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