A Single-center Study of CM313 in Patients With Pemphigus (NCT06904040) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Single-center Study of CM313 in Patients With Pemphigus
China20 participantsStarted 2025-04-01
Plain-language summary
A prospective, single-center, single-arm clinical study aimed to explore the efficacy and safety of the anti-CD38 monoclonal antibody CM313 combined with low-dose glucocorticoids in patients with pemphigus.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinical manifestations:â‘ Flaccid blisters and bullae on the skin that are prone to rupture.â‘¡ Persistent erosions formed after the rupture of blisters and bullae.â‘¢ Blisters or erosions on the mucous membranes.â‘£ Positive Nikolsky's sign.
* 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:
* Pregnant or lactating women and women planning to conceive.
* 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.