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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04779320
Registration number
NCT04779320
Ethics application status
Date submitted
1/03/2021
Date registered
3/03/2021
Date last updated
12/04/2024
Titles & IDs
Public title
A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)
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Scientific title
A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
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Secondary ID [1]
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2020-004301-31
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Secondary ID [2]
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MLN0002-3025
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease (CD)
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Condition category
Condition code
Oral and Gastrointestinal
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Inflammatory bowel disease
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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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Crohn's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Vedolizumab IV
Experimental: Induction Period: 10 to 15 kg, Vedolizumab 150 mg - Vedolizumab 150 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of 10 to 15 kg will be included in this arm group.
Experimental: Induction Period: >15 to <30 kg, Vedolizumab 200 mg - Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of >15 to <30 kg will be included in this arm group.
Experimental: Induction Period: =30 kg, Vedolizumab 300 mg - Vedolizumab 300 mg, IV infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of =30 kg will be included in this arm group.
Experimental: Maintenance Period: 10 to 15 kg Vedolizumab 150 mg - Vedolizumab 150 mg, IV infusion, once every 8 weeks (Q8W) from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of 10 to 15 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 150 mg.
Experimental: Maintenance Period: 10 to 15 kg Vedolizumab 100 mg - Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of 10 to 15 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 100 mg.
Experimental: Maintenance Period: >15 to <30 kg, Vedolizumab 200 mg - Vedolizumab 200 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 200 mg.
Experimental: Maintenance Period: >15 to <30 kg Vedolizumab 100 mg - Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 100 mg.
Experimental: Maintenance Period: =30 kg, Vedolizumab 300 mg - Vedolizumab 300 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of =30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 300 mg.
Experimental: Maintenance Period: =30 kg: Vedolizumab 150 mg - Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of =30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 150 mg.
Treatment: Drugs: Vedolizumab IV
Vedolizumab IV
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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 54 Based on Pediatric Crohn's Disease Activity Index (PCDAI) Score =10
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Assessment method [1]
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Clinical remission is defined by PCDAI score =10. The PCDAI was specifically designed for use in children. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: hematocrit (HCT) (adjusted for age and sex), erythrocyte sedimentation rate (ESR), and albumin level. The PCDAI score ranges from 0 to 100, with higher scores indicating more active disease. A score of <10 will be consistent with inactive disease, 11 to 30 will indicate mild disease, and >30 will indicate moderate to severe disease. A decrease of 12.5 points is taken as evidence of improvement.
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Timepoint [1]
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Week 54
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Primary outcome [2]
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Percentage of Participants With Endoscopic Response at Week 54 Based on Simple Endoscopic Score for Crohn's Disease [SES-CD] Score
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Assessment method [2]
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Endoscopic response is defined as at least a 50% reduction in SES-CD score from Baseline. The overall SES-CD score ranges from 0 to 56 and is the sum of 4 variables (ie, size of ulcers [cm], ulcerated surface, affected surface [%], and presence of narrowing) across 5 bowel segments (ie, rectum, descending and sigmoid colon, transverse colon, ascending colon, and ileum). Each variable is coded from 0 to 3 based on severity, where 0 is none or not severe and 3 is the most severe case, with the sum of the scores for each variable ranging from 0 to 15, except for presence of narrowing. Presence of narrowing ranges from 0 to 11 since a severity of 3 represents a narrowing which a colonoscope cannot be passed and, thus, can only be observed once among the bowel segments. The segmental SES-CD score is the sum of the 4 variables for each bowel segment and can range from 0 to 12, where each individual variable score ranges from 0 to 3.
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Timepoint [2]
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Week 54
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Secondary outcome [1]
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Percentage of Participants with Clinical and Endoscopic Remission at Week 14 Based on Both PCDAI Score and SES-CD Score
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Assessment method [1]
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Clinical and endoscopic remission is where participant achieves both clinical and endoscopic remission. Clinical remission is defined by PCDAI score =10. Endoscopic remission is defined by SES-CD score of =4 with at least a 2-point reduction from Baseline and no sub-score >1. PCDAI includes child-specific item: height velocity variable as well as three laboratory parameters: HCT, ESR, albumin level. PCDAI score ranges from 0 to 100, with higher scores indicating more active disease. The SES-CD score ranges from 0 to 56 and is the sum of 4 variables, size of ulcers [cm], ulcerated surface, affected surface [%], and presence of narrowing) across 5 bowel segments (ie, rectum, descending and sigmoid colon, transverse colon, ascending colon, and ileum), where higher scores indicate more severe disease.
