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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03945188
Registration number
NCT03945188
Ethics application status
Date submitted
8/05/2019
Date registered
10/05/2019
Titles & IDs
Public title
Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis
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Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
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Secondary ID [1]
0
0
2018-003985-15
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Secondary ID [2]
0
0
APD334-301
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Universal Trial Number (UTN)
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Trial acronym
ELEVATE UC 52
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
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0
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Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
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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
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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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Etrasimod
Treatment: Drugs - Placebo
Experimental: Etrasimod 2 mg -
Placebo comparator: Placebo -
Treatment: Drugs: Etrasimod
Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment
Treatment: Drugs: Placebo
Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment
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Intervention code [1]
0
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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 Achieving Clinical Remission at Week 12
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Assessment method [1]
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Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily eDiary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF subscore = 0 (or = 1 with a = 1-point decrease from Baseline), RB subscore = 0, and ES = 1 (excluding friability). Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
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Timepoint [1]
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0
At Week 12
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Primary outcome [2]
0
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Percentage of Participants Achieving Clinical Remission at Week 52
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Assessment method [2]
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0
Clinical remission was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical remission was defined as SF subscore = 0 (or = 1 with a = 1-point decrease from Baseline), RB subscore = 0, and ES = 1 (excluding friability). Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
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Timepoint [2]
0
0
At Week 52
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Secondary outcome [1]
0
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Percentage of Participants Achieving Endoscopic Improvement at Week 12
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Assessment method [1]
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Endoscopic improvement was defined as an ES = 1 (excluding friability). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease).
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Timepoint [1]
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0
At Week 12
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Secondary outcome [2]
0
0
Percentage of Participants Achieving Endoscopic Improvement at Week 52
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Assessment method [2]
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Endoscopic improvement was defined as an ES = 1 (excluding friability). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease).
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Timepoint [2]
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0
At Week 52
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Secondary outcome [3]
0
0
Percentage of Participants Achieving Symptomatic Remission at Week 12
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Assessment method [3]
0
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Symptomatic remission was defined as an SF subscore = 0 (or = 1 with a = 1-point decrease from Baseline) and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease.
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Timepoint [3]
0
0
At Week 12
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Secondary outcome [4]
0
0
Percentage of Participants Achieving Symptomatic Remission at Week 52
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Assessment method [4]
0
0
Symptomatic remission was defined as an SF subscore = 0 (or = 1 with a = 1-point decrease from Baseline) and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease.
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Timepoint [4]
0
0
At Week 52
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Secondary outcome [5]
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Percentage of Participants With Mucosal Healing at Week 12
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Assessment method [5]
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Mucosal healing was defined as an ES = 1 (excluding friability) with histologic remission measured by a Geboes Index score \< 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease.
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Timepoint [5]
0
0
At Week 12
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Secondary outcome [6]
0
0
Percentage of Participants With Mucosal Healing at Week 52
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Assessment method [6]
0
0
Mucosal healing was defined as an ES = 1 (excluding friability) with histologic remission measured by a Geboes Index score \< 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease.
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Timepoint [6]
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0
At Week 52
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Secondary outcome [7]
0
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Percentage of Participants Achieving Corticosteroid-free Clinical Remission at Week 52
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Assessment method [7]
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Corticosteroid-free clinical remission was defined as an SF subscore = 0 (or = 1 with a = 1-point decrease from Baseline), RB subscore = 0, ES = 1 (excluding friability), and have not received corticosteroids for = 12 weeks in the 40-Week Treatment Period. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
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Timepoint [7]
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0
At Week 52
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Secondary outcome [8]
0
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Percentage of Participants Achieving Sustained Clinical Remission at Both Weeks 12 and 52
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Assessment method [8]
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Sustained clinical remission was defined as an SF subscore = 0 (or = 1 with a = 1-point decrease from Baseline), RB subscore = 0, and ES = 1 (excluding friability) at both Week 12 and Week 52. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
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Timepoint [8]
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0
At Weeks 12 and 52
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Secondary outcome [9]
0
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Percentage of Participants Achieving Clinical Response at Week 12
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Assessment method [9]
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Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a = 2-point and = 30% decrease from Baseline MMS, and a = 1-point decrease from Baseline in RB subscore or an absolute RB subscore = 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
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Timepoint [9]
0
0
At Week 12
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Secondary outcome [10]
0
0
Percentage of Participants Achieving Clinical Response at Week 52
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Assessment method [10]
0
0
Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a = 2-point and = 30% decrease from Baseline MMS, and a = 1-point decrease from Baseline in RB subscore or an absolute RB sub-score = 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
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Timepoint [10]
0
0
At Week 52
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Secondary outcome [11]
0
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Percentage of Participants Achieving Clinical Response at Both Weeks 12 and 52
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Assessment method [11]
0
0
Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a = 2-point and = 30% decrease from Baseline MMS, and a = 1-point decrease from Baseline in RB subscore or an absolute RB subscore = 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
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Timepoint [11]
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0
At Weeks 12 and 52
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Secondary outcome [12]
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Percentage of Participants With Mucosal Healing at Both Weeks 12 and 52
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Assessment method [12]
0
0
Mucosal healing was defined as an ES = 1 (excluding friability) with histologic remission measured by a Geboes Index score \< 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease.
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Timepoint [12]
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0
At Weeks 12 and 52
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Secondary outcome [13]
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Percentage of Participants Achieving Endoscopic Normalization at Week 12
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Assessment method [13]
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Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease).
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Timepoint [13]
0
0
At Week 12
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Secondary outcome [14]
0
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Percentage of Participants Achieving Endoscopic Normalization at Week 52
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Assessment method [14]
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Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease).
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Timepoint [14]
0
0
At Week 52
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Secondary outcome [15]
0
0
Percentage of Participants Achieving Endoscopic Normalization at Both Weeks 12 and 52
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Assessment method [15]
0
0
Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease).
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Timepoint [15]
0
0
At Weeks 12 and 52
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Secondary outcome [16]
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0
Percentage of Participants Achieving Symptomatic Remission by Study Visit
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Assessment method [16]
0
0
Symptomatic remission was defined as an SF subscore = 0 (or = 1 with a = 1-point decrease from Baseline) and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease.
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Timepoint [16]
0
0
At Weeks 2, 4, 8, 16, 20, 24, 32, 40, and 48
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Secondary outcome [17]
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Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit
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Assessment method [17]
0
0
Complete symptomatic remission was defined as an SF subscore = 0 and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease.
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Timepoint [17]
0
0
At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48 and 52
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Secondary outcome [18]
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0
Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit
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Assessment method [18]
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Non-invasive clinical response was defined as a = 30% decrease from Baseline in composite RB and SF subscores, and a = 1-point decrease from Baseline in RB subscore or RB subscore = 1. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease.
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Timepoint [18]
0
0
At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
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Secondary outcome [19]
0
0
Percentage of Participants Achieving Symptomatic Response by Study Visit
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Assessment method [19]
0
0
Symptomatic response was defined as a = 30% decrease from Baseline in composite RB and SF subscores. The SF subscore ranged from 0 to 3 (where 0= normal number of stools and 3= at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0= no blood and 3= blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease.
