Overview
Principal investigator
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
* 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
For Referring Providers
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