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NCT Number: NCT06454357

A Clinical Study of B007 in the Treatment of Pemphigus.

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Peking University First Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

B007

Drug

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

Primary outcomes

  1. Proportion of subjects:Complete remission with minimal treatment

    Time frame: Approximately36 weeks

Secondary outcomes

  1. The number of relapses of the disease

    Time frame: Approximately 1 years

  2. Proportion of subjects:Partial remission

    Time frame: Approximately 36weeks

  3. Change: PDAI(Pemphigus disease area index)

    Time frame: Approximately 36 weeks

  4. CR/PR Proportion of subjects:Complete remission /Partial remission

    Time frame: Approximately 52 weeks

  5. DoR (Duration of Response)

    Time frame: Approximately 1 years

  6. Incidence of Treatment-Emergent Adverse Events

    Time frame: Approximately 1 years

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shanghai Jiaolian Drug Research and Development Co., Ltd

Industry

Collaborators

  • Shanghai Pharmaceuticals Holding Co., Ltd

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2024
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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