A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

Description

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

Ulcerative Colitis

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Study Overview

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Study Details

Study overview

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).

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

A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

Condition
Ulcerative Colitis
Intervention / Treatment

-

Contacts and Locations

Little Rock

Arkansas Children's (IP Address), Little Rock, Arkansas, United States, 72202

Little Rock

Arkansas Children's, Little Rock, Arkansas, United States, 72202

Garden Grove

Valley View Wellness Medical Center, Garden Grove, California, United States, 92845

Loma Linda

Loma Linda Children's Hospital, Loma Linda, California, United States, 92354

Loma Linda

Loma Linda University Clinical Trial Center, Loma Linda, California, United States, 92354

Loma Linda

Loma Linda University Eye Institute, Loma Linda, California, United States, 92354

Loma Linda

Loma Linda University Medical Center, Loma Linda, California, United States, 92354

Loma Linda

Loma Linda University Pediatric Clinics, Loma Linda, California, United States, 92354

San Bernardino

Loma Linda University Children's Hospital Pediatric Specialty Clinics, San Bernardino, California, United States, 92408

San Francisco

University of California San Francisco,, San Francisco, California, United States, 94158

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

12 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pfizer,

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

2031-08-07