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 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07314567
Eligibility Criteria:
Inclusion Criteria:
* Male or female 18 to 60 years (inclusive)
* History of meeting the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria, or the 1997 ACR criteria, or the 2012 Systemic Lupus International Collaborating Clinics (SLICC)
* Presence of anti-dsDNA antibodies and/or anti-nuclear antibodies (ANA) and/or anti-Smith (anti-Sm) antibodies positive
* SLE is in the moderate to severe active phase with the SLEDAI-2000 score ≥ 8
* At least one British Isle Lupus Rating Group Index (BILAG-2004) Class A (severe manifestation) or two Class B (moderate manifestation) organ scores, or both
* Inadequate response to glucocorticoids and at least 2 of treatments used for at least 3 months
* Women of childbearing potential and their partners must agree to use at least 1 highly effective method of contraception throughout the study period and for 1 year after treatment
* Signed informed consent
Exclusion Criteria:
* Severe lupus nephritis requiring prohibited medications for active nephritis treatment，or hemodialysis, or eGFR \< 50 ml/min/1.73m²
* Central nervous system disease caused by SLE or other conditions
* Significant medical history that would pose a risk to the patients safety from the investigator's opinion, or patients medical condition could worsen during the study
* Malignancies within 5 years
* Presence of active, recurrent, chronic infection requiring treatment , or latent infection (HBV, HCV, HIV, TB, syphilis)
* Received any B-cell depletion biologic therapy
* Received immunosuppressive small molecule drug therapy， or other systemic corticosteroid therapy ， or prednisone
* Pregnant or lactating women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT07314567
Study Brief:
Protocol Section:
NCT07314567