A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

Last updated: June 5, 2026
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

2

Condition

Inflammatory Bowel Disease

Ulcerative Colitis

Crohn's Disease

Treatment

Etrasimod

Clinical Study ID

NCT05287126
APD334-207
2022-500345-25-00
C5041010
2021-003627-15
  • Ages 12-17
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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

Exclusion criteria:

  • Severe extensive colitis

  • Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence orhistory of a fistula consistent with CD

  • Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

Study Design

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: Etrasimod
Phase: 2
Study Start date:
December 16, 2022
Estimated Completion Date:
July 10, 2033

Connect with a study center

  • Landeskrankenhaus Salzburg

    Salzburg, 5020
    Austria

    Site Not Available

  • University Hospitals Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Tsujinaka Hospital - Kashiwanoha

    Kashiwa, Chiba 277-0871
    Japan

    Active - Recruiting

  • Ishii Eye Clinic

    Nagareyama-shi, Chiba 270-0116
    Japan

    Active - Recruiting

  • Gunma University Hospital

    Maebashi, Gunma 371-8511
    Japan

    Active - Recruiting

  • Hyogo Medical University Hospital

    Nishinomiya, Hyōgo 663-8501
    Japan

    Active - Recruiting

  • Kinki University - Nara Hospital

    Ikoma, Nara 630-0293
    Japan

    Active - Recruiting

  • Saitama Prefectural Children's Medical Center

    Saitama-shi, Saitama 330-8777
    Japan

    Active - Recruiting

  • Jichi Medical University Hospital

    Shimotsuke, Tochigi 329 0498
    Japan

    Active - Recruiting

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo 113-8431
    Japan

    Active - Recruiting

  • Japanese Red Cross Kyoto Daini Hospital

    Kyoto, 602-8026
    Japan

    Active - Recruiting

  • Saga University Hospital

    Saga, 849-8501
    Japan

    Active - Recruiting

  • Toyama Prefectural Central Hospital

    Toyama, 930-8550
    Japan

    Active - Recruiting

  • Instytut "Pomnik - Centrum Zdrowia Dziecka" (IPCZD) (The Children's Memorial Health Institute)

    Warsaw, Masovian Voivodeship 04-730
    Poland

    Active - Recruiting

  • WIP Warsaw IBD Point Profesor Kierkuś

    Warsaw, Masovian Voivodeship 04-501
    Poland

    Active - Recruiting

  • Instytut "Pomnik - Centrum Zdrowia Dziecka" (IPCZD) (The Children's Memorial Health Institute)

    Warsaw 756135, Masovian Voivodeship 858787 04-730
    Poland

    Active - Recruiting

  • WIP Warsaw IBD Point Profesor Kierkuś

    Warsaw 756135, Masovian Voivodeship 858787 04-501
    Poland

    Active - Recruiting

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, Łódź Voivodeship 93-338
    Poland

    Site Not Available

  • Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero

    Katowice, 40-600
    Poland

    Site Not Available

  • Uniwersytecki Szpital Dziecięcy w Krakowie

    Krakow, 30-663
    Poland

    Active - Recruiting

  • Twoja Przychodnia - Szczecińskie Centrum Medyczne

    Szczecin, 71-434
    Poland

    Active - Recruiting

  • Centrum Zdrowia MDM

    Warsaw, 00-189
    Poland

    Active - Recruiting

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 00-728
    Poland

    Active - Recruiting

  • Centrum Zdrowia MDM

    Warsaw 756135, 00-189
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    Wroclaw, 50-369
    Poland

    Active - Recruiting

  • Narodny ustav detskych chorob

    Bratislava 3060972, Bratislava Region 3343955 833 40
    Slovakia

    Site Not Available

  • Cliniq s.r.o.

    Bratislava, 811 09
    Slovakia

    Site Not Available

  • K.M. Management, spol. s r.o.

