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

Pyoderma Gangrenosum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04895566
• Other study ID #: SBPM0311m
• Status: Completed
• Phase: Early Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Pyoderma
• Pyoderma Gangrenosum

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