NCT05287126RecruitingPhase 2
A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
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
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 10 Mar 2022
- Start date
- 16 Dec 2022
- Primary completion date
- 16 Jun 2029
- Lead sponsor
- Pfizer
- Diseases
- Ulcerative colitis
- NCT number
- NCT05287126
- EU CT number
- 2022-500345-25-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 36
- From 16 Dec 2022 to the primary completion date, 16 Jun 2029
- 50 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
Other
- Severe extensive colitis
- Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
Who the study is looking for
- 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
Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (50)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH Coordinator of this site? Confirm its status | Salzburg | Austria | Completed |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Recruiting |
| Parc Tauli Hospital Universitari Coordinator of this site? Confirm its status | Sabadell | Spain | Recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| Juntendo University Hospital Coordinator of this site? Confirm its status | Bunkyo-ku | Japan | Recruiting |
| Kinki University - Nara Hospital Coordinator of this site? Confirm its status | Ikoma | Japan | Recruiting |
| Tsujinaka Hospital Kashiwanoha Coordinator of this site? Confirm its status | Kashiwa | Japan | Recruiting |
| Japanese Red Cross Kyoto Daini Hospital Coordinator of this site? Confirm its status | Kyoto | Japan | Recruiting |
| Gunma University Hospital Coordinator of this site? Confirm its status | Maebashi | Japan | Recruiting |
| Ishii Eye Clinic Coordinator of this site? Confirm its status | Nagareyama-shi | Japan | Recruiting |
| Hyogo Medical University Hospital Coordinator of this site? Confirm its status | Nishinomiya | Japan | Recruiting |
| Saga University Hospital Coordinator of this site? Confirm its status | Saga | Japan | Recruiting |
| Saitama Prefectural Children's Medical Center Coordinator of this site? Confirm its status | Saitama-Shi | Japan | Recruiting |
| Jichi Medical University Hospital Coordinator of this site? Confirm its status | Shimotsuke | Japan | Recruiting |
| Toyama Prefectural Central Hospital Coordinator of this site? Confirm its status | Toyama | Japan | Recruiting |
| Uniwersytecki Szpital Dzieciecy W Krakowie Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Gyncentrum Sp. z o.o. Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Instytut Centrum Zdrowia Matki Polki Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o. Coordinator of this site? Confirm its status | Szczecin | Poland | Recruiting |
| EB GROUP Spółka Z Ograniczoną Odpowiedzialnością Centrum Zdrowia MDM Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Instytut Pomnik Centrum Zdrowia Dziecka Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Medical Network Sp z o o Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| University Hospital Bratislava Coordinator of this site? Confirm its status | Bratislava | Slovakia | Recruiting |
| Cliniq s.r.o. Coordinator of this site? Confirm its status | Bratislava | Slovakia | Recruiting |
| Detská fakultná nemocnica Košice Coordinator of this site? Confirm its status | Košice | Slovakia | Recruiting |
| KM Management spol. s r.o. Coordinator of this site? Confirm its status | Nitra | Slovakia | Recruiting |
| ACT-Midwest G1 Coordinator of this site? Confirm its status | Abilene | United States | Recruiting |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of Chicago Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| University Hospitals Cleveland Medical Center* Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Cook Children's Medical Center Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| Cook Children's Health Care System-Dodson Specialty Clinics Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| Valley View Wellness Medical Center Coordinator of this site? Confirm its status | Garden Grove | United States | Recruiting |
| Arkansas Children's Coordinator of this site? Confirm its status | Little Rock | United States | Not yet recruiting |
| Arkansas Children's (IP Address) Coordinator of this site? Confirm its status | Little Rock | United States | Not yet recruiting |
| Loma Linda University Clinical Trial Center Coordinator of this site? Confirm its status | Loma Linda | United States | Not yet recruiting |
| Loma Linda Children's Hospital Coordinator of this site? Confirm its status | Loma Linda | United States | Not yet recruiting |
| Loma Linda University Eye Institute Coordinator of this site? Confirm its status | Loma Linda | United States | Not yet recruiting |
| Loma Linda University Pediatric Clinics Coordinator of this site? Confirm its status | Loma Linda | United States | Not yet recruiting |
| Loma Linda University Medical Center Coordinator of this site? Confirm its status | Loma Linda | United States | Not yet recruiting |
| Arnold Palmer Hospital - Center for Digestive Health and Nutrition Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| William Beaumont Hospitals Reference Laboratory Coordinator of this site? Confirm its status | Royal Oak | United States | Recruiting |
| William Beaumont Hospital/Corewell Health - East Coordinator of this site? Confirm its status | Royal Oak | United States | Recruiting |
| Loma Linda University Children's Hospital Pediatric Specialty Clinics Coordinator of this site? Confirm its status | San Bernardino | United States | Not yet recruiting |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| University of California,San Francisco Pediatric ClinicalResearch Center (PCRC) Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.