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    Clinical Trial Results:
    A Randomized Double-blind Pharmacokinetic Study of Ustekinumab in Pediatric Subjects with Moderately to Severely Active Crohn's Disease

    Summary
    EudraCT number
    		 2016-001956-22
    Trial protocol
    		 BE   DE   PL   FR   Outside EU/EEA  
    Global end of trial date
    18 Mar 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Oct 2022
    First version publication date
    04 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CNTO1275CRD1001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02968108
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development LLC
    Sponsor organisation address
    920 Route 202, South Raritan NJ, United States, 08869
    Public contact
    Clinical Registry Group, Janssen Research & Development LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research & Development LLC, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000311-PIP04-13
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Mar 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Mar 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this trial was to evaluate the pharmacokinetics (PK) of ustekinumab in subjects from 2 through less than (<) 18 years old and determine if it was similar to that observed in adults with moderately to severely active Crohn’s disease, to assess the safety, immunogenicity, and the efficacy of ustekinumab in the treatment of moderately to severely active Crohn’s disease, including assessment of improvement in the endoscopic appearance of the mucosa. The objective of the long-term extension (LTE) period of study CNTO1275CRD1001 was to evaluate the PK, efficacy, safety, and immunogenicity of ustekinumab in pediatric subjects 2 to <18 years old with moderately to severely active Crohn’s disease.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Jan 2017
    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
    Belgium: 11
    Country: Number of subjects enrolled
    Canada: 5
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    France: 5
    Country: Number of subjects enrolled
    Poland: 10
    Country: Number of subjects enrolled
    United States: 10
    Worldwide total number of subjects
    44
    EEA total number of subjects
    29
    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)
    10
    Adolescents (12-17 years)
    34
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Out of 45 randomised subjects, 44 were treated in double-blind (DB) period (23 in Ustekinumab 3 mg/kg or 130 mg + 2 mg/kg or 90 mg and 21 in 9 mg/kg or 390 mg + 2 mg/kg or 90 mg). In long-term extension (LTE) period, 34 subjects were treated (18 in Ustekinumab 3 mg/kg or 130 mg + 2 mg/kg or 90 mg and 16 in 9 mg/kg or 390 mg + 2 mg/kg or 90 mg).

    Period 1
    Period 1 title
    DB Period (Through Week 16)
    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
    		 Ustekinumab 3 mg/kg or 130 mg + 2 mg/kg or 90 mg
    Arm description
    		 Subjects received single intravenous (IV) ustekinumab induction dose of 3 milligrams per kilogram (mg/kg) (for body weight [BW] less than [<]40 kg) or 130 mg (for BW greater than or equal to [>=]40 kg) at Week 0, followed by single subcutaneous (SC) maintenance dose of ustekinumab 2 mg/kg (for BW <40 kg) or 90 mg (for BW >=40 kg) at Week 8 in the DB period. The duration of DB period was up to prior SC dose administration at Week 16.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab 3 mg/kg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received Ustekinumab 3 mg/kg (if body weight <40 kg).

    Investigational medicinal product name
    Ustekinumab 90 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received Ustekinumab 90 mg (if body weight >=40 kg).

    Investigational medicinal product name
    Ustekinumab 2 mg/kg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received Ustekinumab 2 mg/kg (if body weight <40 kg).

    Investigational medicinal product name
    Ustekinumab 130 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received Ustekinumab 130 mg (if body weight >=40 kg).

    Arm title
    		 Ustekinumab 9 mg/kg or 390 mg + 2 mg/kg or 90 mg
    Arm description
    		 Subjects received single IV ustekinumab induction dose of 9 mg/kg (for BW <40 kg) or 390 mg (for BW >=40 kg) at Week 0, followed by single SC maintenance dose of ustekinumab 2 mg/kg (for BW <40 kg) or 90 mg (for BW >=40 kg) at Week 8 in the DB period. The duration of DB period was up to prior SC dose administration at Week 16.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab 9 mg/kg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received Ustekinumab 9 mg/kg (if body weight <40 kg).

    Investigational medicinal product name
    Ustekinumab 2 mg/kg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received Ustekinumab 2 mg/kg (if body weight <40 kg).

    Investigational medicinal product name
    Ustekinumab 90 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received Ustekinumab 90 mg (if body weight >=40 kg).

    Investigational medicinal product name
    Ustekinumab 390 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received Ustekinumab 390 mg (if body weight >=40 kg).

