A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis
Recruiting · NCT07470879 · Interventional (participants receive a specific treatment) · Lead sponsor: Pfizer
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Age range
2 Years to 11 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
42 locations listed across 1 US state.
- 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
- Bristol Royal Hospital for Children - Bristol, United Kingdom
- Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero - Katowice, Poland
- Japanese Red Cross Kumamoto Hospital - Kumamoto, Japan
- Alder Hey Children's Hospital - Liverpool, United Kingdom
- Evelina London Children's Hospital - London, United Kingdom
- Hôpital Universitaire Necker Enfants Malades - Paris, France
- Sheffield Children's Hospital - Sheffield, United Kingdom
- Juntendo University Hospital - Tokyo, Japan
- Universitaetsklinikum Tuebingen - Tübingen, Germany
- Instytut "Pomnik - Centrum Zdrowia Dziecka" - Warsaw, Poland
- HELIOS Klinikum Wuppertal - Wuppertal, Germany
- Hospices Civils de Lyon - Hôpital Femme Mère Enfant - Bron, Auvergne-Rhône-Alpes, France
- 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
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Bergamo, Lombardy, Italy
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Milan, Lombardy, Italy
- King's College Hospital - London, London, CITY of, United Kingdom
- Health Sciences Centre Winnipeg - Winnipeg, Manitoba, Canada
- Children's Hospital Research Institute of Manitoba - Winnipeg, Manitoba, Canada
- Centrum Zdrowia MDM - Warsaw, Masovian Voivodeship, Poland
- Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś - Warsaw, Masovian Voivodeship, Poland
- The Children's Hospital at Westmead - Westmead, New South Wales, Australia
- Universitätsklinikum Münster - Albert Schweitzer Campus - Münster, North Rhine-Westphalia, Germany
- Rambam Health Care Campus - Haifa, Northern District, Israel
- Carmel Medical Center - Haifa, Northern District, Israel
- CHU de Québec - Université Laval - Québec, Quebec, Canada
- Saitama Prefectural Children's Medical Center - Saitama-shi, Saitama, Japan
- Universitätsklinikum Leipzig - Leipzig, Saxony, Germany
- Azienda Ospedaliera Universitaria Meyer IRCCS - Florence, Tuscany, Italy
- Monash Health - Clayton, Victoria, Australia
- Perth Children's Hospital - Perth, Western Australia, Australia