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Not yet recruiting NCT07210554

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

Phase III Interventional Bullous Pemphigoid (BP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stapokibart injection, Placebo.
Who it may be relevant to
Registry conditions: Bullous Pemphigoid (BP). Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

  • Biological Stapokibart injection
    subcutaneous injection
  • Drug Placebo
    subcutaneous injection

Primary outcome measures

  • Percentage of subjects achieving sustained complete remission (CR) at W36 [Time frame: Up to 36 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University First Hospital — Beijing

Identifiers

NCT: NCT07210554 · CM310-116201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