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

Chengdu Kangnuoxing Biopharma,Inc.

Status and phase: Not yet enrolling; Phase 3

Conditions: Bullous Pemphigoid (BP)

Treatments: Biological: Stapokibart injection; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07210554

CM310-116201

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Group 1

Experimental group

Treatment:

Biological: Stapokibart injection

Group 2

Placebo Comparator group

Treatment:

Drug: Placebo