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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05470985
Registration number
NCT05470985
Ethics application status
Date submitted
12/07/2022
Date registered
22/07/2022
Date last updated
22/04/2025
Titles & IDs
Public title
A Study to Evaluate the Efficacy, Safety, and Drug Levels of Oral Ozanimod in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy
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Scientific title
A Phase 2/3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy
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Secondary ID [1]
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0
2021-005019-30
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Secondary ID [2]
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0
IM047-023
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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 Disease
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0
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Condition category
Condition code
Oral and Gastrointestinal
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0
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0
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Inflammatory bowel disease
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Inflammatory and Immune System
0
0
0
0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
0
0
0
0
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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 - Ozanimod
Experimental: Ozanimod Dose Level 1 -
Experimental: Ozanimod Dose Level 2 -
Treatment: Drugs: Ozanimod
Specific dose on specific days
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Intervention code [1]
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0
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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0
Percentage of Participants Who Achieve Pediatric Crohn's Disease Activity Index (PCDAI) Score < 10 at Week 64
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Assessment method [1]
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0
The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD. The PCDAI consists of the following 11 variables: Abdominal pain, stools per day, wellbeing, weight, height velocity, abdominal tenderness, peri-rectal disease, extra-intestinal manifestation, hematocrit, erythrocyte sedimentation rate and albumin. The category of severity for each index item is assigned a score: 0=normal;5=mild abnormality; 10= severe abnormality. For hematocrit and erythrocyte SR, the maximum score =5. For albumin level, the maximum score = 10. The PCDAI score is average of 11 variables scoring range of 0 to 100. Mild disease corresponds to scores of 11 to 30; moderate to severe disease corresponds to scores \> 30. Remission (no disease activity) is defined as a PCDAI score \< 10.
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Timepoint [1]
0
0
Week 64
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Primary outcome [2]
0
0
Percentage of Participants Achieving Simple Endoscopic Score for Crohn's Disease (SES-CD) = 2 or SES-CD = 4 Points With no SES-CD Subscore > 1 Point at Week 64
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Assessment method [2]
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0
SES-CD assesses the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these 4 components are assessed in the five segments of the ileum and colon: ileum, right colon, transverse colon, left (descending and sigmoid) colon, and rectum, and is scored on a scale of severity 0 (Normal) to 3 (High). Sub-scores for each segment will be derived by adding component scores within segments. Total SES-CD score is the sum of the sub-scores across the five segments. The sum of each component across all segments ranges from 0 to 15, except for the presence of narrowing where it varies from 0 to 11. The range of the overall SES-CD score is 0-56, with larger scores indicating greater severity of disease.
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Timepoint [2]
0
0
Week 64
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Secondary outcome [1]
0
0
Percentage of Participants Who Achieve Pediatric Crohn's Disease Activity Index (PCDAI) < 10 at Week 12 Based on Data as Observed
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Assessment method [1]
0
0
The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD. The PCDAI consists of the following 11 variables: Abdominal pain, stools per day, wellbeing, weight, height velocity, abdominal tenderness, peri-rectal disease, extra-intestinal manifestation, hematocrit, erythrocyte sedimentation rate and albumin. The category of severity for each index item is assigned a score: 0=normal;5=mild abnormality; 10= severe abnormality. For hematocrit and erythrocyte SR, the maximum score =5. For albumin level, the maximum score = 10. The PCDAI score is average of 11 variables scoring range of 0 to 100. Mild disease corresponds to scores of 11 to 30; moderate to severe disease corresponds to scores \> 30. Remission (no disease activity) is defined as a PCDAI score \< 10.
