Clinical trial NCT04895566: Phase 0/1 Local Application of the Monoclonal Antibody (Mab) sB24M in Patients With Purulent Pyoderma
Official title: Phase 0/1 Topical Application of the Monoclonal Antibody (Mab) sB24M in Patients With Severe Pyoderma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pyoderma
Pyoderma Gangrenosum
Pyoderma Vegetans
Pyoderma Gangrenosum Surrounding Surgical Stoma
Lead sponsor: SWISS BIOPHARMA MED GmbH
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Objective response rate (ORR) in patients with severe pyoderma
timeFrame: Approximately 1 year
Secondary outcomes:
measure: Duration of response (DoR) of patients with severe forms of pyoderma
timeFrame: Approximately 1 year
Other outcomes:
measure: Evaluation of genetic factors for severe forms of pyoderma.
timeFrame: Approximately 1 year
measure: Effect of sB24M monoclonal antibody (Mab) therapy on the expression of certain genes in severe forms of pyoderma
timeFrame: Approximately 1 year
Locations:
city: Minsk
country: Belarus
facility: Contract Research Organization
city: Rīga
country: Latvia
facility: Contract Research Organization
Study officials:
References: