A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
- Registration Number
- NCT05287126
- Lead Sponsor
- Pfizer
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Etrasimod Etrasimod -
- Primary Outcome Measures
Name Time Method Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52 Week 52
- Secondary Outcome Measures
Name Time Method Proportion of Participants Achieving Clinical Response at Week 12 Week 12 Plasma Concentration of Etrasimod at 4 Hours Post-dose (C4h) 4 hours (± 15 minutes) post-dose Proportion of Participants Achieving Clinical Remission by Pediatric Ulcerative Colitis Activity Index (PUCAI) at Week 12 Week 12 Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 52 Week 52 Proportion of Participants Achieving Endoscopic Improvement at Week 12 Week 12 Proportion of Participants Achieving Symptomatic Remission at Week 52 Week 52 Proportion of Participants with Clinical Remission at Week 12 Who Had Not been Receiving Corticosteroids for ≥ 2 weeks Prior to Week 12 Week 12 Plasma Steady State Trough Concentration (Ctrough,ss) of Etrasimod 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 with Clinical Remission at Week 52 Who Had Not been Receiving Corticosteroids for ≥ 12 weeks Prior to Week 52 Week 52 Proportion of Participants Achieving Clinical Response at Week 52 Week 52 Number and Severity of Adverse Events Up to Week 52 Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
Proportion of Participants Achieving Endoscopic Improvement at Week 52 Week 52 Proportion of Participants Achieving Symptomatic Remission at Week 12 Week 12 Proportion of Participants Achieving Clinical Remission as Assessed by MMS at Week 12 Week 12 Proportion of Participants Achieving Clinical Remission as Assessed by PUCAI at Week 52 Week 52 Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 12 Week 12
Trial Locations
- Locations (46)
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
Scroll for more (36 remaining)Arkansas Children's (IP Address)🇺🇸Little Rock, Arkansas, United States