A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

An Open-Label, Single-Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Adolescent Subjects With Moderately to Severely Active Ulcerative Colitis - An Open-Label, Single-Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Adolescent Subjects With Moderately to Severely Active Ulcerative Colitis

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031230586

Enrollment

Registered

2024-01-22

Start date

2024-05-25

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Ulcerative Colitis

Interventions

Drug: Etrasimod Etrasimod tablet by mouth, once daily up to 52 weeks of treatment. Other Name: APD334

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: * Have a diagnosis of ulcerative colitis (UC) that is moderately to severely active * Participants are permitted to be receiving a therapeutic dose of select UC therapies

Exclusion criteria

Exclusion criteria: Exclusion criteria: * Severe extensive colitis * Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD * Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

Design outcomes

Primary

Measure	Time frame
Primary Outcome Measures: 1.Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52 [ Time Frame: Week 52 ]	—

Secondary

Measure	Time frame
Secondary Outcome Measures: 1.Plasma Concentration of Etrasimod at 4 Hours Post-dose (C4h) [ Time Frame: 4 hours (+/- 15 minutes) post-dose ] 2.Plasma Steady State Trough Concentration (Ctrough,ss) of Etrasimod [ Time Frame: pre-dose and 4 hours (+/-15 minutes) post-dose at Day 1; at trough concentrations (approximately 24 hours after the dose taken the day before the study visit) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ] 3.Proportion of Participants Achieving Clinical Remission as Assessed by MMS at Week 12 [ Time Frame: Week 12 ] 4.Proportion of Participants Achieving Endoscopic Improvement at Week 12 [ Time Frame: Week 12 ] 5.Proportion of Participants Achieving Endoscopic Improvement at Week 52 [ Time Frame: Week 52 ] 6.Proportion of Participants Achieving Symptomatic Remission at Week 12 [ Time Frame: Week 12 ] 7.Proportion of Participants Achieving Symptomatic Remission at Week 52 [ Time Frame: Week 52 ] 8.Proportion of Participants with Clinical Remission at Week 12 Who Had Not been Receiving Corticosteroids for >= 2 weeks Prior to Week 12 [ Time Frame: Week 12 ] 9.Proportion of Participants with Clinical Remission at Week 52 Who Had Not been Receiving Corticosteroids for >= 12 weeks Prior to Week 52 [ Time Frame: Week 52 ] 10.Proportion of Participants Achieving Clinical Response at Week 12 [ Time Frame: Week 12 ] 11.Proportion of Participants Achieving Clinical Response at Week 52 [ Time Frame: Week 52 ] 12.Proportion of Participants Achieving Clinical Remission by Pediatric Ulcerative Colitis Activity Index (PUCAI) at Week 12 [ Time Frame: Week 12 ] 13.Proportion of Participants Achieving Clinical Remission as Assessed by PUCAI at Week 52 [ Time Frame: Week 52 ] 14.Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 12 [ Time Frame: Week 12 ] 15.Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 52 [ Time Frame: Week 52 ] 16.Number and Severity of Adverse Events [ Time Frame:	—

Measure

Time frame

Secondary Outcome Measures: 1.Plasma Concentration of Etrasimod at 4 Hours Post-dose (C4h) [ Time Frame: 4 hours (+/- 15 minutes) post-dose ] 2.Plasma Steady State Trough Concentration (Ctrough,ss) of Etrasimod [ Time Frame: pre-dose and 4 hours (+/-15 minutes) post-dose at Day 1; at trough concentrations (approximately 24 hours after the dose taken the day before the study visit) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ] 3.Proportion of Participants Achieving Clinical Remission as Assessed by MMS at Week 12 [ Time Frame: Week 12 ] 4.Proportion of Participants Achieving Endoscopic Improvement at Week 12 [ Time Frame: Week 12 ] 5.Proportion of Participants Achieving Endoscopic Improvement at Week 52 [ Time Frame: Week 52 ] 6.Proportion of Participants Achieving Symptomatic Remission at Week 12 [ Time Frame: Week 12 ] 7.Proportion of Participants Achieving Symptomatic Remission at Week 52 [ Time Frame: Week 52 ] 8.Proportion of Participants with Clinical Remission at Week 12 Who Had Not been Receiving Corticosteroids for >= 2 weeks Prior to Week 12 [ Time Frame: Week 12 ] 9.Proportion of Participants with Clinical Remission at Week 52 Who Had Not been Receiving Corticosteroids for >= 12 weeks Prior to Week 52 [ Time Frame: Week 52 ] 10.Proportion of Participants Achieving Clinical Response at Week 12 [ Time Frame: Week 12 ] 11.Proportion of Participants Achieving Clinical Response at Week 52 [ Time Frame: Week 52 ] 12.Proportion of Participants Achieving Clinical Remission by Pediatric Ulcerative Colitis Activity Index (PUCAI) at Week 12 [ Time Frame: Week 12 ] 13.Proportion of Participants Achieving Clinical Remission as Assessed by PUCAI at Week 52 [ Time Frame: Week 52 ] 14.Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 12 [ Time Frame: Week 12 ] 15.Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 52 [ Time Frame: Week 52 ] 16.Number and Severity of Adverse Events [ Time Frame:

—

Countries

Austria, Belgium, Japan, Poland, Slovakia, Spain, United States

Contacts

Public ContactClinical Trials Information Desk

Pfizer R&D Japan G.K.

clinical-trials@pfizer.com+81-3-5309-7000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026