Status:
NOT_YET_RECRUITING
Study of Stapokibart Injection in Subjects With Moderate to Severe Bullous Pemphigoid
Lead Sponsor:
Chengdu Kangnuoxing Biopharma,Inc.
Conditions:
Bullous Pemphigoid (BP)
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief 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 Stapokiba...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 8 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07210554
Start Date
November 11 2025
End Date
May 8 2028
Last Update
October 7 2025
Active Locations (1)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China