A Clinical Study of B007 in the Treatment of Pemphigus.

April 29, 2026 updated by: Shanghai Jiaolian Drug Research and Development Co., Ltd

A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of B007 in Subjects With Pemphigus.

The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with pemphigus.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

132

Phase

  • Phase 2
  • 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, China
        • Recruiting
        • Peking University First Hospital
        • Contact:
          • Hang Li
      • Changsha, China
        • Recruiting
        • The second Xiangya hospital of central south university
        • Contact:
          • Yi Zhan
      • Chengdu, China
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
          • Wei Li
      • Chengdu, China
        • Recruiting
        • Chengdu Second People's Hospital
        • Contact:
          • Yanyan Feng
      • Chongqing, China
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Sheng Fang
      • Fuzhou, China
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:
          • Chao Ji
      • Guangzhou, China
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
          • Zhu Shen
      • Guangzhou, China
        • Recruiting
        • Dermatology Hospital of Southern Medical University
        • Contact:
          • Ruzeng Xue
      • Jinan, China
        • Recruiting
        • Shandong First Medical University-Affiliated Skin Hospital
        • Contact:
          • Furen Zhang
      • Shanghai, China
        • Recruiting
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:
          • Meng Pan
      • Wuhan, China
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Juan Tao
      • Zhengzhou, China
        • Recruiting
        • Henan Provincial People's Hospital
        • Contact:
          • Jianguo Li

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:

  1. Subjects who voluntarily participate in this study and sign informed consent form;
  2. Subjects who meet the clinical manifestations of pemphigus and are clinically diagnosed as prescribed diseases;
  3. Subjects with first diagnosis or relapse;
  4. Subjects who have the ability to follow the study protocol as determined by the investigator.

Exclusion Criteria:

  1. Subjects diagnosed with prescribed diseases;
  2. Since the diagnosis of pemphigus, Disease duration>4 years;
  3. Subjects using prescribed drugs;
  4. Presence of a specified disease or history of disease;
  5. The subjects has prescribed examination abnormalities that are assessed as unsuitable for participation in the study by the investigator;
  6. A history of severe allergy or allergic reaction to human or mouse monoclonal antibodies; known contraindications to orally prescribed drugs;
  7. Subjects who participate in another interventional clinical trial at a specified time before randomization;
  8. Subjects who received live vaccine at the specified time before the first dose and are expected to receive the vaccine at the specified time after the last dose;
  9. Pregnant and lactating women;

  10. Fertile female subjects do not agree to use effective contraception from signing the informed consent form to the prescribed time after the last dose.

    Women who are considered fertile by the investigator must have negative serum pregnancy tests before starting the drug;

  11. Sexually active male subjects who do not intend to use an effective contraceptive method during the trial period or within specified time after the last dose, or male subjects who plan to donate sperm at a specified time during the trial or after the last dose.
  12. Other conditions deemed unsuitable for participation in this study by the researchers.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: B007
Drug: B007
B007：high dose/low dose: Subcutaneous injection was administered on days 1 and 15

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects：Complete remission with minimal treatment
Time Frame: Approximately36 weeks
Approximately36 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of relapses of the disease
Time Frame: Approximately 1 years
Approximately 1 years
Proportion of subjects：Partial remission
Time Frame: Approximately 36weeks
Approximately 36weeks
Change: PDAI（Pemphigus disease area index）
Time Frame: Approximately 36 weeks
Approximately 36 weeks
CR/PR Proportion of subjects：Complete remission /Partial remission
Time Frame: Approximately 52 weeks
Approximately 52 weeks
DoR （Duration of Response）
Time Frame: Approximately 1 years
Approximately 1 years
Incidence of Treatment-Emergent Adverse Events
Time Frame: Approximately 1 years
Approximately 1 years

Collaborators and Investigators

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

Sponsor

Shanghai Jiaolian Drug Research and Development Co., Ltd

Collaborators

Shanghai Pharmaceuticals Holding Co., Ltd

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 (Actual)

July 12, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 6, 2024

First Submitted That Met QC Criteria

June 6, 2024

First Posted (Actual)

June 12, 2024

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPH-B007-304

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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