Table 3.
Studies exploring the potential of Etrasimod in treating ulcerative colitis (UC), covering different phases, patient populations, and study statuses
| NCT number | Study acronym | Type of study | Aim | Study population | Primary outcome measures | Sponsor | Phases | Study status |
|---|---|---|---|---|---|---|---|---|
| NCT02447302 | OASIS | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study | To investigate Etrasimod's safety and efficacy in Moderately to Severely Active UC |
Moderately to Severely Active UC, defined as per Mayo Score (MS) or Evidence of colonic UC activity on endoscopy (18–80 Years) |
Clinical remission assessed by Change From Baseline in Adapted MS At Week 12 |
Arena Pharmaceuticals | Phase-2 | Completed (Published Results) |
| NCT02536404 | NA | Extension Study of NCT02447302 | To evaluate Etrasimod's safety and efficacy in Moderately to Severely Active UC after 52 weeks |
Participants with Moderately to Severely Active UC, who completed the NCT02447302 study (18–80 Years) |
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Up to Week 48 |
Arena Pharmaceuticals | Phase-2 | Completed (Published Results) |
| NCT04607837 | GLADIATOR UC | A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study | To Assess the Efficacy and Safety of Etrasimod |
Subjects With Moderately Active UC, defined as a modified MS of 4 to 6 and an endoscopic score ≥ 2 and rectal bleeding score ≥ 1 (18–80 Years) |
Proportion of Participants Achieving Clinical Remission At week 12 and 52 Safety up to week 56 |
Pfizer | Phase-2 | Active, Not Recruiting |
| NCT05061446 | NA | Dose-Ranging Study of Etrasimod | To assess the safety and efficacy of Etrasimod administered for 12 weeks, in Japanese subjects |
Japanese Subjects With Moderately to Severely Active UC (18–80 Years) |
Proportion of Participants Achieving Clinical Remission. At week 12 Adverse Events (AEs) up to 16 weeks |
Pfizer | Phase-2 | Completed (Results Not Published) |
| NCT03996369 | ELEVATE UC 12 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study | To assess the Efficacy and Safety of Etrasimod |
Participants with moderately to severely active UC, confirmed by endoscopy (16–80 Years) |
Percentage of Participants Achieving Clinical Remission At week 12 |
Arena Pharmaceuticals | Phase-3 | Completed (Published Results) |
| NCT03945188 | ELEVATE UC 52 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study | To Assess the Efficacy and Safety of Etrasimod |
Subjects with moderately to severely active UC, confirmed by endoscopy (16–80 Years) |
Percentage of Participants Achieving Clinical Remission At week 12 and 52 |
Arena Pharmaceuticals | Phase-3 | Completed (Published Results) |
| NCT04706793 | ELEVATE UC 40 JAPAN |
A Phase 3, Double-Blind, Placebo-Controlled, 40-Week Extension Study of |
To Assess the Efficacy and Safety of Etrasimod |
Japanese Subjects With Moderately to Severely Active UC (16–80 Years) |
Percentage of Participants Achieving Clinical Remission At Week 40 of Study NCT03996369 |
Pfizer | Phase-3 | Completed (Published Results) |
| NCT03950232 | ELEVATE UC OLE | An Open-Label Extension Study | To evaluate the safety and efficacy of etrasimod |
Subjects With Moderately to Severely Active UC who previously received double-blind treatment in in parent studies (16–80 Years) |
Number and Severity of Safety Measures Up to approximately 8 years |
Pfizer | Phase-3 | Recruiting |
| NCT04176588 | NA | A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Study | to Evaluate the Efficacy and Safety of Etrasimod for Induction and Maintenance Treatment |
Subjects With Moderately to Severely Active UC, confirmed by endoscopy with ≥ 10 cm rectal involved (18–75 Years) |
The proportion of Subjects With Clinical Remission Assessed by modified MS At week 12 and 40 |
Everstar Therapeutics Limited | Phase-3 | Unknown Status |
| NCT05287126 | NA | An Open-Label, Single-Arm Study | To Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod |
Adolescent Subjects With Moderately to Severely Active UC (12–17 Years) |
The proportion of Participants Achieving Clinical Remission as Assessed by Modified MS at Week 52. Participants who complete 52 weeks have the option to continue in a long-term extension period of up to 4 years or until marketing authorization is obtained in their country | Pfizer | Phase-2 | Recruiting |
MS Mayo score, TEAEs Treatment-emergent adverse events, AEs Adverse events, SAEs Serious adverse events