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

NCT ID: NCT04895566

Last Updated: 2023-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-24
• Study Completion Date: 2023-03-16

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.

Conditions

Pyoderma; Pyoderma Gangrenosum; Pyoderma Vegetans; Pyoderma Gangrenosum Surrounding Surgical Stoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

monoclonal antibody (Mab) sB24M

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

Group Type: EXPERIMENTAL

Monoclonal antibody (Mab) sB24M

Intervention Type: BIOLOGICAL

200 mg monoclonal antibody (Mab) sB24 by injection into the affected areas.

Interventions

Monoclonal antibody (Mab) sB24M

200 mg monoclonal antibody (Mab) sB24 by injection into the affected areas.

Intervention Type: BIOLOGICAL

Other Intervention Names

CD47 / TNF-α Monoclonal antibody

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SWISS BIOPHARMA MED GmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Contract Research Organization

Minsk, , Belarus

Contract Research Organization

Riga, , Latvia

Countries

Belarus; Latvia

Other Identifiers

SBPM0311m

Identifier Type: -

Identifier Source: org_study_id