A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

a study on Inflammatory Bowel Disease Ulcerative Colitis

Summary

Eligibility
for people ages 12-17 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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), or until marketing authorization is obtained in the participant's country, whichever comes first.

Official Title

An Open-Label, Single-Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Adolescent Subjects With Moderately to Severely Active Ulcerative Colitis

Keywords

Ulcerative Colitis, Pharmacokinetics, Adolescents, Active Ulcerative Colitis, APD334, Colitis, Ulcer, Etrasimod

Eligibility

You can join if…

Open to people ages 12-17

  • 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 CAN'T join 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

Locations

  • UCSF, accepting new patients
    San Francisco California 94158 United States
  • UCSF accepting new patients
    San Francisco California 94158 United States
  • UCSF Pediatric ClinicalResearch Center (PCRC) accepting new patients
    San Francisco California 94158 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT05287126
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 36 study participants
Last Updated
Contact us about this trial