    Number of subjects in period 1
    		Ustekinumab 3 mg/kg or 130 mg + 2 mg/kg or 90 mg Ustekinumab 9 mg/kg or 390 mg + 2 mg/kg or 90 mg
    Started
    23
    21
    Completed
    22
    18
    Not completed
    1
    3
         Consent withdrawn by subject
    1
    -
         Unspecified
    -
    3
    Period 2
    Period 2 title
    LTE Period: Week 16 Post Dose - Week 268
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ustekinumab 3mg/kg or 130mg in DB then 2mg/kg or 90mg in LTE
    Arm description
    		 After completion of DB period (prior to Week 16 SC dose), subjects received single SC maintenance dose of ustekinumab 2 mg/kg (for BW <40 kg) or 90 mg (for BW >=40 kg) every 8 weeks (Q8W) from Week 16 up to Week 268 or upon availability of Study CNTO1275ISD3001 or completed 20 weeks safety follow-up post last dose or terminated study participation, whichever occurred first.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab 90 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received Ustekinumab 90 mg (for BW >=40 kg).

    Investigational medicinal product name
    Ustekinumab 2 mg/kg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received Ustekinumab 2 mg/kg (for BW <40 kg).

    Arm title
    		 Ustekinumab 9mg/kg or 390mg in DB then 2mg/kg or 90mg in LTE
    Arm description
    		 After completion of DB period (prior to Week 16 SC dose), subjects received single SC maintenance dose of ustekinumab 2 mg/kg (for BW <40 kg) or 90 mg (for BW >=40 kg) Q8W from Week 16 up to Week 268 or upon availability of Study CNTO1275ISD3001 or completed 20 weeks safety follow-up post last dose or terminated study participation, whichever occurred first.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab 90 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received Ustekinumab 90 mg (for BW >=40 kg).

    Investigational medicinal product name
    Ustekinumab 2 mg/kg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received Ustekinumab 2 mg/kg (for BW <40 kg).

    Number of subjects in period 2 [1]
    		Ustekinumab 3mg/kg or 130mg in DB then 2mg/kg or 90mg in LTE Ustekinumab 9mg/kg or 390mg in DB then 2mg/kg or 90mg in LTE
    Started
    18
    16
    Completed
    6
    2
    Not completed
    12
    14
         Consent withdrawn by subject
    5
    5
         Unspecified
    7
    9
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Out of 40 subjects who completed the DB period, only 34 subjects entered the LTE period, as 6 subjects discontinued the study before initiation of LTE period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ustekinumab 3 mg/kg or 130 mg + 2 mg/kg or 90 mg
    Reporting group description
    		 Subjects received single intravenous (IV) ustekinumab induction dose of 3 milligrams per kilogram (mg/kg) (for body weight [BW] less than [<]40 kg) or 130 mg (for BW greater than or equal to [>=]40 kg) at Week 0, followed by single subcutaneous (SC) maintenance dose of ustekinumab 2 mg/kg (for BW <40 kg) or 90 mg (for BW >=40 kg) at Week 8 in the DB period. The duration of DB period was up to prior SC dose administration at Week 16.

    Reporting group title
    Ustekinumab 9 mg/kg or 390 mg + 2 mg/kg or 90 mg
    Reporting group description
    		 Subjects received single IV ustekinumab induction dose of 9 mg/kg (for BW <40 kg) or 390 mg (for BW >=40 kg) at Week 0, followed by single SC maintenance dose of ustekinumab 2 mg/kg (for BW <40 kg) or 90 mg (for BW >=40 kg) at Week 8 in the DB period. The duration of DB period was up to prior SC dose administration at Week 16.

    Reporting group values
    		 Ustekinumab 3 mg/kg or 130 mg + 2 mg/kg or 90 mg Ustekinumab 9 mg/kg or 390 mg + 2 mg/kg or 90 mg Total
    Number of subjects
    		 23 21 44
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 6 4 10
        Adolescents (12-17 years)
    		 17 17 34
        Adults (18-64 years)
    		 0 0 0
        From 65 to 84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 13.2 ± 2.89 13.6 ± 2.62 -
    Title for Gender
    Units: subjects
        Female
    		 17 9 26
        Male
    		 6 12 18

    End points

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    End points reporting groups
    Reporting group title
    Ustekinumab 3 mg/kg or 130 mg + 2 mg/kg or 90 mg
    Reporting group description
    		 Subjects received single intravenous (IV) ustekinumab induction dose of 3 milligrams per kilogram (mg/kg) (for body weight [BW] less than [<]40 kg) or 130 mg (for BW greater than or equal to [>=]40 kg) at Week 0, followed by single subcutaneous (SC) maintenance dose of ustekinumab 2 mg/kg (for BW <40 kg) or 90 mg (for BW >=40 kg) at Week 8 in the DB period. The duration of DB period was up to prior SC dose administration at Week 16.

