pemphigus vulgaris and bullous pemphigoid
Conditions
Interventions
Pemphigus Vulgaris group:CM336 (BCMA/CD3 Bispecific Antibody)
Bullous Pemphigoid group:CM336 (BCMA/CD3 Bispecific Antibody)
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 70 Years
Inclusion criteria
Inclusion criteria: 1.Patients meeting diagnostic criteria for pemphigus vulgaris (a: clinical manifestations of flaccid vesicles, erosions on skin and mucous membranes, positive Nikolsky's sign; b: histopathological examination showing intraepidermal vesicles and acantholysis; c: direct immunofluorescence revealing IgG and C3 intercellular deposition) or bullous pemphigoid (a: clinical manifestations of flaccid vesicles, erosions on skin and mucous membranes, negative Nikolsky's sign; b: histopathological examination indicating subepidermal vesicles; c: direct immunofluorescence demonstrating IgG and/or C3 deposition in a reticular pattern at the basement membrane zone). 2.Adult patients aged 18-70 years. 3.Moderate to severe pemphigus vulgaris (PDAI score: moderate 9-24, severe >25) or moderate to severe bullous pemphigoid (BPDAI score: moderate 20-56, severe >57). 4.Treatment-naïve to CM336. 5.Provided written informed consent. 6. Able to adhere to the treatment schedule and follow-up protocol.
Exclusion criteria
Exclusion criteria: 1.Patients who are either under the age of 18 or over the age of 70; 2.individuals with contraindications to medication use, encompassing severe cardiovascular diseases, significant hepatic or renal impairment, active and severe infections, history of severe infusion reactions, a known history of severe allergic reactions to related medications, a history of cancer, pregnant and lactating women, as well as those who have recently received or are scheduled to receive vaccinations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients achieving complete remission at 24 weeks with minimal dose of prednisone (or equivalent) treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse rates;The proportion of pathogenic antibodies converting to negative.;Cumulative glucocorticoid dose (prednisone equivalent);complete remission off therapy; | — |
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