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Timepoint [1]
0
0
Week 12
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Secondary outcome [2]
0
0
Percentage of Participants Who Achieve Simple Endoscopic Score for Crohn's Disease (SES-CD) Decrease From Baseline of = 50% (ER-50) at Week 64
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Assessment method [2]
0
0
SES-CD assesses the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these 4 components are assessed in the five segments of the ileum and colon: ileum, right colon, transverse colon, left (descending and sigmoid) colon, and rectum, and is scored on a scale of severity 0 (Normal) to 3 (High). Sub-scores for each segment will be derived by adding component scores within segments. Total SES-CD score is the sum of the sub-scores across the five segments. The sum of each component across all segments ranges from 0 to 15, except for the presence of narrowing where it varies from 0 to 11. The range of the overall SES-CD score is 0-56, with larger scores indicating greater severity of disease.
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Timepoint [2]
0
0
Week 64
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Secondary outcome [3]
0
0
Percentage of Participants Who Achieve Simple Endoscopic Score for Crohn's Disease (SES-CD) Decrease From Baseline of = 50% (ER-50) at Week 12 Based on Data as Observed
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Assessment method [3]
0
0
SES-CD assesses the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these 4 components are assessed in the five segments of the ileum and colon: ileum, right colon, transverse colon, left (descending and sigmoid) colon, and rectum, and is scored on a scale of severity 0 (Normal) to 3 (High). Sub-scores for each segment will be derived by adding component scores within segments. Total SES-CD score is the sum of the sub-scores across the five segments. The sum of each component across all segments ranges from 0 to 15, except for the presence of narrowing where it varies from 0 to 11. The range of the overall SES-CD score is 0-56, with larger scores indicating greater severity of disease.
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Timepoint [3]
0
0
Week 12
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Secondary outcome [4]
0
0
Percentage of Participants Who Achieve Reduction in Pediatric Crohn's Disease Activity Index (PCDAI) Score = 12.5 and a Total PCDAI Score of < 30 Points at Week 64
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Assessment method [4]
0
0
The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD. The PCDAI consists of the following 11 variables: Abdominal pain, stools per day, wellbeing, weight, height velocity, abdominal tenderness, peri-rectal disease, extra-intestinal manifestation, hematocrit, erythrocyte sedimentation rate and albumin. The category of severity for each index item is assigned a score: 0=normal;5=mild abnormality; 10= severe abnormality. For hematocrit and erythrocyte SR, the maximum score =5. For albumin level, the maximum score = 10. The PCDAI score is average of 11 variables scoring range of 0 to 100. Mild disease corresponds to scores of 11 to 30; moderate to severe disease corresponds to scores \> 30. Remission (no disease activity) is defined as a PCDAI score \< 10.
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Timepoint [4]
0
0
Week 64
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Secondary outcome [5]
0
0
Percentage of Participants Who Achieve Reduction in Pediatric Crohn's Disease Activity Index (PCDAI) Score = 12.5 and a Total PCDAI Score of < 30 Points at Week 12 Based on Data as Observed
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Assessment method [5]
0
0
The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD. The PCDAI consists of the following 11 variables: Abdominal pain, stools per day, wellbeing, weight, height velocity, abdominal tenderness, peri-rectal disease, extra-intestinal manifestation, hematocrit, erythrocyte sedimentation rate and albumin. The category of severity for each index item is assigned a score: 0=normal;5=mild abnormality; 10= severe abnormality. For hematocrit and erythrocyte SR, the maximum score =5. For albumin level, the maximum score = 10. The PCDAI score is average of 11 variables scoring range of 0 to 100. Mild disease corresponds to scores of 11 to 30; moderate to severe disease corresponds to scores \> 30. Remission (no disease activity) is defined as a PCDAI score \< 10.
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Timepoint [5]
0
0
Week 12
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Secondary outcome [6]
0
0
Percentage of Adolescents Who Achieve an Average Daily Abdominal Pain Score = 1 Point and an Average Daily Stool Frequency = 3 Points With Abdominal Pain and Stool Frequency no Worse Than Baseline at Week 12 Based on Data as Observed
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Assessment method [6]
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Abdominal pain (AP) and stool frequency (SF) clinical remission was defined as average daily abdominal pain score =1 point, and average daily stool frequency = 3 times with AP and SF no worse than baseline at Week 12. Participants entered responses in diaries daily. The 7 days entries prior to visit were considered for calculating average AP score and SF. The AP was graded on severity of 0 (none) to 3 (severe) scale and SF was defined number of liquid or soft stools per day.
