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    Clinical Trial Results:
    A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus

    Summary
    EudraCT number
    2017-001489-53
    Trial protocol
    ES   LT   DE   BG   HU   PL   PT  
    Global end of trial date
    05 Nov 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    21 May 2021
    First version publication date
    21 May 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CNTO1275SLE3001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03517722
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Research and Development, LLC
    Sponsor organisation address
    Welsh & McKean Roads, P.O. Box 776, Spring House, United States, PA 19477
    Public contact
    Clinical Registry Group, Janssen Research and Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research and Development, LLC, ClinicalTrialsEU@its.jnj.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Nov 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Nov 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of this study was to evaluate the efficacy of ustekinumab in subjects with active systemic lupus erythematosus (SLE) who had not adequately responded to one or more standard-of-care treatments.
    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. The safety assessments included vital signs, general and targeted physical examination, adverse events (AEs)/serious adverse events (SAEs), study agent administration reaction, concomitant medications, laboratory tests including pregnancy testing, chemistry, coagulation, hematology, and urinalysis, and immunogenicity.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    03 May 2018
    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
    Argentina: 28
    Country: Number of subjects enrolled
    Bulgaria: 27
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    China: 8
    Country: Number of subjects enrolled
    Colombia: 17
    Country: Number of subjects enrolled
    Germany: 19
    Country: Number of subjects enrolled
    Hungary: 14
    Country: Number of subjects enrolled
    Japan: 46
    Country: Number of subjects enrolled
    Lithuania: 21
    Country: Number of subjects enrolled
    Poland: 38
    Country: Number of subjects enrolled
    Portugal: 1
    Country: Number of subjects enrolled
    Korea, Republic of: 5
    Country: Number of subjects enrolled
    Russian Federation: 30
    Country: Number of subjects enrolled
    Serbia: 42
    Country: Number of subjects enrolled
    Spain: 10
    Country: Number of subjects enrolled
    South Africa: 12
    Country: Number of subjects enrolled
    Taiwan: 25
    Country: Number of subjects enrolled
    Thailand: 12
    Country: Number of subjects enrolled
    Ukraine: 30
    Country: Number of subjects enrolled
    United States: 129
    Worldwide total number of subjects
    516
    EEA total number of subjects
    130
    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)
    4
    Adults (18-64 years)
    485
    From 65 to 84 years
    27
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 1029 subjects were screened, out of which 516 subjects were randomized to the study. Out of 516, 208 subjects were randomized to placebo and 308 subjects were randomized to ustekinumab.

    Period 1
    Period 1 title
    Through Week 52
    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
    Placebo - Ustekinumab
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Subjects received matching placebo to ustekinumab IV at Week 0, followed by matching placebo to ustekinumab SC at Week 8 and q8w thereafter through Week 48 during double-blind period. Eligible subjects who entered the extension period will cross-over to receive 90 mg ustekinumab SC q8w through Week 160.

    Arm title
    Ustekinumab
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Subjects received ustekinumab approximately 6 milligram per kilogram (mg/kg) intravenously (IV) based on body weight-range at Week 0 followed by 90 mg ustekinumab subcutaneously (SC) at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. Eligible subjects who will enter the extension period will continue to receive 90 mg ustekinumab SC q8w through Week 160.

    Number of subjects in period 1
    Placebo - Ustekinumab Ustekinumab
    Started
    208
    308
    Completed
    105
    153
    Not completed
    103
    155
         Adverse event, serious fatal
    1
    4
         Consent withdrawn by subject
    11
    11
         Adverse event, non-fatal
    2
    3
         Initiated prohibited medication
    -
    2
         Other
    4
    3
         Pregnancy
    -
    1
         Study terminated by sponsor
    76
    120
         Serious Adverse Event, non-fatal
    6
    8
         Lack of efficacy
    2
    3
         Protocol deviation
    1
    -
    Period 2
    Period 2 title
    After Week 52
    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
    Placebo - Ustekinumab
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Subjects received matching placebo to ustekinumab IV at Week 0, followed by matching placebo to ustekinumab SC at Week 8 and q8w thereafter through Week 48 during double-blind period. Eligible subjects who entered the extension period will cross-over to receive 90 mg ustekinumab SC q8w through Week 160.

    Arm title
    Ustekinumab
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Subjects received ustekinumab approximately 6 milligram per kilogram (mg/kg) intravenously (IV) based on body weight-range at Week 0 followed by 90 mg ustekinumab subcutaneously (SC) at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. Eligible subjects who will enter the extension period will continue to receive 90 mg ustekinumab SC q8w through Week 160.

    Number of subjects in period 2 [1]
    Placebo - Ustekinumab Ustekinumab
    Started
    88
    137
    Completed
    0
    0
    Not completed
    88
    137
         Consent withdrawn by subject
    1
    1
         Study terminated by sponsor
    87
    134
         Serious Adverse Event, non-fatal
    -
    1
         Lack of efficacy
    -
    1
    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: These are the subjects who entered the extension phase at Week 52.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo - Ustekinumab
    Reporting group description
    -

    Reporting group title
    Ustekinumab
    Reporting group description
    -

    Reporting group values
    Placebo - Ustekinumab Ustekinumab Total
    Number of subjects
    208 308 516
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    3 1 4
        Adults (18-64 years)
    191 294 485
        From 65 to 84 years
    14 13 27
        85 years and over
    0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    44.5 ( 12.31 ) 42.9 ( 11.38 ) -
    Title for Gender
    Units: subjects
        Female
    191 291 482
        Male
    17 17 34

    End points

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    End points reporting groups
    Reporting group title
    Placebo - Ustekinumab
    Reporting group description
    -

