drugset / Trial / NCT04934072
A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary objective of this study is to demonstrate equivalent efficacy of the proposed biosimilar denosumab FKS518 to US-licensed Prolia in women with postmenopausal osteoporosis (PMO).
Timeline
- Start
- 2021-06-16
- Primary completion
- 2023-08-07
- Completion
- 2023-08-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Denosumab | Monoclonal antibody | 60 mg | Subcutaneous |
| Subject | FKS518 | Unknown | 60 mg | Subcutaneous |