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

Primary Purpose

Pyoderma, Pyoderma Gangrenosum, Pyoderma Vegetans

Status

Completed

Phase

Early Phase 1

Locations

International

Study Type

Interventional

Intervention

Monoclonal antibody (Mab) sB24M

About this trial

This is an interventional treatment trial for Pyoderma

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Contract Research Organization
Contract Research Organization

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

monoclonal antibody (Mab) sB24M

Arm Description

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

Outcomes

Primary Outcome Measures

Objective response rate (ORR) in patients with severe pyoderma

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

Duration of response (DoR) of patients with severe forms of pyoderma

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

Full Information

NCT ID

NCT04895566

First Posted

May 17, 2021

Last Updated

March 16, 2023

Sponsor

SWISS BIOPHARMA MED GmbH

1. Study Identification

Unique Protocol Identification Number

NCT04895566

Brief Title

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

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

May 24, 2021 (Actual)

Primary Completion Date

March 10, 2023 (Actual)

Study Completion Date

March 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SWISS BIOPHARMA MED GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pyoderma, Pyoderma Gangrenosum, Pyoderma Vegetans, Pyoderma Gangrenosum Surrounding Surgical Stoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Masking Description

This trial is an open-label, Phase 0, a non-randomized trial that will enroll up to 10 participants

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

monoclonal antibody (Mab) sB24M

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Monoclonal antibody (Mab) sB24M

Other Intervention Name(s)

CD47 / TNF-α Monoclonal antibody

Intervention Description

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

Primary Outcome Measure Information:

Title

Objective response rate (ORR) in patients with severe pyoderma

Description

The ORR is defined as the percentage of participants who had a confirmed Complete Response or Partial Response using RECIST 1.1

Time Frame

Approximately 1 year

Secondary Outcome Measure Information:

Title

Duration of response (DoR) of patients with severe forms of pyoderma

Description

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

Time Frame

Approximately 1 year

Other Pre-specified Outcome Measures:

Title

Evaluation of genetic factors for severe forms of pyoderma.

Description

Comparative analysis of gene expression in severe forms of pyoderma by partial genome sequencing prior to treatment

Time Frame

Approximately 1 year

Title

Effect of sB24M monoclonal antibody (Mab) therapy on the expression of certain genes in severe forms of pyoderma

Description

Comparative analysis of gene expression in severe forms of pyoderma by partial genome sequencing before treatment and after three courses of local injections of monoclonal antibody (Mab) sB24M into the areas affected by pyoderma

Time Frame

Approximately 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Contract Research Organization

City

Minsk

ZIP/Postal Code

12001

Country

Belarus

Facility Name

Contract Research Organization

City

Rīga

ZIP/Postal Code

LV-1079

Country

Latvia

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Time Frame

within three months after the end of the trial

IPD Sharing URL

https://sbpm.swiss/

Learn more about this trial

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

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