A Single-center Study of CM313 in Patients With Pemphigus

Launched by SICHUAN PROVINCIAL PEOPLE'S HOSPITAL · Mar 25, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for pemphigus, a condition where the immune system mistakenly attacks the skin, causing painful blisters and sores. The study will test a medication called CM313, which is given along with low doses of glucocorticoids (a type of steroid) to see how well it works and how safe it is for patients. This trial is not yet recruiting participants, but it will take place at a single center and is designed for adults aged 18 to 80 who have moderate to severe pemphigus vulgaris or foliaceus.

To be eligible for the study, participants need to have certain symptoms, like blisters that are easy to rupture and persistent sores that develop afterward. Those with other serious infections or who have had specific treatments recently will not be able to join. If selected, participants can expect to receive the study drug and be closely monitored for any side effects and improvements in their condition. This trial is an important step in finding better treatments for pemphigus patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• 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.