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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06260163
Registration number
NCT06260163
Ethics application status
Date submitted
7/02/2024
Date registered
15/02/2024
Date last updated
25/05/2025
Titles & IDs
Public title
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
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Scientific title
A Phase 3 Randomized, Open-label Induction, Double-blind Maintenance, Parallel-group, Multicenter Protocol to Evaluate the Efficacy, Safety, and Pharmacokinetics of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
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Secondary ID [1]
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CNTO1959PUC3001
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Secondary ID [2]
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CR109251
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Universal Trial Number (UTN)
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Trial acronym
QUASAR Jr
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colitis, Ulcerative
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Guselkumab Subcutaneous
Treatment: Drugs - Guselkumab Intravenous
Experimental: Open-label Induction Phase: Guselkumab Intravenously (IV) - Participants will receive a guselkumab dose IV based on their body weight (BW) during the 12-week open-label induction phase.
Experimental: Open-label Induction Phase: Guselkumab Subcutaneously (SC) - Participants will receive a guselkumab dose SC based on their BW during the 12-week open-label induction phase.
Experimental: Double-blind Maintenance Phase: Guselkumab Dose Regimen 1 - At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 1 SC based on their BW up to Week 56.
Experimental: Double-blind Maintenance Phase: Guselkumab Dose Regimen 2 - At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 2 SC based on their BW up to Week 56.
Experimental: Open-label Maintenance Phase: Guselkumab SC - Week 12 non-responders will not be randomized and will enter an open-label maintenance phase to receive guselkumab SC dosing regimen based on their body weight up to Week 56.
Treatment: Drugs: Guselkumab Subcutaneous
Guselkumab will be administered subcutaneously.
Treatment: Drugs: Guselkumab Intravenous
Guselkumab will be administered intravenously.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants with Clinical Remission at Week 56
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Assessment method [1]
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Percentage of participants with clinical remission as assessed by modified Mayo score at Week 56 among participants who were induction responders will be reported. Clinical remission per modified Mayo score is defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.
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Timepoint [1]
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Week 56
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Secondary outcome [1]
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Percentage of Participants with Clinical Response at Week 12
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Assessment method [1]
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Percentage of participants with clinical response as assessed by modified Mayo score at Week 12 will be reported. Modified Mayo score is a 3-component (stool frequency, rectal bleeding, and endoscopy subscores) assessment and does not include the physician's global assessment. A decrease from baseline in the modified Mayo score by greater than or equal to (\>=) 30 percent and \>= 2 points, with either a decrease from baseline in the rectal bleeding subscore of \>= 1 or a rectal bleeding subscore of 0 or 1.
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Timepoint [1]
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Week 12
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Secondary outcome [2]
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Percentage of Participants with Clinical Remission at Week 12
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Assessment method [2]
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Percentage of participants with clinical remission at Week 12 as assessed by modified Mayo score will be reported. Clinical remission per modified Mayo score is defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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Percentage of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 12
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Assessment method [3]
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Percentage of participants with PUCAI remission at Week 12 will be reported. It comprises 6 scales and ranges between 0 and 85 points. The scales are abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level. The PUCAI score is calculated as the sum of the 6 subscores. A PUCAI score of less than (\<) 10 indicates remission.
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Timepoint [3]
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Week 12
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Secondary outcome [4]
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Percentage of Participants with Symptomatic Remission at Week 12
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Assessment method [4]
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Percentage of participants with symptomatic remission at Week 12 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline.
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Timepoint [4]
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Week 12
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Secondary outcome [5]
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United States: Percentage of Participants with Endoscopic Improvement at Week 12
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Assessment method [5]
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Percentage of participants with endoscopic improvement as assessed by Mayo endoscopy subscore at Week 12 will be reported. Endoscopic improvement is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.
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Timepoint [5]
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Week 12
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Secondary outcome [6]
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European Union: Percentage of Participants with Endoscopic Healing at Week 12
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Assessment method [6]
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Percentage of participants with endoscopic healing as assessed by Mayo endoscopy subscore at Week 12 will be reported. Endoscopic healing is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.
