Status:

RECRUITING

A Clinical Study of B007 in the Treatment of Pemphigus.

Lead Sponsor:

Shanghai Jiaolian Drug Research and Development Co., Ltd

Collaborating Sponsors:

Shanghai Pharmaceuticals Holding Co., Ltd

Conditions:

Pemphigus

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

PHASE3

Brief Summary

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

Eligibility Criteria

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.

Key Trial Info

Start Date :

July 12 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

132 Patients enrolled

Trial Details

Trial ID

NCT06454357

Start Date

July 12 2024

End Date

December 31 2026

Last Update

October 10 2024

Active Locations (12)

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Page 1 of 3 (12 locations)

1

Peking University First Hospital

Beijing, China

2

The Second Xiangya Hospital of Central South University

Changsha, China

3

Chengdu Second People's Hospital

Chengdu, China

4

West China Hospital, Sichuan University

Chengdu, China

A Clinical Study of B007 in the Treatment of Pemphigus. | DecenTrialz