A Long-Term Study of JNT-517 in Participants With Phenylketonuria

Part of paid clinical trials in Gainesville, Florida.

Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study ID
NCT06628128
Phase
PHASE3
Status
Recruiting
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Conditions

  • Phenylketonuria (PKU)

Eligibility Criteria

Sex
ALL
Age
4 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • JNT-517 — DRUG
    JNT-517 administered orally twice daily using age- and weight-banded dosing.

Study Details

The goal of this Phase 3, open-label study is to evaluate the long-term safety of JNT-517 in pediatric and adult participants with Phenylketonuria (PKU) after completion of either Study JNT517-101 (NCT05781399) or JNT517-201 (NCT06637514) as well as participants who have not participated in a prior JNT-517 study. In this trial, all participants will receive JNT-517 using age- and weight-banded dosing as outlined in the protocol, regardless of any dose received in a previous study.

Key Dates

Start date
Aug 11, 2025
Status verified
Apr 2026
Primary completion
Nov 1, 2027
Completion
Feb 1, 2028

Study Design

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

Arms

  • Experimental: JNT-517

Primary Outcome Measure

Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Screening to +2 weeks from last dose ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
University of Florida (UF) Health Shands HospitalGainesvilleFlorida32608
Otsuka Call Center
[email protected]
844-687-8522
Zori (PRINCIPAL_INVESTIGATOR)
University of South FloridaTampaFlorida33606
Otsuka Call Center
[email protected]
844-687-8522
Sanchez-Valle (PRINCIPAL_INVESTIGATOR)
Oregon Health and Science UniversityPortlandOregon97239
Otsuka Call Center
[email protected]
844-687-8522
Harding (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical Center (UPMC) - Children's Hospital of PittsburghPittsburghPennsylvania15224
Otsuka Call Center
[email protected]
844-687-8522
Vockley (PRINCIPAL_INVESTIGATOR)
Children's Medical Center DallasDallasTexas75235
Otsuka Call Center
[email protected]
844-687-8522
McNutt (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern Medical CenterDallasTexas75390
Otsuka Call Center
[email protected]
844-687-8522
McNutt (PRINCIPAL_INVESTIGATOR)
University of Texas Health (UTHealth) Science Center at HoustonHoustonTexas77030
Otsuka Call Center
[email protected]
844-687-8522
Northrup (PRINCIPAL_INVESTIGATOR)
Utah Health - The University of Utah HospitalSalt Lake CityUtah84112
Otsuka Call Center
[email protected]
844-687-8522
Andrews (PRINCIPAL_INVESTIGATOR)

Find similar trials in Gainesville, FL

By research site
University of Florida (UF) Health Shands Hospital· Gainesville, FLUniversity of South Florida· Tampa, FLOregon Health and Science University· Portland, ORUniversity of Pittsburgh Medical Center (UPMC) - Children's Hospital of Pittsburgh· Pittsburgh, PAChildren's Medical Center Dallas· Dallas, TXUniversity of Texas Southwestern Medical Center· Dallas, TX

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