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Completed

NCT Number: NCT05780515

A Study of ANX009 in Adult Participants With Lupus Nephritis

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Annexon Investigational Site 203, Angeles City, Philippines

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About this study

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]).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 exclusion criteria may apply.

Treatment and study plan

ANX009

Biological

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

Other names: Recombinant humanized immunoglobulin G1 (IgG1) Fab

Primary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Baseline (Week 1) up to Week 15

Secondary outcomes

  1. Change From Baseline in Free Complement Component 1q (C1q) Concentrations in Serum Over Time

    Time frame: Baseline (Week 1), up to Day 31

  2. 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)

Sponsors and collaborators

Lead sponsor

Annexon, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 22, 2023
Registry last updated
Aug 22, 2024

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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