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    Clinical Trial Results:
    An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants with Moderate to Severe Crohn’s Disease or Moderate to Severe Ulcerative Colitis

    Summary
    EudraCT number
    		 2020-004461-40
    Trial protocol
    		 DE   IT   ES   PT   NL  
    Global end of trial date
    29 Aug 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Sep 2024
    First version publication date
    13 Sep 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IM011-077
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Nov 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Aug 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety and tolerability of long-term use of deucravacitinib in participants with moderate to severe CD
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 May 2021
    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
    Canada: 1
    Country: Number of subjects enrolled
    China: 2
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Hungary: 3
    Country: Number of subjects enrolled
    Italy: 3
    Country: Number of subjects enrolled
    Japan: 4
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Poland: 32
    Country: Number of subjects enrolled
    Portugal: 1
    Country: Number of subjects enrolled
    Russian Federation: 2
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Taiwan: 1
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    United States: 14
    Worldwide total number of subjects
    67
    EEA total number of subjects
    42
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    59
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 67 subjects randomized

    Period 1
    Period 1 title
    Pre-treatment
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Crohn’s Disease
    Arm description
    		 Deucravacitinib (BMS-986165) 6 mg twice daily (BID)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deucravacitinib
    Investigational medicinal product code
    BMS-986165
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    6 mg twice daily (BID)

    Arm title
    		 Ulcerative Colitis
    Arm description
    		 Deucravacitinib (BMS-986165) 6 mg twice daily (BID)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deucravacitinib
    Investigational medicinal product code
    BMS-986165
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    6 mg twice daily (BID)

    Number of subjects in period 1
    		Crohn’s Disease Ulcerative Colitis
    Started
    26
    41
    Completed
    24
    41
    Not completed
    2
    0
         Other reasons
    2
    -
    Period 2
    Period 2 title
    Treatment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Crohn’s Disease
    Arm description
    		 Deucravacitinib (BMS-986165) 6 mg twice daily (BID)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deucravacitinib
    Investigational medicinal product code
    BMS-986165
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    6 mg twice daily (BID)

    Arm title
    		 Ulcerative Colitis
    Arm description
    		 Deucravacitinib (BMS-986165) 6 mg twice daily (BID)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deucravacitinib
    Investigational medicinal product code
    BMS-986165
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    6 mg twice daily (BID)

    Number of subjects in period 2
    		Crohn’s Disease Ulcerative Colitis
    Started
    24
    41
    Completed
    0
    0
    Not completed
    24
    41
         Consent withdrawn by subject
    2
    6
         Adverse Event
    2
    1
         Other reasons
    3
    1
         Administrative reasons by sponsor
    17
    33

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Crohn’s Disease
    Reporting group description
    		 Deucravacitinib (BMS-986165) 6 mg twice daily (BID)

    Reporting group title
    Ulcerative Colitis
    Reporting group description
    		 Deucravacitinib (BMS-986165) 6 mg twice daily (BID)

    Reporting group values
    		 Crohn’s Disease Ulcerative Colitis Total
    Number of subjects
    		 26 41 67
    Age categorical
    Units:
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.7 ( 14.08 ) 44.3 ( 15.70 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 10 19 29
        Male
    		 16 22 38
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 21 38 59
        Black or African American
    		 1 0 1
        Asian
    		 2 0 2
        American Indian or Alaska Native
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Other
    		 0 0 0
        Asian Indian
    		 0 0 0
        Chinese
    		 2 0 2
        Japanese
    		 0 3 3
        Asian Other
    		 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 1 1
        Not Hispanic or Latino
    		 21 35 56
        Unknown or Not Reported
    		 5 5 10

    End points

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    End points reporting groups
    Reporting group title
    Crohn’s Disease
    Reporting group description
    		 Deucravacitinib (BMS-986165) 6 mg twice daily (BID)

    Reporting group title
    Ulcerative Colitis
    Reporting group description
    		 Deucravacitinib (BMS-986165) 6 mg twice daily (BID)
    Reporting group title
    Crohn’s Disease
    Reporting group description
    		 Deucravacitinib (BMS-986165) 6 mg twice daily (BID)

    Reporting group title
    Ulcerative Colitis
    Reporting group description
    		 Deucravacitinib (BMS-986165) 6 mg twice daily (BID)

