clarify diary collection methods. • Specified the full colonoscopy required criteria, endoscopic subscore evaluation method and assessment window of endoscopy to clarify. • Revised window of biopsy to clarify histologic assessment window. • Revised immunogenicity testing to analysis further NAb assays, in consideration of the Regulatory authority’s suggestions. • Added text to allow retesting once during Screening. • Added statistical method of endoscopic subscore and RHI score for clarification. • Revised analytic facilities to update information of analytical facilities. • Updated schedule of events for clarification. • Other administrative changes.
    04 Aug 2020
    • Add text to explain how the number of enrolled patients may vary. • Exclusion criteria was revised in consideration of the potential risk of the infection. • Revised study design and study overview for clarification. • Revised study design for induction and maintenance phase, and study design for extension phase to clarify. • Added withdrawal criteria to clarify the reason for withdrawal. • Binding and unblinding details were updated based on CELLTRION, Inc. internal standard operating procedure (SOP). • Added further PK-PD modelling for possible PK-PD modelling. • Added text for biopsy sampling for histologic assessment collections. • Deleted analytical facilities to simplify analytical facilities section. • Updated schedule of events to clarify the time points of efficacy assessments and dosing window. • Other administrative 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.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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