Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis
- Registration Number
- NCT03996369
- Lead Sponsor
- Arena Pharmaceuticals
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 354
- Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening
- Active UC confirmed by endoscopy
- Severe extensive colitis
- Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
- Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Etrasimod 2 mg Etrasimod -
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Clinical Remission Week 12 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving Symptomatic Remission Week 12 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.
Percentage of Participants Achieving Endoscopic Normalization Week 12 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.
Percentage of Participants Achieving Clinical Response Week 12 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.
Percentage of Participants Achieving Symptomatic Response Weeks 2, 4, 8 and 12 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.
Percentage of Participants With Mucosal Healing Week 12 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.
Percentage of Participants Achieving Non-invasive Clinical Response Weeks 2, 4, 8 and 12 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.
Percentage of Participants Achieving Symptomatic Remission at Weeks 2, 4 and 8 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.
Percentage of Participants Achieving Complete Symptomatic Remission Weeks 2, 4, 8 and 12 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.
Percentage of Participants Achieving Endoscopic Improvement Week 12 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.
Trial Locations
- Locations (406)
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
Scroll for more (396 remaining)Digestive Health Specialists of the Southeast🇺🇸Dothan, Alabama, United States