Pyoderma, Pyoderma Gangrenosum, Pyoderma Gangrenosum Surrounding Surgical Stoma, Pyoderma Vegetans
Conditions
Brief summary
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
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.
Interventions
BIOLOGICALMonoclonal antibody (Mab) sB24M
200 mg monoclonal antibody (Mab) sB24 by injection into the affected areas.
Sponsors
SWISS BIOPHARMA MED GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
This trial is an open-label, Phase 0, a non-randomized trial that will enroll up to 10 participants
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) in patients with severe pyoderma | Approximately 1 year | The ORR is defined as the percentage of participants who had a confirmed Complete Response or Partial Response using RECIST 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response (DoR) of patients with severe forms of pyoderma | Approximately 1 year | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of genetic factors for severe forms of pyoderma. | Approximately 1 year | Comparative analysis of gene expression in severe forms of pyoderma by partial genome sequencing prior to treatment |
| Effect of sB24M monoclonal antibody (Mab) therapy on the expression of certain genes in severe forms of pyoderma | Approximately 1 year | Comparative analysis of gene expression in severe forms of pyoderma by partial genome sequencing before treatment and after three courses of local injections of monoclonal antibody (Mab) sB24M into the areas affected by pyoderma |
Countries
Belarus, Latvia
Outcome results
None listed