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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/NCT04779307
Registration number
NCT04779307
Ethics application status
Date submitted
1/03/2021
Date registered
3/03/2021
Date last updated
19/04/2024
Titles & IDs
Public title
A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC)
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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 Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
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Secondary ID [1]
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2020-004300-34
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Secondary ID [2]
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MLN0002-3024
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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:
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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0
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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 - Vedolizumab
Experimental: Induction Period: Participants =30 kg, Vedolizumab 300 mg - Vedolizumab 300 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of =30 kg are included in this arm.
Experimental: Induction Period: Participants >15 to <30 kg, Vedolizumab 200 mg - Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of >15 to <30 kg are included in this arm.
Experimental: Induction Period: Participants 10 to 15 kg, Vedolizumab 150 mg - Vedolizumab 150 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of 10 to 15 kg are included in this arm.
Experimental: Maintenance Period: Participants =30 kg, Vedolizumab 300 mg - Vedolizumab 300 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 =30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 300 mg.
Experimental: Maintenance Period: Participants =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.
Experimental: Maintenance Period: Participants >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: Participants >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: Participants 10 to 15 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 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: Participants 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.
Treatment: Drugs: Vedolizumab
Vedolizumab IV infusion.
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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 Modified Mayo Score
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Assessment method [1]
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Clinical remission based on the modified Mayo score is defined as stool frequency subscore 0 to 1 and a decrease of 1 or more from Baseline; rectal bleeding subscore of 0; and, endoscopy subscore 0 to 1 (modified so that a score of 1 does not include friability). Mayo score is an instrument designed to measure disease activity of UC. Modified Mayo score consists of 3 sub-scores: stool frequency, rectal bleeding, and Mayo endoscopic subscore (findings on endoscopy). Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher score indicates more severe disease.
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Timepoint [1]
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Week 54
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Secondary outcome [1]
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Percentage of Participants with Clinical Remission at Week 14 Based on Modified Mayo Score
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Assessment method [1]
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Clinical remission based on the modified Mayo score is defined as stool frequency subscore 0 to 1 and a decrease of 1 or more from Baseline; rectal bleeding subscore of 0; and, endoscopy subscore 0 to 1 (modified so that a score of 1 does not include friability). Mayo score is an instrument designed to measure disease activity of UC. Modified Mayo score consists of 3 sub-scores: stool frequency, rectal bleeding, and Mayo endoscopic subscore (findings on endoscopy). Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher score indicates 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 Sustained Clinical Remission at Week 14 Based on Modified Mayo Score
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Assessment method [2]
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Sustained clinical remission is where a participant achieves clinical remission at Weeks 14 and 54, based on the modified Mayo score. It is defined as stool frequency subscore 0 to 1 and a decrease of 1 or more from Baseline; rectal bleeding subscore of 0; and, endoscopy subscore 0 to 1 (modified so that a score of 1 does not include friability). Mayo score is an instrument designed to measure disease activity of UC. Modified Mayo score consists of 3 sub-scores: stool frequency, rectal bleeding, and Mayo endoscopic subscore (findings on endoscopy). Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher score indicates more severe disease.
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Timepoint [2]
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Week 14
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Secondary outcome [3]
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Percentage of Participants with Sustained Clinical Remission at Week 54 Based on Modified Mayo Score
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Assessment method [3]
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Sustained clinical remission is where a participant achieves clinical remission at Weeks 14 and 54, based on the modified Mayo score. It is defined as stool frequency subscore 0 to 1 and a decrease of 1 or more from Baseline; rectal bleeding subscore of 0; and, endoscopy subscore 0 to 1 (modified so that a score of 1 does not include friability). Mayo score is an instrument designed to measure disease activity of UC. Modified Mayo score consists of 3 sub-scores: stool frequency, rectal bleeding, and Mayo endoscopic subscore (findings on endoscopy). Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher score indicates 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 Sustained Endoscopic Remission at Week 14
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Assessment method [4]
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Sustained endoscopic remission was defined as Mayo endoscopic score (MES) of =1 point. MES is a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale is graded from 0 to 3 based on the findings on endoscopy where 0=normal or inactive disease, 1=mild disease (erythema, decreased vascular pattern), 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). Higher scores indicate more severe disease.
