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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
CM313 injection
Biological/Vaccine600 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
Biological/VaccineAdminister medium- or long-acting glucocorticoids 1-3 hours before injection
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Group 1Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Efficacy evaluation
The time to achieve disease control and consolidate the end
Time frame
up to 52 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: