A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease
← catalyst calendarSponsored by Pfizer (industry) · PFE — their whole pipeline →. With Arena is a wholly owned subsidiary of Pfizer.
Phase
Phase 2/3
Status
Terminated
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
379actual
Sites
510
Countries
Argentina, Australia, Austria +38
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
The study was prematurely discontinued due to a lack of efficacy in sub-study 1
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-01-06 | actual | When the study began enrolling |
| Primary completion | 2025-04-23 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-06-09 | actual | The whole study's end, after follow-up |
| First posted | 2019-11-21 | actual | When this record first appeared on the registry |
| Results posted | 2026-07-01 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-07-01 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Crohn's Disease
Interventions
- Drug: Etrasimod — also filed as APD334
- Drug: Etrasimod — also filed as APD334
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFPercentage of Participants With Endoscopic Response by Simple Endoscopic Score in Crohn's Disease (SES-CD) at Week 14: SSA
measured Week 14 of SSA
Percentage of Participants With Endoscopic Response by SES-CD at Week 14: SS1
measured Week 14 of SS1
Percentage of Participants With Clinical Remission by CDAI at Week 52: SS3 Responder Cohort
measured Week 52 of study
Percentage of Participants With Clinical Remission by CDAI at Week 52: SS3 Non-Responder Cohort
measured Week 52 of study
Percentage of Participants With Endoscopic Response by SES-CD at Week 52: SS3 Responder Cohort
measured Week 52 of study
Percentage of Participants With Endoscopic Response by SES-CD at Week 52: SS3 Non-Responder Cohort
measured Week 52 of study
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-01-31 · 24.4 MB · Prot_000.pdf
Statistical Analysis Plan: APD334_202_SAP_substudy 1_ph2B_CT 1_09AUG2023posted 2023-08-09 · 1.4 MB · SAP_001.pdf
Statistical Analysis Plan: APD334-202_SAP_Substudy 1-Ph2B_CT 2_06OCT2024.posted 2024-10-06 · 6.1 MB · SAP_002.pdf
Statistical Analysis Plan: APD334_202_SAP_substudy A_24May2023posted 2023-05-24 · 6.2 MB · SAP_003.pdf
Statistical Analysis Plan: APD334_202_SAP_substudy 3_16May2025posted 2025-05-16 · 2.7 MB · SAP_004.pdf
Statistical Analysis Plan: APD334_202_SAP_substudy 4_03JUL2025posted 2025-07-03 · 2.3 MB · SAP_005.pdf
Publications
- PMID 39575597 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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