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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07314060
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 or ≤75 years old at screening, regardless of gender;
* Meet the diagnostic criteria defined by the 2017 European Society for Clinical Nutrition and Metabolism (ESPEN) Research Workshop (ERASPEN) consensus and be diagnosed as （generalized pustular psoriasis(GPP);
* Compliant with GPP acute onset;
* Able to read and understand, and willing to sign the informed consent form;
* Willing and compliant with study visits and related procedures;
* Female subjects of childbearing age should agree that contraceptive measures must be used during the study and for 6 months after the end of the study;
Exclusion Criteria:
* Pustules are limited to psoriasis vulgaris on psoriasis plaques;
* Concomitant skin disease or medical disease that may interfere with the investigator's evaluation of the subject's treatment response;
* Presence of severe, progressive, or uncontrolled disease, or signs and symptoms that are not suitable for participation in the investigator, in the judgment of the investigator:
* Serum virological abnormalities during the screening period;
* Chest radiology examination shows that the subject has active tuberculosis or a history of contact with open tuberculosis subjects in the past 6 months or a positive Interferon-Gamma Release Assays(IGRA) test;
* History of serious infection leading to hospitalization within 2 months prior to baseline;
* Active infection requiring systemic antibiotics, systemic antifungals, or systemic antiviral therapy within 2 weeks prior to baseline, according to the investigator's assessment;
* History of opportunistic infection within 6 months prior to baseline;
* Received live (attenuated) vaccine treatment within 12 weeks prior to baseline;
* Any major surgery within 4 weeks prior to baseline or planned major surgery during the study;
* Received blood transfusion within 4 weeks prior to baseline;
* Participated in clinical trials of other drugs or medical devices within 4 weeks before baseline;
* Any known or suspected congenital or acquired immunodeficiency state or condition that may compromise the subject's immune status;
* Subjects with any type of active malignancy or a history of malignancy;
* Alcohol, drug and known drug dependence;
* Pregnant or lactating women;
* Subjects cannot tolerate intravenous infusion administration.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07314060
Study Brief:
Protocol Section:
NCT07314060