Clinical trial Recruiting at 39 sites Phase 2 Interventional Ages 12 to 17

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

PhasePhase 2
Study typeInterventional
Ages12 Years to 17 Years
SexAll
Enrollment36 (estimated)
SponsorPfizer
Industry-sponsored
Locations47 sites (Little Rock, Arkansas and 46 other locations)
StatusRecruiting
StartedDecember 16, 2022
Main results expectedJune 16, 2029
Study endsJuly 10, 2033
Registry record updatedOctober 27, 2026
Trial IDNCT05287126 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.