ClinicalTrials.gg
RecruitingNCT06454357Updated May 5, 2026

A Clinical Study of B007 in the Treatment of Pemphigus.

A Phase 2/3 interventional study of B007 in Pemphigus, sponsored by Shanghai Jiaolian Drug Research and Development Co., Ltd. Recruiting at 12 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-05.

Sponsored by Shanghai Jiaolian Drug Research and Development Co., Ltd · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 3 months later.
Phase
Phase 2/3
Study type
Interventional
Enrollment
132
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Pemphigus

Browse trials for

03

In context

Pemphigus

76 studies on the registry are indexed under Pemphigus; 18 are open to participants now.

This study's planned enrollment of 132 is above the median of 30 across 53 interventional studies indexed under Pemphigus.

Browse Pemphigus studies →

Lead sponsor

Shanghai Jiaolian Drug Research and Development Co., Ltd is the lead sponsor of 7 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subjects who voluntarily participate in this study and sign 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

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 to orally prescribed drugs;
  7. Subjects who participate in another interventional clinical trial at a specified time before randomization;
  8. Subjects who received 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 from signing the 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
132 participants (estimated)

Study arms

  • Experimental
    B007

    Drug: B007

Interventions

  • DrugB007

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

06

What researchers measure

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

07

Study locations

12 of 12 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2024 (actual). Primary completion is estimated for Dec 2026, 29 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 6, 2024
First posted
Jun 12, 2024
StartActual
Jul 12, 2024
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
May 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06454357
Lead sponsor
Shanghai Jiaolian Drug Research and Development Co., Ltd
Responsible party
Sponsor
First posted
Jun 12, 2024
Start date
Jul 12, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
May 5, 2026

Study contacts

Hang Li
Contact
bdyyec@163.com
0086-010-66119025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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