About this trial
This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of Stapokibart in subjects with Moderate to Severe Bullous Pemphigoid.
Eligibility criteria
Qualifiers
Ability to understand the study content and voluntarily sign the Informed Consent Form (ICF).
Aged between 18 and 90 years, inclusive, regardless of gender.
Confirmed diagnosis of bullous pemphigoid prior to randomization.
Bullous Pemphigoid Disease Area Index (BPDAI) activity score ≥ 24 points at the screening visit and at randomization.
Disqualifiers
Diagnosis of other forms of pemphigoid or other autoimmune blistering diseases.
Presence of other active skin comorbidities that may interfere with the study evaluations, apart from bullous pemphigoid.
Insufficient washout period for prior treatments.
Any condition that, in the opinion of the investigator, would preclude the subject's participation in the study.
Trial design
Treatments tested in this trial
- Stapokibart injection
- Placebo