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NCT Number: NCT07210554

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

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.

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Key information

Conditions

Bullous Pemphigoid (BP) Autoimmune Diseases Immune System Diseases Pemphigoid, Bullous Skin Diseases Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, China

Location contact

Hang Li, Chief physician

CONTACT

[email protected]

86+010-83572211

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stapokibart Injection

Biological

subcutaneous injection

Placebo

Drug

subcutaneous injection

Primary outcomes

  1. Percentage of subjects achieving sustained complete remission (CR) at W36

    Time frame: Up to 36 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Qian Jia

CONTACT

[email protected]

86+028-88610620

Sponsors and collaborators

Lead sponsor

Chengdu Kangnuoxing Biopharma,Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 7, 2025
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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