Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44393   clinical trials with a EudraCT protocol, of which   7405   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Loss of RESponse to Ustekinumab treated by dose Escalation

    Summary
    EudraCT number
    		 2018-004269-14
    Trial protocol
    		 BE  
    Global end of trial date
    25 Sep 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Apr 2026
    First version publication date
    05 Apr 2026
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    BIRD2018001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04245215
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Belgian IBD Research and Development (BIRD)
    Sponsor organisation address
    Leuvensesteenweg 643, Zaventem, Belgium, 1930
    Public contact
    Chief operating officer, Belgian IBD Research and Development (BIRD), 0032 499317005, ingrid.arijs@birdgroup.be
    Scientific contact
    Chief operating officer, Belgian IBD Research and Development (BIRD), 0032 499317005, ingrid.arijs@birdgroup.be
    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
    25 Sep 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Sep 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Sep 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the clinical effect of ustekinumab re-induction ≈6mg/kg intravenously (IV) followed by either 90 mg subcutaneous (SC) ustekinumab every 8 weeks (q8w) or 90 mg SC ustekinumab every 4 weeks (q4w) in patients with Crohn's Disease who show a secondary loss of response over time
    Protection of trial subjects
    This clinical trial was conducted in compliance with the principles of the Declaration of Helsinki (2008), the principles of Good Clinical Practice, and in accordance with all applicable regulatory requirements. The study was conducted on the basis of prior informed consent by the subjects to participate in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Feb 2020
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 108
    Worldwide total number of subjects
    108
    EEA total number of subjects
    108
    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)
    102
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Between February 2020 and October 2023 a total of 132 patients were screened and 108 patients were randomized. First Patient In (FPI) was on 11Mar2020. Last Patient In (LPI) was on 17Oct2023. Last Patient Out (LPO) was on 25Sep2024.

    Pre-assignment
    Screening details
    		 Eligible Crohn's Disease patients were treated with ustekinumab at a standard maintenance dose of 90 mg every 8 weeks SC. Patients needed to have a documented primary response to standard IV induction with ustekinumab and a documented secondary loss of response based on Patient-Reported Outcomes and objective documentation of disease activity.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ustekinumab q4w
    Arm description
    		 Subjects received a re-induction at baseline, with intravenous ustekinumab, in line with the EU SmPC, on a weight-tiered basis at a dose of approximately 6 mg/kg. At week 4, the subjects in the q4w arm received the first blinded 90 mg SC injection of ustekinumab. Subsequently, subjects in the q4w arm received commercial available q8w ustekinumab (90 mg SC syringe at week 8, 16, 24, 32, 40, 48) alternated with q8w double blinded active ustekinumab (at week 12, 20, 28, 36, 44).
    Arm type
    		 Experimental

    Investigational medicinal product name
    ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received subcutaneous ustekinumab 90 mg at week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48.

    Investigational medicinal product name
    ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received a re-induction at baseline (Week 0), with intravenous ustekinumab, in line with the EU SmPC, on a weight-tiered basis at a dose of approximately 6 mg/kg. Subjects with body weight ≤55 kg at Week 0 received 260 mg IV ustekinumab. Those subjects with body weight >55 kg and ≤85 kg received 390 mg IV ustekinumab. Subjects with body weight >85 kg at Week 0 received 520 mg IV ustekinumab.

    Arm title
    		 ustekinumab q8w
    Arm description
    		 Subjects received a re-induction at baseline, with intravenous ustekinumab, in line with the EU SmPC, on a weight-tiered basis at a dose of approximately 6 mg/kg. At week 4, the subjects in the q8w arm received the first blinded placebo injection. Subsequently, subjects in the q8w arm received commercial available q8w ustekinumab (90 mg SC syringe at week 8, 16, 24, 32, 40, 48) alternated with q8w double blinded placebo (at week 12, 20, 28, 36, 44).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received a re-induction at baseline (Week 0), with intravenous ustekinumab, in line with the EU SmPC, on a weight-tiered basis at a dose of approximately 6 mg/kg. Subjects with body weight ≤55 kg at Week 0 received 260 mg IV ustekinumab. Those subjects with body weight >55 kg and ≤85 kg received 390 mg IV ustekinumab. Subjects with body weight >85 kg at Week 0 received 520 mg IV ustekinumab.

