Trials / Recruiting
RecruitingNCT05287126
A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
An Open-Label, Single-Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Etrasimod | Etrasimod tablet or granules by mouth, once daily up to 52 weeks of treatment. |
Timeline
- Start date
- 2022-12-16
- Primary completion
- 2029-06-16
- Completion
- 2033-07-10
- First posted
- 2022-03-18
- Last updated
- 2026-03-30
Locations
47 sites across 7 countries: United States, Austria, Belgium, Japan, Poland, Slovakia, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05287126. Inclusion in this directory is not an endorsement.