A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

Pfizer

Status and phase: Enrolling; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: Etrasimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT05287126

APD334-207

2021-003627-15 (EudraCT Number)

2022-500345-25-00 (Registry Identifier)

C5041010 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Etrasimod

Experimental group

Treatment:

Drug: Etrasimod