BENITIONSClinical Trial Intelligence

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 질환Crohn's Disease
임상 단계2/3상
스폰서Pfizer
상태조기 종료
참여자 수379 명
중재(약물)Etrasimod, Etrasimod
시작일2020년 1월 6일
완료일2025년 4월 23일
결과 공개일2026년 7월 1일

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 PeriodNA Percentage of participants
SSA: Etrasimod 2 mg in Induction Period21.4 Percentage of participants
SSA: Etrasimod 3 mg in Induction Period12.2 Percentage of participants

Percentage of Participants With Endoscopic Response by SES-CD at Week 14: SS1

Week 14 of SS1 · Percentage of participants

SS1: Placebo in Induction Period14.9 Percentage of participants
SS1: Etrasimod 2 mg in Induction Period17.3 Percentage of participants
SS1: Etrasimod 3 mg in Induction Period14.9 Percentage of participants
p-value=0.3147
Percentage Difference2.5 (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/Placebo36.4 Percentage of participants
SS3 Responder Cohort: Etrasimod 2 mg/Etrasimod 2 mg69.6 Percentage of participants
SS3 Responder Cohort: Etrasimod 2 mg/Placebo50.0 Percentage of participants
SS3 Responder Cohort: Etrasimod 3 mg/Etrasimod 3 mg87.5 Percentage of participants
SS3 Responder Cohort: Etrasimod 3 mg/Placebo73.3 Percentage of participants

BENITIONS에서 보기 ClinicalTrials.gov 원문 보기

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