NCT07470879

Brief Summary

The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in pediatrics participants (≥ 2 years up to \< 12 years of age). Participants who will complete the total 52-week treatment period will have the opportunity to continue in a Long-Term Extension (LTE) Period of up to 4 years (5 years after study enrollment).

Trial Health

80
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
100mo left

Started May 2026

Longer than P75 for phase_2

Geographic Reach
4 countries

9 active sites

Status
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

First Submitted

Initial submission to the registry

March 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

May 30, 2026

Expected
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2030

3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2034

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

4.3 years

First QC Date

March 10, 2026

Last Update Submit

May 4, 2026

Conditions

Colitis, Ulcerative

Keywords

ulcerativecolitisulcerative colitisetrasimodpediatrics

Outcome Measures

Primary Outcomes (1)

  • Number and percent of enrolled participants with clinical remission based on Modified Mayo Score (MMS) at 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.

    Week 52

Secondary Outcomes (17)

  • Number and percent of enrolled participants with clinical remission based on MMS at Week 12

    Week 12

  • Number and percent of enrolled participants with clinical response based on MMS score components at Week 12

    Week 12

  • Number and percent of enrolled participants with clinical response based on MMS score components at Week 52

    Week 52

  • Number and percent of enrolled participants endoscopic improvement based on MMS score components at Week 12

    Week 12

  • Number and percent of enrolled participants endoscopic improvement based on MMS score components at Week 52

    Week 52

  • +12 more secondary outcomes

Study Arms (1)

Etrasimod

EXPERIMENTAL

Etrasimod by mouth, once daily up to 52 weeks

Drug: Etrasimod

Interventions

EtrasimodDRUG

Once daily by mouth

Also known as: APD334
Etrasimod

Eligibility Criteria

Age2 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

CHU de Québec - Université Laval

Québec, Quebec, G1V4G2, Canada

RECRUITING

Universitätsklinikum Leipzig

Leipzig, Saxony, 04103, Germany

NOT YET RECRUITING

Universitaetsklinikum Tuebingen

Tübingen, 72076, Germany

NOT YET RECRUITING

Saitama Prefectural Children's Medical Center

Saitama-shi, Saitama, 330-8777, Japan

RECRUITING

Japanese Red Cross Kumamoto Hospital

Kumamoto, 861-8520, Japan

RECRUITING

Juntendo University Hospital

Tokyo, 113-8431, Japan

RECRUITING

Centrum Zdrowia MDM

Warsaw, Masovian Voivodeship, 00-189, Poland

NOT YET RECRUITING

Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś

Warsaw, Masovian Voivodeship, 04-501, Poland

RECRUITING

Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero

Katowice, 40-600, Poland

NOT YET RECRUITING

Related Links

MeSH Terms

Conditions

Colitis, UlcerativeUlcerColitis

Interventions

etrasimod

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 13, 2026

Study Start (Estimated)

May 30, 2026

Primary Completion (Estimated)

September 10, 2030

Study Completion (Estimated)

August 20, 2034

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

More information

Locations

JP(3)CA(1)DE(2)PL(3)