Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-01-05 @ 6:05 PM
Study NCT ID:
NCT07129759
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-19
First Post:
2025-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 3 Long Term Safety Extension Study of LUM-201 in Children With Growth Hormone Deficiency
Sponsor:
Lumos Pharma
Organization:
Study Overview
Official Title:
A Long-term Extension Study to Evaluate the Safety and Tolerability of Daily Oral LUM-201 in Children With Growth Hormone Deficiency (GHD)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Multi-national Trial. The Goal of the Trial is to Offer Subjects Who Complete 12 Months in the LUM-201-10 Phase 3 Trial up to an Additional 36 Months of Treatment of LUM-201 While Evaluating Safety and Tolerability of LUM-201.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: