Recruiting
Phase 2

Etrasimod

Sponsor:

Pfizer

Code:

NCT05287126

Conditions

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Etrasimod

Study Details

Brief 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).

Conditions

Ulcerative Colitis

Study ID

NCT05287126

Start date

Dec 16, 2022

Status verified date

Jul, 2026

Completion date

Jul 10, 2033

Anticipated

Primary completion date

Jun 16, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

36 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Etrasimod

Interventions

Etrasimod

Etrasimod tablet or granules by mouth, once daily up to 52 weeks of treatment.

Primary outcome measure

  • Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52 [ Time Frame: Week 52 ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Valley View Wellness Medical Center

Recruiting

Garden Grove, California, United States, 92845

University of California San Francisco,

Recruiting

San Francisco, California, United States, 94158

University of California San Francisco

Recruiting

San Francisco, California, United States, 94158

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

Recruiting

San Francisco, California, United States, 94158

Arnold Palmer Hospital - Center for Digestive Health and Nutrition

Recruiting

Orlando, Florida, United States, 32806

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

William Beaumont Hospital/Corewell Health - East

Recruiting

Royal Oak, Michigan, United States, 48073

William Beaumont Hospitals Reference Laboratory

Recruiting

Royal Oak, Michigan, United States, 48073

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

Recruiting

Cleveland, Ohio, United States, 44106

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

ACT-Midwest G1

Recruiting

Abilene, Texas, United States, 79606

More Information

Sponsor

Pfizer

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Keywords

  • Pharmacokinetics
  • Adolescents
  • Active Ulcerative Colitis
  • APD334

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pfizer on 2026-07-08.