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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02226146 | Evaluation of Safety, Efficacy and Pharmacodynamic Effect of Bertilimumab in Patients With Bullous Pemphigoid | PHASE2 | COMPLETED | 11 | — | — | Feb 29, 2016 | Apr 30, 2018 | Nov 26, 2025 | 8 | United States, Israel |
An AE is any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the study treatment. TEAEs were defined as AEs that started on or after the first administration of study drug until the end of the follow up period. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.
| Arm | Type | Description |
|---|---|---|
| Bertilimumab | EXPERIMENTAL | Intravenous injection over 30 minutes of 10 mg/kg of Bertilimumab in physiological solution (PBS) |
| Name | Type | Description |
|---|---|---|
| Bertilimumab | BIOLOGICAL | - |
Inclusion Criteria: 1. Males or females, ≥ 60 years of age. 2. Karnofsky performance status \> 60% 3. Newly diagnosed, Bullous Pemphigoid per standard diagnostic criteria: * Clinical presentation \[2\] * Skin biopsy from a fresh blister showing subepidermal clefting and an inflammatory infil...