Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bertilimumab · 1 trial · 1 indication
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...
Bertilimumab is being studied for the treatment of bullous pemphigoid, a rare autoimmune skin blistering disease. It is an investigational monoclonal antibody developed by AstraZeneca PLC and has been evaluated in a Phase 2 clinical trial in patients with this condition.
Bertilimumab targets CCL11, also known as eotaxin-1, a chemokine that attracts eosinophils. By inhibiting CCL11, the antibody aims to reduce eosinophil-driven inflammation, which is thought to contribute to blister formation in bullous pemphigoid.
Bertilimumab is being developed by AstraZeneca PLC, a global biopharmaceutical company traded on the Nasdaq under the ticker AZN. AstraZeneca holds the rights to the asset and is responsible for its clinical development.
Bertilimumab is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The completed Phase 2 trial evaluated its safety, efficacy, and pharmacodynamic effect in patients with bullous pemphigoid.
Bertilimumab has been studied in one completed Phase 2 trial, NCT02226146, titled Evaluation of Safety, Efficacy and Pharmacodynamic Effect of Bertilimumab in Patients With Bullous Pemphigoid. The trial enrolled 11 patients in the United States and Israel and is no longer active.