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
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
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).
Inclusion criteria:
Exclusion criteria:
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Loma Linda, California 92354, United States
Loma Linda, California 92354, United States
San Bernardino, California 92408, United States
San Francisco, California 94158, United States
Orlando, Florida 32806, United States
Cleveland, Ohio 44106, United States
Nagareyama-shi, Chiba 270-0116, Japan
Saitama-shi, Saitama 330-8777, Japan
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Warsaw, Masovian Voivodeship 04-730, Poland
Wroclaw, 50-369, Poland
Santiago de Compostela, A Coruna 15706, Spain