A Study of ANX009 in Adult Participants With Lupus Nephritis

Last updated: August 20, 2024
Sponsor: Annexon, Inc.
Overall Status: Completed

Phase

1

Condition

Kidney Disease

Lupus Nephritis

Nephritis

Treatment

ANX009

Clinical Study ID

NCT05780515
ANX009-LN-01
  • Ages 18-75
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Participants who have a diagnosis of SLE according to European League AgainstRheumatism/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 biopsywithin 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 proteinto 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

Exclusion

Key Exclusion Criteria:

  • Has a history of ISN/RPS Class VI or isolated Class V (withoutco-existent/predominant Class III or IV glomerulonephritis) glomerulonephritis onrenal biopsy.

  • Has severe kidney disease defined as eGFR of <30 milliliters (mL)/minute/1.73 squaremeter (m^2) or end-stage renal disease (ESRD) requiring dialysis or kidneytransplantation.

  • Has a concurrent systemic autoimmune disease that may confound study assessmentsother than SLE, LN, or cutaneous lupus erythematosus.

NOTE: Other inclusion and/or exclusion criteria may apply.

Study Design

Total Participants: 7
Treatment Group(s): 1
Primary Treatment: ANX009
Phase: 1
Study Start date:
August 09, 2022
Estimated Completion Date:
October 31, 2023

Study 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]).

Connect with a study center

  • Annexon Investigational Site 203

    Angeles City,
    Philippines

    Site Not Available

  • Annexon Investigational Site 204

    Iloilo City,
    Philippines

    Site Not Available

  • Annexon Investigational Site 201

    Manila,
    Philippines

    Site Not Available

  • Annexon Investigational Site 202

    Quezon city,
    Philippines

    Site Not Available

  • Annexon Investigational Site 101

    Taichung City,
    Taiwan

    Site Not Available

  • Annexon Investigational Site 102

    Taipei,
    Taiwan

    Site Not Available

  • Annexon Investigational Site 103

    Taoyuan County,
    Taiwan

    Site Not Available

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