MedTrace Logo

A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

NCT05287126 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-05-15

No results posted yet for this 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).

Conditions

Interventions

DRUG

Etrasimod

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

Sponsors & Collaborators

  • Arena is a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-16
Primary Completion
2029-06-16
Completion
2033-07-10
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Japan
  • Poland
  • Slovakia
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05287126 on ClinicalTrials.gov