A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
Start Date
12/16/2022
Completion Date
7/10/2033
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).
Eligibility Criteria
Age Range: 12 years to 17 years
Interventions
Etrasimod
Conditions
Locations
Arkansas Children's (IP Address)
Little Rock, Arkansas 72202
United States
Arkansas Children's
Little Rock, Arkansas 72202
United States
Valley View Wellness Medical Center
Garden Grove, California 92845
United States
Loma Linda Children's Hospital
Loma Linda, California 92354
United States
Loma Linda University Clinical Trial Center
Loma Linda, California 92354
United States
Loma Linda University Eye Institute
Loma Linda, California 92354
United States
Loma Linda University Medical Center
Loma Linda, California 92354
United States
Loma Linda University Pediatric Clinics
Loma Linda, California 92354
United States
Loma Linda University Children's Hospital Pediatric Specialty Clinics
San Bernardino, California 92408
United States
University of California San Francisco,
San Francisco, California 94158
United States
University of California San Francisco
San Francisco, California 94158
United States
University of California,San Francisco Pediatric ClinicalResearch Center (PCRC)
San Francisco, California 94158
United States
Arnold Palmer Hospital - Center for Digestive Health and Nutrition
Orlando, Florida 32806
United States
University of Chicago Medical Center
Chicago, Illinois 60637
United States
Boston Children's Hospital
Boston, Massachusetts 02115
United States
William Beaumont Hospital/Corewell Health - East
Royal Oak, Michigan 48073
United States
William Beaumont Hospitals Reference Laboratory
Royal Oak, Michigan 48073
United States
University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital
Cleveland, Ohio 44106
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
ACT-Midwest G1
Abilene, Texas 79606
United States
Tsujinaka Hospital - Kashiwanoha
Kashiwa, Chiba 277-0871
Japan
Ishii Eye Clinic
Nagareyama-shi, Chiba 270-0116
Japan
Gunma University Hospital
Maebashi, Gunma 371-8511
Japan
Hyogo Medical University Hospital
Nishinomiya, Hyōgo 663-8501
Japan
Kinki University - Nara Hospital
Ikoma, Nara 630-0293
Japan
Saitama Prefectural Children's Medical Center
Saitama-shi, Saitama 330-8777
Japan
Jichi Medical University Hospital
Shimotsuke, Tochigi 329 0498
Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo 113-8431
Japan
Japanese Red Cross Kyoto Daini Hospital
Kyoto, 602-8026
Japan
Saga University Hospital
Saga, 849-8501
Japan
Toyama Prefectural Central Hospital
Toyama, 930-8550
Japan
WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, Masovian Voivodeship 04-501
Poland
Instytut "Pomnik - Centrum Zdrowia Dziecka" (IPCZD) (The Children's Memorial Health Institute)
Warsaw, Masovian Voivodeship 04-730
Poland
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
Katowice, 40-600
Poland
Uniwersytecki Szpital Dziecięcy w Krakowie
Krakow, 30-663
Poland
Twoja Przychodnia - Szczecińskie Centrum Medyczne
Szczecin, 71-434
Poland
Centrum Zdrowia MDM
Warsaw, 00-189
Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 00-728
Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, 50-369
Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, Łódź Voivodeship 93-338
Poland
K.M. Management, spol. s r.o.
Nitra, 949 01
Slovakia
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruna 15706
Spain
Consorci Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona 08208
Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Spain
Hospital Reina Sofia
Córdoba, 14004
Spain