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received subcutaneous ustekinumab 90 mg at week 8, 16, 24, 32, 40 and 48.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received subcutaneous placebo at week 4, 12, 20, 28, 36 and 44.

    Number of subjects in period 1
    		ustekinumab q4w ustekinumab q8w
    Started
    54
    54
    Completed
    37
    35
    Not completed
    17
    19
         Consent withdrawn by subject
    1
    3
         Adverse event, non-fatal
    -
    1
         Pregnancy
    -
    1
         Patient non-compliance
    1
    -
         Disease exacerbation
    12
    10
         Lack of efficacy
    3
    4

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    ustekinumab q4w
    Reporting group description
    		 Subjects received a re-induction at baseline, with intravenous ustekinumab, in line with the EU SmPC, on a weight-tiered basis at a dose of approximately 6 mg/kg. At week 4, the subjects in the q4w arm received the first blinded 90 mg SC injection of ustekinumab. Subsequently, subjects in the q4w arm received commercial available q8w ustekinumab (90 mg SC syringe at week 8, 16, 24, 32, 40, 48) alternated with q8w double blinded active ustekinumab (at week 12, 20, 28, 36, 44).

    Reporting group title
    ustekinumab q8w
    Reporting group description
    		 Subjects received a re-induction at baseline, with intravenous ustekinumab, in line with the EU SmPC, on a weight-tiered basis at a dose of approximately 6 mg/kg. At week 4, the subjects in the q8w arm received the first blinded placebo injection. Subsequently, subjects in the q8w arm received commercial available q8w ustekinumab (90 mg SC syringe at week 8, 16, 24, 32, 40, 48) alternated with q8w double blinded placebo (at week 12, 20, 28, 36, 44).

    Reporting group values
    		 ustekinumab q4w ustekinumab q8w Total
    Number of subjects
    		 54 54 108
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 52 50 102
        From 65-84 years
    		 2 4 6
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 41 (32 to 57) 40 (32 to 53) -
    Gender categorical
    Units: Subjects
        Female
    		 35 32 67
        Male
    		 19 22 41

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    ustekinumab q4w
    Reporting group description
    		 Subjects received a re-induction at baseline, with intravenous ustekinumab, in line with the EU SmPC, on a weight-tiered basis at a dose of approximately 6 mg/kg. At week 4, the subjects in the q4w arm received the first blinded 90 mg SC injection of ustekinumab. Subsequently, subjects in the q4w arm received commercial available q8w ustekinumab (90 mg SC syringe at week 8, 16, 24, 32, 40, 48) alternated with q8w double blinded active ustekinumab (at week 12, 20, 28, 36, 44).

    Reporting group title
    ustekinumab q8w
    Reporting group description
    		 Subjects received a re-induction at baseline, with intravenous ustekinumab, in line with the EU SmPC, on a weight-tiered basis at a dose of approximately 6 mg/kg. At week 4, the subjects in the q8w arm received the first blinded placebo injection. Subsequently, subjects in the q8w arm received commercial available q8w ustekinumab (90 mg SC syringe at week 8, 16, 24, 32, 40, 48) alternated with q8w double blinded placebo (at week 12, 20, 28, 36, 44).

    Primary: Proportion of patients with steroid free clinical remission (PRO-2 remission: AP ≤ 1 AND SF ≤ 3) and FCP <250µg/g at week 48

    		 Close Top of page
    End point title
    		 Proportion of patients with steroid free clinical remission (PRO-2 remission: AP ≤ 1 AND SF ≤ 3) and FCP <250µg/g at week 48
    End point description
    PRO : Patient Reported Outcomes AP : Abdominal Pain : average scoring for abdominal pain for 7 days (0=none; 1=mild, 2=moderate; 3= severe) SF : Stool Frequency : average number of liquid/very soft stools for 7 days FCP : Fecal Calprotectin
    End point type
    Primary
    End point timeframe
    Week 48
    End point values
    		 ustekinumab q4w ustekinumab q8w
    Number of subjects analysed
    54
    54
    Units: subjects
        steroid free clinical remission
    8
    10
    Statistical analysis title
    		 Primary endpoint analysis
    Comparison groups
    ustekinumab q4w v ustekinumab q8w
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.0502
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.09487
         upper limit
    		 0.1953

