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
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 11
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Canada
CHU de Québec - Université Laval
RECRUITING
Québec
Germany
Universitätsklinikum Leipzig
NOT_YET_RECRUITING
Leipzig
Universitaetsklinikum Tuebingen
NOT_YET_RECRUITING
Tübingen
Japan
Japanese Red Cross Kumamoto Hospital
RECRUITING
Kumamoto
Saitama Prefectural Children's Medical Center
RECRUITING
Saitama-shi
Juntendo University Hospital
RECRUITING
Tokyo
Poland
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
NOT_YET_RECRUITING
Katowice
Centrum Zdrowia MDM
NOT_YET_RECRUITING
Warsaw
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
RECRUITING
Warsaw
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2026-05-30
Estimated Completion Date: 2034-08-20
Participants
Target number of participants: 24
Treatments
Experimental: Etrasimod
Etrasimod by mouth, once daily up to 52 weeks
Related Therapeutic Areas
Sponsors
Leads: Pfizer