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 an investigational monoclonal antibody being studied for the treatment of bullous pemphigoid, a rare autoimmune blistering skin condition. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Bertilimumab is a monoclonal antibody that targets eotaxin, a chemokine involved in the recruitment of eosinophils. By binding to eotaxin, it aims to reduce eosinophil activity, which is thought to play a role in the inflammation seen in bullous pemphigoid.
Bertilimumab is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 2 clinical trials for bullous pemphigoid.
Bertilimumab is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory agencies. A Phase 2 trial has been completed, but the drug remains under investigation.
Bertilimumab has been studied in one completed Phase 2 clinical trial with the identifier NCT02226146. This trial evaluated the safety, efficacy, and pharmacodynamic effects of Bertilimumab in patients with bullous pemphigoid. The study enrolled 11 participants and was conducted in the United States and Israel.
Bertilimumab is the sole name provided for this drug in the available information. No alternative names or aliases have been reported for this investigational monoclonal antibody.