Bullous pemphigoid
Conditions
Interventions
Control group:Placebo combined with corticosteroid treatment
Experimental group:CD22 monoclonal antibody (SM03) combined with corticosteroid treatment
Sponsors
Shandong Provincial Hospital for Skin Diseases & Shandong Provincial Institute of Dermatology and Venerology, Shandong First Medical University & Shandong Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients who meet the diagnostic criteria for bullous pemphigoid: (1) Clinical manifestations include tense blisters and erosions on the skin and/or mucous membranes, with a negative Nikolsky sign; (2) Histopathological examination reveals subepidermal blistering; (3) Direct immunofluorescence (DIF) shows reticular deposition of IgG and C3 along the basement membrane zone. 2. Adult patients aged 18 to 65 years. 3. Patients with moderate to severe bullous pemphigoid, as defined by a Bullous Pemphigoid Disease Area Index (BPDAI) score of 24-49 for moderate disease, and >= 50 for severe disease. 4. Patients receiving systemic treatment for the first time. 5. Patients who have signed the informed consent form. 6. Patients who are able to receive treatment and complete follow-up as planned.
Exclusion criteria
Exclusion criteria: 1.Patients aged 65 years; 2.Presence of contraindications to treatment, including severe cardiovascular disease, severe hepatic or renal impairment, severe active infection, history of severe infusion reactions, history of severe allergy to relevant drugs, history of malignancy, pregnancy or breastfeeding,Those who have recently received or plan to receive vaccines;Patients previously treated with biologics such as rituximab, IL-4Ra inhibitors, or anti-CD22 monoclonal antibodies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| relapse;negative conversion of pathogenic antibodies;Proportion of improvement in peak pruritus as measured by the Numerical Rating Scale (NRS);time to achieve complete remission; | — |
Countries
China
Contacts
Public ContactZhang Furen
Shandong Provincial Hospital for Skin Diseases & Shandong Provincial Institute of Dermatology and Venerology, Shandong First Medical University & Shandong Academy of Medical Sciences
Outcome results
None listed