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
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).
Eligibility
- Age range
- 12–17 years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DrugEtrasimod
Etrasimod tablet or granules by mouth, once daily up to 52 weeks of treatment.
Locations (24)
- Arkansas Children's (IP Address)Little Rock, Arkansas
- Loma Linda University Eye InstituteLoma Linda, California
- Loma Linda University Medical CenterLoma Linda, California
- Loma Linda University Pediatric ClinicsLoma Linda, California
- Loma Linda University Children's Hospital Pediatric Specialty ClinicsSan Bernardino, California
- Arnold Palmer Hospital - Center for Digestive Health and NutritionOrlando, Florida