Phase 0/1 Local Application of the Monoclonal Antibody (Mab) sB24M in Patients With Purulent Pyoderma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase 0/1 Topical Application of the Monoclonal Antibody (Mab) sB24M in Patients With Severe Pyoderma

Conditions
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Pyoderma, Pyoderma Gangrenosum, Pyoderma Vegetans, Pyoderma Gangrenosum Surrounding Surgical Stoma

Intervention / Treatment
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* Biological: Monoclonal antibody (Mab) sB24M


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A confirmed severe form of any type of pyoderma with lesions of the skin and muscle tissue was diagnosed Male or female, age ≥ 21 years Previous treatment with TNF antagonists (infliximab, adalimumab, etanercept, certolizumab, golimumab) ended no earlier than 30 days before starting therapy Secondary treatment failure with up to one previous TNFα antagonist treatment (from the list above) Secondary failure of corticosteroid treatment Adequate hematologic, hepatic, and renal function Written informed consent. Exclusion Criteria: History of primary resistance or intolerance to any TNFα antagonist. History of congestive heart failure or current, controlled or uncontrolled Women who are pregnant or breastfeeding, or women of childbearing age if no effective method of contraception has been used during and for 3 months after the trial Men, if no effective contraceptive method was used during the study and for 3 months afterward Any prior exposure to Hu5F9-G4 or other CD47 targeting agents Previous allogeneic stem cell transplant within 6 months prior to enrollment, active graft versus host disease (GVHD), or need for graft-associated immunosuppression Refusal to sign the informed consent

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: monoclonal antibody (Mab) sB24M<br>Therapy by injecting 200 mg of the monoclonal antibody (Mab) sB24M into the areas affected by pyoderma | Biological: Monoclonal antibody (Mab) sB24M<br>* 200 mg monoclonal antibody (Mab) sB24 by injection into the affected areas.<br>* Other names: CD47 / TNF-α Monoclonal antibody;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Approximately 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Approximately 1 year |