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:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT06265220
Eligibility Criteria:
Inclusion Criteria for all subjects (Lupus Nephritis or SLE)
* Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria
* Subjects must have had an inadequate response with at least two prior lines of standard of care (SoC) treatment.
Inclusion Criteria for LN:
* Adult subjects with lupus nephritis Class III or IV (with or without the presence of Class V)
* Evidence of active disease on renal biopsy.
* All subjects are required to receive adequate concomitant antihypertensive and antiproteinuric therapy with blockade of the renin-angiotensin system
Inclusion Criteria for SLE:
* Total systemic lupus erythematosus disease activity index (SLEDAI-2K score) ≥ 8, and clinical SLEDAI-2K ≥ 4.
* British Isles Lupus Assessment Group 2004 (BILAG-2004) activity score of A in ≥ 1 organ, or a BILAG-2004 activity score of B in ≥ 2 organs.
* Subjects have failed at least two conventional therapies
Exclusion Criteria:
* Known past or current malignancy
* Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SLE
* Subjects with known active viral infections
* Severe active CNS Lupus
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06265220
Study Brief:
Protocol Section:
NCT06265220