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 Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI 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 Clinical Remission as Assessed by PUCAI at Week 52 Week 52 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
Trial Locations
- Locations (47)
Centrum Zdrowia MDM
🇵🇱Warszawa, Poland
Narodny ustav detskych chorob
🇸🇰Bratislava, Bratislavský KRAJ, Slovakia
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
University of California San Francisco
🇺🇸San Francisco, California, United States
University of California,San Francisco Pediatric ClinicalResearch Center (PCRC)
🇺🇸San Francisco, California, United States
Arnold Palmer Hospital - Center for Digestive Health and Nutrition
🇺🇸Orlando, Florida, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital
🇺🇸Cleveland, Ohio, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Advance Clinical Trial PLLC
🇺🇸Abilene, Texas, United States
Landeskrankenhaus Salzburg
🇦🇹Salzburg, Austria
University Hospitals Leuven
🇧🇪Leuven, Belgium
Tsujinaka Hospital - Kashiwanoha
🇯🇵Kashiwa, Chiba, Japan
Ishii Eye Clinic
🇯🇵Nagareyama-shi, Chiba, Japan
Gunma University Hospital
🇯🇵Maebashi, Gunma, Japan
Hyogo Medical University Hospital
🇯🇵Nishinomiya, Hyogo, Japan
Kinki University - Nara Hospital
🇯🇵Ikoma City, Nara, Japan
Saitama Prefectural Children's Medical Center
🇯🇵Saitama-shi, Saitama, Japan
Jichi Medical University Hospital
🇯🇵Shimotsuke, Tochigi, Japan
Juntendo University Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
Japanese Red Cross Kyoto Daini Hospital
🇯🇵Kyoto, Japan
Saga University Hospital
🇯🇵Saga, Japan
Toyama Prefectural Central Hospital
🇯🇵Toyama, Japan
Instytut "Pomnik - Centrum Zdrowia Dziecka" (IPCZD) (The Children's Memorial Health Institute)
🇵🇱Warsaw, Mazowieckie, Poland
Uniwersytecki Szpital Dziecięcy w Krakowie
🇵🇱Krakow, Poland
Twoja Przychodnia - Szczecińskie Centrum Medyczne
🇵🇱Szczecin, Poland
WIP Warsaw IBD Point Profesor Kierkus
🇵🇱Warsaw, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
🇵🇱Wroclaw, Poland
Instytut Centrum Zdrowia Matki Polki
🇵🇱Lodz, Łódzkie, Poland
Cliniq s.r.o.
🇸🇰Bratislava, Slovakia
Hospital Clinico Universitario de Santiago de Compostela
🇪🇸Santiago de Compostela, A Coruna, Spain
Consorci Corporacio Sanitaria Parc Tauli
🇪🇸Sabadell, Barcelona, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Reina Sofia
🇪🇸Cordoba, Spain