RecruitingPhase 2Phase 3NCT06454357

A Clinical Study of B007 in the Treatment of Pemphigus.

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


Sponsor

Shanghai Jiaolian Drug Research and Development Co., Ltd

Enrollment

132 participants

Start Date

Jul 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

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

Exclusion Criteria13

  • Subjects diagnosed with prescribed diseases;
  • Since the diagnosis of pemphigus, Disease duration\>4 years;
  • Subjects using prescribed drugs;
  • Presence of a specified disease or history of disease;
  • The subjects has prescribed examination abnormalities that are assessed as unsuitable for participation in the study by the investigator;
  • A history of severe allergy or allergic reaction to human or mouse monoclonal antibodies; known contraindications to orally prescribed drugs;
  • Subjects who participate in another interventional clinical trial at a specified time before randomization;
  • 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;
  • Pregnant and lactating women;
  • 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;
  • 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.
  • Other conditions deemed unsuitable for participation in this study by the researchers.

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Interventions

DRUGB007

B007:high dose/low dose: Subcutaneous injection was administered on days 1 and 15


Locations(12)

Peking University First Hospital

Beijing, China

The Second Xiangya Hospital of Central South University

Changsha, China

Chengdu Second People's Hospital

Chengdu, China

West China Hospital, Sichuan University

Chengdu, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, China

Dermatology Hospital of Southern Medical University

Guangzhou, China

Guangdong Provincial People's Hospital

Guangzhou, China

Shandong First Medical University-Affiliated Skin Hospital

Jinan, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Henan Provincial People's Hospital

Zhengzhou, China

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NCT06454357


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