NCT06454357 A Clinical Study of B007 in the Treatment of Pemphigus.
| NCT ID | NCT06454357 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Shanghai Jiaolian Drug Research and Development Co., Ltd |
| Condition | Pemphigus |
| Study Type | INTERVENTIONAL |
| Enrollment | 132 participants |
| Start Date | 2024-07-12 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 132 participants in total. It began in 2024-07-12 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06454357 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Pemphigus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06454357 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06454357 currently recruiting?
Yes, NCT06454357 is actively recruiting participants. Contact the research team at bdyyec@163.com for enrollment information.
Where is the NCT06454357 trial being conducted?
This trial is being conducted at Beijing, China, Changsha, China, Chengdu, China, Chengdu, China and 8 additional locations.
Who is sponsoring the NCT06454357 clinical trial?
NCT06454357 is sponsored by Shanghai Jiaolian Drug Research and Development Co., Ltd. The trial plans to enroll 132 participants.