A Study of ANX009 in Adult Participants With Lupus Nephritis

Phase 1

Completed

• Conditions: Lupus Nephritis
• Interventions: Biological: ANX009

• Registration Number: NCT05780515
• Lead Sponsor: Annexon, Inc.

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 \[ARBs\]).

Study Timeline

• Study Start: 2022-08-09
• Study First Submitted: 2023-03-10
• Study First Submitted QC: 2023-03-10
• Study First Posted: 2023-03-22
• Primary Completion: 2023-08-31
• Study Completion: 2023-10-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Read More

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 exclusion criteria may apply.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ANX009	ANX009	Participants will receive repeat doses of ANX009 administered by subcutaneous (SC) infusion 3 times weekly during the approximate 3-week intervention period.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)
Change From Baseline in Free Complement Component 1q (C1q) Concentrations in Serum Over Time	Baseline (Week 1), up to Day 31

Trial Locations

Locations (7)

Annexon Investigational Site 102; 🇨🇳 Taipei, Taiwan

Annexon Investigational Site 201; 🇵🇭 Manila, Philippines

Annexon Investigational Site 101; 🇨🇳 Taichung City, Taiwan

Annexon Investigational Site 202; 🇵🇭 Quezon city, Philippines

Annexon Investigational Site 203; 🇵🇭 Angeles City, Philippines

Annexon Investigational Site 204; 🇵🇭 Iloilo City, Philippines

Annexon Investigational Site 103; 🇨🇳 Taoyuan County, Taiwan