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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04895566
Other study ID # SBPM0311m
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date May 24, 2021
Est. completion date March 16, 2023

Study information

Verified date March 2023
Source SWISS BIOPHARMA MED GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date March 16, 2023
Est. primary completion date March 10, 2023
Accepts healthy volunteers No
Gender All
Age group 21 Years to 80 Years
Eligibility 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 TNFa 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 TNFa 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Monoclonal antibody (Mab) sB24M
200 mg monoclonal antibody (Mab) sB24 by injection into the affected areas.

Locations

Country Name City State
Belarus Contract Research Organization Minsk
Latvia Contract Research Organization Riga

Sponsors (1)

Lead Sponsor Collaborator
SWISS BIOPHARMA MED GmbH

Countries where clinical trial is conducted

Belarus,  Latvia, 

Outcome

Type Measure Description Time frame Safety issue
Other Evaluation of genetic factors for severe forms of pyoderma. Comparative analysis of gene expression in severe forms of pyoderma by partial genome sequencing prior to treatment Approximately 1 year
Other Effect of sB24M monoclonal antibody (Mab) therapy on the expression of certain genes in severe forms of pyoderma 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 Approximately 1 year
Primary 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 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
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