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

Early Phase 1

Completed

• Conditions: Pyoderma Gangrenosum; Pyoderma Vegetans; Pyoderma; Pyoderma Gangrenosum Surrounding Surgical Stoma
• Interventions: Biological: Monoclonal antibody (Mab) sB24M

• Registration Number: NCT04895566
• Lead Sponsor: SWISS BIOPHARMA MED GmbH

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.

Study Timeline

• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-20
• Study Start: 2021-05-24
• Status Verified: 2023-03
• Primary Completion: 2023-03-10
• Study Completion: 2023-03-16
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
monoclonal antibody (Mab) sB24M	Monoclonal antibody (Mab) sB24M	Therapy by injecting 200 mg of the monoclonal antibody (Mab) sB24M into the areas affected by pyoderma

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Contract Research Organization; 🇱🇻 Rīga, Latvia