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A Study to Evaluate Etrasimod Treatment in Adolescents With 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 adolescents (≥ 12 years up to \< 18 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: An Open-Label, Single-Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
Key Details
Gender
All
Age Range
12 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2022-12-16
Completion Date
2033-07-10
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
Etrasimod
Etrasimod tablet or granules by mouth, once daily up to 52 weeks of treatment.
Locations (47)
Arkansas Children's (IP Address)
Little Rock, Arkansas, United States
Arkansas Children's
Little Rock, Arkansas, United States
Valley View Wellness Medical Center
Garden Grove, California, United States
Loma Linda Children's Hospital
Loma Linda, California, United States
Loma Linda University Clinical Trial Center
Loma Linda, California, United States
Loma Linda University Eye Institute
Loma Linda, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Loma Linda University Pediatric Clinics
Loma Linda, California, United States
Loma Linda University Children's Hospital Pediatric Specialty Clinics
San Bernardino, California, United States
University of California San Francisco,
San Francisco, California, United States
University of California San Francisco
San Francisco, California, United States
University of California,San Francisco Pediatric ClinicalResearch Center (PCRC)
San Francisco, California, United States
Arnold Palmer Hospital - Center for Digestive Health and Nutrition
Orlando, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Boston Children's Hospital
Boston, Massachusetts, United States
William Beaumont Hospital/Corewell Health - East
Royal Oak, Michigan, United States
William Beaumont Hospitals Reference Laboratory
Royal Oak, Michigan, United States
University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital
Cleveland, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
ACT-Midwest G1
Abilene, Texas, United States
Landeskrankenhaus Salzburg
Salzburg, Austria
University Hospitals Leuven
Leuven, Belgium
Tsujinaka Hospital - Kashiwanoha
Kashiwa, Chiba, Japan
Ishii Eye Clinic
Nagareyama-shi, Chiba, Japan
Gunma University Hospital
Maebashi, Gunma, Japan
Hyogo Medical University Hospital
Nishinomiya, Hyōgo, Japan
Kinki University - Nara Hospital
Ikoma, Nara, Japan
Saitama Prefectural Children's Medical Center
Saitama-shi, Saitama, Japan
Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
Japanese Red Cross Kyoto Daini Hospital
Kyoto, Japan
Saga University Hospital
Saga, Japan
Toyama Prefectural Central Hospital
Toyama, Japan
WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, Masovian Voivodeship, Poland
Instytut "Pomnik - Centrum Zdrowia Dziecka" (IPCZD) (The Children's Memorial Health Institute)
Warsaw, Masovian Voivodeship, Poland
Uniwersytecki Szpital Dziecięcy w Krakowie
Krakow, Poland
Twoja Przychodnia - Szczecińskie Centrum Medyczne
Szczecin, Poland
Centrum Zdrowia MDM
Warsaw, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, Łódź Voivodeship, Poland
Narodny ustav detskych chorob
Bratislava, Bratislava Region, Slovakia
Cliniq s.r.o.
Bratislava, Slovakia
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruna, Spain
Consorci Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Reina Sofia
Córdoba, Spain