    Nitra, 949 01
    Slovakia

    Active - Recruiting

  • Hospital Clinico Universitario de Santiago de Compostela

    Santiago de Compostela, A Coruna 15706
    Spain

    Active - Recruiting

  • Consorci Corporacio Sanitaria Parc Tauli

    Sabadell, Barcelona 08208
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Reina Sofia

    Córdoba, 14004
    Spain

    Active - Recruiting

  • Arkansas Children's

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • Arkansas Children's (IP Address)

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • Arkansas Children's (IP Address)

    Little Rock 4119403, Arkansas 4099753 72202
    United States

    Site Not Available

  • Valley View Wellness Medical Center

    Garden Grove, California 92845
    United States

    Active - Recruiting

  • Loma Linda Children's Hospital

    Loma Linda, California 92354
    United States

    Site Not Available

  • Loma Linda University Clinical Trial Center

    Loma Linda, California 92354
    United States

    Site Not Available

  • Loma Linda University Eye Institute

    Loma Linda, California 92354
    United States

    Site Not Available

  • Loma Linda University Medical Center

    Loma Linda, California 92354
    United States

    Site Not Available

  • Loma Linda University Pediatric Clinics

    Loma Linda, California 92354
    United States

    Site Not Available

  • Childrens Hospital of Orange County

    Orange, California 92868
    United States

    Active - Recruiting

  • Loma Linda University Children's Hospital Pediatric Specialty Clinics

    San Bernardino, California 92408
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94158
    United States

    Active - Recruiting

  • University of California San Francisco,

    San Francisco, California 94158
    United States

    Active - Recruiting

  • University of California,San Francisco Pediatric ClinicalResearch Center (PCRC)

    San Francisco, California 94158
    United States

    Active - Recruiting

  • Loma Linda University Clinical Trial Center

    Loma Linda 5367696, California 5332921 92354
    United States

    Site Not Available

  • Loma Linda University Eye Institute

    Loma Linda 5367696, California 5332921 92354
    United States

    Site Not Available

  • Loma Linda University Medical Center

    Loma Linda 5367696, California 5332921 92354
    United States

    Site Not Available

  • Loma Linda University Pediatric Clinics

    Loma Linda 5367696, California 5332921 92354
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco 5391959, California 5332921 94158
    United States

    Active - Recruiting

  • University of California,San Francisco Pediatric ClinicalResearch Center (PCRC)

    San Francisco 5391959, California 5332921 94158
    United States

    Active - Recruiting

  • Arnold Palmer Hospital - Center for Digestive Health and Nutrition

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Nemours Children's Hospital

    Orlando, Florida 32827
    United States

    Active - Recruiting

  • Children's Center for Digestive Health Care, LLC

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Beaumont Hospital

    Royal Oak, Michigan 48073
    United States

    Active - Recruiting

  • William Beaumont Hospital

    Royal Oak, Michigan 48073
    United States

    Active - Recruiting

  • William Beaumont Hospital/Corewell Health - East

    Royal Oak, Michigan 48073
    United States

    Active - Recruiting

  • William Beaumont Hospitals Reference Laboratory

    Royal Oak, Michigan 48073
    United States

    Active - Recruiting

  • William Beaumont Hospitals Reference Laboratory

    Royal Oak 5007804, Michigan 5001836 48073
    United States

    Active - Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Active - Recruiting

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Active - Recruiting

  • East Tennessee Children's Hospital

    Knoxville, Tennessee 37916
    United States

    Active - Recruiting

  • GI for Kids

    Knoxville, Tennessee 37922
    United States

    Active - Recruiting

  • Statcare Pulmonary

    Knoxville, Tennessee 37919
    United States

    Active - Recruiting

  • Tennessee Eye Care

    Knoxville, Tennessee 37909
    United States

    Active - Recruiting

  • Tennova

    Knoxville, Tennessee 37934
    United States

    Active - Recruiting

  • ACT-Midwest G1

    Abilene, Texas 79606
    United States

    Active - Recruiting

  • DCT - Midwest GI

    Abilene, Texas 79606
    United States

    Site Not Available

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