A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT05076175
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Colitis, Ulcerative

Eligibility Criteria

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

Interventions

  • Ozanimod — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission. Ozanimod will be administered orally to pediatric participants with moderate to severe active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.

Key Dates

Start date
May 30, 2022
Status verified
Jun 2026
Primary completion
Jul 12, 2032
Completion
Jul 12, 2032

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ozanimod High Dose
  • Experimental: Ozanimod Low Dose

Primary Outcome Measure

Proportion of participants who achieve clinical remission [ Time Frame: At Week 52 ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (36)

FacilityCityStateZIPSite coordinators
Local Institution - 0041PhoenixArizona85016-7710-
University of ArizonaTucsonArizona85724-
Local Institution - 0052Garden GroveCalifornia92845-
Loma Linda University Health SystemLoma LindaCalifornia92354
Kalyan Ray Parashette, Site 0087
505-274-0704
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Shervin Rabizadeh, Site 0074
310-423-7100
Lucile Packard Children's HospitalPalo AltoCalifornia94304
Jonathan Moses, Site 0080
650-721-2250
University of California Davis HealthSacramentoCalifornia95817
Trinh Truong, Site 0096
310-597-1251
Local Institution - 0007HartfordConnecticut06106-
Local Institution - 0064Washington D.C.District of Columbia20010-
Local Institution - 0075OrlandoFlorida32803-
Local Institution - 0016AtlantaGeorgia30342-
Local Institution - 0101Park RidgeIllinois60068
Site 0101
Local Institution - 0100IndianapolisIndiana46202
Site 0100
Local Institution - 0049Iowa CityIowa52242-
Maine Medical PartnersPortlandMaine04102
Noah Hoffman, Site 0090
207-662-5522
Boston Children's HospitalBostonMassachusetts02115
Athos Bousvaros, Site 0005
617-699-1021
Local Institution - 0042SpringfieldMassachusetts01199-
University of Massachusetts Chan Medical SchoolWorcesterMassachusetts01655
Basavaraj Kerur, Site 0095
774-441-8082
Local Institution - 0093DetroitMichigan48201-
Mayo Clinic in Rochester, MinnesotaRochesterMinnesota55905
Michael Stephens, Site 0070
111111
Washington UniversitySt LouisMissouri63110
Charles Samson, Site 0053
513-518-8949
Columbia University Medical CenterNew YorkNew York10032
JOSEPH PICORARO, Site 0040
212-305-5903
Local Institution - 0023New YorkNew York10065-
Local Institution - 0028New YorkNew York10029-
University of North Carolina Medical CenterChapel HillNorth Carolina27599-
Local Institution - 0047CharlotteNorth Carolina28203-
Cleveland ClinicClevelandOhio44124
Jessica Barry, Site 0036
216444231
Local Institution - 0062Oklahoma CityOklahoma73112-
Local Institution - 0045HersheyPennsylvania17033-
Local Institution - 0099CharlestonSouth Carolina29425
Site 0099
Local Institution - 0103Fort WorthTexas76104
Site 0103
Texas Children's HospitalHoustonTexas77030
Lina Karam, Site 0067
832-822-3612
Local Institution - 0091SeattleWashington98122-
Seattle Children's HospitalSeattleWashington98105
Ghassan Wahbeh, Site 0060
111111
MultiCare Health SystemTacomaWashington98405
Raghu Varier, Site 0046
503-847-4748
Local Institution - 0037MilwaukeeWisconsin53226-

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