    Reporting group title
    Ustekinumab
    Reporting group description
    -
    Reporting group title
    Placebo - Ustekinumab
    Reporting group description
    -

    Reporting group title
    Ustekinumab
    Reporting group description
    -

    Primary: Percentage of Subjects Achieving an Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Composite Response at Week 52

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    End point title
    Percentage of Subjects Achieving an Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Composite Response at Week 52 [1]
    End point description
    End point type
    Primary
    End point timeframe
    Week 52
    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: No formal statistical hypothesis testing was planned for this study due to the descriptive nature of this study.
    End point values
    Placebo - Ustekinumab Ustekinumab
    Number of subjects analysed
    116
    173
    Units: percentage of subjects
        number (not applicable)
    65
    76
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 182
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Placebo (Prior to entering LTE)
    Reporting group description
    Subjects only received placebo administration through Week 52 double blinded period. Data prior to the first administration of ustekinumab, or through the last follow-up if the subject did not receive any ustekinumab, were included.

    Reporting group title
    Placebo to Ustekinumab (After entering LTE)
    Reporting group description
    Subjects only received placebo administration through Week 52 double blinded period, and crossed over to ustekinumab in the extension period. Data from the first administration of ustekinumab through the last follow-up were included.

    Reporting group title
    Ustekinumab (Through Week 176)
    Reporting group description
    Subjects received ustekinumab administration through Week 52 double blinded period, and continued to receive ustekinumab in the extension period. Data from the first administration of ustekinumab through the last follow-up were included.

    Serious adverse events
    Placebo (Prior to entering LTE) Placebo to Ustekinumab (After entering LTE) Ustekinumab (Through Week 176)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    28 / 208 (13.46%)
    5 / 88 (5.68%)
    44 / 307 (14.33%)
         number of deaths (all causes)
    1
    0
    5
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acoustic Neuroma
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diffuse Large B-Cell Lymphoma
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 88 (0.00%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric Cancer
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Aortic Aneurysm
         subjects affected / exposed
    0 / 208 (0.00%)
    1 / 88 (1.14%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Deep Vein Thrombosis
         subjects affected / exposed
    0 / 208 (0.00%)
    1 / 88 (1.14%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemic Shock
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Lupus Vasculitis
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Hyperemesis Gravidarum
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign Prostatic Hyperplasia
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 88 (0.00%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ovarian Cyst
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Respiratory Failure
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    2 / 307 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lupus Pleurisy
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural Effusion
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 88 (0.00%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary Hypertension
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 88 (0.00%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 88 (0.00%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Implantation Complication
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 88 (0.00%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infusion Related Reaction
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Patella Fracture
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post Procedural Fever
         subjects affected / exposed
    0 / 208 (0.00%)
    1 / 88 (1.14%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post Procedural Haemorrhage
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 88 (0.00%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Splenic Rupture
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 88 (0.00%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Ulna Fracture
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 88 (0.00%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute Myocardial Infarction
         subjects affected / exposed
    2 / 208 (0.96%)
    1 / 88 (1.14%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    0 / 208 (0.00%)
    1 / 88 (1.14%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac Failure
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    2 / 307 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Pericardial Effusion
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 88 (0.00%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Embolic Stroke
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Facial Paralysis
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic Stroke
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Neuropsychiatric Lupus
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    2 / 307 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    2 / 208 (0.96%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinal Detachment
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 88 (0.00%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Visual Impairment
         subjects affected / exposed
    0 / 208 (0.00%)
    1 / 88 (1.14%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Hernia
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal Pain
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 88 (0.00%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis Acute
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small Intestinal Obstruction
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 88 (0.00%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatorenal Syndrome
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermal Cyst
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity Vasculitis
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pemphigoid
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 88 (0.00%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxic Epidermal Necrolysis
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 88 (0.00%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 88 (0.00%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lupus Nephritis
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephritic Syndrome
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 88 (0.00%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    2 / 307 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neurogenic Bladder
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 88 (0.00%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal Colic
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral Disc Protrusion
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Systemic Lupus Erythematosus
         subjects affected / exposed
    4 / 208 (1.92%)
    0 / 88 (0.00%)
    2 / 307 (0.65%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 88 (0.00%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Covid-19
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    4 / 307 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Diverticulitis
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 88 (0.00%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocarditis Staphylococcal
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Gastroenteritis
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    2 / 307 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpes Zoster
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 88 (0.00%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infected Bite
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nosocomial Infection
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 88 (0.00%)
    4 / 307 (1.30%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary Tuberculosis
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 88 (0.00%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    2 / 208 (0.96%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 88 (0.00%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral Infection
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 88 (0.00%)
    0 / 307 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vulval Cellulitis
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Electrolyte Imbalance
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 88 (0.00%)
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo (Prior to entering LTE) Placebo to Ustekinumab (After entering LTE) Ustekinumab (Through Week 176)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    60 / 208 (28.85%)
    3 / 88 (3.41%)
    79 / 307 (25.73%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    14 / 208 (6.73%)
    1 / 88 (1.14%)
    19 / 307 (6.19%)
         occurrences all number
    15
    1
    42
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    19 / 208 (9.13%)
    2 / 88 (2.27%)
    24 / 307 (7.82%)
         occurrences all number
    23
    2
    32
    Upper Respiratory Tract Infection
         subjects affected / exposed
    17 / 208 (8.17%)
    0 / 88 (0.00%)
    25 / 307 (8.14%)
         occurrences all number
    21
    0
    31
    Urinary Tract Infection
         subjects affected / exposed
    20 / 208 (9.62%)
    0 / 88 (0.00%)
    26 / 307 (8.47%)
         occurrences all number
    25
    0
    34

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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.
    Study was early terminated for futility.
    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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