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Not yet recruitingNCT07210554Updated Oct 7, 2025

Study of Stapokibart Injection in Subjects With Moderate to Severe Bullous Pemphigoid

A Phase 3 interventional study of Stapokibart injection and Placebo in Bullous Pemphigoid (BP), sponsored by Chengdu Kangnuoxing Biopharma,Inc.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-10-07.

Sponsored by Chengdu Kangnuoxing Biopharma,Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Bullous Pemphigoid (BP)

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03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Group 1

    Biological: Stapokibart injection

  • Placebo comparator
    Group 2

    Drug: Placebo

Interventions

  • BiologicalStapokibart injection

    subcutaneous injection

  • DrugPlacebo

    subcutaneous injection

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What researchers measure

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.

    Time frame: Up to 36 weeks

06

Study locations

1 site
  • Peking University First Hospital
    Beijing, Beijing Municipality, China
07

Registry details

Key details

Study ID
NCT07210554
Lead sponsor
Chengdu Kangnuoxing Biopharma,Inc.
Responsible party
Sponsor
First posted
Oct 7, 2025
Start date
Nov 11, 2025 (estimated)
Primary completion
Mar 27, 2028 (estimated)
Completion
May 8, 2028 (estimated)
Last update
Oct 7, 2025

Study contacts

Qian Jia
Contact
qianjia@keymedbio.com
86+028-88610620
Hang Li, Chief physician
principal investigator · Peking University First Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Chengdu Kangnuoxing Biopharma,Inc.

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