Phase 0/1 Local Application of the Monoclonal Antibody (Mab) sB24M in Patients With Purulent Pyod… (NCT04895566) | Clinical Trial Compass
CompletedEarly Phase 1
Phase 0/1 Local Application of the Monoclonal Antibody (Mab) sB24M in Patients With Purulent Pyoderma
Belarus, Latvia10 participantsStarted 2021-05-24
Plain-language 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.
Who can participate
Age range21 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Objective response rate (ORR) in patients with severe pyoderma