A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis

A Phase 2 Open-Label, Single Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis - A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071260002

Enrollment

Registered

2026-04-02

Start date

2026-02-27

Completion date

Unknown

Last updated

2026-05-25

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

Conditions

Colitis, Ulcerative

Interventions

Drug: Etrasimod Once daily by mouth Other Names: APD334

Eligibility

Sex/Gender

All

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: 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
Number and percent of enrolled participants with clinical remission based on Modified Mayo Score (MMS) at Week 52 [Time Frame: Week 52] Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point (SF= 1 or 0), ES=1 or 0 and RB=0. Mayo score: instrument designed to measure disease activity of ulcerative colitis. will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI.	—

Measure

Time frame

Number and percent of enrolled participants with clinical remission based on Modified Mayo Score (MMS) at Week 52 [Time Frame: Week 52] Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point (SF= 1 or 0), ES=1 or 0 and RB=0. Mayo score: instrument designed to measure disease activity of ulcerative colitis. will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI.

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Secondary

Measure	Time frame
Number and percent of enrolled participants with clinical remission based on MMS at Week 12 [Time Frame: Week 12] -Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point (SF= 1 or 0), ES=1 or 0 and RB=0. Mayo score: instrument designed to measure disease activity of ulcerative colitis. will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI. Number and percent of enrolled participants with clinical response based on MMS score components at Week 12 [Time Frame: Week 12] -Clinical response was defined as a >=2-point and >=30% decrease from baseline in MMS, and a >=1-point decrease from baseline in RB subscore or an absolute RB subscore =2-point and >=30% decrease from baseline in MMS, and a >=1-point decrease from baseline in RB subscore or an absolute RB subscore =2 weeks immediately prior to Week 12 [Time Frame: Week 12] -Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point (SF= 1 or 0), ES=1 or 0 and RB=0. Number of weeks off corticosteroids prior to week 12 visit will be used to determine end point. Mayo score: instrument designed to measure disease activity of ulcerative colitis. These results will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI. *Number and percent of enrolled participants Clinical remission at Week 52 and who had not been receiving corticosteroids for >=12 weeks immediately prior to Week 52 [Time Frame: Week 52] -Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point (SF= 1 or 0), ES=1 or 0 and RB=0. Number of weeks off corticosteroids prior to week 52 visit will be used to determine end point. Mayo score: instrument designed to measure disease activity of ulcerative colitis. These results will be summarized by the numbe	—

Measure

Time frame

*Number and percent of enrolled participants with clinical remission based on MMS at Week 12 [Time Frame: Week 12] -Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point (SF= 1 or 0), ES=1 or 0 and RB=0. Mayo score: instrument designed to measure disease activity of ulcerative colitis. will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI. *Number and percent of enrolled participants with clinical response based on MMS score components at Week 12 [Time Frame: Week 12] -Clinical response was defined as a >=2-point and >=30% decrease from baseline in MMS, and a >=1-point decrease from baseline in RB subscore or an absolute RB subscore =2-point and >=30% decrease from baseline in MMS, and a >=1-point decrease from baseline in RB subscore or an absolute RB subscore =2 weeks immediately prior to Week 12 [Time Frame: Week 12] -Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point (SF= 1 or 0), ES=1 or 0 and RB=0. Number of weeks off corticosteroids prior to week 12 visit will be used to determine end point. Mayo score: instrument designed to measure disease activity of ulcerative colitis. These results will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI. *Number and percent of enrolled participants Clinical remission at Week 52 and who had not been receiving corticosteroids for >=12 weeks immediately prior to Week 52 [Time Frame: Week 52] -Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point (SF= 1 or 0), ES=1 or 0 and RB=0. Number of weeks off corticosteroids prior to week 52 visit will be used to determine end point. Mayo score: instrument designed to measure disease activity of ulcerative colitis. These results will be summarized by the numbe

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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: May 30, 2026