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

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

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.

Study Overview

• Status: Completed
• Conditions: Pyoderma; Pyoderma Gangrenosum; Pyoderma Vegetans; Pyoderma Gangrenosum Surrounding Surgical Stoma
• Intervention / Treatment: Biological: Monoclonal antibody (Mab) sB24M

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Belarus
  • Minsk, Belarus, 12001
    • Contract Research Organization
• Latvia
  • Rīga, Latvia, LV-1079
    • Contract Research Organization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: SWISS BIOPHARMA MED GmbH

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2021
• Primary Completion (Actual): March 10, 2023
• Study Completion (Actual): March 16, 2023

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Skin Diseases, Vascular; Pyoderma; Pyoderma Gangrenosum; Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Antibodies; Immunoglobulins; Antibodies, Monoclonal; Antineoplastic Agents, Immunological
• Other Study ID Numbers: SBPM0311m

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: within three months after the end of the trial
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No