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Timepoint [4]
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Week 14
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Secondary outcome [5]
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Percentage of Participants with Sustained Endoscopic Remission at Week 54
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Assessment method [5]
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Sustained endoscopic remission was defined as Mayo endoscopic score (MES) of =1 point. MES is a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale is graded from 0 to 3 based on the findings on endoscopy where 0=normal or inactive disease, 1=mild disease (erythema, decreased vascular pattern), 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). Higher scores indicate more severe disease.
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Timepoint [5]
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Week 54
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Secondary outcome [6]
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Percentage of Participants with Endoscopic Response at Week 14
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Assessment method [6]
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Endoscopic response was defined as a decrease in MES by =1 grade. MES is a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale is graded from 0 to 3 based on the findings on endoscopy where 0=normal or inactive disease, 1=mild disease (erythema, decreased vascular pattern), 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). Higher scores indicate more severe disease.
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Timepoint [6]
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Week 14
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Secondary outcome [7]
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Percentage of Participants with Endoscopic Response at Week 54
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Assessment method [7]
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Endoscopic response was defined as a decrease in MES by =1 point. MES is a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale is graded from 0 to 3 based on the findings on endoscopy where 0=normal or inactive disease, 1=mild disease (erythema, decreased vascular pattern), 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). Higher scores indicate more severe disease.
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Timepoint [7]
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Week 54
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Secondary outcome [8]
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Percentage of Participants with Corticosteroid-free Clinical Remission at Week 54
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Assessment method [8]
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Corticosteroid-free clinical remission is where a participant achieves corticosteroid-free clinical remission at Week 54, and was off corticosteroids at least 12 weeks prior to and at Week 54. Clinical remission based on the modified Mayo score is defined as stool frequency subscore 0 to 1 and a decrease of 1 or more from Baseline; rectal bleeding subscore of 0; and, endoscopy subscore 0 to 1 (modified so that a score of 1 does not include friability). Mayo score is an instrument designed to measure disease activity of UC. Modified Mayo score consists of 3 sub-scores: stool frequency, rectal bleeding, and Mayo endoscopic subscore (findings on endoscopy). Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher score indicates more severe disease.
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Timepoint [8]
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Week 54
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Secondary outcome [9]
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Percentage of Participants with Clinical Remission at Week 54 Based on Complete Mayo Score
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Assessment method [9]
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Clinical remission based on the complete Mayo score is where a participant achieved a complete Mayo score =2 points with no individual subscore >1 at Week 54. Mayo score is an instrument designed to measure disease activity of UC. Complete Mayo score consists of 4 sub-scores: stool frequency, rectal bleeding, Mayo endoscopic subscore (findings on endoscopy), and Physician's global assessment. Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 12. Here, higher score indicates more severe disease.
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Timepoint [9]
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Week 54
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Secondary outcome [10]
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Serum Trough Concentrations of Vedolizumab over Time
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Assessment method [10]
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Timepoint [10]
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Predose and postdose at multiple time points (up to 54 weeks)
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Secondary outcome [11]
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Percentage of Participants with Positive Anti-vedolizumab Antibodies (AVA)
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Assessment method [11]
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Timepoint [11]
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Predose (up to 54 weeks)
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Secondary outcome [12]
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Percentage of Participants with Positive Neutralizing AVA
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Assessment method [12]
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Timepoint [12]
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Predose (up to 54 weeks)
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Secondary outcome [13]
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Percentage of Participants with Sustained Clinical Response at Week 14 Based on Complete Mayo Score
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Assessment method [13]
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Clinical response is where a participant has a reduction in complete Mayo score of =3 points and =30% from Baseline with an accompanying decrease in rectal bleeding subscore of =1 point or absolute rectal bleeding subscore of =1 point. Mayo score is an instrument designed to measure disease activity of UC. Complete Mayo score consists of 4 sub-scores: stool frequency, rectal bleeding, Mayo endoscopic subscore (findings on endoscopy), and Physician's global assessment. Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 12. Here, higher score indicates more severe disease.
