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C5041006 (APD334 202 or APD334-202EU): A Multicenter, Randomized, Double Blind, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513569-38-00
Acronym
C5041006
Enrollment
367
Registered
2024-09-03
Start date
2021-07-09
Completion date
2025-01-22
Last updated
2025-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Brief summary

SSA-P2:Proportion of subjects with endoscopic response, SS1-P2b:Proportion of subjects with endoscopic response at Week 14, SS2-I: • Proportion of subjects with endoscopic response at Week 14. • Proportion of subjects with clinical remission CDAI at Week 14, SS3-M: • Proportion of subjects with clinical remission CDAI at Week 52 • Proportion of subjects with endoscopic response at Week 52

Detailed description

SSA-P2:• Proportion of subjects with clinical remission CDAI • Change from baseline in SES-CD score • Change from baseline in CDAI score. •Etrasimod plasma concentrations at 4 hours postdose and at steady-state trough concentrations at selected timepoints.• Change and percentage change from baseline in ALC., SS1-P2b:• Proportion of subjects with clinical remission CDAI at Week 14 • Proportion of subjects with clinical remission by PRO2 at Week 14, SS2-I:• Proportion of subjects with clinical remission PRO2 at Week 14 • Proportion of subjects with clinical response CDAI at Week 14 • Proportion of subjects with endoscopic response and clinical remission CDAI at Week 14 • Proportion of subjects with endoscopic remission at Week 14 •, SS3-M: • Proportion of subjects with clinical remission CDAI at Week 52 among subjects in clinical remission CDAI at SS3-M baseline • Proportion of subjects with endoscopic response at Week 52 among subjects in endoscopic response at SS3-M baseline, SS4-E:• Proportion of subjects with clinical remission CDAI by visit up to the end of treatment • Proportion of subjects with clinical remission PRO2 by visit up to the end of treatment

Interventions

DRUGEtrasimod Arginine Blue Placebo

Sponsors

Arena Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
SSA-P2:Proportion of subjects with endoscopic response, SS1-P2b:Proportion of subjects with endoscopic response at Week 14, SS2-I: • Proportion of subjects with endoscopic response at Week 14. • Proportion of subjects with clinical remission CDAI at Week 14, SS3-M: • Proportion of subjects with clinical remission CDAI at Week 52 • Proportion of subjects with endoscopic response at Week 52

Secondary

MeasureTime frame
SSA-P2:• Proportion of subjects with clinical remission CDAI • Change from baseline in SES-CD score • Change from baseline in CDAI score. •Etrasimod plasma concentrations at 4 hours postdose and at steady-state trough concentrations at selected timepoints.• Change and percentage change from baseline in ALC., SS1-P2b:• Proportion of subjects with clinical remission CDAI at Week 14 • Proportion of subjects with clinical remission by PRO2 at Week 14, SS2-I:• Proportion of subjects with clinical remission PRO2 at Week 14 • Proportion of subjects with clinical response CDAI at Week 14 • Proportion of subjects with endoscopic response and clinical remission CDAI at Week 14 • Proportion of subjects with endoscopic remission at Week 14 •, SS3-M: • Proportion of subjects with clinical remission CDAI at Week 52 among subjects in clinical remission CDAI at SS3-M baseline • Proportion of subjects with endoscopic response at Week 52 among subjects in endoscopic response at SS3-M base

Countries

Austria, Belgium, Bulgaria, Croatia, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026