A PHASE 2 OPEN-LABEL, SINGLE ARM STUDY TO EVALUATE THE EFFICACY, PHARMACOKINETICS, AND SAFETY OF ETRASIMOD IN PEDIATRIC PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

Pfizer

Summary

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 pediatrics participants (≥ 2 years up to \< 12 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).

Eligibility

Age range: 2–11 years
Sex: All
Healthy volunteers: No

Detailed criteria

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

Locations (42)

Fink Children's Ambulatory Care Center
New York, New York
Kimmel Pavilion - NYU Langone
New York, New York
NYU Grossman School of Medicine
New York, New York
NYU Langone Health (Tisch Hospital)
New York, New York
NYU Langone Inflammatory Bowel Disease Center
New York, New York
NYU Langone Radiology - Tisch Hospital
New York, New York

Summary

Eligibility

Interventions

Locations (42)