A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
Recruiting · NCT05287126 · Interventional (participants receive a specific treatment) · Lead sponsor: Pfizer
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Age range
12 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
45 locations listed across 8 US states.
- 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/Corewell Health - East - Royal Oak, Michigan, United States
- William Beaumont Hospitals Reference Laboratory - Royal Oak, Michigan, 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
- ACT-Midwest G1 - Abilene, Texas, United States
- Hospital Universitari Vall d'Hebron - Barcelona, Spain
- Hospital Reina Sofia - Córdoba, Spain
- Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero - Katowice, Poland
- Uniwersytecki Szpital Dziecięcy w Krakowie - Krakow, Poland
- Japanese Red Cross Kyoto Daini Hospital - Kyoto, Japan
- K.M. Management, spol. s r.o. - Nitra, Slovakia
- Saga University Hospital - Saga, Japan
- Twoja Przychodnia - Szczecińskie Centrum Medyczne - Szczecin, Poland
- Toyama Prefectural Central Hospital - Toyama, Japan
- Centrum Zdrowia MDM - Warsaw, Poland
- WIP Warsaw IBD Point Profesor Kierkus - Warsaw, Poland
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu - Wroclaw, Poland
- Hospital Clinico Universitario de Santiago de Compostela - Santiago de Compostela, A Coruna, Spain
- Consorci Corporacio Sanitaria Parc Tauli - Sabadell, Barcelona, Spain
- Tsujinaka Hospital - Kashiwanoha - Kashiwa, Chiba, Japan
- Ishii Eye Clinic - Nagareyama-shi, Chiba, Japan
- Gunma University Hospital - Maebashi, Gunma, Japan
- Hyogo Medical University Hospital - Nishinomiya, Hyōgo, Japan
- WIP Warsaw IBD Point Profesor Kierkuś - Warsaw, Masovian Voivodeship, Poland
- Instytut "Pomnik - Centrum Zdrowia Dziecka" (IPCZD) (The Children's Memorial Health Institute) - Warsaw, Masovian Voivodeship, Poland
- Kinki University - Nara Hospital - Ikoma, 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
- Instytut Centrum Zdrowia Matki Polki - Lodz, Łódź Voivodeship, Poland