RecruitingPhase 2NCT07470879

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

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


Sponsor

Pfizer

Enrollment

24 participants

Start Date

May 28, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 2 YearsMax Age: 11 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Etrasimod for people with colitis ulcerative. The study is currently recruiting participants at 9 locations. People eligible for this study include aged 2 Years to 11 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEtrasimod

Once daily by mouth


Locations(25)

Health Sciences Centre Winnipeg

Winnipeg, Manitoba, Canada

Children's Hospital Research Institute of Manitoba

Winnipeg, Manitoba, Canada

CHU de Québec - Université Laval

Québec, Quebec, Canada

Hospices Civils de Lyon - Hôpital Femme Mère Enfant

Bron, Auvergne-Rhône-Alpes, France

Hôpital Universitaire Necker Enfants Malades

Paris, France

Universitätsklinikum Münster - Albert Schweitzer Campus

Münster, North Rhine-Westphalia, Germany

Universitätsklinikum Leipzig

Leipzig, Saxony, Germany

Universitaetsklinikum Tuebingen

Tübingen, Germany

HELIOS Klinikum Wuppertal

Wuppertal, Germany

Sheba Medical Center

Ramat Gan, Central District, Israel

Yitzhak Shamir Medical Center

Ẕerifin, Central District, Israel

Shaare Zedek Medical Center

Jerusalem, Jerusalem, Israel

Hadassah Medical Center

Jerusalem, Jerusalem, Israel

Rambam Health Care Campus

Haifa, Northern District, Israel

Azienda Ospedaliera Universitaria Meyer IRCCS

Florence, Tuscany, Italy

Saitama Prefectural Children's Medical Center

Saitama-shi, Saitama, Japan

Japanese Red Cross Kumamoto Hospital

Kumamoto, Japan

Juntendo University Hospital

Tokyo, Japan

Centrum Zdrowia MDM

Warsaw, Masovian Voivodeship, Poland

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

Warsaw, Masovian Voivodeship, Poland

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

Katowice, Poland

Instytut "Pomnik - Centrum Zdrowia Dziecka"

Warsaw, Poland

King's College Hospital

London, London, CITY of, United Kingdom

Evelina London Children's Hospital

London, United Kingdom

Sheffield Children's Hospital

Sheffield, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07470879


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