A Single-center Study of CM313 in Patients With Pemphigus
NCT ID: NCT06904040
Last Updated: 2025-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2025-04-01
2028-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Group 1
CM313 injection
600 mg (4 mL per vial), administer once at Week 0, 1, and 2, and then every 6 months thereafter or determined based on clinical assessment
glucocorticoids
Administer medium- or long-acting glucocorticoids 1-3 hours before injection
Interventions
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CM313 injection
600 mg (4 mL per vial), administer once at Week 0, 1, and 2, and then every 6 months thereafter or determined based on clinical assessment
glucocorticoids
Administer medium- or long-acting glucocorticoids 1-3 hours before injection
Eligibility Criteria
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Inclusion Criteria
* Adult patients aged between 18 and 80 years old.
* Moderate - to - severe pemphigus vulgaris/foliaceus: According to the Pemphigus Disease Area Index (PDAI) score, a score of 9 - 24 indicates moderate severity, and a score of ≥25 indicates severe severity.
Exclusion Criteria
* Patients with known positive serology for HIV, syphilis, tuberculosis, hepatitis B, or hepatitis C in the active stage of the disease.
* Patients who have received intravenous cyclophosphamide injection, plasma exchange, or immunoadsorption therapy within 8 weeks before screening and enrollment.
18 Years
80 Years
ALL
No
Sponsors
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Sichuan Provincial People's Hospital
OTHER
Responsible Party
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Jianing Yang
Head of Dermatology
Principal Investigators
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Jianing Yang
Role: PRINCIPAL_INVESTIGATOR
Sichuan Provincial People's Hospital
Locations
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Sichuan Provincial People's Hospital
Chengdu, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CM313-IIS-PP01
Identifier Type: -
Identifier Source: org_study_id
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