A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease
2/3상
조기 종료
NCT04173273
| 대상 질환 | Crohn's Disease |
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| 임상 단계 | 2/3상 |
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| 스폰서 | Pfizer |
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| 상태 | 조기 종료 |
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| 참여자 수 | 379 명 |
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| 중재(약물) | Etrasimod, Etrasimod |
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| 시작일 | 2020년 1월 6일 |
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| 완료일 | 2025년 4월 23일 |
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| 결과 공개일 | 2026년 7월 1일 |
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요약
This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up to 282 weeks, inclusive of the Screening Period, Treatment Period of up to 274 weeks (Induction, Extension or Maintenance, and Long-term Extension Periods), and the 4-Week Follow-Up Period for safety assessment.
Percentage of Participants With Endoscopic Response by Simple Endoscopic Score in Crohn's Disease (SES-CD) at Week 14: SSA
Week 14 of SSA · Percentage of participants
| SSA: Placebo in Induction Period | NA Percentage of participants |
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| SSA: Etrasimod 2 mg in Induction Period | 21.4 Percentage of participants |
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| SSA: Etrasimod 3 mg in Induction Period | 12.2 Percentage of participants |
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Percentage of Participants With Endoscopic Response by SES-CD at Week 14: SS1
Week 14 of SS1 · Percentage of participants
| SS1: Placebo in Induction Period | 14.9 Percentage of participants |
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| SS1: Etrasimod 2 mg in Induction Period | 17.3 Percentage of participants |
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| SS1: Etrasimod 3 mg in Induction Period | 14.9 Percentage of participants |
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| p-value | =0.3147 |
| Percentage Difference | 2.5 (95% CI -6.1–11.1) |
Percentage of Participants With Clinical Remission by CDAI at Week 52: SS3 Responder Cohort
Week 52 of study · Percentage of participants
| SS3 Responder Cohort: Placebo/Placebo | 36.4 Percentage of participants |
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| SS3 Responder Cohort: Etrasimod 2 mg/Etrasimod 2 mg | 69.6 Percentage of participants |
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| SS3 Responder Cohort: Etrasimod 2 mg/Placebo | 50.0 Percentage of participants |
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| SS3 Responder Cohort: Etrasimod 3 mg/Etrasimod 3 mg | 87.5 Percentage of participants |
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| SS3 Responder Cohort: Etrasimod 3 mg/Placebo | 73.3 Percentage of participants |
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