A Study of ANX009 in Adult Participants With Lupus Nephritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-09

Study Completion Date

2023-10-31

Brief Summary

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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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Detailed Description

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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

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Lupus Nephritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ANX009

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

Group Type EXPERIMENTAL

ANX009

Intervention Type BIOLOGICAL

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

Interventions

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ANX009

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Recombinant humanized immunoglobulin G1 (IgG1) Fab

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No