Trials / Not Yet Recruiting
Not Yet RecruitingNCT07129759
Phase 3 Long Term Safety Extension Study of LUM-201 in Children With Growth Hormone Deficiency
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Lumos Pharma · Industry
- Sex
- All
- Age
- 4 Years – 12 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LUM-201 | 1.6 mg/kg/day, administered orally once daily |
Timeline
- Start date
- 2026-09-01
- Primary completion
- 2030-02-01
- Completion
- 2030-02-01
- First posted
- 2025-08-19
- Last updated
- 2025-08-19
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07129759. Inclusion in this directory is not an endorsement.