A Phase 1 interventional study of ANX009 in Lupus Nephritis, sponsored by Annexon, Inc.. Completed at 7 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-22.
Sponsored by Annexon, Inc. · Phase 1, Interventional, and Treatment
The main purpose of this study is to determine the safety and tolerability of repeat doses of ANX009 in participants with lupus nephritis (LN).
All participants may continue to receive stable background standard of care therapy for LN and systemic lupus erythematosus (SLE) as permitted by the protocol (for example, mycophenolate mofetil [MMF], azathioprine, antimalarials, glucocorticoids, cyclosporin, voclosporin, tacrolimus, angiotensin converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs]).
245 studies on the registry are indexed under Nephritis; 56 are open to participants now.
This study's enrollment of 7 is below the median of 49 across 156 interventional studies indexed under Nephritis.
Browse Nephritis studies →Annexon, Inc. is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 2 (25%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other inclusion and/or exclusion criteria may apply.
Participants will receive repeat doses of ANX009 administered by subcutaneous (SC) infusion 3 times weekly during the approximate 3-week intervention period.
Biological: ANX009
ANX009 will be administered per schedule specified in the arm description.
Also known as: Recombinant humanized immunoglobulin G1 (IgG1) Fab
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline (Week 1) up to Week 15
Change From Baseline in Free Complement Component 1q (C1q) Concentrations in Serum Over Time
Time frame: Baseline (Week 1), up to Day 31
Change From Baseline in Complement Factor C4 Concentration and its Activation Product (Complement Component 4d [C4d]) in Plasma Over Time
Time frame: Baseline (Week 1), up to End of Study (up to Week 15)
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Annexon, Inc.