Phase 3 Long Term Safety Extension Study of LUM-201 in Children With Growth Hormone Deficiency
NCT07129759 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2025-08-19
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.
Conditions
- Growth Hormone Deficiency (GHD)
Interventions
- DRUG
-
LUM-201
1.6 mg/kg/day, administered orally once daily
Sponsors & Collaborators
-
Lumos Pharma
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 4 Years
- Max Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-30
- Primary Completion
- 2030-02-28
- Completion
- 2030-02-28
- FDA Drug
- Yes
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