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NCT07470879PHASE2Recruiting

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

Pfizer

Start Date

5/28/2026

Completion Date

8/18/2034

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 Criteria

Age Range: 2 years to 11 years

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

Interventions

DRUG

Etrasimod

Interested in This Trial?

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Conditions

Colitis, Ulcerative

Locations

Fink Children's Ambulatory Care Center

New York, New York 10016

United States

Kimmel Pavilion - NYU Langone

New York, New York 10016

United States

NYU Grossman School of Medicine

New York, New York 10016

United States

NYU Langone Health (Tisch Hospital)

New York, New York 10016

United States

NYU Langone Inflammatory Bowel Disease Center

New York, New York 10016

United States

NYU Langone Radiology - Tisch Hospital

New York, New York 10016

United States

NYU Medical Science Building (MSB)

New York, New York 10016

United States

The Children's Hospital at Westmead

Westmead, New South Wales 2145

Australia

Monash Health

Clayton, Victoria 3168

Australia

Perth Children's Hospital

Perth, Western Australia 6009

Australia

Health Sciences Centre Winnipeg

Winnipeg, Manitoba R3A 1S1

Canada

Children's Hospital Research Institute of Manitoba

Winnipeg, Manitoba R3E 3P4

Canada

CHU de Québec - Université Laval

Québec, Quebec G1V4G2

Canada

Hospices Civils de Lyon - Hôpital Femme Mère Enfant

Bron, Auvergne-Rhône-Alpes 69500

France

Hôpital Universitaire Necker Enfants Malades

Paris, 75015

France

Universitätsklinikum Münster - Albert Schweitzer Campus

Münster, North Rhine-Westphalia 48149

Germany

Universitätsklinikum Leipzig

Leipzig, Saxony 04103

Germany

Universitaetsklinikum Tuebingen

Tübingen, 72076

Germany

HELIOS Klinikum Wuppertal

Wuppertal, 42283

Germany

Sheba Medical Center

Ramat Gan, Central District 5262100

Israel

Kaplan Medical Center Pharmacy

Rehovot, Central District 7610001

Israel

Kaplan Medical Center

Rehovot, Central District 7610001

Israel

Yitzhak Shamir Medical Center

Ẕerifin, Central District 70300

Israel

Shaare Zedek Medical Center

Jerusalem, Jerusalem 9013102

Israel

Hadassah Medical Center

Jerusalem, Jerusalem 9112001

Israel

Rambam Health Care Campus

Haifa, Northern District 3109601

Israel

Carmel Medical Center

Haifa, Northern District 3436212

Israel

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

Bergamo, Lombardy 24127

Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Lombardy 20122

Italy

Azienda Ospedaliera Universitaria Meyer IRCCS

Florence, Tuscany 50139

Italy

Saitama Prefectural Children's Medical Center

Saitama-shi, Saitama 330-8777

Japan

Japanese Red Cross Kumamoto Hospital

Kumamoto, 861-8520

Japan

Juntendo University Hospital

Tokyo, 113-8431

Japan

Centrum Zdrowia MDM

Warsaw, Masovian Voivodeship 00-189

Poland

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

Warsaw, Masovian Voivodeship 04-501

Poland

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

Katowice, 40-600

Poland

Instytut "Pomnik - Centrum Zdrowia Dziecka"

Warsaw, 04-730

Poland

King's College Hospital

London, London, CITY of SE5 9RL

United Kingdom

Bristol Royal Hospital for Children

Bristol, BS2 8BJ

United Kingdom

Alder Hey Children's Hospital

Liverpool, L14 5AB

United Kingdom

Evelina London Children's Hospital

London, SE1 7EH

United Kingdom

Sheffield Children's Hospital

Sheffield, S10 2TH

United Kingdom