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Timepoint [1]
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Week 14
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Secondary outcome [2]
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Percentage of Participants with Clinical and Endoscopic Remission at Week 54 Based on Both PCDAI Score and SES-CD Score
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Assessment method [2]
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Clinical and endoscopic remission is where participant achieves both clinical and endoscopic remission. Clinical remission is defined by PCDAI score =10. Endoscopic remission is defined by SES-CD score of =4 with at least a 2-point reduction from Baseline and no sub-score >1. PCDAI includes child-specific item: height velocity variable as well as three laboratory parameters: HCT, ESR, albumin level. PCDAI score ranges from 0 to 100, with higher scores indicating more active disease. The SES-CD score ranges from 0 to 56 and is the sum of 4 variables, size of ulcers [cm], ulcerated surface, affected surface [%], and presence of narrowing) across 5 bowel segments (ie, rectum, descending and sigmoid colon, transverse colon, ascending colon, and ileum), where higher scores indicate more severe disease.
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Timepoint [2]
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Week 54
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Secondary outcome [3]
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Percentage of Participants with Sustained Clinical and Endoscopic Remission at Week 54
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Assessment method [3]
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Sustained clinical and endoscopic remission is where a participant achieved clinical and endoscopic remission based on PCDAI and SES-CD scores at Weeks 14 and 54. Clinical remission is defined by PCDAI score =10. Endoscopic remission is defined as =4 with at least a 2-point reduction from Baseline and no sub-score >1 by SES-CD. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score ranges from 0 to 100, with higher scores indicating more active disease. The SES-CD score ranges from 0 to 56 and is the sum of 4 variables, size of ulcers [cm], ulcerated surface, affected surface [%], and presence of narrowing) across 5 bowel segments (ie, rectum, descending and sigmoid colon, transverse colon, ascending colon, and ileum), where higher scores indicate more severe disease.
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Timepoint [3]
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Week 54
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Secondary outcome [4]
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Percentage of Participants with Corticosteroid-free Remission at Week 54 Based on PCDAI Score
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Assessment method [4]
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Corticosteroid-free clinical remission is where participants achieves corticosteroid-free clinical remission based on PCDAI at Week 54 and has been off corticosteroids at least 12 weeks prior to and at Week 54. Clinical remission is defined by PCDAI score =10. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score ranges from 0 to 100, with higher scores indicating more active disease.
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Timepoint [4]
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Week 54
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Secondary outcome [5]
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Percentage of Participants with Sustained Endoscopic Remission Based on SES-CD Score
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Assessment method [5]
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Sustained endoscopic remission is where participants achieves endoscopic remission based on SES-CD =4 with at least a 2-point reduction from Baseline and no sub-score >1. The SES-CD evaluates 4 endoscopic variables (Size of ulcers, Ulcerated surface, Affected surface and Presence of narrowing). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is the sum of the four endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
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Timepoint [5]
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Week 14
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Secondary outcome [6]
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Percentage of Participants with Sustained Endoscopic Remission Based on SES-CD Score
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Assessment method [6]
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Sustained endoscopic remission is where participants achieves endoscopic remission based on SES-CD =4 with at least a 2-point reduction from Baseline and no sub-score >1. The SES-CD evaluates 4 endoscopic variables (Size of ulcers, Ulcerated surface, Affected surface and Presence of narrowing). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is the sum of the four endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
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Timepoint [6]
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Week 54
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Secondary outcome [7]
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Percentage of Participants with Sustained Clinical Remission at Week 14 Based on PCDAI Score
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Assessment method [7]
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Sustained Clinical Remission is where participants will achieve clinical remission based on PCDAI at Weeks 14 and 54. Clinical remission is defined by PCDAI score =10. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
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Timepoint [7]
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Week 14
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Secondary outcome [8]
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Percentage of Participants with Sustained Clinical Remission at Week 54 Based on PCDAI Score
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Assessment method [8]
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Sustained Clinical Remission is where participants will achieve clinical remission based on PCDAI at Weeks 14 and 54. Clinical remission is defined by PCDAI score =10. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
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Timepoint [8]
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Week 54
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Secondary outcome [9]
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Serum Trough Concentrations of Vedolizumab Over Time
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Assessment method [9]
