The trial is taking place at:
C

Centrum Zdrowia MDM | Gastroenterology

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A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

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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)

36 participants in 1 patient group

Etrasimod
Experimental group
Treatment:
Drug: Etrasimod

Trial contacts and locations

53

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Central trial contact

Pfizer CT.gov Call Center

Data sourced from clinicaltrials.gov

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