A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

NCT05287126 · tracked via the Priya Life Science USA tracker

Sponsor

Pfizer

Phase

Phase 2

Started

2022-12-16

Last updated

2026-07-08

Condition(s) studied

Ulcerative Colitis

Investigational drug(s) / intervention(s)

Etrasimod

Etrasimod: Etrasimod tablet or granules by mouth, once daily up to 52 weeks of treatment.

Study 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 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).

Eligibility

Sex

ALL

Min age

12 Years

Max age

17 Years

Healthy volunteers

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

Primary outcome measure(s)

Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52 — Week 52

Trial sites (45)

Facility	City	Region	Status
Arkansas Children's (IP Address)	Little Rock	Arkansas	Not Yet Recruiting
Arkansas Children's	Little Rock	Arkansas	Not Yet Recruiting
Valley View Wellness Medical Center	Garden Grove	California	Recruiting
Loma Linda Children's Hospital	Loma Linda	California	Not Yet Recruiting
Loma Linda University Clinical Trial Center	Loma Linda	California	Not Yet Recruiting
Loma Linda University Eye Institute	Loma Linda	California	Not Yet Recruiting
Loma Linda University Medical Center	Loma Linda	California	Not Yet Recruiting
Loma Linda University Pediatric Clinics	Loma Linda	California	Not Yet Recruiting
Loma Linda University Children's Hospital Pediatric Specialty Clinics	San Bernardino	California	Not Yet Recruiting
University of California San Francisco,	San Francisco	California	Recruiting
University of California San Francisco	San Francisco	California	Recruiting
University of California,San Francisco Pediatric ClinicalResearch Center (PCRC)	San Francisco	California	Recruiting
Arnold Palmer Hospital - Center for Digestive Health and Nutrition	Orlando	Florida	Recruiting
University of Chicago Medical Center	Chicago	Illinois	Recruiting
Boston Children's Hospital	Boston	Massachusetts	Recruiting
William Beaumont Hospital/Corewell Health - East	Royal Oak	Michigan	Recruiting
William Beaumont Hospitals Reference Laboratory	Royal Oak	Michigan	Recruiting
University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital	Cleveland	Ohio	Recruiting
University Hospitals Cleveland Medical Center	Cleveland	Ohio	Recruiting
ACT-Midwest G1	Abilene	Texas	Recruiting
Tsujinaka Hospital - Kashiwanoha	Kashiwa	Chiba	Recruiting
Ishii Eye Clinic	Nagareyama-shi	Chiba	Recruiting
Gunma University Hospital	Maebashi	Gunma	Recruiting
Hyogo Medical University Hospital	Nishinomiya	Hyōgo	Recruiting
Kinki University - Nara Hospital	Ikoma	Nara	Recruiting
Saitama Prefectural Children's Medical Center	Saitama-shi	Saitama	Recruiting
Jichi Medical University Hospital	Shimotsuke	Tochigi	Recruiting
Juntendo University Hospital	Bunkyo-ku	Tokyo	Recruiting
Japanese Red Cross Kyoto Daini Hospital	Kyoto	Japan	Recruiting
Saga University Hospital	Saga	Japan	Recruiting
Toyama Prefectural Central Hospital	Toyama	Japan	Recruiting
WIP Warsaw IBD Point Profesor Kierkuś	Warsaw	Masovian Voivodeship	Recruiting
Instytut "Pomnik - Centrum Zdrowia Dziecka" (IPCZD) (The Children's Memorial Health Institute)	Warsaw	Masovian Voivodeship	Recruiting
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero	Katowice	Poland	Not Yet Recruiting
Uniwersytecki Szpital Dziecięcy w Krakowie	Krakow	Poland	Recruiting
Twoja Przychodnia - Szczecińskie Centrum Medyczne	Szczecin	Poland	Recruiting
Centrum Zdrowia MDM	Warsaw	Poland	Recruiting
WIP Warsaw IBD Point Profesor Kierkus	Warsaw	Poland	Recruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu	Wroclaw	Poland	Recruiting
Instytut Centrum Zdrowia Matki Polki	Lodz	Łódź Voivodeship	Active Not Recruiting

+ 5 more sites — see the full list on the official registry below.

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Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis Active, not recruiting

A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA) Active, not recruiting

R-3750 in Patients With Mild to Moderate Ulcerative Colitis Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05287126 on ClinicalTrials.gov ↗ ← All trials in the USA