Status:
COMPLETED
Phase 0/1 Local Application of the Monoclonal Antibody (Mab) sB24M in Patients With Purulent Pyoderma
Lead Sponsor:
SWISS BIOPHARMA MED GmbH
Conditions:
Pyoderma
Pyoderma Gangrenosum
Eligibility:
All Genders
21-80 years
Phase:
EARLY_PHASE1
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) sB2...
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 area...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04895566
Start Date
May 24 2021
End Date
March 16 2023
Last Update
March 20 2023
Active Locations (2)
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1
Contract Research Organization
Minsk, Belarus, 12001
2
Contract Research Organization
Riga, Latvia, LV-1079