Study of Stapokibart Injection in Subjects With Moderate to Severe Bullous Pemphigoid
A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Stapokibart Injection in Subjects With Moderate to Severe Bullous Pemphigoid
1 other identifier
interventional
200
1 country
1
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 Stapokibart in subjects with Moderate to Severe Bullous Pemphigoid.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2025
CompletedFirst Posted
Study publicly available on registry
October 7, 2025
CompletedStudy Start
First participant enrolled
November 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 27, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 8, 2028
October 7, 2025
September 1, 2025
2.4 years
September 30, 2025
September 30, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Up to 36 weeks
Study Arms (2)
Group 1
EXPERIMENTALGroup 2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University First Hospital
Beijing, Beijing Municipality, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hang Li, Chief physician
Peking University First Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2025
First Posted
October 7, 2025
Study Start
November 11, 2025
Primary Completion (Estimated)
March 27, 2028
Study Completion (Estimated)
May 8, 2028
Last Updated
October 7, 2025
Record last verified: 2025-09