Qilu Reports Initiation of P-III Trial for QL1206 (biosimilar- denosumab) in China
Shots:
- The P-III trial involves assessing QL1206 (60 mg- SC) vs PBO (SC) in 216 patients every 6 months for 1 year. Additionally- the candidates will receive 500 mg of calcium and 1-000 IU of vitamin D daily
- The 1EP of the trial is to evaluate the effect of QL1206 and the 2EP is to evaluate the safety- efficacy- immunogenicity- PK & PD including the objective to evaluate effect of anti-drug antibodies (ADA) and AEs. The trial is expected to complete in July 2021
- QL1206 has been currently evaluate in P-I trial assessing its PK- PD- safety in comparison with Xgeva enrolling 168 patients with its expected completion in May 2019
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