A Single-center Study of CM313 in Patients With Pemphigus
ConditionPemphigus
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSichuan Provincial People's Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Clinical manifestations:① Flaccid blisters and bullae on the skin that are prone to rupture.② Persistent erosions formed after the rupture of blisters and bullae.③ Blisters or erosions on the mucous membranes.④ 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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- CM313 injection
- glucocorticoids
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov