Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2025-12-24 @ 4:23 PM
NCT ID:
NCT04895566
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT04895566
Study Brief:
Protocol Section:
NCT04895566