RECRUITING

A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2022-12-16
Study Completion:2031-08-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05287126

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.

Ages Eligible for Study:12 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Have a diagnosis of ulcerative colitis (UC) that is moderately to severely active
  2. * Participants are permitted to be receiving a therapeutic dose of select UC therapies
  1. * Severe extensive colitis
  2. * Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
  3. * Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

Contacts and Locations

Study Contact

Pfizer CT.gov Call Center
CONTACT
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

Arkansas Children's (IP Address)
Little Rock, Arkansas, 72202
United States
Arkansas Children's
Little Rock, Arkansas, 72202
United States
Valley View Wellness Medical Center
Garden Grove, California, 92845
United States
Loma Linda Children's Hospital
Loma Linda, California, 92354
United States
Loma Linda University Clinical Trial Center
Loma Linda, California, 92354
United States
Loma Linda University Eye Institute
Loma Linda, California, 92354
United States
Loma Linda University Medical Center
Loma Linda, California, 92354
United States
Loma Linda University Pediatric Clinics
Loma Linda, California, 92354
United States
Loma Linda University Children's Hospital Pediatric Specialty Clinics
San Bernardino, California, 92408
United States
University of California San Francisco,
San Francisco, California, 94158
United States
University of California San Francisco
San Francisco, California, 94158
United States
University of California,San Francisco Pediatric ClinicalResearch Center (PCRC)
San Francisco, California, 94158
United States
Arnold Palmer Hospital - Center for Digestive Health and Nutrition
Orlando, Florida, 32806
United States
University of Chicago Medical Center
Chicago, Illinois, 60637
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
William Beaumont Hospital
Royal Oak, Michigan, 48073
United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Advance Clinical Trial PLLC
Abilene, Texas, 79606
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-16
Study Completion Date2031-08-07

Study Record Updates

Study Start Date2022-12-16
Study Completion Date2031-08-07

Terms related to this study

Keywords Provided by Researchers

  • Pharmacokinetics
  • Adolescents
  • Active Ulcerative Colitis
  • APD334

Additional Relevant MeSH Terms

  • Ulcerative Colitis