Phase 0/1 local application of the monoclonal antibody (Mab) sB24M in patients with purulent pyoderma (chronic ulcerative pyoderma) by injection into the affected areas. Monoclonal antibody (Mab) sB24 negatively regulates immune-inflammatory processes through CD47 / TNF-α Axis promotes epithelialization of damaged tissue.
This is an open-label Phase 0 trial that will enroll up to 10 participants with purulent pyoderma (chronic ulcerative pyoderma) by injecting 200 mg of the monoclonal antibody (Mab) sB24M into the areas affected by pyoderma. Monoclonal antibody (Mab) sB24 negatively regulates immune-inflammatory processes through CD47 / TNF-α Axis promotes epithelialization of damaged tissue. This study is a first-in-man since previously no Clinical Studies on the local application (injections) of monoclonal antibodies in pyoderma gangrenosum have been conducted.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
200 mg monoclonal antibody (Mab) sB24 by injection into the affected areas.
Contract Research Organization
Minsk, Belarus
Contract Research Organization
Riga, Latvia
Objective response rate (ORR) in patients with severe pyoderma
The ORR is defined as the percentage of participants who had a confirmed Complete Response or Partial Response using RECIST 1.1
Time frame: Approximately 1 year
Duration of response (DoR) of patients with severe forms of pyoderma
The DoR is defined as the time from the first registration of the onset of visible epithelialization of damaged tissues to the first recorded progression of pyoderma
Time frame: Approximately 1 year
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