A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Pfizer
Study ID
NCT05287126
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Etrasimod — DRUG
    Etrasimod tablet or granules by mouth, once daily up to 52 weeks of treatment.

Study Details

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).

Key Dates

Start date
Dec 16, 2022
Status verified
Jun 2026
Primary completion
Jun 16, 2029
Completion
Jul 10, 2033

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Etrasimod

Primary Outcome Measure

Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52 [ Time Frame: Week 52 ]

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
Arkansas Children'sLittle RockArkansas72202-
Arkansas Children's (IP Address)Little RockArkansas72202-
Valley View Wellness Medical CenterGarden GroveCalifornia92845-
Loma Linda Children's HospitalLoma LindaCalifornia92354-
Loma Linda University Clinical Trial CenterLoma LindaCalifornia92354-
Loma Linda University Eye InstituteLoma LindaCalifornia92354-
Loma Linda University Medical CenterLoma LindaCalifornia92354-
Loma Linda University Pediatric ClinicsLoma LindaCalifornia92354-
Loma Linda University Children's Hospital Pediatric Specialty ClinicsSan BernardinoCalifornia92408-
University of California San FranciscoSan FranciscoCalifornia94158-
University of California San Francisco,San FranciscoCalifornia94158-
University of California,San Francisco Pediatric ClinicalResearch Center (PCRC)San FranciscoCalifornia94158-
Arnold Palmer Hospital - Center for Digestive Health and NutritionOrlandoFlorida32806-
University of Chicago Medical CenterChicagoIllinois60637-
Boston Children's HospitalBostonMassachusetts02115-
William Beaumont Hospital/Corewell Health - EastRoyal OakMichigan48073-
William Beaumont Hospitals Reference LaboratoryRoyal OakMichigan48073-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
University Hospitals Cleveland Medical Center Rainbow Babies & Children's HospitalClevelandOhio44106-
ACT-Midwest G1AbileneTexas79606-

Find similar trials in Little Rock, AR

By condition
Ulcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Arkansas Children's· Little Rock, ARArkansas Children's (IP Address)· Little Rock, ARValley View Wellness Medical Center· Garden Grove, CALoma Linda Children's Hospital· Loma Linda, CALoma Linda University Clinical Trial Center· Loma Linda, CALoma Linda University Eye Institute· Loma Linda, CA

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