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Timepoint [6]
0
0
Week 12
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Secondary outcome [7]
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0
Percentage of Adolescents Who Achieve an Average Daily Abdominal Pain Score = 1 Point and an Average Daily Stool Frequency = 3 Points With Abdominal Pain and Stool Frequency no Worse Than Baseline at Week 64
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Assessment method [7]
0
0
Abdominal pain (AP) and stool frequency (SF) clinical remission was defined as average daily abdominal pain score =1 point, and average daily stool frequency = 3 times with AP and SF no worse than baseline at Week 12. Participants entered responses in diaries daily. The 7 days entries prior to visit were considered for calculating average AP score and SF. The AP was graded on severity of 0 (none) to 3 (severe) scale and SF was defined number of liquid or soft stools per day.
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Timepoint [7]
0
0
Week 64
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Secondary outcome [8]
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0
Change From Baseline in Stool Frequency (SF) Score at Week 64
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Assessment method [8]
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SF was defined number of liquid or soft stools per day.
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Timepoint [8]
0
0
Baseline and Week 64
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Secondary outcome [9]
0
0
Change From Baseline in Abdominal Pain (AP) Score at Week 64
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Assessment method [9]
0
0
Participants entered Reponses in diaries daily. The 7 days entries prior to visit were considered for calculating average AP score. The AP score was graded on severity of 0 (none) to 3 (severe) scale.
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Timepoint [9]
0
0
Baseline and Week 64
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Secondary outcome [10]
0
0
Percentage of Adolescents Who Achieve Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12 Based on Data as Observed
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Assessment method [10]
0
0
The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \[none\] to 3 \[Severe\]), general well-being (0 \[well\] to 4 \[terrible\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
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Timepoint [10]
0
0
Week 12
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Secondary outcome [11]
0
0
Percentage of Adolescents Who Achieve Crohn's Disease Activity Index (CDAI) Score < 150 at Week 64
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Assessment method [11]
0
0
The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \[none\] to 3 \[Severe\]), general well-being (0 \[well\] to 4 \[terrible\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
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Timepoint [11]
0
0
Week 64
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Secondary outcome [12]
0
0
Percentage of Adolescents Who Achieve Crohn's Disease Activity Index (CDAI) Reduction From Baseline of = 100 Points or CDAI Score < 150 at Week 64
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Assessment method [12]
0
0
The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \[none\] to 3 \[Severe\]), general well-being (0 \[well\] to 4 \[terrible\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
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Timepoint [12]
0
0
Week 64
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Secondary outcome [13]
0
0
Percentage of Adolescents Who Achieve Crohn's Disease Activity Index (CDAI) Reduction From Baseline of = 100 Points or CDAI Score < 150 at Week 12 Based on Data as Observed
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Assessment method [13]
0
0
The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \[none\] to 3 \[Severe\]), general well-being (0 \[well\] to 4 \[terrible\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
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Timepoint [13]
0
0
Week 12
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Secondary outcome [14]
0
0
Percentage of Participants Who Achieve a Pediatric Crohn's Disease Activity Index (PCDAI) Score < 10 at Week 64 While Remaining Corticosteroid Free in the Prior 12 Weeks
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Assessment method [14]
0
0
The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD. The PCDAI consists of the following 11 variables: Abdominal pain, stools per day, wellbeing, weight, height velocity, abdominal tenderness, peri-rectal disease, extra-intestinal manifestation, hematocrit, erythrocyte sedimentation rate and albumin. The category of severity for each index item is assigned a score: 0=normal;5=mild abnormality; 10= severe abnormality. For hematocrit and erythrocyte SR, the maximum score =5. For albumin level, the maximum score = 10. The PCDAI score is average of 11 variables scoring range of 0 to 100. Mild disease corresponds to scores of 11 to 30; moderate to severe disease corresponds to scores \> 30. Remission (no disease activity) is defined as a PCDAI score \< 10.