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Timepoint [9]
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Predose and postdose at multiple time points (up to 54 weeks)
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Secondary outcome [10]
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Percentage of Participants With Positive Antivedolizumab Antibodies
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Assessment method [10]
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Timepoint [10]
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Pre-dose (up to 54 weeks)
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Secondary outcome [11]
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Percentage of Participants With Positive Neutralizing Antivedolizumab Antibody Titers
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Assessment method [11]
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Timepoint [11]
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Pre-dose (up to 54 weeks)
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Secondary outcome [12]
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Sustained Clinical Response at Week 14 Based on PCDAI Score
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Assessment method [12]
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Sustained clinical response is where a participant achieve clinical response based on PCDAI score =30 and reduction of the PCDAI by =15 points from Baseline. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
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Timepoint [12]
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Week 14
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Secondary outcome [13]
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Sustained Clinical Response at Week 54 Based on PCDAI Score
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Assessment method [13]
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Sustained clinical response is where a participant achieve clinical response based on PCDAI score =30 and reduction of the PCDAI by =15 points from Baseline. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
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Timepoint [13]
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Week 54
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Secondary outcome [14]
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Percentage of Participants with Clinical Remission at Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
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Assessment method [14]
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Clinical remission is defined by PCDAI score < 10. The PCDAI was specifically designed for use in children. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT (adjusted for age and sex), ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
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Timepoint [14]
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Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
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Secondary outcome [15]
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Percentage of Participants with Change in Baseline in Clinical Response at Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
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Assessment method [15]
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Clinical Response is where participants achieves clinical response if PCDAI =30 with reduction in the PCDAI of =15 points from Baseline. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
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Timepoint [15]
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Baseline, weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
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Secondary outcome [16]
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Percentage of Participants with at Least One Adverse Event (AE), Serious Adverse Event (SAE), and AE of special interest (AESI)
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Assessment method [16]
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An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have causal relationship with this treatment. AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether it is considered related to drug. SAE is any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to congenital anomaly/birth defect and/or is important medical event. An AESI (serious or non-serious) is one of scientific and medical concern specific to compound or program, for which ongoing monitoring and rapid communication by investigator. AESIs include- opportunistic infection, such as progressive multifocal leukoencephalopathy (PML), liver injury, malignancies, infusion-related reactions, hypersensitivity.
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Timepoint [16]
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From first dose of study drug before each dose on dosing days through the Week 72
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Secondary outcome [17]
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Change from Baseline in Weight
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Assessment method [17]
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Change from in Baseline in weight will be calculated as: Weight at each study visit (up to Week 54) - Weight at Baseline.
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Timepoint [17]
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Baseline up to Week 54
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Secondary outcome [18]
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Change from Baseline in Linear Growth Z-score
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Assessment method [18]
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Linear growth Z-score will be calculated as: Z-score = (observed value - median value of the reference population)/ standard deviation value of reference population.
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Timepoint [18]
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Baseline up to Week 54
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Secondary outcome [19]
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Change from Baseline in Tanner Stages at Week 54
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Assessment method [19]
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Tanner Stage is used to define physical measurements of sexual development based on external primary and secondary sex characteristics. Female and male participants are evaluated for breast development and genital development respectively and both genders for pubic hair distribution based on a 5-stage scale ranging from Stage I (prepubertal/preadolescent characteristics) to Stage V (mature or adult characteristics).
