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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Etrasimod tablet or granules by mouth, once daily up to 52 weeks of treatment.
Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52
Time frame: Week 52
Plasma Concentration of Etrasimod at 4 Hours Post-dose (C4h)
Time frame: 4 hours (± 15 minutes) post-dose
Plasma Steady State Trough Concentration (Ctrough,ss) of Etrasimod
Time frame: pre-dose and 4 hours (±15 minutes) post-dose at Day 1; at trough concentrations (approximately 24 hours after the dose taken the day before the study visit) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Proportion of Participants Achieving Clinical Remission as Assessed by MMS at Week 12
Time frame: Week 12
Proportion of Participants Achieving Endoscopic Improvement at Week 12
Time frame: Week 12
Proportion of Participants Achieving Endoscopic Improvement at Week 52
Time frame: Week 52
Proportion of Participants Achieving Symptomatic Remission at Week 12
Time frame: Week 12
Proportion of Participants Achieving Symptomatic Remission at Week 52
Time frame: Week 52
Proportion of Participants with Clinical Remission at Week 12 Who Had Not been Receiving Corticosteroids for ≥ 2 weeks Prior to Week 12
Time frame: Week 12
Proportion of Participants with Clinical Remission at Week 52 Who Had Not been Receiving Corticosteroids for ≥ 12 weeks Prior to Week 52
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Arkansas Children's (IP Address)
Little Rock, Arkansas, United States
NOT_YET_RECRUITINGArkansas Children's
Little Rock, Arkansas, United States
NOT_YET_RECRUITINGValley View Wellness Medical Center
Garden Grove, California, United States
RECRUITINGLoma Linda Children's Hospital
Loma Linda, California, United States
NOT_YET_RECRUITINGLoma Linda University Clinical Trial Center
Loma Linda, California, United States
NOT_YET_RECRUITINGLoma Linda University Eye Institute
Loma Linda, California, United States
NOT_YET_RECRUITINGLoma Linda University Medical Center
Loma Linda, California, United States
NOT_YET_RECRUITINGLoma Linda University Pediatric Clinics
Loma Linda, California, United States
NOT_YET_RECRUITINGLoma Linda University Children's Hospital Pediatric Specialty Clinics
San Bernardino, California, United States
NOT_YET_RECRUITINGUniversity of California San Francisco,
San Francisco, California, United States
RECRUITING...and 37 more locations
Time frame: Week 52
Proportion of Participants Achieving Clinical Response at Week 12
Time frame: Week 12
Proportion of Participants Achieving Clinical Response at Week 52
Time frame: Week 52
Proportion of Participants Achieving Clinical Remission by Pediatric Ulcerative Colitis Activity Index (PUCAI) at Week 12
Time frame: Week 12
Proportion of Participants Achieving Clinical Remission as Assessed by PUCAI at Week 52
Time frame: Week 52
Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 12
Time frame: Week 12
Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 52
Time frame: Week 52
Number and Severity of Adverse Events
Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
Time frame: Up to Week 52