    Secondary: Proportion of patients with complete endoscopic remission (SES-CD <3) at week 48

    		 Close Top of page
    End point title
    		 Proportion of patients with complete endoscopic remission (SES-CD <3) at week 48
    End point description
    SES-CD : simple endoscopic score for Crohn's Disease
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 ustekinumab q4w ustekinumab q8w
    Number of subjects analysed
    51
    50
    Units: subjects
    4
    3
    Statistical analysis title
    		 Complete endoscopic remission analysis
    Comparison groups
    ustekinumab q4w v ustekinumab q8w
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.787
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.164
         upper limit
    		 3.792

    Secondary: Proportion of patients with endoscopic remission (SES-CD <5) at week 48

    		 Close Top of page
    End point title
    		 Proportion of patients with endoscopic remission (SES-CD <5) at week 48
    End point description
    SES-CD : simple endoscopic score for Crohn's Disease
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 ustekinumab q4w ustekinumab q8w
    Number of subjects analysed
    51
    50
    Units: subjects
    15
    8
    Statistical analysis title
    		 endoscopic remission analysis
    Comparison groups
    ustekinumab q4w v ustekinumab q8w
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.467
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.178
         upper limit
    		 1.223

    Secondary: Proportion of patients with endoscopic response (≥50% decrease in SES-CD) at week 48

    		 Close Top of page
    End point title
    		 Proportion of patients with endoscopic response (≥50% decrease in SES-CD) at week 48
    End point description
    SES-CD : simple endoscopic score for Crohn's Disease
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 ustekinumab q4w ustekinumab q8w
    Number of subjects analysed
    51
    50
    Units: subjects
    12
    8
    Statistical analysis title
    		 endoscopic response analysis
    Comparison groups
    ustekinumab q4w v ustekinumab q8w
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.837
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.32
         upper limit
    		 2.187

    Secondary: Proportion of patients with clinical remission (PRO-2 remission: AP ≤ 1 AND SF ≤ 3) at week 8 after IV re-induction

    		 Close Top of page
    End point title
    		 Proportion of patients with clinical remission (PRO-2 remission: AP ≤ 1 AND SF ≤ 3) at week 8 after IV re-induction
    End point description
    PRO : Patient Reported Outcomes AP : Abdominal Pain : average scoring for abdominal pain for 7 days (0=none; 1=mild, 2=moderate; 3= severe) SF : Stool Frequency : average number of liquid/very soft stools for 7 days
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 ustekinumab q4w ustekinumab q8w
    Number of subjects analysed
    53
    54
    Units: subjects
    19
    21
    Statistical analysis title
    		 clinical remission week 8 analysis
    Comparison groups
    ustekinumab q4w v ustekinumab q8w
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.143
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.526
         upper limit
    		 2.484

    Secondary: Proportion of patients with clinical remission (PRO-2 remission: AP ≤ 1 AND SF ≤ 3) at week 48

    		 Close Top of page
    End point title
    		 Proportion of patients with clinical remission (PRO-2 remission: AP ≤ 1 AND SF ≤ 3) at week 48
    End point description
    PRO : Patient Reported Outcomes AP : Abdominal Pain : average scoring for abdominal pain for 7 days (0=none; 1=mild, 2=moderate; 3= severe) SF : Stool Frequency : average number of liquid/very soft stools for 7 days
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 ustekinumab q4w ustekinumab q8w
    Number of subjects analysed
    52
    50
    Units: subjects
    16
    18
    Statistical analysis title
    		 clinical remission week 48 analysis
    Comparison groups
    ustekinumab q4w v ustekinumab q8w
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.278
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.562
         upper limit
    		 2.904

    Secondary: Proportion of patients with biomarker remission (CRP <5 mg/L and FCP <250 µg/g) at week 48

    		 Close Top of page
    End point title
    		 Proportion of patients with biomarker remission (CRP <5 mg/L and FCP <250 µg/g) at week 48
    End point description
    CRP : C-reactive protein FCP : Fecal calprotectin
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 ustekinumab q4w ustekinumab q8w
    Number of subjects analysed
    50
    50
    Units: subjects
    18
    13
    Statistical analysis title
    		 biomarker remission analysis
    Comparison groups
    ustekinumab q4w v ustekinumab q8w
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.268
         upper limit
    		 1.483

