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.
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.
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.
Parallel
Stapokibart injection
Biological/Vaccinesubcutaneous injection
Placebo
Drugsubcutaneous injection
Percentage of subjects achieving sustained complete remission (CR) at W36
Sustained complete remission (CR) defined as discontinuation of oral corticosteroid (OCS) therapy and achievement of CR on or before Week 16, no relapse during the period from OCS discontinuation up to Week 36, and no requirement for rescue therapy up to Week 36.
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This trial is not recruiting at the moment. You can still explore other options:
