A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous Pemphigoid
Summary
The main purpose of this study is to investigate whether dupilumab is effective and safe for the treatment of bullous pemphigoid. Dupilumab is a type of drug called a "monoclonal antibody". An antibody is a special kind of protein that the immune (defense) system normally makes to fight bacteria and viruses. Bullous pemphigoid is an autoimmune subepidermal blistering disease, predominately affecting the elderly (typical onset after age 60). The study is looking at several other research questions, including: * Side effects that may be experienced by people taking dupilumab * How dupilumab works in the body and affects the body * How dupilumab affects quality of life * How much dupilumab is present in the blood * To see if dupilumab works to wean the patient off oral corticosteroids
Timeline
- Start
- 2020-10-28
- Primary completion
- 2024-07-12
- Completion
- 2025-01-05
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs Dupilumab Q2W; p = 0.0250; Risk Difference (RD) 14.2 (95% CI 1.97 to 27.74) NCT04206553 ↗
release “A Dupixent® (dupilumab) pivotal trial (ADEPT) in bullous pemphigoid (BP) met the primary and all key secondary endpoints” regeneron.com ↗
release “Dupixent in 106 adults with moderate-to-severe BP. The primary endpoint was met” regeneron.com ↗
release “The ADEPT study met all primary and key secondary endpoints, enrolling 106 adults with moderate-to-severe BP” sanofi.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dupilumab | Monoclonal antibody | — | Subcutaneous |
| Background | Prednisolone | Other / unclassified | — | — |
| Background | Prednisone | Other / unclassified | — | — |