    Primary: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

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    End point title
    		 Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) [1]
    End point description
    Number of participants experiencing AEs, SAEs, AEs leading to study discontinuation, and AEs of interest (AEIs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. SAEs is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect. TEAEs are defined as AEs with an onset date on or after the first dose of study treatment up to 30 days after the last dose of study treatment in the study, or if a pre-existing condition worsens in severity or becomes serious after receiving the first dose of study treatment
    End point type
    Primary
    End point timeframe
    From first dose to 30 days post last dose (Up to 110 weeks)
    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: Only summary statistics planned for this endpoint
    End point values
    		 Crohn’s Disease Ulcerative Colitis
    Number of subjects analysed
    24
    41
    Units: Participants
        TEAEs
    18
    19
        TESAEs
    2
    2
        TEAEs leading to study discontinuation
    1
    1
        AEs of Interest - Skin-related events
    0
    2
        AEs of Interest - Creatine Kinase events
    2
    3
    No statistical analyses for this end point

    Primary: Number of Participants with Laboratory Abnormalities

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    End point title
    		 Number of Participants with Laboratory Abnormalities [2]
    End point description
    Number of participants experiencing abnormalities in laboratory testing including chemistry, hematology, and renal.
    End point type
    Primary
    End point timeframe
    From first dose to 30 days post last dose (Up to 110 weeks)
    Notes
    [2] - 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: Only summary statistics planned for this endpoint
    End point values
    		 Crohn’s Disease Ulcerative Colitis
    Number of subjects analysed
    23
    41
    Units: Participants
        Sodium < 130 or > 150 MEQ/L (MMOL/L)
    0
    0
        Potassium < 3 or > 5.5 MEQ/L (MMOL/L)
    0
    1
        Calcium > 12.5 MG/DL
    0
    0
        Fasting Serum Glucose < 50 MG/DL or > 250 MG/DL
    0
    0
        Albumin < 2.0 G/DL
    0
    0
        Creatine Kinase > 10xupper limit of normal
    0
    0
        Hemoglobin < 7.0 G/DL or > 30% reduction
    0
    0
        Hematocrit < 20% or 30% reduction
    0
    0
        White Blood Cell < 1.5 x 10^9/L or > 35 x 10^9/L
    0
    0
        Lymphocyte Count < 0.5 x 10^9/L
    0
    0
        Neutrophil Count < 0.75 x 10^9/L
    0
    0
        Platelet Count < 75 x 10^9/L or > 999 x 10^9/L
    0
    0
        Serum Creatinine Increase > 50% and > 44.2 UMOL/L
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants with Electrocardiogram (ECG) Abnormalities

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    End point title
    		 Number of Participants with Electrocardiogram (ECG) Abnormalities [3]
    End point description
    End point type
    Primary
    End point timeframe
    From first dose to 30 days post last dose (Up to 110 weeks)
    Notes
    [3] - 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: Only summary statistics planned for this endpoint
    End point values
    		 Crohn’s Disease Ulcerative Colitis
    Number of subjects analysed
    24
    41
    Units: Participants
        QTCF (MSEC) 450 - < 480
    1
    0
        QTCF (MSEC) 480 - < 500
    0
    1
        QTCF (MSEC) >= 500
    0
    0
        30 < CHANGE FROM IM011077 BASELINE <= 60 MSEC
    3
    0
        CHANGE FROM IM011077 BASELINE > 60 MSEC
    3
    5
        PRAG P WAVE AND R WAVE (PR) INTERVAL >= 240 MSEC
    0
    0
        QRSAG QRS INTERVAL >= 200 MSEC
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants with Vital Signs Abnormalities

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    End point title
    		 Number of Participants with Vital Signs Abnormalities [4]
    End point description
    End point type
    Primary
    End point timeframe
    From first dose to 30 days post last dose (Up to 110 weeks)
    Notes
    [4] - 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: Only summary statistics planned for this endpoint
    End point values
    		 Crohn’s Disease Ulcerative Colitis
    Number of subjects analysed
    24
    41
    Units: Participants
        HR: VALUE > 100 AND CHANGE FROM BASELINE > 30
    1
    1
        HR: VALUE < 55 AND CHANGE FROM BASELINE < -15
    1
    0
        SYSTOLIC BP: > 140 AND CHANGE FROM BASELINE > 20
    3
    5
        SYSTOLIC BP: < 90 AND CHANGE FROM BASELINE < -20
    0
    0
        DIASTOLIC BP: > 90 AND CHANGE FROM BASELINE > 10
    3
    5
        DIASTOLIC BP: < 55 AND CHANGE FROM BASELINE < -10
    0
    0
    No statistical analyses for this end point

