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

RecruitingPhase 2

Sponsor: Pfizer

Conditions: Colitis, Ulcerative

Interventions: Etrasimod

Countries: Canada, France, Germany, Israel, Italy, Japan, Poland, United Kingdom

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 overview

Sex: ALL

Age: 2 Years to 11 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (25)

Winnipeg, Manitoba, Canada
Winnipeg, Manitoba, Canada
Québec, Quebec, Canada
Bron, Auvergne-Rhône-Alpes, France
Paris, France
Münster, North Rhine-Westphalia, Germany
Leipzig, Saxony, Germany
Tübingen, Germany
Wuppertal, Germany
Ramat Gan, Central District, Israel
Ẕerifin, Central District, Israel
Jerusalem, Jerusalem, Israel
Jerusalem, Jerusalem, Israel
Haifa, Northern District, Israel
Florence, Tuscany, Italy
Saitama-shi, Saitama, Japan
Kumamoto, Japan
Tokyo, Japan
Warsaw, Masovian Voivodeship, Poland
Warsaw, Masovian Voivodeship, Poland
Katowice, Poland
Warsaw, Poland
London, London, CITY of, United Kingdom
London, United Kingdom
Sheffield, United Kingdom