    Reporting group title
    Ustekinumab 9 mg/kg or 390 mg + 2 mg/kg or 90 mg
    Reporting group description
    		 Subjects received single IV ustekinumab induction dose of 9 mg/kg (for BW <40 kg) or 390 mg (for BW >=40 kg) at Week 0, followed by single SC maintenance dose of ustekinumab 2 mg/kg (for BW <40 kg) or 90 mg (for BW >=40 kg) at Week 8 in the DB period. The duration of DB period was up to prior SC dose administration at Week 16.
    Reporting group title
    Ustekinumab 3mg/kg or 130mg in DB then 2mg/kg or 90mg in LTE
    Reporting group description
    		 After completion of DB period (prior to Week 16 SC dose), subjects received single SC maintenance dose of ustekinumab 2 mg/kg (for BW <40 kg) or 90 mg (for BW >=40 kg) every 8 weeks (Q8W) from Week 16 up to Week 268 or upon availability of Study CNTO1275ISD3001 or completed 20 weeks safety follow-up post last dose or terminated study participation, whichever occurred first.

    Reporting group title
    Ustekinumab 9mg/kg or 390mg in DB then 2mg/kg or 90mg in LTE
    Reporting group description
    		 After completion of DB period (prior to Week 16 SC dose), subjects received single SC maintenance dose of ustekinumab 2 mg/kg (for BW <40 kg) or 90 mg (for BW >=40 kg) Q8W from Week 16 up to Week 268 or upon availability of Study CNTO1275ISD3001 or completed 20 weeks safety follow-up post last dose or terminated study participation, whichever occurred first.

    Primary: Serum Concentrations of Ustekinumab at Week 16

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    End point title
    		 Serum Concentrations of Ustekinumab at Week 16 [1]
    End point description
    Serum concentrations of ustekinumab at Week 16 was reported. Pharmacokinetics (PK) analysis set included all randomised subjects who received at least 1 administration of ustekinumab and who had one or more PK blood samples obtained after the first ustekinumab dose and were analysed according to the actual treatment received. Here, 'N' (number of subjects analysed) signifies number of subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    At Week 16
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics was done, no inferential statistical analysis was performed.
    End point values
    		 Ustekinumab 3 mg/kg or 130 mg + 2 mg/kg or 90 mg Ustekinumab 9 mg/kg or 390 mg + 2 mg/kg or 90 mg
    Number of subjects analysed
    17
    13
    Units: micrograms (mcg)/millilitre (mL)
        arithmetic mean (standard deviation)
    1.47 ± 1.323
    1.80 ± 2.356
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Clinical Response Measured by the Pediatric Crohn's Disease Activity Index (PCDAI) Score at Weeks 8 and 16

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    End point title
    		 Percentage of Subjects with Clinical Response Measured by the Pediatric Crohn's Disease Activity Index (PCDAI) Score at Weeks 8 and 16
    End point description
    Clinical response was defined as a reduction from baseline in the PCDAI score of greater than or equal to (>=)15 points. PCDAI is an index used to measure disease activity of pediatric subjects with Crohn's Disease assessing abdominal pain, stool frequency, subjects functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdominal tenderness or mass, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Efficacy analysis set included all randomised subjects who received at least 1 administration of ustekinumab analysed according to the assigned treatment.
    End point type
    Secondary
    End point timeframe
    Week 8 and Week 16
    End point values
    		 Ustekinumab 3 mg/kg or 130 mg + 2 mg/kg or 90 mg Ustekinumab 9 mg/kg or 390 mg + 2 mg/kg or 90 mg
    Number of subjects analysed
    23
    21
    Units: Percentage of Subjects
    number (not applicable)
        Week 8
    47.8
    47.6
        Week 16
    52.2
    52.4
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Clinical Remission Measured by the PCDAI Score at Weeks 8 and 16

