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A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis
Sponsor: Pfizer
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).
Official title: 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
Key Details
Gender
All
Age Range
2 Years - 11 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2026-05-28
Completion Date
2034-08-18
Last Updated
2026-08-24
Healthy Volunteers
No
Conditions
Interventions
Etrasimod
Once daily by mouth
Locations (42)
Fink Children's Ambulatory Care Center
New York, New York, United States
Kimmel Pavilion - NYU Langone
New York, New York, United States
NYU Grossman School of Medicine
New York, New York, United States
NYU Langone Health (Tisch Hospital)
New York, New York, United States
NYU Langone Inflammatory Bowel Disease Center
New York, New York, United States
NYU Langone Radiology - Tisch Hospital
New York, New York, United States
NYU Medical Science Building (MSB)
New York, New York, United States
The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Monash Health
Clayton, Victoria, Australia
Perth Children's Hospital
Perth, Western Australia, Australia
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
Kaplan Medical Center Pharmacy
Rehovot, Central District, Israel
Kaplan Medical Center
Rehovot, 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
Carmel Medical Center
Haifa, Northern District, Israel
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, Lombardy, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
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
Bristol Royal Hospital for Children
Bristol, United Kingdom
Alder Hey Children's Hospital
Liverpool, United Kingdom
Evelina London Children's Hospital
London, United Kingdom
Sheffield Children's Hospital
Sheffield, United Kingdom