NCT04895566

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started May 2021

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

May 24, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2023

Completed
Last Updated

March 20, 2023

Status Verified

March 1, 2023

Enrollment Period

1.8 years

First QC Date

May 17, 2021

Last Update Submit

March 16, 2023

Conditions

PyodermaPyoderma GangrenosumPyoderma VegetansPyoderma Gangrenosum Surrounding Surgical Stoma

Outcome Measures

Primary Outcomes (1)

  • 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

    Approximately 1 year

Secondary Outcomes (1)

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

    Approximately 1 year

Other Outcomes (2)

  • Evaluation of genetic factors for severe forms of pyoderma.

    Approximately 1 year

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

    Approximately 1 year

Study Arms (1)

monoclonal antibody (Mab) sB24M

EXPERIMENTAL

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

Biological: Monoclonal antibody (Mab) sB24M

Interventions

Monoclonal antibody (Mab) sB24MBIOLOGICAL

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

Also known as: CD47 / TNF-α Monoclonal antibody
monoclonal antibody (Mab) sB24M

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Contract Research Organization

Minsk, 12001, Belarus

Location

Contract Research Organization

Riga, LV-1079, Latvia

Location

MeSH Terms

Conditions

PyodermaPyoderma Gangrenosum

Interventions

Antibodies, Monoclonal

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, VascularSkin Ulcer

Intervention Hierarchy (Ancestors)

AntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Masking Details
This trial is an open-label, Phase 0, a non-randomized trial that will enroll up to 10 participants
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2021

First Posted

May 20, 2021

Study Start

May 24, 2021

Primary Completion

March 10, 2023

Study Completion

March 16, 2023

Last Updated

March 20, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share
Shared Documents
CSR
Time Frame
within three months after the end of the trial
More information

Locations

BE(1)LA(1)