A Long-Term Study of JNT-517 in Participants With Phenylketonuria (NCT06628128)
An Open-Label Study to Evaluate the Long-Term Safety of JNT-517 in Participants With Phenylketonuria
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Florida (UF) Health Shands Hospital — Gainesville, Florida
Age range: 4 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (12 Sites)
- University of Florida (UF) Health Shands Hospital — Gainesville, Florida
- University of South Florida — Tampa, Florida
- Oregon Health and Science University — Portland, Oregon
- University of Pittsburgh Medical Center (UPMC) - Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania
- Children's Medical Center Dallas — Dallas, Texas
- University of Texas Southwestern Medical Center — Dallas, Texas
- University of Texas Health (UTHealth) Science Center at Houston — Houston, Texas
- Utah Health - The University of Utah Hospital — Salt Lake City, Utah
- Children's Health Queensland - Queensland Children's Hospital — South Brisbane, Queensland
- Mater Health - Mater Hospital Brisbane — South Brisbane, Queensland
- Royal Adelaide Hospital — Adelaide, South Australia
- Murdoch Children's Research Institute — Parkville, Victoria
📞 Contact the Study Coordinator
Phone: (844) 687-8522
Email: otsuka-professionalservices@otsuka-us.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Phenylketonuria (PKU)
- Study to Evaluate the Safety and Efficacy of Pegvaliase in Adolescents (Ages 12-17) With Phenylketonuria — Phoenix, Arizona
- AAV Gene Therapy Study for Subjects with PKU — Tampa, Florida
- A Long-term, Post-marketing Safety Study of Palynziq in Patients With PKU (PALace) — Aurora, Colorado
- A Study of MZE782 in Adults With PKU — Oakland, California
- A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade) — Aurora, Colorado
Explore by condition: All Phenylketonuria (PKU) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.