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Timepoint [13]
0
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Week 14
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Secondary outcome [14]
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Percentage of Participants with Sustained Clinical Response at Week 54 Based on Complete Mayo Score
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Assessment method [14]
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Clinical response is where a participant has a reduction in complete Mayo score of =3 points and =30% from Baseline with an accompanying decrease in rectal bleeding subscore of =1 point or absolute rectal bleeding subscore of =1 point. Mayo score is an instrument designed to measure disease activity of UC. Complete Mayo score consists of 4 sub-scores: stool frequency, rectal bleeding, Mayo endoscopic subscore (findings on endoscopy), and Physician's global assessment. Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 12. Here, higher score indicates more severe disease.
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Timepoint [14]
0
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Week 54
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Secondary outcome [15]
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Percentage of Participants with Clinical Response up to Week 54 Based on Partial Mayo Score
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Assessment method [15]
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Clinical response is defined as reduction of =2 points and =25% from the Baseline partial Mayo score, including a =1-point decrease in the Mayo stool frequency subscore and a =1-point reduction in the rectal bleeding subscore or absolute rectal bleeding subscore of =1 point. Partial Mayo score consists of 3 sub-scores: stool frequency, rectal bleeding, and Physician's global assessment. Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Higher score indicates more severe disease.
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Timepoint [15]
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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 Clinical Remission up to Week 54 Based on Partial Mayo Score
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Assessment method [16]
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A partial Mayo score =2 points and no individual subscore >1 point.
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Timepoint [16]
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Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
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Secondary outcome [17]
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Percentage of Participants with at least One Adverse Event (AE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI)
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Assessment method [17]
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An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug which does not necessarily have to have a causal relationship with the treatment. An SAE is defined as 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 a congenital anomaly/birth defect and/or is a important medical event. An AESI (serious or non-serious) is one of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator to Takeda may be appropriate. AESIs include: infusion-related reactions and hypersensitivity, serious infection, malignancy, or other (liver injury and progressive multifocal leukoencephalopathy [PML]).
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Timepoint [17]
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Up to 158 weeks
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Secondary outcome [18]
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Change from Baseline in Weight
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Assessment method [18]
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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 [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 Linear Growth Z-score
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Assessment method [19]
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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 [19]
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Baseline, up to Week 54
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Secondary outcome [20]
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Change in Tanner Stage at Week 54 Compared with Baseline
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Assessment method [20]
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Tanner Stage is used to measure pubertal development. Female (F) and male (M) participants are evaluated for breast development and genital development respectively and both genders for pubic hair development. Tanner Stage is based on progression through 5-stages.
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Timepoint [20]
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Week 54
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Eligibility
Key inclusion criteria
1. Has moderately to severely active UC, unresponsive or intolerant to their current
standard of care (SOC).
2. Weighs =10 kg at the time of screening and enrollment into the study.
3. Participants with UC diagnosed at least 1 month before screening. Participants with
moderately to severely active UC based on a modified Mayo score of 5 to 9 (sum of Mayo
endoscopic subscore, stool frequency subscore, and rectal bleeding subscore) with a
Mayo endoscopic subscore of =2 (with the presence of mucosal friability excluding an
endoscopic subscore of 1 and mandating a score of at least 2) at screening endoscopy.
4. Has failed, lost response to, or been intolerant to treatment with at least 1 of the
following agents: corticosteroids (eg, azathioprine [AZA], 6-mercaptopurine [6-MP],
methotrexate [MTX]), immunomodulators, and/or tumor necrosis factor alpha (TNF-a)
antagonist therapy (eg, infliximab, adalimumab). This includes participants who are
dependent on corticosteroids to control symptoms and who are experiencing worsening of
disease in the moderate-to-severe range when attempting to wean off corticosteroids.
5. Has evidence of UC extending proximal to the rectum (i.e., not limited to proctitis),
at a minimum.
6. Has 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.
7. Participants with vaccinations that are up-to-date based on the countrywide, accepted
schedule of childhood vaccines.