    Secondary: Proportion of Patients With Serious Adverse Events at Week 48

    		 Close Top of page
    End point title
    		 Proportion of Patients With Serious Adverse Events at Week 48
    End point description
    End point type
    Secondary
    End point timeframe
    week 48
    End point values
    		 ustekinumab q4w ustekinumab q8w
    Number of subjects analysed
    54
    54
    Units: subjects
    9
    7
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From signature of informed consent form up to week 48 in the study. For SAE's up to 60 days after the last study treatment.
    Adverse event reporting additional description
    At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27
    Reporting groups
    Reporting group title
    q4w arm
    Reporting group description
    		 -

    Reporting group title
    q8w arm
    Reporting group description
    		 -

    Serious adverse events
    		 q4w arm q8w arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 54 (16.67%)
    7 / 54 (12.96%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Abdominal pain after right hemicolectomy
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Cardiac ablation
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laparoscopic right hemicolectomy
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Extensive colitis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastro-enteritis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 54 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small bowel ileus
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    (sub) Obstruction
         subjects affected / exposed
    3 / 54 (5.56%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bowel obstruction terminal ileitis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presacral abscess
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stricturing Crohn's Disease
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Flare of Crohn's Disease
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stenosis hepaticojejunostomia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Stress fracture femoral neck left
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthralgia due to Infliximab
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Recurrent abdominal wall hernia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infection Giardia Lamblia
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    E. Coli urosepsis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Electrolyte abnormalities
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 q4w arm q8w arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    44 / 54 (81.48%)
    46 / 54 (85.19%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 54 (9.26%)
    7 / 54 (12.96%)
         occurrences all number
    8
    8
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    8 / 54 (14.81%)
    5 / 54 (9.26%)
         occurrences all number
    8
    5
    Gastrointestinal disorders
    gastro-enteritis
         subjects affected / exposed
    4 / 54 (7.41%)
    4 / 54 (7.41%)
         occurrences all number
    4
    5
    Worsening of Crohn's Disease
         subjects affected / exposed
    6 / 54 (11.11%)
    4 / 54 (7.41%)
         occurrences all number
    6
    5
    Abdominal pain
         subjects affected / exposed
    10 / 54 (18.52%)
    13 / 54 (24.07%)
         occurrences all number
    11
    14
    Skin and subcutaneous tissue disorders
    Skin abnormalities
         subjects affected / exposed
    6 / 54 (11.11%)
    9 / 54 (16.67%)
         occurrences all number
    6
    11
    Psychiatric disorders
    Psychiatric symptoms
         subjects affected / exposed
    5 / 54 (9.26%)
    3 / 54 (5.56%)
         occurrences all number
    7
    5
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorders
         subjects affected / exposed
    18 / 54 (33.33%)
    22 / 54 (40.74%)
         occurrences all number
    24
    42
    Infections and infestations
    Respiratory infection
         subjects affected / exposed
    21 / 54 (38.89%)
    25 / 54 (46.30%)
         occurrences all number
    35
    32
    Flu
         subjects affected / exposed
    7 / 54 (12.96%)
    8 / 54 (14.81%)
         occurrences all number
    9
    9
    Metabolism and nutrition disorders
    Lab abnormalities/deficiencies
         subjects affected / exposed
    10 / 54 (18.52%)
    15 / 54 (27.78%)
         occurrences all number
    12
    22

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Mar 2020
    Modifications regarding inclusion criteria (less strict), addition of 'window' regarding IV re-induction of ustekinumab and patient visits, update of the timelines for the study.
    17 Dec 2020
    Modifications regarding inclusion criteria (to ensure that included patients have at least inflammation in the gut if loss of response was based on the increase in biomarker(s)) and exclusion criteria (clarification), update of study timelines, removal of collection of additional stool samples for substudy.
    01 Apr 2022
    Modification in one of the inclusion criteria (to ensure patients with primary response at week 20 instead of week 16 are not screenfailed), modification regarding the visit window for the screening endoscopy.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/41747777
    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.

    European Medicines Agency © 1995-Wed Apr 15 06:04:30 CEST 2026 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA