PemphigusPhase 2/3NCT06454357
A Clinical Study of B007 in the Treatment of Pemphigus.
A Phase 2/3 study testing B007 in people with Pemphigus, run by Shanghai Jiaolian Drug Research and Development Co., Ltd at 12 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with pemphigus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pemphigus
- What is being tested?
- B007
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 12 sitesChina
- Study dates
- 12 Jul 2024to 31 Dec 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
China12 sites, 12 recruiting
- Recruiting
Peking University First Hospital
Beijing
Hang Li
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha
Yi Zhan
- Recruiting
Chengdu Second People's Hospital
Chengdu
Yanyan Feng
- Recruiting
West China Hospital, Sichuan University
Chengdu
Wei Li
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Sheng Fang
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou
Chao Ji
- Recruiting
Dermatology Hospital of Southern Medical University
Guangzhou
Ruzeng Xue
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou
Zhu Shen
- Recruiting
Shandong First Medical University-Affiliated Skin Hospital
Jinan
Furen Zhang
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
Meng Pan
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Juan Tao
- Recruiting
Henan Provincial People's Hospital
Zhengzhou
Jianguo Li
About this study
Official title: 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.
- Conditions
- Pemphigus
- Being tested
- B007
- Medical subject headings
- Pemphigus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B007Drug
B007：high dose/low dose: Subcutaneous injection was administered on days 1 and 15
| Study group | Role | What they receive |
|---|---|---|
| B007 | Experimental | Not described Receives: Drug: B007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects：Complete remission with minimal treatment
Measured: Approximately36 weeks
Secondary outcomes (6)
The number of relapses of the disease
Measured: Approximately 1 years
Proportion of subjects：Partial remission
Measured: Approximately 36weeks
Change: PDAI（Pemphigus disease area index）
Measured: Approximately 36 weeks
CR/PR Proportion of subjects：Complete remission /Partial remission
Measured: Approximately 52 weeks
DoR （Duration of Response）
Measured: Approximately 1 years
Incidence of Treatment-Emergent Adverse Events
Measured: Approximately 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start12 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PemphigusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiaolian Drug Research and Development Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Pharmaceuticals Holding Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454357
- Sponsor's protocol ID
- SPH-B007-304
- Status last verified
- Apr 2026
- First submitted
- 6 Jun 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of B007 in Subjects With Pemphigus.
- ClinicalTrials.gov ID
- NCT06454357
- Acronym / sponsor ID
- SPH-B007-304
- Conditions
- Pemphigus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Shanghai Jiaolian Drug Research and Development Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Pharmaceuticals Holding Co., Ltd
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with pemphigus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| B007 | Experimental | Drug: B007 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B007B007：high dose/low dose: Subcutaneous injection was administered on days 1 and 15 | Drug | B007 |
Primary outcome
Proportion of subjects：Complete remission with minimal treatment
Time frame: Approximately36 weeks
6 secondary outcomes
The number of relapses of the disease
Time frame: Approximately 1 years
Proportion of subjects：Partial remission
Time frame: Approximately 36weeks
Change: PDAI（Pemphigus disease area index）
Time frame: Approximately 36 weeks
CR/PR Proportion of subjects：Complete remission /Partial remission
Time frame: Approximately 52 weeks
DoR （Duration of Response）
Time frame: Approximately 1 years
Incidence of Treatment-Emergent Adverse Events
Time frame: Approximately 1 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing B007 in people with Pemphigus, run by Shanghai Jiaolian Drug Research and Development Co., Ltd at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hang Li (0086-010-66119025, bdyyec@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects：Complete remission with minimal treatment (time frame: Approximately36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.