Study of Stapokibart Injection in Subjects With Moderate to Severe Bullous Pemphigoid (NCT07210554) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Study of Stapokibart Injection in Subjects With Moderate to Severe Bullous Pemphigoid
China200 participantsStarted 2025-11-11
Plain-language summary
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.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion Criteria:
* 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.
* Weekly average of the Pruritus Numerical Rating Scale (NRS) score ≥ 4 points at randomization.
* Karnofsky Performance Status score ≥50% at the screening visit.
Exclusion Criteria:
* 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.
What they're measuring
1
Percentage of subjects achieving sustained complete remission (CR) at W36