The purpose of this study is to assess the efficacy of etrasimod on clinical remission in participants with moderately to severely active ulcerative colitis (UC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
354
Percentage of Participants Achieving Clinical Remission
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 electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to \[\>=\] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (\<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Time frame: Week 12
Percentage of Participants Achieving Endoscopic Improvement
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); higher score indicated more severe disease.
Time frame: Week 12
Percentage of Participants Achieving Symptomatic Remission
Symptomatic remission was defined as an SF sub-score = 0 (or = 1 with a \>= 1 point decrease from Baseline) and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease.
Time frame: Week 12
Percentage of Participants With Mucosal Healing
Mucosal healing was defined as an ES \<= 1 (excluding friability) with histologic remission measured by a Geboes Index score less than \[\<\] 2.0). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system, was 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 indicated more severe disease.
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Digestive Health Specialists of the Southeast
Dothan, Alabama, United States
East View Medical Research, LLC
Mobile, Alabama, United States
Arizona Digestive Health
Sun City, Arizona, United States
Om Research, LLC
Lancaster, California, United States
Entertainment Medical Group, Inc.
Los Angeles, California, United States
United Medical Doctors
Murrieta, California, United States
ACRC Studies,LLC
San Diego, California, United States
Paradigm Clinical Research Institute
Torrance, California, United States
University of Colorado
Aurora, Colorado, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
...and 397 more locations
Time frame: Week 12
Percentage of Participants Achieving Clinical Response
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 percent (%) decrease from Baseline MMS, and a \>= 1-point decrease from Baseline in RB sub-score or an absolute RB sub-score \<= 1. Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Time frame: Week 12
Percentage of Participants Achieving Endoscopic Normalization
Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease); higher score indicated more severe disease.
Time frame: Week 12
Percentage of Participants Achieving Symptomatic Remission at Weeks 2, 4 and 8
Symptomatic remission was defined as an SF sub-score = 0 (or = 1 with a \>= 1 point decrease from Baseline) and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease.
Time frame: Weeks 2, 4 and 8
Percentage of Participants Achieving Complete Symptomatic Remission
Complete symptomatic remission was defined as an SF sub-score = 0 and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease.
Time frame: Weeks 2, 4, 8 and 12
Percentage of Participants Achieving Non-invasive Clinical Response
Non-invasive clinical response was defined as a \>= 30% decrease from Baseline in composite RB and SF sub-scores, and a \>= 1 point decrease from Baseline in RB sub-score or RB sub-score \<= 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 sub-score 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.
Time frame: Weeks 2, 4, 8 and 12
Percentage of Participants Achieving Symptomatic Response
Symptomatic response was defined as a \>= 30% decrease from Baseline in composite RB and SF score. The SF sub-score ranged from 0 to 3 (where 0= normal number of stools and 3= at least 5 stools more than normal) and RB sub-score 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.
Time frame: Weeks 2, 4, 8 and 12