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 \[ARBs\]).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
ANX009 will be administered per schedule specified in the arm description.
Annexon Investigational Site 203
Angeles City, Philippines
Annexon Investigational Site 204
Iloilo City, Philippines
Annexon Investigational Site 201
Manila, Philippines
Annexon Investigational Site 202
Quezon City, Philippines
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)
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Annexon Investigational Site 101
Taichung, Taiwan
Annexon Investigational Site 102
Taipei, Taiwan
Annexon Investigational Site 103
Taoyuan, Taiwan