Brief Summary

The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 \[NCT03945188\] or APD334-302 \[NCT03996369\] or APD334-210 \[NCT04607837\]).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

896

participants targeted

Target at P75+ for phase_3

Timeline

38mo left

Started Sep 2019

Longer than P75 for phase_3

Geographic Reach

36 countries

439 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9.8 years study duration

Study Progress68%

Sep 2019Jun 2029

First Submitted

Initial submission to the registry

May 13, 2019

Completed

2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2019

Completed

4 months until next milestone

Study Start

First participant enrolled

September 5, 2019

Completed

9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2029

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2029

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

9.8 years

First QC Date

May 13, 2019

Last Update Submit

April 22, 2026

Conditions

Ulcerative Colitis

Keywords

Ulcerative ColitisEtrasimodAPD334

Outcome Measures

Primary Outcomes (1)

Number and Severity of Safety Measures
Safety as assessed by the evaluation of adverse events
Up to approximately 8 years

Secondary Outcomes (6)

Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores
Week 52 and Week 104
Proportion of Participants Achieving Clinical Remission at Weeks 52 and 104 Among Participants Achieving Clinical Remission at Study Entry
Week 52 and Week 104
Change From Baseline in the Total Mayo Score
Baseline, Week 52, and Week 104
Change From Baseline in Partial Mayo Score
Baseline, Week 52, Week 104, Week 156, Week 208 and Week 260
Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores
Week 52 and Week 104
+1 more secondary outcomes

Other Outcomes (4)

Percentage of Participants With Histologic Improvement Assessed by the Geboes, Robarts, and Nancy Histopathology Scores
Week 52 and Week 104
Percentage of Participants With Histologic Remission Assessed by the Geboes, Robarts, and Nancy Histopathology Scores
Week 52 and Week 104
Time to Loss of Response Assessed by Mayo Component Sub-scores
Up to Week 260
+1 more other outcomes

Study Arms (1)

Etrasimod 2 mg

EXPERIMENTAL

Drug: Etrasimod

Interventions

EtrasimodDRUG

Etrasimod 2 mg tablet by mouth, once daily up to approximately 8 years or until marketing authorization is obtained in the participant's country, whichever comes first

Also known as: APD334

Etrasimod 2 mg

Eligibility Criteria

Age16 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Must have met the eligibility criteria and have been enrolled in the qualified Phase 2 or 3 parent studies listed below or other qualified region-specific studies and meet the following additional criteria:
Participants previously enrolled in Study APD334-301 (NCT03945188) or APD334-210 (NCT04607837) must have completed the Week 12 visit and have been assessed to have active UC that has not improved or has worsened from baseline or completed the Week 52 visit
Participants previously enrolled in APD334-302 (NCT03996369) must have completed the Week 12 visit

You may not qualify if:

If Investigator considers the participant to be unsuitable for any reason to participate in the Open-Label Extension study
Experienced an adverse event that led to discontinuation from parent study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead
Arena is a wholly owned subsidiary of Pfizercollaborator

Study Sites (463)

Center for Digestive Health (Colonoscopy Location)

Dothan, Alabama, 36301, United States

Location

Digestive Health Specialists (IP Address)

Dothan, Alabama, 36301, United States

Location

Pulmonary Associates (Secondary PFT Location)

Dothan, Alabama, 36301, United States

Location

Gut P.C., dba Digestive Health Specialists of the Southeast (IP Address)

Dothan, Alabama, 36305, United States

Location

Inland Pulmonary Specialists [PFT Only]

Lake Elsinore, California, 92532, United States

Location

A V Pediatrics,Allergy and Family Medicine