Recruiting

Phase 2

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

Sponsor:

Pfizer

Code:

NCT07470879

Conditions

Colitis, Ulcerative

Eligibility Criteria

Sex: All

Age: 2 - 11

Healthy Volunteers: Not accepted

Interventions

Etrasimod

Study Details

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).

Conditions

Colitis, Ulcerative

Study ID

NCT07470879

Start date

May 28, 2026

Status verified date

Aug, 2026

Completion date

Aug 18, 2034

Anticipated

Primary completion date

Sep 8, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 2 - 11

Healthy Volunteers: Not accepted

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:

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

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Etrasimod

Etrasimod by mouth, once daily up to 52 weeks

Interventions

Etrasimod

Once daily by mouth

Primary outcome measure

Number and percent of enrolled participants with clinical remission based on Modified Mayo Score (MMS) at Week 52 [ Time Frame: Week 52 ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

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

Locations

Fink Children's Ambulatory Care Center

Recruiting