    Primary: Change from Baseline in Laboratory Parameters

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    End point title
    		 Change from Baseline in Laboratory Parameters [5]
    End point description
    Change from baseline in laboratory parameters including lipid profile, chemistry liver function, chemistry (other), and chemistry renal function. 99999=NA 00000= 0 subjects analyzed
    End point type
    Primary
    End point timeframe
    Baseline, Week 12, Week 108
    Notes
    [5] - 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: Only summary statistics planned for this endpoint
    End point values
    		 Crohn’s Disease Ulcerative Colitis
    Number of subjects analysed
    23
    38
    Units: mg/dL
    arithmetic mean (standard error)
        Cholesterol, Fasting Week 12
    10.20 ( 7.207 )
    -9.17 ( 4.629 )
        Cholesterol, Fasting Week 108
    -12.00 ( 99999 )
    00000 ( 00000 )
        HDL Cholesterol, Fasting Week 12
    -0.75 ( 3.400 )
    -0.83 ( 2.626 )
        HDL Cholesterol, Fasting Week 108
    0.00 ( 99999 )
    00000 ( 00000 )
        LDL Cholesterol, Fasting Week 12
    4.75 ( 4.270 )
    -6.50 ( 4.689 )
        LDL Cholesterol, Fasting Week 108
    1.00 ( 99999 )
    00000 ( 00000 )
        Triglycerides, Fasting Week 12
    2.3 ( 11.31 )
    3.2 ( 4.78 )
        Triglycerides, Fasting Week 108
    -62.0 ( 99999 )
    00000 ( 00000 )
        Bilirubin, Week 12
    0.0650 ( 0.05028 )
    0.0043 ( 0.03566 )
        Bilirubin, Week 108
    -0.1000 ( 0.00000 )
    00000 ( 00000 )
        Glucose, Fasting Serum Week 12
    1.75 ( 0.946 )
    0.80 ( 1.114 )
        Glucose, Fasting Serum Week 108
    29.00 ( 99999 )
    00000 ( 00000 )
        Calcium, Week 12
    0.152 ( 0.0915 )
    0.041 ( 0.0612 )
        Calcium, Week 108
    0.350 ( 0.1500 )
    00000 ( 00000 )
        Creatinine, Week 12
    -0.008 ( 0.0182 )
    0.004 ( 0.0153 )
        Creatinine, Week 108
    0.080 ( 0.0100 )
    00000 ( 00000 )
        Phosphate, Week 12
    0.153 ( 0.0893 )
    0.019 ( 0.1198 )
        Phosphate, Week 108
    -0.150 ( 0.1500 )
    00000 ( 00000 )
        Urea Nitrogen, Week 12
    -0.269 ( 1.0631 )
    0.511 ( 0.5902 )
        Urea Nitrogen, Week 108
    5.500 ( 0.5000 )
    00000 ( 00000 )
    No statistical analyses for this end point

    Primary: Change from Baseline in Electrocardiogram (ECG) Parameters - ECG Mean Heart Rate

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    End point title
    		 Change from Baseline in Electrocardiogram (ECG) Parameters - ECG Mean Heart Rate [6]
    End point description
    Changes from IM011077 study baseline in electrocardiogram (ECG) parameters - ECG mean heart rate. 99999=NA
    End point type
    Primary
    End point timeframe
    Baseline, Week 48, Week 96
    Notes
    [6] - 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: Only summary statistics planned for this endpoint
    End point values
    		 Crohn’s Disease Ulcerative Colitis
    Number of subjects analysed
    9
    17
    Units: beats/min
    arithmetic mean (standard deviation)
        ECG Mean Heart Rate, Week 48
    -1.4 ( 9.21 )
    2.6 ( 12.76 )
        ECG Mean Heart Rate, Week 96
    -1.0 ( 11.27 )
    -1.0 ( 99999 )
    No statistical analyses for this end point

    Primary: Change from Baseline in Electrocardiogram (ECG) Parameters

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    End point title
    		 Change from Baseline in Electrocardiogram (ECG) Parameters [7]
    End point description
    Changes from IM011077 study baseline in electrocardiogram (ECG) parameters. 99999=NA 00000= 0 subjects analyzed
    End point type
    Primary
    End point timeframe
    Baseline, Week 48, Week 96
    Notes
    [7] - 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: Only summary statistics planned for this endpoint
    End point values
    		 Crohn’s Disease Ulcerative Colitis
    Number of subjects analysed
    9
    16
    Units: msec
    arithmetic mean (standard deviation)
        PR Interval, Aggregate, Week 48
    9.1 ( 20.62 )
    -2.4 ( 22.65 )
        PR Interval, Aggregate, Week 96
    14.7 ( 16.56 )
    -22.0 ( 99999 )
        QRS Duration, Aggregate, Week 48
    -1.2 ( 8.47 )
    -0.9 ( 8.53 )
        QRS Duration, Aggregate, Week 96
    -9.3 ( 2.89 )
    0.0 ( 99999 )
        QT Interval, Aggregate, Week 48
    18.6 ( 30.33 )
    7.6 ( 40.35 )
        QT Interval, Aggregate, Week 96
    27.0 ( 62.55 )
    96.0 ( 99999 )
        QTcB Interval, Aggregate, Week 48
    -2.3 ( 21.78 )
    7.7 ( 19.41 )
        QTcB Interval, Aggregate, Week 96
    00000 ( 00000 )
    00000 ( 00000 )
        QTcF Interval, Aggregate, Week 48
    -20.6388 ( 197.49472 )
    31.1621 ( 141.14597 )
        QTcF Interval, Aggregate, Week 96
    -86.9797 ( 198.61888 )
    101.0000 ( 99999 )
    No statistical analyses for this end point