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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. Has previous exposure to approved or investigational anti-integrins including, but not
limited to natalizumab, efalizumab, etrolizumab, or Abrilumab (AMG 181), or mucosal
addressin cell adhesion molecule-1 (MAdCAM-1) antagonists or rituximab.
2. Has received an investigational biologic within 60 days or 5 half-lives before
screening (whichever is longer); or an approved biologic or biosimilar agent within 2
weeks before the first dose of study drug or at any time during the screening period.
3. Has 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.
4. Has had clinically significant infection (eg, pneumonia, pyelonephritis, coronavirus
disease 2019 [COVID-19]) within 30 days prior to first dose of study drug.
5. Has received any live vaccinations within 30 days prior to first dose of study drug.
6. Participants who currently require surgical intervention or are anticipated to require
surgical intervention for UC during this study.
7. Has had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy,
ileo-anal pouch, or known fixed stenosis of the intestine.
8. Participants with a current diagnosis of indeterminate colitis.
9. Participants with clinical features suggesting monogenic very early onset inflammatory
bowel disease.
10. Participant with 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. NOTE: If participants have received Bacillus
Calmette-Guérin vaccine then a QuantiFERON TB Gold test should be performed
instead of the TB skin test.
11. Participants with evidence of positive hepatitis B surface antigen (HBsAg) or
hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune participants (ie,
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.
Participants with chronic hepatitis C virus (HCV) (ie, positive HCV antibody [HCVAb]
and HCV RNA). Note: Subjects 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 participant has evidence of dysplasia or history of malignancy other than a
successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma or
localized carcinoma in situ of the cervix.
13. Has positive stool studies for ova and/or parasites or stool culture at screening
visit.
14. Has 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
18/04/2022
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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
30/08/2025
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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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0
United States of America
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Georgia
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0
0
United States of America
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0
Illinois
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0
0
United States of America
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0
0
Maryland
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0
0
United States of America
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0
0
Massachusetts
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0
0
United States of America
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State/province [7]
0
0
Minnesota
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0
0
United States of America
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0
New Jersey
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0
0
United States of America
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0
New York
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0
0
United States of America
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0
Ohio
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0
0
United States of America
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0
Pennsylvania
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0
0
United States of America
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0
0
Texas
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0
0
United States of America
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0
0
Virginia
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0
0
Belgium
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State/province [14]
0
0
Antwerpen
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0
0
Belgium
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0
0
Brussels
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0
0
Belgium
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0
Vlaams Brabant
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0
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Canada
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Alberta
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0
0
Canada
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0
0
British Columbia
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0
0
Canada
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State/province [19]
0
0
Ontario
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0
0
China
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State/province [20]
0
0
Beijing
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0
0
China
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State/province [21]
0
0
Henan
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0
0
China
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0
0
Shanghai
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0
0
China
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State/province [23]
0
0
Zhejiang
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0
0
Croatia
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State/province [24]
0
0
Grad Zagreb
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0
0
Croatia
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State/province [25]
0
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Split
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0
0
Czechia
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State/province [26]
0
0
Praha
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0
0
Greece
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Attiki
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Greece
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Hungary
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Budapest
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Miskolc
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Israel
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HaDarom
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Israel
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Israel
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Israel
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Petah Tikva
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Israel
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Tel Aviv
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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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Monza E Brianza
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Italy
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Toscana
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Italy
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Italy
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Hukuoka
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Japan
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Japan
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Kumamoto
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Japan
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Saitama
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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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Seoul Teugbyeolsi
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Poland
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Lodzkie
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Podkarpackie
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Slaskie
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Zachodniopomorskie
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United Kingdom
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London, City Of
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United Kingdom
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West Midlands
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United Kingdom
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Cardiff
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Funding & Sponsors
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Commercial sector/Industry
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Takeda
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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 ulcerative colitis will be
treated with vedolizumab.
The main aim of the study is to check if participants achieve remission after treatment with
vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no or
limited signs of disease.
The study is also evaluating side effects of vedolizumab in the children and teenager with
moderately to severely active ulcerative colitis.
Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a
clinical response will receive 1 of 3 doses 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/NCT04779307
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Takeda Contact
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+1-877-825-3327
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[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/NCT04779307
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