ANX009
BiologicalANX009 will be administered per schedule specified in the arm description.
Other names: Recombinant humanized immunoglobulin G1 (IgG1) Fab
NCT Number: NCT05780515
The main purpose of this study is to determine the safety and tolerability of repeat doses of ANX009 in participants with lupus nephritis (LN).
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Annexon Investigational Site 203, Angeles City, Philippines
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]).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other inclusion and/or exclusion criteria may apply.
ANX009 will be administered per schedule specified in the arm description.
Other names: Recombinant humanized immunoglobulin G1 (IgG1) Fab
Time frame: Baseline (Week 1) up to Week 15
Time frame: Baseline (Week 1), up to Day 31
Time frame: Baseline (Week 1), up to End of Study (up to Week 15)
Annexon, Inc.
Industry
A Single-Arm, Phase 1b, Open-Label Study to Assess the Safety, Tolerability, and Pharmacodynamics of Repeat-Doses of Subcutaneous ANX009 With Standard of Care Therapy in Adult Participants With Lupus Nephritis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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