Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis
- Registration Number
- NCT02447302
- Lead Sponsor
- Arena Pharmaceuticals
- Brief Summary
The purpose of this study is to determine whether etrasimod is a safe and effective treatment for ulcerative colitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 156
- Moderately to severely active ulcerative colitis defined as a 3-component Mayo Clinic score
- Evidence of colonic ulcerative colitis activity on endoscopy
- Within 30 days prior to randomization, receipt of any of the following for the treatment of underlying disease: Non-biologic therapies (eg, cyclosporine, tacrolimus, tofacitinib, thalidomide), a non-biologic investigational therapy or an approved non-biologic therapy in an investigational protocol
- Within 60 days prior to randomization, receipt of any of the following: Infliximab, adalimumab, golimumab, certolizumab, vedolizumab, any other investigational or approved biologic agent
- Any prior exposure to natalizumab, efalizumab, or rituximab
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Oral, placebo, daily for 12 weeks. Etrasimod Low Dose Etrasimod Oral, low dose, daily for 12 Weeks Etrasimod High Dose Etrasimod Oral, high dose, daily for 12 weeks
- Primary Outcome Measures
Name Time Method Change From Baseline in Adapted Mayo Score (MCS) at Week 12 Baseline and Week 12 The adapted MCS was used to measure disease activity of ulcerative colitis. It consisted of 3 subscores (stool frequency, rectal bleeding, and findings of endoscopy), each of which was rated on a scale from 0 to 3, indicating normal to severe. The adapted MCS was calculated as the sum of the 3 subscores, and the overall score values ranged from 0 to 9, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Achieved Endoscopic Improvement at Week 12 Week 12 For determination of the endoscopic subscore of the MCS, a flexible proctosigmoidoscopy, performed with a videoendoscope following a cleansing prep (oral or rectal cathartic) was performed at screening (within 10 days prior to administration of the first dose of study drug) and the Week 12 visit. This efficacy procedure assessed endoscopic mucosal appearance. The results were rated on a scale from 0 to 3, indicating normal to severe. Endoscopic improvement was defined as Mayo endoscopic subscore (using findings of flexible proctosigmoidoscopy) of ≤1 point. Multiple imputation method was used to handle missing data.
Change From Baseline in Total Mayo Score (TMS) at Week 12 Baseline and Week 12 The TMS was used to measure disease activity of ulcerative colitis. It consisted of 4 subscores \[stool frequency, rectal bleeding, findings of endoscopy (flexible proctosigmoidoscopy), and Physician's Global Assessment (PGA) score\], each of which was rated on a scale from 0 to 3, indicating normal to severe. The TMS was calculated as the sum of the 4 subscores, and the overall score values ranged from 0 to 12, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data.
Change From Baseline in 2-component MCS at Week 12 Baseline and Week 12 The 2-component MCS was used to measure disease activity of ulcerative colitis. It consisted of 2 subscores (rectal bleeding and findings on endoscopy), each of which was rated on a scale from 0 to 3, indicating normal to severe. The 2-component MCS was calculated as the sum of the 2 subscores, and the overall score value ranged from 0 to 6, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data.
Trial Locations
- Locations (134)
Arena 1119
🇺🇸Birmingham, Alabama, United States
Arena 1133
🇺🇸Dothan, Alabama, United States
Arena 1143
🇺🇸Thousand Oaks, California, United States
Arena 1107
🇺🇸Hollywood, Florida, United States
Arena 1138
🇺🇸Miami, Florida, United States
Arena 1123
🇺🇸Naples, Florida, United States
Arena 1141
🇺🇸Orlando, Florida, United States
Arena 1106
🇺🇸Port Orange, Florida, United States
Arena 1137
🇺🇸Sweetwater, Florida, United States
Arena 1131
🇺🇸Chicago, Illinois, United States
Scroll for more (124 remaining)Arena 1119🇺🇸Birmingham, Alabama, United States