UCRecruiting
A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
Phase 2 · Testing Etrasimod · 45 sites · Pfizer
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Etrasimod (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis.
It is open-label: participants know what they are receiving.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 12 to 17
- Any sex
Some of the main requirements, copied from the record:
- 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
There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 36 participants are expected to take part.
- Start date: 2022-12-16.
- Main results expected around 2029-06-16 (estimate from the record).
- 45 study sites listed (35 marked recruiting) in Japan, Poland, Slovakia, Spain and United States.
Main thing being measured
- Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52 (Week 52)
In the researchers’ words
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).
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Pfizer |
| Collaborators | Arena is a wholly owned subsidiary of Pfizer |
| Enrollment | 36 (estimated) |
| Start date | 2022-12-16 |
| Primary completion (est.) | 2029-06-16 |
| First posted | 2022-03-18 |
| Last updated | 2026-07-08 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT05287126 |
Interventions
- Etrasimod (Drug)
Etrasimod tablet or granules by mouth, once daily up to 52 weeks of treatment.
Full eligibility criteria (from the record)
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
Locations (45)
Show all 45 sites
| Site | City | Country | Site status |
|---|---|---|---|
| Arkansas Children's (IP Address) | Little Rock, Arkansas | United States | Not yet recruiting |
| Arkansas Children's | Little Rock, Arkansas | United States | Not yet recruiting |
| Valley View Wellness Medical Center | Garden Grove, California | United States | Recruiting |
| Loma Linda Children's Hospital | Loma Linda, California | United States | Not yet recruiting |
| Loma Linda University Clinical Trial Center | Loma Linda, California | United States | Not yet recruiting |
| Loma Linda University Eye Institute | Loma Linda, California | United States | Not yet recruiting |
| Loma Linda University Medical Center | Loma Linda, California | United States | Not yet recruiting |
| Loma Linda University Pediatric Clinics | Loma Linda, California | United States | Not yet recruiting |
| Loma Linda University Children's Hospital Pediatric Specialty Clinics | San Bernardino, California | United States | Not yet recruiting |
| University of California San Francisco, | San Francisco, California | United States | Recruiting |
| University of California San Francisco | San Francisco, California | United States | Recruiting |
| University of California,San Francisco Pediatric ClinicalResearch Center (PCRC) | San Francisco, California | United States | Recruiting |
| Arnold Palmer Hospital - Center for Digestive Health and Nutrition | Orlando, Florida | United States | Recruiting |
| University of Chicago Medical Center | Chicago, Illinois | United States | Recruiting |
| Boston Children's Hospital | Boston, Massachusetts | United States | Recruiting |
| William Beaumont Hospital/Corewell Health - East | Royal Oak, Michigan | United States | Recruiting |
| William Beaumont Hospitals Reference Laboratory | Royal Oak, Michigan | United States | Recruiting |
| University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital | Cleveland, Ohio | United States | Recruiting |
| University Hospitals Cleveland Medical Center | Cleveland, Ohio | United States | Recruiting |
| ACT-Midwest G1 | Abilene, Texas | United States | Recruiting |
| Japanese Red Cross Kyoto Daini Hospital | Kyoto | Japan | Recruiting |
| Saga University Hospital | Saga | Japan | Recruiting |
| Toyama Prefectural Central Hospital | Toyama | Japan | Recruiting |
| Tsujinaka Hospital - Kashiwanoha | Kashiwa, Chiba | Japan | Recruiting |
| Ishii Eye Clinic | Nagareyama-shi, Chiba | Japan | Recruiting |
| Gunma University Hospital | Maebashi, Gunma | Japan | Recruiting |
| Hyogo Medical University Hospital | Nishinomiya, Hyōgo | Japan | Recruiting |
| Kinki University - Nara Hospital | Ikoma, Nara | Japan | Recruiting |
| Saitama Prefectural Children's Medical Center | Saitama-shi, Saitama | Japan | Recruiting |
| Jichi Medical University Hospital | Shimotsuke, Tochigi | Japan | Recruiting |
| Juntendo University Hospital | Bunkyo-ku, Tokyo | Japan | Recruiting |
| Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero | Katowice | Poland | Not yet recruiting |
| Uniwersytecki Szpital Dziecięcy w Krakowie | Krakow | Poland | Recruiting |
| Twoja Przychodnia - Szczecińskie Centrum Medyczne | Szczecin | Poland | Recruiting |
| Centrum Zdrowia MDM | Warsaw | Poland | Recruiting |
| WIP Warsaw IBD Point Profesor Kierkus | Warsaw | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu | Wroclaw | Poland | Recruiting |
| WIP Warsaw IBD Point Profesor Kierkuś | Warsaw, Masovian Voivodeship | Poland | Recruiting |
| Instytut "Pomnik - Centrum Zdrowia Dziecka" (IPCZD) (The Children's Memorial Health Institute) | Warsaw, Masovian Voivodeship | Poland | Recruiting |
| Instytut Centrum Zdrowia Matki Polki | Lodz, Łódź Voivodeship | Poland | Active, not recruiting |
| K.M. Management, spol. s r.o. | Nitra | Slovakia | Recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Recruiting |
| Hospital Reina Sofia | Córdoba | Spain | Recruiting |
| Hospital Clinico Universitario de Santiago de Compostela | Santiago de Compostela, A Coruna | Spain | Recruiting |
| Consorci Corporacio Sanitaria Parc Tauli | Sabadell, Barcelona | Spain | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.