Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628128
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
A Study to Evaluate the Long-Term Safety and Efficacy of JNT-517 in Participants with Phenylketonuria
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of JNT-517 in Participants with Phenylketonuria
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this Phase 3 open-label extension study is to evaluate the long-term safety and efficacy of JNT-517 in participants with Phenylketonuria PKU after completion of either Study JNT517-101 or JNT517-201 In this long-term extension LTE study all adults aged 18 years who complete Study JNT517-101 will be randomized 11 to receive JNT-517 at 75 mg twice daily BID or 150 mg BID regardless of their previous dose Adolescent participants who complete Study JNT517-201 will receive the same JNT-517 dose of the cohort they were initially assigned to either 75 mg BID or 150 mg BID
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None