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Denosumab/ML · 1 trial · 1 indication
The primary efficacy endpoint will be measured through the incidence of patients with active disease at Month 8. Given that all patients have active disease at baseline the incidence of patients with active disease at Month 8 will provide the efficacy of denosumab in controlling the disease within this time frame.
| Arm | Type | Description |
|---|---|---|
| Treatment arm | EXPERIMENTAL | This is a single arm study; the study arm include all patients participating in the study who will all receive Denosumab 70 MG/ML \[Xgeva\] |
| Name | Type | Description |
|---|---|---|
| Denosumab 70 MG/ML [Xgeva] | DRUG | As already described in arm description |
Inclusion Criteria: * Adults (\>18 years of age) * Definitive diagnosis of LCH \[Based on clinic-pathological evidence with microscopic examination and at least one of the following immunological staining: Langerin (CD 207) positivity, Cluster of Differentiation 1a (CD1a) positivity, Presence of Bi...
Denosumab/ML is used for the treatment of Langerhans Cell Histiocytosis (LCH), a rare disease. It is being developed as a small molecule therapy for this condition. The drug is currently in clinical development and has completed a Phase 2 trial in adult patients with LCH.
Denosumab/ML targets RANKL, a protein involved in bone metabolism. By inhibiting RANKL, the drug aims to modulate the disease process in Langerhans Cell Histiocytosis. This mechanism is relevant to the bone lesions often seen in LCH patients.
Denosumab/ML is being developed by Bone Biologics Corp, a biopharmaceutical company. The company's stock is traded under the ticker symbol BBLG. Bone Biologics is focused on advancing this therapy for Langerhans Cell Histiocytosis, a rare disease indication.
Denosumab/ML is in Phase 2 of clinical development. It has completed a Phase 2 trial for Langerhans Cell Histiocytosis, with the study status marked as completed. The drug is investigational and has not been approved by regulatory authorities.
Denosumab/ML has been studied in one clinical trial with the identifier NCT03270020. This Phase 2 trial, titled 'Denosumab for the Treatment of Adult LCH', was completed and enrolled 10 participants. The study was conducted in Greece and included adults aged 18 years and older.
Denosumab/ML is a formulation of denosumab, a monoclonal antibody that targets RANKL. While the base drug denosumab is approved for other indications, Denosumab/ML is being investigated specifically for Langerhans Cell Histiocytosis. It is in Phase 2 development for this rare disease.