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Timepoint [19]
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Week 54
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Eligibility
Key inclusion criteria
Main
1. The participants has moderately to severely active CD, unresponsive or intolerant to
their current standard of care (SOC).
2. The participants weigh =10 kg at the time of screening and enrollment into the study.
3. Participants with Crohn's disease (CD) diagnosed at least 1 month before screening.
Participants with moderately to severely active CD defined by a Pediatric Crohn's
Disease Activity Index (PCDAI) >30 and an simple endoscopic score for Crohn's Disease
(SES-CD) >6 (or an SES-CD =4 if disease is confined to terminal ileum) at screening
endoscopy.
4. Participants who have failed, lost response to, or been intolerant to treatment with
at least 1 of the following agents: corticosteroids, immunomodulators (eg,
azathioprine (AZA), 6-mercaptopurine (6-MP), methotrexate [MTX]), and/or tumor
necrosis factor (TNF)-a antagonist therapy (eg, infliximab, adalimumab). This includes
participants who are dependent on corticosteroids or exclusive or partial enteral
nutrition to control symptoms and who are experiencing worsening of disease in the
moderate-to-severe range when attempting to wean off corticosteroids or discontinue
exclusive enteral nutrition.
5. Participants with extensive colitis or pancolitis of >8 years' duration or left-sided
colitis of >12 years' duration must have documented evidence of a negative
surveillance colonoscopy within 12 months before screening.
6. Participants with vaccinations that are up-to-date based on the countrywide accepted
schedule of childhood vaccines.
Main
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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
1. Participants who have received either (1) an investigational biologic (other than
those listed in Exclusion Criterion #1) within 60 days or 5 half-lives before
screening (whichever is longer); or (2) an approved biologic or biosimilar agent
within 2 weeks before the first dose of study drug or at any time during the screening
period.
2. Participants with active cerebral/meningeal disease, signs/symptoms or history of
progressive multifocal leukoencephalopathy (PML) or any other major neurological
disorders including stroke, multiple sclerosis, brain tumor or neurodegenerative
disease.
3. The participants had a clinically significant infection (eg, pneumonia,
pyelonephritis, coronavirus disease 2019 [COVID-19]) within 30 days prior to first
dose of study drug.
4. The participants has received any live vaccinations within 30 days prior to first
dose.
5. Participants who currently require surgical intervention or are anticipated to require
surgical intervention for CD during this study.
6. Participants who have had subtotal or total colectomy or have a jejunostomy,
ileostomy, colostomy, ileo-anal pouch, known fixed stenosis of the intestine, short
bowel syndrome, or >3 small intestine resections.
7. Participants with a current diagnosis of indeterminate colitis.
8. Participants with clinical features suggesting monogenic very early-onset inflammatory
bowel disease.
9. Active or latent tuberculosis (TB), as evidenced by a diagnostic TB test performed
within 30 days of screening or during the screening Period that is positive, defined
as:
- Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR
- A TB skin test reaction =5 mm.
10. Participants with evidence of positive hepatitis B surface antigen (HBsAg) or
hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune participants(i.e.,
hepatitis B surface antigen [HBsAg]-negative and hepatitis B antibody-positive) may,
however, be included.
Note: If a participant tests negative for HBsAg, but positive for HBcAb, the
participant would be considered eligible if the absence of HBV DNA is confirmed by HBV
DNA polymerase chain reaction reflex testing performed in the central laboratory.
11. Participants with chronic hepatitis C virus (HCV) (ie, positive HCV antibody [HCVAb]
and HCV RNA).
Note: Participants who are HCVAb-positive without evidence of HCV RNA may be
considered eligible (spontaneous viral clearance or previously treated and cured
[defined as no evidence of HCV RNA at least 12 weeks before baseline]).
12. The participants has any identified congenital or acquired immunodeficiency (eg,
common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ
transplantation).
13. The participant has evidence of dysplasia or history of malignancy other than a
successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or
localized carcinoma in situ of the cervix.
14. Participants with positive stool studies for ova and/or parasites or stool culture at
screening visit.
15. Participants with positive Clostridioides difficile (C difficile) stool test at
screening visit.