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Timepoint [19]
0
0
At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
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Secondary outcome [20]
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Percentage of Participants Achieving 4-week Corticosteroid-free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline
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Assessment method [20]
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Four-week corticosteroid-free clinical remission was defined as an SF subscore = 0 (or = 1 with a = 1-point decrease from Baseline), RB subscore = 0, and ES = 1, and have not received corticosteroids for = 4 weeks in the 40-Week Treatment Period. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
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Timepoint [20]
0
0
At Week 52
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Secondary outcome [21]
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Percentage of Participants Achieving Clinical Remission at Week 52 Among Participants in Clinical Response at Week 12
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Assessment method [21]
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0
Clinical remission and clinical response were based on the MMS which is a composite of 3 assessments: SF, RB and ES. Clinical remission was defined as an SF subscore = 0 (or = 1 with a = 1-point decrease from Baseline), RB subscore = 0, and ES = 1 (excluding friability). Clinical response was defined as a = 2-point and = 30% decrease from Baseline MMS, and a = 1-point decrease from Baseline in RB subscore or an absolute RB subscore = 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
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Timepoint [21]
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At Week 52
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Eligibility
Key inclusion criteria
Inclusion criteria:
1. Diagnosed with ulcerative colitis (UC) = 3 months prior to screening
2. Active UC confirmed by endoscopy
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Minimum age
16
Years
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Maximum age
80
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
Exclusion criteria:
1. Severe extensive colitis
2. Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
3. Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
13/06/2019
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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
16/02/2022
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Sample size
Target
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Accrual to date
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Final
433
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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0
Bankstown-Lidcombe Hospital - Bankstown
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Recruitment hospital [2]
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Nepean Hospital - Kingswood
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Recruitment hospital [3]
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Coastal Digestive Health Pty Ltd - Maroochydore
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Recruitment hospital [4]
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Coral Sea Clinical Research Institute - North Mackay
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Recruitment hospital [5]
0
0
Austin Health Gastroenterology Department - Heidelberg
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Recruitment hospital [6]
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Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
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0
2200 - Bankstown
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Recruitment postcode(s) [2]
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2747 - Kingswood
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Recruitment postcode(s) [3]
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4558 - Maroochydore
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Recruitment postcode(s) [4]
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4740 - North Mackay
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Recruitment postcode(s) [5]
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3084 - Heidelberg
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Recruitment postcode(s) [6]
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3050 - 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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Alabama
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United States of America
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Arizona
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Georgia
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Illinois
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United States of America
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Louisiana
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Maryland
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Michigan
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Mississippi
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Nevada
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North Carolina
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Ohio
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Oklahoma
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Argentina
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Tucuman
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Linz
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Wien
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Minsk
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Gent
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Pleven
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Ruse
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Bulgaria
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Sliven
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Bulgaria
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Sofia
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Bulgaria
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Stara Zagora
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Canada
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Ontario
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Santiago
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Chile
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Osijek
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Zadar
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Zagreb
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Brno
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Hradec Kralove
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Czechia
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Klatovy
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Czechia
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Olomouc
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Czechia
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Ostrava-Poruba
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Praha
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Czechia
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Slany
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Denmark
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Tallinn
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France
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Israel
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Petach Tikva
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Israel
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Ramat Gan
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Italy
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Catania
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Italy
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Catanzaro
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Italy
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Modena
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Italy
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Roma
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Italy
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Vicenza
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Korea, Republic of
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Daegu
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Bedzin
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Rzeszow
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Portugal
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Russian Federation
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Novosibirsk
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Omsk
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Russian Federation
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Penza
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Russian Federation
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Saint Petersburg
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Russian Federation
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Samara
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Russian Federation
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Russian Federation
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Smolensk
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Russian Federation
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Stavropol
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Serbia
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Sremska Mitrovica
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Presov
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Bardejov
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Nitra
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Slovakia
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Nove Zamky
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Slovakia
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Sahy
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Centurion
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Gauteng
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Western Cape
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Spain
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Madrid
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Taichung
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Bangkok
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Thailand
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Chiang Mai
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Turkey
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Yenimahalle / Ankara
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Turkey
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Ankara
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Turkey
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Antalya
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Turkey
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Kocaeli
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Ukraine
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Dnipro
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kharkiv
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Ukraine
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Ukraine
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Kremenchuk
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Ukraine
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Odesa
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Ukraine
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Uzhgorod
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Ukraine
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Vinnytsia
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Ukraine
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Zaporizhzhia
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United Kingdom
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Greater London
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United Kingdom
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Norfolk
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United Kingdom
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Somerset
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United Kingdom
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Belfast
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United Kingdom
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Hemel Hempstead
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Arena Pharmaceuticals
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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 determine whether oral etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03945188
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Arena CT.gov Administrator
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Address
0
0
Arena Pharmaceuticals
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Country
0
0
Query!
Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
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Address
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Phone
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Fax
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0
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Email
0
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/88/NCT03945188/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/88/NCT03945188/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03945188