drugset / Trial / NCT04614337
Phase 2 Study of LUM-201 in Children With Growth Hormone Deficiency (OraGrowtH210 Trial)
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multi-national trial. The goals of the trial are to study LUM-201 as a possible treatment for Pediatric Growth Hormone Deficiency (PGHD) and investigate a predictive enrichment marker (PEM) strategy to select subjects likely to respond to therapy with LUM-201.
Timeline
- Start
- 2020-12-31
- Primary completion
- 2024-09-04
- Completion
- 2024-09-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LUM-201 | Unknown | 0.8 mg/kg | Oral |
| Subject | LUM-201 | Unknown | 1.6 mg/kg | Oral |
| Subject | LUM-201 | Unknown | 3.2 mg/kg | Oral |
| Comparator | Somatropin | Protein / enzyme biologic | 34 ug/kg | Subcutaneous |