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Timepoint [6]
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Week 12
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Secondary outcome [7]
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Percentage of Participants with Clinical Response at Week 56
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Assessment method [7]
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Percentage of participants with clinical response as assessed by modified Mayo score at Week 56 will be reported. Modified Mayo score is a 3-component (stool frequency, rectal bleeding, and endoscopy subscores) assessment and does not include the physician's global assessment. A decrease from baseline in the modified Mayo score by \>= 30 percent and \>= 2 points, with either a decrease from baseline in the rectal bleeding subscore of \>= 1 or a rectal bleeding subscore of 0 or 1.
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Timepoint [7]
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Week 56
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Secondary outcome [8]
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Percentage of Participants With PUCAI Remission at Week 56
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Assessment method [8]
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Percentage of participants with PUCAI remission at Week 56 will be reported. PUCAI comprises of 6 scales and ranges between 0 and 85 points. The scales are: abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level. The PUCAI score is calculated as the sum of the 6 subscores. A PUCAI score of less than (\<) 10 indicates remission.
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Timepoint [8]
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Week 56
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Secondary outcome [9]
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Percentage of Participants with Symptomatic Remission at Week 56
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Assessment method [9]
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Percentage of participants with symptomatic remission at Week 56 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline.
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Timepoint [9]
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Week 56
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Secondary outcome [10]
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Percentage of Participants with Symptomatic Remission at Week 56 Among Participants who had Symptomatic Remission at Week 12
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Assessment method [10]
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Percentage of participants with symptomatic remission at Week 56 among participants who had symptomatic remission at Week 12 will be reported. Symptomatic remission score is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline.
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Timepoint [10]
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Week 56
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Secondary outcome [11]
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United States: Percentage of Participants With Endoscopic Improvement at Week 56
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Assessment method [11]
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Percentage of participants with endoscopic improvement as assessed by Mayo endoscopy subscore at Week 56 will be reported. Endoscopic improvement is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.
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Timepoint [11]
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Week 56
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Secondary outcome [12]
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European Union: Percentage of Participants With Endoscopic Healing at Week 56
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Assessment method [12]
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Percentage of participants with endoscopic healing as assessed by Mayo endoscopy subscore at Week 56 will be reported. Endoscopic healing is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.
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Timepoint [12]
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Week 56
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Secondary outcome [13]
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Percentage of Participants Who Achieve Endoscopic Normalization at Week 56
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Assessment method [13]
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Percentage of participants who achieve endoscopic normalization with an endoscopy subscore of 0 at Week 56 will be reported.
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Timepoint [13]
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Week 56
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Secondary outcome [14]
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Percentage of Participants Histo-endoscopic Mucosal Improvement at Week 56
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Assessment method [14]
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Percentage of participants histo-endoscopic mucosal healing per endoscopy subscore and histologic improvement at Week 56 will be reported. Histologic-endoscopic mucosal healing is defined as achieving a combination of histologic improvement and endoscopic improvement (US) or endoscopic healing (EU) (endoscopy subscore of 0 or 1).
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Timepoint [14]
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Week 56
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Secondary outcome [15]
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Percentage of Participants with Corticosteroid-free Clinical Remission at Week 56
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Assessment method [15]
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Percentage of participants with corticosteroid-free clinical remission at Week 56 will be reported. Corticosteroid free clinical remission is defined as a Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline (Week 0), and not receiving corticosteroids for at least 8 weeks prior to Week 56
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Timepoint [15]
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Week 56
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Secondary outcome [16]
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Serum Concentration of Guselkumab During Induction Phase
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Assessment method [16]
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Serum samples will be analyzed to determine concentrations of guselkumab overtime.
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Timepoint [16]
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From Week 0 to Week 12
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Secondary outcome [17]
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Serum Concentration of Guselkumab During Maintenance Phase
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Assessment method [17]
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Serum samples will be analyzed to determine concentrations of guselkumab over time.
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Timepoint [17]
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From Week 12 to Week 56
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Secondary outcome [18]
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Number of Participants with Incidence of Anti-guselkumab Antibodies
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Assessment method [18]
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Number of participants with anti-guselkumab antibodies for all study treatment regimens will be assessed.