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    End point title
    		 Percentage of Subjects with Clinical Remission Measured by the PCDAI Score at Weeks 8 and 16
    End point description
    Clinical remission was defined as a reduction from baseline in the PCDAI score of less than or equal to (<=)10 points. PCDAI is an index used to measure disease activity of pediatric subjects with Crohn's Disease assessing abdominal pain, stool frequency, subjects functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdominal tenderness or mass, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Efficacy analysis set included all randomised subjects who received at least 1 administration of ustekinumab analysed according to the assigned treatment.
    End point type
    Secondary
    End point timeframe
    Week 8 and Week 16
    End point values
    		 Ustekinumab 3 mg/kg or 130 mg + 2 mg/kg or 90 mg Ustekinumab 9 mg/kg or 390 mg + 2 mg/kg or 90 mg
    Number of subjects analysed
    23
    21
    Units: Percentage of Subjects
    number (not applicable)
        Week 8
    21.7
    19.0
        Week 16
    21.7
    28.6
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Endoscopic Response at Week 16

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    End point title
    		 Percentage of Subjects with Endoscopic Response at Week 16
    End point description
    Endoscopic response was defined as a reduction from induction baseline in simple endoscopic score for Crohn's disease (SES-CD) score >=50 percent (%). SES-CD is a validated instrument reflecting an endoscopist global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments:ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables:ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. The total SES-CD was calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum.Scores range from 0 to 60, with higher scores indicating more severe disease. Efficacy analysis set included all randomised subjects who received at least 1 administration of ustekinumab analysed according to the assigned treatment. Here, 'N' (number of subjects analysed) signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    At Week 16
    End point values
    		 Ustekinumab 3 mg/kg or 130 mg + 2 mg/kg or 90 mg Ustekinumab 9 mg/kg or 390 mg + 2 mg/kg or 90 mg
    Number of subjects analysed
    19
    18
    Units: Percentage of Subjects
        number (not applicable)
    31.6
    27.8
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Endoscopic Remission at Week 16

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    End point title
    		 Percentage of Subjects with Endoscopic Remission at Week 16
    End point description
    Endoscopic remission was defined as a reduction from induction baseline in SES-CD score of <=2 %. SES-CD is a validated instrument reflecting an endoscopist global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. The total SES-CD was calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease. Efficacy analysis set included all randomised subjects who received at least 1 administration of ustekinumab analysed according to the assigned treatment. Here, 'N' (number of subjects analysed) signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    At Week 16
    End point values
    		 Ustekinumab 3 mg/kg or 130 mg + 2 mg/kg or 90 mg Ustekinumab 9 mg/kg or 390 mg + 2 mg/kg or 90 mg
    Number of subjects analysed
    19
    18
    Units: Percentage of Subjects
        number (not applicable)
    15.8
    11.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Clinically Meaningful Endoscopic Improvement at Week 16

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    End point title
    		 Percentage of Subjects with Clinically Meaningful Endoscopic Improvement at Week 16
    End point description
    Clinically meaningful endoscopic improvement is defined as a reduction in SES-CD of >=3 from baseline. SES-CD is a validated instrument reflecting an endoscopist global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. The total SES-CD was calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease. Efficacy analysis set included all randomised subjects who received at least 1 administration of ustekinumab analysed according to the assigned treatment. Here, 'N' (number of subjects analysed) signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    At Week 16
    End point values
    		 Ustekinumab 3 mg/kg or 130 mg + 2 mg/kg or 90 mg Ustekinumab 9 mg/kg or 390 mg + 2 mg/kg or 90 mg
    Number of subjects analysed
    19
    18
    Units: Percentage of Subjects
        number (not applicable)
    42.1
    33.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Double-blind (DB) period: From Week 0 (Day 1) up to Week 16 (prior to SC dose) and Long-term extension (LTE) period: From Week 16 (post SC dose) up to Week 268
    Adverse event reporting additional description
    Safety analysis set included all randomised subjects who received at least one administration of ustekinumab and analysed according to the actual treatment received.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    DB Period: Ustekinumab 3mg/kg or 130mg +2mg/kg or 90mg
    Reporting group description
    		 Subjects received single intravenous (IV) ustekinumab induction dose of 3 milligrams per kilogram (mg/kg) (for body weight [BW] less than [<]40 kg) or 130 mg (for BW greater than or equal to [>=]40 kg) at Week 0, followed by single subcutaneous (SC) maintenance dose of ustekinumab 2 mg/kg (for BW <40 kg) or 90 mg (for BW >=40 kg) at Week 8 in the DB period. The duration of DB period was up to prior SC dose administration at Week 16.

