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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05780515

Enrollment

Registered

2023-03-22

Start date

2022-08-09

Completion date

2023-10-31

Last updated

2024-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Nephritis

Brief 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 \[ARBs\]).

Interventions

BIOLOGICALANX009

ANX009 will be administered per schedule specified in the arm description.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * Participants who have a diagnosis of SLE according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 2019 Criteria * Has a history of International Society of Nephrology/Renal Pathology Society (ISN/RPS) Class III or IV with or without Class V glomerulonephritis on renal biopsy within 24 months prior to screening or as performed during screening. * Has proteinuria level between ≥0.5 to 3.0 grams (g)/g/day assessed via urine protein to creatine ratio (UPCR) during screening. * Has evidence of classical complement activation at screening * Has a history of receiving one or more standard therapies for LN Key

Exclusion criteria

* Has a history of ISN/RPS Class VI or isolated Class V (without co-existent/predominant Class III or IV glomerulonephritis) glomerulonephritis on renal biopsy. * Has severe kidney disease defined as eGFR of \<30 milliliters (mL)/minute/1.73 square meter (m\^2) or end-stage renal disease (ESRD) requiring dialysis or kidney transplantation. * Has a concurrent systemic autoimmune disease that may confound study assessments other than SLE, LN, or cutaneous lupus erythematosus. NOTE: Other inclusion and/or

Design outcomes

Primary

Measure	Time frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Baseline (Week 1) up to Week 15

Secondary

Measure	Time frame
Change From Baseline in Free Complement Component 1q (C1q) Concentrations in Serum Over Time	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	Baseline (Week 1), up to End of Study (up to Week 15)

Countries

Philippines, Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026