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Timepoint [14]
0
0
Week 64
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Secondary outcome [15]
0
0
Percentage of Adolescents Who Achieve a Pediatric Crohn's Disease Activity Index (PCDAI) Score < 10 at Week 64 While Remaining Corticosteroid Free in the Prior 12 Weeks
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Assessment method [15]
0
0
The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD. The PCDAI consists of the following 11 variables: Abdominal pain, stools per day, wellbeing, weight, height velocity, abdominal tenderness, peri-rectal disease, extra-intestinal manifestation, hematocrit, erythrocyte sedimentation rate and albumin. The category of severity for each index item is assigned a score: 0=normal;5=mild abnormality; 10= severe abnormality. For hematocrit and erythrocyte SR, the maximum score =5. For albumin level, the maximum score = 10. The PCDAI score is average of 11 variables scoring range of 0 to 100. Mild disease corresponds to scores of 11 to 30; moderate to severe disease corresponds to scores \> 30. Remission (no disease activity) is defined as a PCDAI score \< 10.
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Timepoint [15]
0
0
Week 64
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Secondary outcome [16]
0
0
Percentage of Participants Who Achieve a Crohn's Disease Activity Index (CDAI) Score < 150 at Week 64 While Remaining Corticosteroid Free in the Prior 12 Weeks
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Assessment method [16]
0
0
The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \[none\] to 3 \[Severe\]), general well-being (0 \[well\] to 4 \[terrible\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
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Timepoint [16]
0
0
Week 64
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Secondary outcome [17]
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0
Percentage of Participants Achieving Simple Endoscopic Score for Crohn's Disease (SES-CD) = 2 or SES-CD = 4 Points With no SES-CD Subscore > 1 Point at Week 12 Based on Data as Observed
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Assessment method [17]
0
0
SES-CD assesses the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these 4 components are assessed in the five segments of the ileum and colon: ileum, right colon, transverse colon, left (descending and sigmoid) colon, and rectum, and is scored on a scale of severity 0 (Normal) to 3 (High). Sub-scores for each segment will be derived by adding component scores within segments. Total SES-CD score is the sum of the sub-scores across the five segments. The sum of each component across all segments ranges from 0 to 15, except for the presence of narrowing where it varies from 0 to 11. The range of the overall SES-CD score is 0-56, with larger scores indicating greater severity of disease.
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Timepoint [17]
0
0
Week 12
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Secondary outcome [18]
0
0
Steady State Systemic Exposures of Ozanimod at Week 20 and Throughout the Study
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Assessment method [18]
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0
Blood samples were collected to assess steady state exposure of ozanimod.
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Timepoint [18]
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0
Week 20 and up to end of study (Week 64)
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Secondary outcome [19]
0
0
Absolute Lymphocyte Count at Week 12 Based on Data as Observed
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Assessment method [19]
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0
Blood samples were collected to assess lymphocyte count.
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Timepoint [19]
0
0
Baseline (Day 1) and Week 12
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Secondary outcome [20]
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0
Absolute Lymphocyte Count at Week 64
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Assessment method [20]
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0
Blood samples were collected to assess lymphocyte count.
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Timepoint [20]
0
0
Week 64
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Secondary outcome [21]
0
0
Number of Participants With Adverse Events
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Assessment method [21]
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0
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect.
