Actively Recruiting

Phase 2
Age: 12Years - 17Years
All Genders
NCT05287126

A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

Led by Pfizer · Updated on 2026-05-06

36

Participants Needed

24

Research Sites

551 weeks

Total Duration

On this page

Sponsors

P

Pfizer

Lead Sponsor

A

Arena is a wholly owned subsidiary of Pfizer

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 adolescents (≥ 12 years up to \< 18 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

Official Title

A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

Who Can Participate

Age: 12Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have a diagnosis of ulcerative colitis that is moderately to severely active
  • Participants may be receiving a therapeutic dose of select ulcerative colitis therapies
Not Eligible

You will not qualify if you...

  • Severe extensive colitis
  • Diagnosis of Crohn's disease, indeterminate colitis, or history of fistula consistent with Crohn's disease
  • Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 24 locations

1

Arkansas Children's (IP Address)

Little Rock, Arkansas, United States, 72202

Not Yet Recruiting

2

Loma Linda University Eye Institute

Loma Linda, California, United States, 92354

Not Yet Recruiting

3

Loma Linda University Medical Center

Loma Linda, California, United States, 92354

Not Yet Recruiting

4

Loma Linda University Pediatric Clinics

Loma Linda, California, United States, 92354

Not Yet Recruiting

5

Loma Linda University Children's Hospital Pediatric Specialty Clinics

San Bernardino, California, United States, 92408

Not Yet Recruiting

6

Arnold Palmer Hospital - Center for Digestive Health and Nutrition

Orlando, Florida, United States, 32806

Actively Recruiting

7

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

Actively Recruiting

8

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

9

William Beaumont Hospitals Reference Laboratory

Royal Oak, Michigan, United States, 48073

Actively Recruiting

10

University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital

Cleveland, Ohio, United States, 44106

Actively Recruiting

11

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

Actively Recruiting

12

Landeskrankenhaus Salzburg

Salzburg, Austria, 5020

Actively Recruiting

13

Gunma University Hospital

Maebashi, Gunma, Japan, 371-8511

Actively Recruiting

14

Hyogo Medical University Hospital

Nishinomiya, Hyōgo, Japan, 663-8501

Actively Recruiting

15

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan, 113-8431

Actively Recruiting

16

Japanese Red Cross Kyoto Daini Hospital

Kyoto, Japan, 602-8026

Actively Recruiting

17

Saga University Hospital

Saga, Japan, 849-8501

Actively Recruiting

18

WIP Warsaw IBD Point Profesor Kierkuś

Warsaw, Masovian Voivodeship, Poland, 04-501

Actively Recruiting

19

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

Katowice, Poland, 40-600

Not Yet Recruiting

20

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, Poland, 00-728

Actively Recruiting

21

Narodny ustav detskych chorob

Bratislava, Bratislava Region, Slovakia, 833 40

Not Yet Recruiting

22

Cliniq s.r.o.

Bratislava, Slovakia, 811 09

Not Yet Recruiting

23

Hospital Universitari Vall d'Hebron

Barcelona, Spain, 08035

Actively Recruiting

24

Hospital Reina Sofia

Córdoba, Spain, 14004

Not Yet Recruiting

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Research Team

P

Pfizer CT.gov Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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