NCT05780515

A Study of ANX009 in Adult Participants With Lupus Nephritis

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Annexon, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to determine the safety and tolerability of repeat doses of ANX009 in participants with lupus nephritis (LN).

Detailed description

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 \[ARBs\]).

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
BIOLOGICAL	ANX009	ANX009 will be administered per schedule specified in the arm description.

Timeline

• Start date: 2022-08-09
• Primary completion: 2023-08-31
• Completion: 2023-10-31
• First posted: 2023-03-22
• Last updated: 2024-08-22

Locations

7 sites across 2 countries: Philippines, Taiwan