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Timepoint [18]
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Up to Week 68
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Secondary outcome [19]
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Percentage of Participants with Adverse Events (AEs)
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Assessment method [19]
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Percentage of participants with AEs will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
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Timepoint [19]
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Up to Week 68
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Secondary outcome [20]
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Percentage of Participants with Serious Adverse Events (SAEs)
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Assessment method [20]
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Percentage of participants with SAEs will be reported. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly.
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Timepoint [20]
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Up to Week 68
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Secondary outcome [21]
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Percentage of Participants with AEs Leading to Discontinuation of Study Intervention
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Assessment method [21]
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Percentage of participants with AEs leading to discontinuation of study intervention will be reported.
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Timepoint [21]
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Up to Week 68
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Eligibility
Key inclusion criteria
* Weight greater than or equal to (>=) 10 kilogram (kg) at the time of consent for screening
* A pathology report to support a documented diagnosis of Ulcerative Colitis (UC) must be available in the source documents. There is no maximum duration for which a participant needs to be diagnosed with UC. If the pathology report to support a documented diagnosis of UC is not available in the source documents, the screening endoscopy with biopsies (obtained within 3 weeks before first study intervention administration) needs to support the diagnosis of UC.
* Moderately to severely active UC, defined by a baseline modified Mayo (without physician's global assessment) score of 5 through 9 inclusive, with a screening Mayo endoscopy subscore >= 2 as determined by a central review of the video of the endoscopy
* Medically stable based on physical examination, medical history, and vital signs, performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and acknowledged by the investigator
* Participants must have had an inadequate response and/or intolerance to biologic therapy and/or conventional therapies or be dependent upon corticosteroids
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Minimum age
2
Years
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Have UC limited to the rectum only or to less than (<) 20 centimeter of the colon
* Presence of a stoma
* Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months of baseline
* Have severe colitis or have evidence of Crohn's Disease (CD)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/01/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
14/08/2028
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Actual
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Sample size
Target
120
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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The Kids Research Institute Australia on behalf of the Centre for Child Health Research - Nedlands
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Recruitment hospital [2]
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Mater Hospital Brisbane Inflammatory Bowel Diseases - South Brisbane
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Recruitment hospital [3]
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The Children's Hospital at Westmead - Westmead
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Recruitment postcode(s) [1]
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6009 - Nedlands
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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Recruitment postcode(s) [3]
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2145 - Westmead
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Indiana
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United States of America
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New York
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Belgium
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Charleroi
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Belgium
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Gent
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Belgium
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Jette
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Belgium
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Leuven
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China
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Beijing
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China
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Changzhou City
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China
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Hangzhou
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China
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Shanghai
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China
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Shenyang
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China
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ZhengZhou
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Denmark
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Aarhus N
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Denmark
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Hvidovre
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France
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Bron cedex
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France
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Dijon
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France
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Lille Cedex
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France
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Paris
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France
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Toulouse
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Italy
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Bergamo
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Italy
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Bologna
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Italy
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Firenze
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Italy
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Pescara
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Italy
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Roma
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Italy
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San Giovanni Rotondo
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Italy
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Trieste
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Japan
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Fuchu
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Japan
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Kanazawa
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Japan
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Kobe
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Japan
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Kumamoto
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Japan
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Matsumoto
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Japan
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Saga
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Japan
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Setagaya Ku
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Japan
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Shinjuku
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Japan
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Takatsuki
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Japan
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Yokohama
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Norway
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Lørenskog
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Norway
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Oslo
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Norway
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Tromso
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Norway
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Trondheim
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Poland
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Gdansk
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Poland
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Rzeszow
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Poland
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Warszawa
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Portugal
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Lisboa
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Portugal
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Porto
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Spain
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Madrid
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Spain
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Sabadell
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Spain
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València
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Turkey
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Ankara
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Turkey
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State/province [51]
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Istanbul
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders.
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Trial website
https://clinicaltrials.gov/study/NCT06260163
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Country
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0
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Study Contact
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Address
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Country
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Phone
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844-434-4210
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06260163
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