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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-90
SponsorChengdu Kangnuoxing Biopharma,Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Stapokibart injection
  • Placebo

Treatment groups

200 Participants
are divided into 2 treatment groups