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

Status: Recruiting
Location: See all (46) 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 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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
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
United States
Arkansas
Arkansas Children's
NOT_YET_RECRUITING
Little Rock
Arkansas Children's (IP Address)
NOT_YET_RECRUITING
Little Rock
California
Valley View Wellness Medical Center
RECRUITING
Garden Grove
Loma Linda Children's Hospital
NOT_YET_RECRUITING
Loma Linda
Loma Linda University Clinical Trial Center
NOT_YET_RECRUITING
Loma Linda
Loma Linda University Eye Institute
NOT_YET_RECRUITING
Loma Linda
Loma Linda University Medical Center
NOT_YET_RECRUITING
Loma Linda
Loma Linda University Pediatric Clinics
NOT_YET_RECRUITING
Loma Linda
Loma Linda University Children's Hospital Pediatric Specialty Clinics
NOT_YET_RECRUITING
San Bernardino
University of California San Francisco
RECRUITING
San Francisco
University of California San Francisco,
RECRUITING
San Francisco
University of California,San Francisco Pediatric ClinicalResearch Center (PCRC)
RECRUITING
San Francisco
Florida
Arnold Palmer Hospital - Center for Digestive Health and Nutrition
RECRUITING
Orlando
Illinois
University of Chicago Medical Center
RECRUITING
Chicago
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Michigan
William Beaumont Hospital
RECRUITING
Royal Oak
New York
University of Rochester Medical Center
RECRUITING
Rochester
Ohio
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital
RECRUITING
Cleveland
Texas
Advance Clinical Trial PLLC
RECRUITING
Abilene
Other Locations
Austria
Landeskrankenhaus Salzburg
RECRUITING
Salzburg
Belgium
University Hospitals Leuven
RECRUITING
Leuven
Japan
Juntendo University Hospital
RECRUITING
Bunkyo-ku
Kinki University - Nara Hospital
RECRUITING
Ikoma
Tsujinaka Hospital - Kashiwanoha
RECRUITING
Kashiwa
Japanese Red Cross Kyoto Daini Hospital
RECRUITING
Kyoto
Gunma University Hospital
NOT_YET_RECRUITING
Maebashi
Ishii Eye Clinic
RECRUITING
Nagareyama-shi
Hyogo Medical University Hospital
RECRUITING
Nishinomiya
Saga University Hospital
RECRUITING
Saga
Saitama Prefectural Children's Medical Center
RECRUITING
Saitama-shi
Jichi Medical University Hospital
RECRUITING
Shimotsuke
Toyama Prefectural Central Hospital
RECRUITING
Toyama
Poland
Uniwersytecki Szpital Dziecięcy w Krakowie
RECRUITING
Krakow
Instytut Centrum Zdrowia Matki Polki
RECRUITING
Lodz
Twoja Przychodnia - Szczecińskie Centrum Medyczne
RECRUITING
Szczecin
Centrum Zdrowia MDM
RECRUITING
Warsaw
Instytut Pomnik - Centrum Zdrowia Dziecka (IPCZD) (The Children's Memorial Health Institute)
RECRUITING
Warsaw
WIP Warsaw IBD Point Profesor Kierkus
RECRUITING
Warsaw
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
RECRUITING
Wroclaw
Slovakia
Cliniq s.r.o.
NOT_YET_RECRUITING
Bratislava
Narodny ustav detskych chorob
NOT_YET_RECRUITING
Bratislava
Spain
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Reina Sofia
NOT_YET_RECRUITING
Córdoba
Consorci Corporacio Sanitaria Parc Tauli
RECRUITING
Sabadell
Hospital Clinico Universitario de Santiago de Compostela
NOT_YET_RECRUITING
Santiago De Compostela
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2022-12-16
Estimated Completion Date: 2031-08-07
Participants
Target number of participants: 36
Treatments
Experimental: Etrasimod
Sponsors
Collaborators: Arena is a wholly owned subsidiary of Pfizer
Leads: Pfizer

This content was sourced from clinicaltrials.gov

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