    Reporting group title
    LTE Period: Ustekinumab 9 mg/kg or 390mg then 2 mg/kg or 90mg
    Reporting group description
    		 After completion of DB period (prior to Week 16 SC dose), subjects received single SC maintenance dose of ustekinumab 2 mg/kg (for BW <40 kg) or 90 mg (for BW >=40 kg) every 8 weeks (Q8W) from Week 16 up to Week 268 or upon availability of Study CNTO1275ISD3001 or completed 20 weeks safety follow-up post last dose or terminated study participation, whichever occurred first.

    Reporting group title
    LTE Period: Ustekinumab 3 mg/kg or 130mg then 2 mg/kg or 90mg
    Reporting group description
    		 After completion of DB period (prior to Week 16 SC dose), subjects received single SC maintenance dose of ustekinumab 2 mg/kg (for BW <40 kg) or 90 mg (for BW >=40 kg) every 8 weeks (Q8W) from Week 16 up to Week 268 or upon availability of Study CNTO1275ISD3001 or completed 20 weeks safety follow-up post last dose or terminated study participation, whichever occurred first.

    Reporting group title
    DB Period: Ustekinumab 9mg/kg or 390mg +2mg/kg or 90mg
    Reporting group description
    		 Subjects received single IV ustekinumab induction dose of 9 mg/kg (for BW <40 kg) or 390 mg (for BW >=40 kg) at Week 0, followed by single SC maintenance dose of ustekinumab 2 mg/kg (for BW <40 kg) or 90 mg (for BW >=40 kg) at Week 8 in the DB period. The duration of DB period was up to prior SC dose administration at Week 16.

