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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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07210554
Enrollment
200
Registered
2025-10-07
Start date
2025-11-11
Completion date
2028-05-08
Last updated
2025-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bullous Pemphigoid (BP)

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.

Interventions

BIOLOGICALStapokibart injection

subcutaneous injection

DRUGPlacebo

subcutaneous injection

Sponsors

Chengdu Kangnuoxing Biopharma,Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of subjects achieving sustained complete remission (CR) at W36Up to 36 weeksSustained 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.

Countries

China

Contacts

Primary ContactQian Jia
qianjia@keymedbio.com86+028-88610620

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026