Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03270020 | Denosumab for the Treatment of Adult LCH | PHASE2 | COMPLETED | 10 | — | — | Sep 7, 2017 | Jan 14, 2025 | Jan 15, 2025 | 1 | Greece |
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...