A Study of ANX009 in Adult Participants With Lupus Nephritis
- Conditions
- Lupus Nephritis
- Registration Number
- NCT05780515
- Lead Sponsor
- Annexon, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Key Inclusion Criteria:<br><br> - Participants who have a diagnosis of SLE according to European League Against<br> Rheumatism/American College of Rheumatology (EULAR/ACR) 2019 Criteria<br><br> - Has a history of International Society of Nephrology/Renal Pathology Society<br> (ISN/RPS) Class III or IV with or without Class V glomerulonephritis on renal biopsy<br> within 24 months prior to screening or as performed during screening.<br><br> - Has proteinuria level between =0.5 to 3.0 grams (g)/g/day assessed via urine protein<br> to creatine ratio (UPCR) during screening.<br><br> - Has evidence of classical complement activation at screening<br><br> - Has a history of receiving one or more standard therapies for LN<br><br>Key Exclusion Criteria:<br><br> - Has a history of ISN/RPS Class VI or isolated Class V (without<br> co-existent/predominant Class III or IV glomerulonephritis) glomerulonephritis on<br> renal biopsy.<br><br> - Has severe kidney disease defined as eGFR of <30 milliliters (mL)/minute/1.73 square<br> meter (m^2) or end-stage renal disease (ESRD) requiring dialysis or kidney<br> transplantation.<br><br> - Has a concurrent systemic autoimmune disease that may confound study assessments<br> other than SLE, LN, or cutaneous lupus erythematosus.<br><br>NOTE: Other inclusion and/or exclusion criteria may apply.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
- Secondary Outcome Measures
Name Time Method Change From Baseline in Free Complement Component 1q (C1q) Concentrations in Serum Over Time;Change From Baseline in Complement Factor C4 Concentration and its Activation Product (Complement Component 4d [C4d]) in Plasma Over Time