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

September 30, 2025 updated by: Chengdu Kangnuoxing Biopharma,Inc.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Peking University First Hospital
        • Contact:
          • Hang Li, Chief physician
          • Phone Number: 86+010-83572211
          • Email: drlihang@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Biological: Stapokibart injection
subcutaneous injection
Placebo Comparator: Group 2
Drug: Placebo
subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu Kangnuoxing Biopharma,Inc.

Investigators

  • Principal Investigator: Hang Li, Chief physician, Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 11, 2025

Primary Completion (Estimated)

March 27, 2028

Study Completion (Estimated)

May 8, 2028

Study Registration Dates

First Submitted

September 30, 2025

First Submitted That Met QC Criteria

September 30, 2025

First Posted (Estimated)

October 7, 2025

Study Record Updates

Last Update Posted (Estimated)

October 7, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CM310-116201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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