    Primary: Change from Baseline in Vital Signs Parameters - Heart Rate

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    End point title
    		 Change from Baseline in Vital Signs Parameters - Heart Rate [8]
    End point description
    Changes from IM011077 study baseline in vital signs parameters - heart rate. 99999=NA 00000= 0 subjects analyzed
    End point type
    Primary
    End point timeframe
    Baseline, Week 12, Week 108
    Notes
    [8] - 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: Only summary statistics planned for this endpoint
    End point values
    		 Crohn’s Disease Ulcerative Colitis
    Number of subjects analysed
    24
    41
    Units: beats/min
    arithmetic mean (standard deviation)
        Heart Rate Week 12
    3.6 ( 11.89 )
    0.9 ( 10.71 )
        Heart Rate Week 108
    1.0 ( 99999 )
    00000 ( 00000 )
    No statistical analyses for this end point

    Primary: Change from Baseline in Vital Signs Parameters

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    End point title
    		 Change from Baseline in Vital Signs Parameters [9]
    End point description
    Changes from IM011077 study baseline in vital signs parameters. 99999=NA 00000= 0 subjects analyzed
    End point type
    Primary
    End point timeframe
    Baseline, Week 12, Week 108
    Notes
    [9] - 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: Only summary statistics planned for this endpoint
    End point values
    		 Crohn’s Disease Ulcerative Colitis
    Number of subjects analysed
    24
    41
    Units: mmHg
    arithmetic mean (standard deviation)
        Systolic Blood Pressure Week 12
    3.8 ( 11.56 )
    3.8 ( 13.62 )
        Systolic Blood Pressure Week 108
    4.0 ( 99999 )
    00000 ( 00000 )
        Diastolic Blood Pressure Week 12
    0.3 ( 7.82 )
    -1.3 ( 7.38 )
        Diastolic Blood Pressure Week 108
    9.0 ( 99999 )
    00000 ( 00000 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAEs and NSAEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for deaths (all-causes) from their first dose to study completion (Up to 120 weeks).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Crohn’s Disease‌
    Reporting group description
    		 Deucravacitinib (BMS-986165) 6 mg twice daily (BID)

    Reporting group title
    Ulcerative Colitis
    Reporting group description
    		 Deucravacitinib (BMS-986165) 6 mg twice daily (BID)

    Serious adverse events
    		 Crohn’s Disease‌ Ulcerative Colitis
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 24 (8.33%)
    2 / 41 (4.88%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Procedural pneumothorax
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure chronic
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Crohn’s Disease‌ Ulcerative Colitis
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 24 (50.00%)
    13 / 41 (31.71%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 24 (8.33%)
    1 / 41 (2.44%)
         occurrences all number
    4
    1
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    0 / 24 (0.00%)
    3 / 41 (7.32%)
         occurrences all number
    0
    3
    Mouth ulceration
         subjects affected / exposed
    2 / 24 (8.33%)
    1 / 41 (2.44%)
         occurrences all number
    3
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 24 (8.33%)
    1 / 41 (2.44%)
         occurrences all number
    4
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 24 (0.00%)
    3 / 41 (7.32%)
         occurrences all number
    0
    3
    Infections and infestations
    COVID-19
         subjects affected / exposed
    6 / 24 (25.00%)
    3 / 41 (7.32%)
         occurrences all number
    8
    3
    Nasopharyngitis
         subjects affected / exposed
    3 / 24 (12.50%)
    0 / 41 (0.00%)
         occurrences all number
    4
    0
    Tonsillitis
         subjects affected / exposed
    0 / 24 (0.00%)
    3 / 41 (7.32%)
         occurrences all number
    0
    4
    Pneumonia
         subjects affected / exposed
    3 / 24 (12.50%)
    0 / 41 (0.00%)
         occurrences all number
    3
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 24 (8.33%)
    5 / 41 (12.20%)
         occurrences all number
    3
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Mar 2022
    Clarifications to exclusion criteria and study procedures

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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