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Purpose

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).

Condition

Eligibility

Eligible Ages
Between 12 Years and 17 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Etrasimod
  • Drug: Etrasimod
    Etrasimod tablet or granules by mouth, once daily up to 52 weeks of treatment.
    Other names:
    • APD334

Recruiting Locations

Valley View Wellness Medical Center
Garden Grove, California 92845

University of California San Francisco,
San Francisco, California 94158

University of California San Francisco
San Francisco, California 94158

University of California,San Francisco Pediatric ClinicalResearch Center (PCRC)
San Francisco, California 94158

Arnold Palmer Hospital - Center for Digestive Health and Nutrition
Orlando, Florida 32806

University of Chicago Medical Center
Chicago, Illinois 60637

Boston Children's Hospital
Boston, Massachusetts 02115

William Beaumont Hospital/Corewell Health - East
Royal Oak, Michigan 48073

William Beaumont Hospitals Reference Laboratory
Royal Oak, Michigan 48073

University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital
Cleveland, Ohio 44106

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106

ACT-Midwest G1
Abilene, Texas 79606

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.