    Serious adverse events
    		 DB Period: Ustekinumab 3mg/kg or 130mg +2mg/kg or 90mg LTE Period: Ustekinumab 9 mg/kg or 390mg then 2 mg/kg or 90mg LTE Period: Ustekinumab 3 mg/kg or 130mg then 2 mg/kg or 90mg DB Period: Ustekinumab 9mg/kg or 390mg +2mg/kg or 90mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 23 (26.09%)
    4 / 16 (25.00%)
    7 / 18 (38.89%)
    1 / 21 (4.76%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General Physical Health Deterioration
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Vision Blurred
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal Ulcer
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Crohn's Disease
         subjects affected / exposed
    2 / 23 (8.70%)
    4 / 16 (25.00%)
    2 / 18 (11.11%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 4
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal Obstruction
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large Intestinal Stenosis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small Intestinal Obstruction
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 16 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Malnutrition
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 DB Period: Ustekinumab 3mg/kg or 130mg +2mg/kg or 90mg LTE Period: Ustekinumab 9 mg/kg or 390mg then 2 mg/kg or 90mg LTE Period: Ustekinumab 3 mg/kg or 130mg then 2 mg/kg or 90mg DB Period: Ustekinumab 9mg/kg or 390mg +2mg/kg or 90mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 23 (78.26%)
    14 / 16 (87.50%)
    18 / 18 (100.00%)
    12 / 21 (57.14%)
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 16 (12.50%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    2
    0
    1
    Chest Pain
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Face Oedema
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    2
    0
    2
    Fatigue
         subjects affected / exposed
    1 / 23 (4.35%)
    4 / 16 (25.00%)
    3 / 18 (16.67%)
    3 / 21 (14.29%)
         occurrences all number
    1
    11
    3
    4
    Influenza Like Illness
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Malaise
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Non-Cardiac Chest Pain
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    3 / 23 (13.04%)
    3 / 16 (18.75%)
    4 / 18 (22.22%)
    1 / 21 (4.76%)
         occurrences all number
    3
    6
    4
    2
    Immune system disorders
    Seasonal Allergy
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Reproductive system and breast disorders
    Breast Enlargement
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dysmenorrhoea
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Menstrual Discomfort
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cough
         subjects affected / exposed
    3 / 23 (13.04%)
    3 / 16 (18.75%)
    4 / 18 (22.22%)
    0 / 21 (0.00%)
         occurrences all number
    3
    3
    4
    0
    Dyspnoea
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Epistaxis
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 16 (6.25%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Nasal Congestion
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 16 (6.25%)
    2 / 18 (11.11%)
    0 / 21 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Oropharyngeal Pain
         subjects affected / exposed
    1 / 23 (4.35%)
    2 / 16 (12.50%)
    4 / 18 (22.22%)
    0 / 21 (0.00%)
         occurrences all number
    1
    2
    5
    0
    Respiratory Depression
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Sinus Congestion
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Upper Respiratory Tract Congestion
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 16 (0.00%)
    3 / 18 (16.67%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    3
    0
    Insomnia
         subjects affected / exposed
    0 / 23 (0.00%)
    3 / 16 (18.75%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    4
    0
    0
    Mood Altered
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 16 (12.50%)
    1 / 18 (5.56%)
    1 / 21 (4.76%)
         occurrences all number
    0
    3
    1
    1
    Sleep Disorder
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Investigations
    Blood Bilirubin Increased
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    0
    1
    Blood Bilirubin Unconjugated Increased
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood Iron Decreased
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    2
    0
    0
    C-Reactive Protein Increased
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Full Blood Count Abnormal
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Haemoglobin Decreased
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hepatic Enzyme Abnormal
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Heart Rate Increased
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Liver Function Test Increased
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Neutrophil Count Increased
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Sars-Cov-2 Test Positive
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vitamin D Decreased
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    1 / 18 (5.56%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    1
    1
    Weight Decreased
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 16 (6.25%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Weight Increased
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    White Blood Cell Count Increased
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Injury, poisoning and procedural complications
    Ankle Fracture
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Concussion
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Head Injury
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Joint Injury
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ligament Sprain
         subjects affected / exposed
    2 / 23 (8.70%)
    1 / 16 (6.25%)
    1 / 18 (5.56%)
    1 / 21 (4.76%)
         occurrences all number
    2
    1
    1
    1
    Limb Injury
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Skin Abrasion
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Road Traffic Accident
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Sunburn
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 16 (0.00%)
    2 / 18 (11.11%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Spinal Compression Fracture
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nervous system disorders
    Dizziness Postural
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Paraesthesia
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 16 (6.25%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Headache
         subjects affected / exposed
    5 / 23 (21.74%)
    5 / 16 (31.25%)
    8 / 18 (44.44%)
    3 / 21 (14.29%)
         occurrences all number
    5
    15
    17
    7
    Sciatica
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Presyncope
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Syncope
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    6 / 23 (26.09%)
    0 / 16 (0.00%)
    5 / 18 (27.78%)
    1 / 21 (4.76%)
         occurrences all number
    6
    0
    5
    1
    Iron Deficiency Anaemia
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Leukocytosis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Microcytic Anaemia
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Thrombocytopenia
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ear and labyrinth disorders
    Excessive Cerumen Production
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vertigo
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 16 (0.00%)
    2 / 18 (11.11%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Eye disorders
    Dry Eye
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eczema Eyelids
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    0
    1
    Eye Pain
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypermetropia
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    0
    1
    Visual Impairment
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Keratitis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 23 (0.00%)
    4 / 16 (25.00%)
    3 / 18 (16.67%)
    1 / 21 (4.76%)
         occurrences all number
    0
    5
    4
    1
    Abdominal Pain Lower
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Anal Fissure