Other inclusion/exclusion criteria may apply.
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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 administering the treatment/s
The people assessing the outcomes
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
30/04/2022
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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
30/11/2024
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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)
NSW,QLD,VIC
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Recruitment hospital [1]
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Children's Hospital at Westmead - Westmead
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Recruitment hospital [2]
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Queensland Childrens Hospital - South Brisbane
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Recruitment hospital [3]
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Monash Health, Monash Medical Centre - Clayton
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Recruitment hospital [4]
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Royal Children's Hospital Melbourne - PIN - Parkville
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Recruitment postcode(s) [1]
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2145 - Westmead
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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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3168 - Clayton
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Recruitment postcode(s) [4]
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3052 - Parkville
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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Arizona
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United States of America
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California
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United States of America
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Florida
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0
United States of America
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Georgia
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0
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United States of America
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Illinois
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0
0
United States of America
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Indiana
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0
0
United States of America
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Maryland
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0
United States of America
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Massachusetts
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United States of America
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Minnesota
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0
United States of America
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New Jersey
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United States of America
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New York
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United States of America
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Ohio
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United States of America
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Pennsylvania
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Rhode Island
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Texas
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United States of America
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Virginia
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Belgium
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Antwerpen
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0
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Belgium
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Brussels
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Belgium
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Vlaams Brabant
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0
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Canada
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Alberta
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0
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Canada
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British Columbia
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0
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Canada
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Ontario
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0
0
Canada
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0
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Quebec
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0
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China
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Beijing
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0
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China
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0
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Henan
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0
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China
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State/province [26]
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0
Shanghai
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0
0
China
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State/province [27]
0
0
Zhejiang
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0
Croatia
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Grad Zagreb
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Croatia
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Split
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Czechia
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Praha, Hlavni Mesto
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Czechia
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Ostrava
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Greece
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Attiki
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Greece
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Athens
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Greece
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Thessaloniki
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Hungary
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Borsod-Abauj-Zemplen
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Hungary
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Csongrad
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Hungary
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Budapest
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Israel
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HaMerkaz
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Israel
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Yerushalayim
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Israel
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Beer Sheba
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Israel
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Israel
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Jerusalem
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Italy
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Campania
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Italy
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Emilia-Romagna
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Italy
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Lazio
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Italy
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Lombardia
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Italy
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Veneto
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Japan
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Hukuoka
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Japan
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Kumamoto
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Japan
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Tokyo
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Korea, Republic of
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Daegu Gwang'yeogsi
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Korea, Republic of
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Incheon Gwang'yeogsi
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Korea, Republic of
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Seongnam
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Korea, Republic of
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Seoul
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Lithuania
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Kauno Apskritis
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Lithuania
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Vilniaus Apskritis
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Poland
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Dolnoslaskie
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Lodzkie
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Poland
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Malopolskie
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Poland
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Poland
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Podkarpackie
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Poland
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Pomorskie
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Country [63]
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Poland
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Slaskie
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Country [64]
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Poland
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Zachodniopomorskie
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Country [65]
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Poland
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Lodz
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Country [66]
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Slovakia
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Banska Bystrica
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Country [67]
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Slovakia
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Bratislava
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Spain
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Barcelona
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Spain
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Valencia
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Spain
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Madrid
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Spain
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Malaga
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Country [72]
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Spain
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Sevilla
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Country [73]
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United Kingdom
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London, City Of
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Country [74]
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United Kingdom
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South Glamorgan
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Country [75]
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United Kingdom
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West Midlands
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United Kingdom
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London
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United Kingdom
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Takeda
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Ethics approval
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Summary
Brief summary
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system.
In this study, children and teenagers with moderate to severe Crohn's disease will be treated
with vedolizumab.
The main aim of the study is to check if participants achieve remission after treatment with
the vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no
signs of inflammation.
Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a
clinical response will receive either a high dose or low dose of vedolizumab once every 8
weeks. They will receive the same dose every time.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04779320
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Contacts
Principal investigator
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Takeda Contact
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Phone
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0
+1-877-825-3327
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0
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Email
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0
[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04779320
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