Bullous pemphigoid
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult patients (=18 years old). 2.Patients diagnosed with BP by clinical and laboratory examinations, who are considered to have moderate-to-severe active BP requiring treatment with dupilumab. 3.Patients or their legally authorized representatives have signed a written informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with other autoimmune blistering diseases (e.g., pemphigus, dermatitis herpetiformis, etc.). 2.Recent relevant medication history: Use of other biologics that may affect efficacy evaluation (e.g., rituximab) within 3 months prior to baseline. 3.Presence of significant comorbidities, such as severe and poorly controlled infections, active tuberculosis, severe heart failure, malignant tumors, etc. 4.Allergy and special populations: Known hypersensitivity to dupilumab or any of its excipients; pregnant or breastfeeding women, or those planning to become pregnant during the study period. 5.Any condition that, in the investigator’s opinion, may prevent the patient from completing the study or render the data unreliable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving disease control at 4 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete remission rate;relapse rate;Bullous Pemphigoid Disease Area Index;NRS score;systemic glucocorticoid usage;adverse events; | — |
Countries
China
Contacts
Sichuan Provincial People's Hospital, Sichuan Academy of Medical Sciences