NCT07470879|RecruitingPhase 2FDA Drug

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

ELEVATE-UCkids

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

Pfizer ClinicalTrials.gov

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4 other identifiers

C5041018APD334-2082025-523100-77-002025

Study Type

interventional

Target

Locations

10 countries

Sites

Timeline

RegisteredMar 2026

StartedMay 2026

CompletionAug 2034

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

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

96mo left

Started May 2026

Longer than P75 for phase_2

Geographic Reach

10 countries

42 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

8.2 years study duration

Study Progress4%

May 2026Aug 2034

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 28, 2026

Completed

4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2030

Expected

3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2034

Last Updated

August 24, 2026

Status Verified

August 1, 2026

Enrollment Period

4.3 years

First QC Date

March 10, 2026

Last Update Submit

August 21, 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.