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

Description

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).

Interventions

• Etrasimod (Drug)
  Once daily by mouth

Eligibility criteria

Conditions

Locations

• 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