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

Overview

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.

Full Title of Study: “Phase 0/1 Topical Application of the Monoclonal Antibody (Mab) sB24M in Patients With Severe Pyoderma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 25, 2022

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

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

Arms, Groups and Cohorts

  • Experimental: monoclonal antibody (Mab) sB24M
    • Therapy by injecting 200 mg of the monoclonal antibody (Mab) sB24M into the areas affected by pyoderma

Clinical Trial Outcome Measures

Primary Measures

  • Objective response rate (ORR) in patients with severe pyoderma
    • Time Frame: 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 Measures

  • Duration of response (DoR) of patients with severe forms of pyoderma
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • SWISS BIOPHARMA MED GmbH
  • Provider of Information About this Clinical Study
    • Sponsor

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