A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

Recruiting now · Phase 2

Conditions studied: Ulcerative Colitis

In brief

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).

Key facts

Study ID

NCT05287126

Run by

Pfizer

People needed

36

Starts

2022-12-16

Expected to finish

2033-07-10

Last updated by the study team

2026-07-08

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Uniwersytecki Szpital Dziecięcy w Krakowie — Krakow, Poland (enrolling)
• Instytut "Pomnik - Centrum Zdrowia Dziecka" (IPCZD) (The Children's Memorial Health Institute) — Warsaw, Masovian Voivodeship, Poland (enrolling)
• Twoja Przychodnia - Szczecińskie Centrum Medyczne — Szczecin, Poland (enrolling)
• Centrum Zdrowia MDM — Warsaw, Poland (enrolling)
• WIP Warsaw IBD Point Profesor Kierkus — Warsaw, Poland (enrolling)
• Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu — Wroclaw, Poland (enrolling)
• K.M. Management, spol. s r.o. — Nitra, Slovakia (enrolling)
• Hospital Clinico Universitario de Santiago de Compostela — Santiago de Compostela, A Coruna, Spain (enrolling)
• Consorci Corporacio Sanitaria Parc Tauli — Sabadell, Barcelona, Spain (enrolling)
• Hospital Universitari Vall d'Hebron — Barcelona, Spain (enrolling)
• Hospital Reina Sofia — Córdoba, Spain (enrolling)
• Valley View Wellness Medical Center — Garden Grove, California, United States (enrolling)
• University of California San Francisco, — San Francisco, California, United States (enrolling)
• University of California San Francisco — San Francisco, California, United States (enrolling)
• University of California,San Francisco Pediatric ClinicalResearch Center (PCRC) — San Francisco, California, United States (enrolling)
• Arnold Palmer Hospital - Center for Digestive Health and Nutrition — Orlando, Florida, United States (enrolling)
• University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
• Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
• William Beaumont Hospital/Corewell Health - East — Royal Oak, Michigan, United States (enrolling)
• William Beaumont Hospitals Reference Laboratory — Royal Oak, Michigan, United States (enrolling)
• University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital — Cleveland, Ohio, United States (enrolling)
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
• ACT-Midwest G1 — Abilene, Texas, United States (enrolling)
• Tsujinaka Hospital - Kashiwanoha — Kashiwa, Chiba, Japan (enrolling)
• Ishii Eye Clinic — Nagareyama-shi, Chiba, Japan (enrolling)

Full record on ClinicalTrials.gov

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