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 16 (0.00%)
    2 / 18 (11.11%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Anal Fistula
         subjects affected / exposed
    3 / 23 (13.04%)
    1 / 16 (6.25%)
    3 / 18 (16.67%)
    1 / 21 (4.76%)
         occurrences all number
    3
    1
    5
    1
    Crohn's Disease
         subjects affected / exposed
    4 / 23 (17.39%)
    3 / 16 (18.75%)
    8 / 18 (44.44%)
    2 / 21 (9.52%)
         occurrences all number
    4
    4
    10
    2
    Constipation
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 16 (12.50%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Dental Discomfort
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 23 (0.00%)
    5 / 16 (31.25%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    8
    1
    0
    Diarrhoea Haemorrhagic
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Food Poisoning
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    0
    1
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    0
    1
    Gingival Pain
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Haematochezia
         subjects affected / exposed
    0 / 23 (0.00%)
    3 / 16 (18.75%)
    3 / 18 (16.67%)
    1 / 21 (4.76%)
         occurrences all number
    0
    9
    5
    1
    Large Intestinal Stenosis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Mucous Stools
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    2 / 18 (11.11%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Nausea
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 16 (12.50%)
    2 / 18 (11.11%)
    2 / 21 (9.52%)
         occurrences all number
    0
    3
    2
    2
    Periodontal Inflammation
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tooth Impacted
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Toothache
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vomiting
         subjects affected / exposed
    2 / 23 (8.70%)
    2 / 16 (12.50%)
    5 / 18 (27.78%)
    0 / 21 (0.00%)
         occurrences all number
    2
    2
    7
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 16 (12.50%)
    2 / 18 (11.11%)
    0 / 21 (0.00%)
         occurrences all number
    0
    6
    2
    0
    Dry Skin
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dermatitis
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Eczema
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    1 / 18 (5.56%)
    1 / 21 (4.76%)
         occurrences all number
    0
    3
    1
    1
    Dyshidrotic Eczema
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Erythema
         subjects affected / exposed
    0 / 23 (0.00%)
    3 / 16 (18.75%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Photosensitivity Reaction
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Neurodermatitis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    1 / 18 (5.56%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    1
    1
    Psoriasis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    0
    1
    Rash
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    1 / 18 (5.56%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    1
    1
    Seborrhoeic Dermatitis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    0
    1
    Skin Mass
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin Striae
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Urticaria
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    0
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Endocrine disorders
    Cushingoid
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 23 (4.35%)
    4 / 16 (25.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    1
    7
    1
    0
    Back Pain
         subjects affected / exposed
    0 / 23 (0.00%)
    3 / 16 (18.75%)
    2 / 18 (11.11%)
    0 / 21 (0.00%)
         occurrences all number
    0
    5
    2
    0
    Arthritis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Chronic Recurrent Multifocal Osteomyelitis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    2
    0
    1
    Joint Stiffness
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Musculoskeletal Pain
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Neck Pain
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    0
    1
    Osteitis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pain in Extremity
         subjects affected / exposed
    1 / 23 (4.35%)
    2 / 16 (12.50%)
    1 / 18 (5.56%)
    1 / 21 (4.76%)
         occurrences all number
    2
    2
    1
    1
    Pain in Jaw
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Sacral Pain
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    4
    0
    0
    Infections and infestations
    Body Tinea
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    0
    1
    Anal Abscess
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Bronchitis
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 16 (6.25%)
    3 / 18 (16.67%)
    0 / 21 (0.00%)
         occurrences all number
    1
    1
    4
    0
    Clostridium Difficile Infection
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 16 (12.50%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    3
    0
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 16 (12.50%)
    1 / 18 (5.56%)
    1 / 21 (4.76%)
         occurrences all number
    0
    2
    1
    1
    Ear Infection
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eczema Infected
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Gastroenteritis Viral
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 16 (12.50%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    2
    0
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 16 (6.25%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Helicobacter Gastritis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Influenza
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 16 (12.50%)
    2 / 18 (11.11%)
    0 / 21 (0.00%)
         occurrences all number
    0
    2
    2
    0
    Localised Infection
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    1 / 18 (5.56%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    2
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 23 (8.70%)
    5 / 16 (31.25%)
    6 / 18 (33.33%)
    1 / 21 (4.76%)
         occurrences all number
    2
    8
    12
    1
    Osteomyelitis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Otitis Media
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Paronychia
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pharyngitis
         subjects affected / exposed
    1 / 23 (4.35%)
    3 / 16 (18.75%)
    2 / 18 (11.11%)
    1 / 21 (4.76%)
         occurrences all number
    1
    3
    2
    1
    Parotitis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 16 (6.25%)
    1 / 18 (5.56%)
    1 / 21 (4.76%)
         occurrences all number
    1
    1
    1
    1
    Sinusitis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Staphylococcal Infection
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tonsillitis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Tracheitis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    2 / 23 (8.70%)
    2 / 16 (12.50%)
    8 / 18 (44.44%)
    2 / 21 (9.52%)
         occurrences all number
    2
    8
    12
    2
    Urinary Tract Infection
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Viral Infection
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    1 / 18 (5.56%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    1
    1
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 16 (6.25%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    2
    0
    1
    Dehydration
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    2
    1
    Hypokalaemia
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypoproteinaemia
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Iron Deficiency
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 16 (0.00%)
    2 / 18 (11.11%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Aug 2017
    This amendment was implemented to include individual stopping criteria for drug-induced liver injury; addition of these criteria is a regulatory authority request.
    11 Mar 2021
    This amendment was implemented to include language for the long-extension basket study (CNTO1275ISD3001) portion of the study.

    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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