Evaluating Etrasimod for Treating Ulcerative Colitis in Adolescents
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
Run by Pfizer · NCT05287126 · Data updated 2026-11-12
This study is testing if a new medication called etrasimod can help teenagers with moderate to severe ulcerative colitis feel better over a year and possibly longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 47 sites (Little Rock, Arkansas and 46 other locations) |
| Status | Recruiting |
| Started | December 16, 2022 |
| Main results expected | June 16, 2029 |
| Study ends | July 10, 2033 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT05287126 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adolescents aged 12 to under 18 years diagnosed with moderately to severely active ulcerative colitis.
✕Probably not a fit
Patients with severe extensive colitis, Crohn's disease, or other specified colitis types may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the safety, efficacy, and pharmacokinetics of etrasimod in adolescents aged 12 to under 18 years with moderately to severely active ulcerative colitis. Participants will undergo a 52-week treatment period, with the option to continue into a Long-Term Extension period lasting up to 4 years. The study will involve monitoring the effects of etrasimod on ulcerative colitis symptoms and overall health outcomes.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of ulcerative colitis in adolescents, leading to better health outcomes.
How similar studies have gone: Other studies have shown promise with similar treatments for ulcerative colitis, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
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Valley View Wellness Medical Center
Garden Grove, California, United States 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
Show 41 more locations
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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 -
Cook Children's Health Care System-Dodson Specialty Clinics
Fort Worth, Texas, United States Recruiting -
Cook Children's Medical Center
Fort Worth, Texas, United States 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 -
Japanese Red Cross Kyoto Daini Hospital
Kyoto, Japan Recruiting -
Saga University Hospital
Saga, Japan Recruiting -
Toyama Prefectural Central Hospital
Toyama, Japan 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 -
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
Katowice, Poland 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 -
Detska fakultna nemocnica Kosice
Košice, Slovakia Recruiting -
K.M. Management, spol. s r.o.
Nitra, Slovakia Recruiting -
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruna, Spain Recruiting -
Consorci Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, Spain Recruiting -
Hospital Universitari Vall d'Hebron
Barcelona, Spain Recruiting -
Hospital Reina Sofia
Córdoba, Spain Recruiting -
Arkansas Children's (IP Address)
Little Rock, Arkansas, United States Not yet recruiting -
Arkansas Children's
Little Rock, Arkansas, United States Not yet 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
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
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Other studies for the same condition or treatment. Recruiting studies are listed first.
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Innovative Multidisciplinary and Virtual Care for IBD in Pregnancy
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A Probiotic Approach to Modulating Gut Microbiota in Mild-to-Moderate Ulcerative Colitis
A specific probiotic given rectally will be tested in adults with mild-to-moderate ulcerative colitis to see if it can help manage symptoms.
-
Advanced therapies for moderately to severely active Crohn's disease or ulcerative colitis in adults
This study tests combinations of risankizumab with either trosunilimab or ABBV-701 in adults with moderately to severely active Crohn's disease or ulcerative colitis.
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Longitudinal Immunophenotyping of People with Inflammatory Bowel Disease
This study will follow adults with Crohn's disease or ulcerative colitis (and some healthy relatives) over three years to see how their immune cells change over time and how genetics and diet relate to their disease.
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High Protein, High Fiber Diet for Ulcerative Colitis
This study tests a high-protein, high-fiber diet to see if it helps people with ulcerative colitis by meeting protein needs and lowering harmful hydrogen sulfide production in the gut.
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Ath-063: Testing a new treatment for moderately to severely active ulcerative colitis in patients who have tried other biologics
This study tests ATH-063 to see if it helps people with moderate to severe ulcerative colitis who did not respond to or relapsed after prior biologic therapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.