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

SWISS BIOPHARMA MED

Status and phase

Completed

Early Phase 1

Conditions

Pyoderma Gangrenosum

Pyoderma Gangrenosum Surrounding Surgical Stoma

Pyoderma

Pyoderma Vegetans

Treatments

Biological: Monoclonal antibody (Mab) sB24M

Study type

Interventional

Funder types

Other

Identifiers

NCT04895566

SBPM0311m

Details and patient eligibility

About

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 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.

Enrollment

10 patients

Sex

All

Ages

21 to 80 years old

Volunteers

No Healthy Volunteers

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