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Timepoint [21]
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0
From first dose (Day 1) and up to Week 12
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Eligibility
Key inclusion criteria
* Participants must have a Pediatric Crohn's Disease Activity Index (PCDAI) score = 30 and a Simple Endoscopic Score for Crohn's Disease (SES-CD) score = 6 (or SES-CD = 4 in participants with isolated ileal disease)
* Participant has an inadequate response, intolerance, or loss of response to at least 1 of the following treatments for Crohn's Disease (CD):
i) corticosteroids ii) immunomodulators iii) biologic therapy iv) other systemic immunomodulatory therapies for CD
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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
* Participant is likely to require, in the physician's judgment, bowel resection within 12 weeks of entry into the study
* Participant has current stoma, ileal-anal pouch anastomosis, fistula that is likely to require, in the physician's judgment, surgical or medical intervention within 12 weeks of entry into the study or need for ileostomy or colostomy
* Participant has extensive small bowel resection (> 100 cm) or known diagnosis of short bowel syndrome or participant requires total parenteral nutrition
Other protocol-defined inclusion/exclusion criteria 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 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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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
22/08/2023
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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
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Actual
13/09/2024
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Sample size
Target
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Accrual to date
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Final
5
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
0
0
Local Institution - 0045 - Joonladup
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Recruitment postcode(s) [1]
0
0
6027 - Joonladup
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Connecticut
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0
0
United States of America
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State/province [3]
0
0
Florida
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0
0
United States of America
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State/province [4]
0
0
Georgia
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Indiana
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Massachusetts
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0
0
United States of America
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0
0
Michigan
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0
0
United States of America
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0
0
Minnesota
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0
0
United States of America
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State/province [9]
0
0
Missouri
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0
0
United States of America
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0
0
New Hampshire
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0
0
United States of America
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State/province [11]
0
0
New York
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0
0
United States of America
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State/province [12]
0
0
Texas
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Washington
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Country [14]
0
0
Belgium
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State/province [14]
0
0
BRU
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0
0
Belgium
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State/province [15]
0
0
VBR
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Country [16]
0
0
Belgium
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State/province [16]
0
0
WLG
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Country [17]
0
0
Belgium
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State/province [17]
0
0
Brussel
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Country [18]
0
0
Belgium
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State/province [18]
0
0
Bruxelles
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Country [19]
0
0
Canada
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State/province [19]
0
0
Nova Scotia
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Country [20]
0
0
Canada
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State/province [20]
0
0
Ontario
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Country [21]
0
0
Canada
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0
0
Quebec
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Country [22]
0
0
France
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State/province [22]
0
0
Bron
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Country [23]
0
0
France
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0
0
Caen
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0
0
France
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0
0
Paris
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0
0
France
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0
0
Toulouse
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Country [26]
0
0
Germany
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State/province [26]
0
0
SN
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Country [27]
0
0
Hungary
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State/province [27]
0
0
Miskolc
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Country [28]
0
0
Hungary
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State/province [28]
0
0
Szeged
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0
0
Poland
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0
0
MZ
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Country [30]
0
0
Poland
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State/province [30]
0
0
PK
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Country [31]
0
0
Poland
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State/province [31]
0
0
Lodz
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Country [32]
0
0
Poland
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State/province [32]
0
0
Warsaw
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0
0
Poland
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State/province [33]
0
0
Warszawa
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Country [34]
0
0
Spain
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State/province [34]
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0
B
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Country [35]
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0
Spain
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State/province [35]
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Badalona
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Country [36]
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Spain
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State/province [36]
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Barcelone
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Country [37]
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Spain
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State/province [37]
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Country
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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, safety, drug levels, and drug effects of ozanimod in pediatric participants with moderately to severely active Crohn's Disease.
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Trial website
https://clinicaltrials.gov/study/NCT05470985
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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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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Country
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0
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Phone
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Fax
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0
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Email
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Contact person for public queries
Name
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BMS Study Connect Contact Center http://www.bmsstudyconnect.com
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Address
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0
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Country
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0
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Phone
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855-907-3286
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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
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/85/NCT05470985/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/85/NCT05470985/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT05470985
Download to PDF