[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585567":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":25,"centralContacts":29,"locations":34,"responsibleParty":46,"collaborators":11,"id":48,"slug":11,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":11,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":11,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":11,"overallStatus":66,"whyStopped":11,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Sichuan Provincial People's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1","EXPERIMENTAL",null,[13,14],"Biological: CM313 injection","Biological: glucocorticoids",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":11},"BIOLOGICAL","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",[9],{"type":17,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"glucocorticoids","Administer medium- or long-acting glucocorticoids 1-3 hours before injection",[9],[26],{"name":27,"affiliation":5,"role":28},"Jianing Yang","PRINCIPAL_INVESTIGATOR",[30],{"name":27,"role":31,"phone":32,"phoneExt":11,"email":33},"CONTACT","+86-17708130389","dryangjn@163.com",[35],{"facility":5,"status":11,"city":36,"state":11,"zip":11,"country":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Chengdu","China",{"type":39,"coordinates":40},"Point",[41,42],104.06667,30.66667,{"lat":42,"lon":41},[45],{"name":27,"role":31,"phone":32,"phoneExt":11,"email":33},{"type":28,"investigatorFullName":27,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Head of Dermatology","100585567",false,"NCT06904040","A Single-center Study of CM313 in Patients With Pemphigus","A Prospective, Single-Center, Single-Arm Clinical Study to Evaluate the Novel Humanized Cluster of Differentiation 38(CD38) Monoclonal Antibody (CM313) for the Treatment of Pemphigus","Inclusion Criteria:\n\n* 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.\n* Adult patients aged between 18 and 80 years old.\n* Moderate - to - severe pemphigus vulgaris\u002Ffoliaceus: 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.\n\nExclusion Criteria:\n\n* Pregnant or lactating women and women planning to conceive.\n* Patients with known positive serology for HIV, syphilis, tuberculosis, hepatitis B, or hepatitis C in the active stage of the disease.\n* Patients who have received intravenous cyclophosphamide injection, plasma exchange, or immunoadsorption therapy within 8 weeks before screening and enrollment.","ALL","18 Years","80 Years",{"count":58,"type":59},20,"ESTIMATED","INTERVENTIONAL",[62],"NA","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.",[65],"Pemphigus","NOT_YET_RECRUITING","2025-03-25",{"date":69,"type":70},"2025-04-01","ACTUAL",{"date":69,"type":59},{"date":73,"type":59},"2028-04-01",{"name":5,"class":6},1]