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NCT07611214PHASE4Recruiting

PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis

Aurinia Pharmaceuticals Inc.

Start Date

4/22/2026

Completion Date

3/2/2029

Summary

The goal of this clinical study is to assess the efficacy and safety of LUPKYNIS® in combination with belimumab, obinutuzumab or anifrolumab at inducing rapid renal response in patients with lupus nephritis (LN).

Detailed Description

Patients with LN will be administered LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab. Additionally, patients will receive treatment with a mycophenolic acid analog (MPAA), specifically mycophenolate mofetil (MMF) or mycophenolic acid (MPA), and oral prednisone (or equivalent).

Eligibility Criteria

Age Range: 18 years to 75 years

Key Inclusion Criteria: * Adults 18-75 years old * Diagnosed with biopsy-proven lupus nephritis (LN) according to the 2003 International Society of Nephrology (ISN) / Renal Pathology Society (RPS) (class III, class IV, class III/V or class IV/V) * Urine protein-to-creatine ratio (UPCR) ≥0.5 g/g and \<5.0 g/g from a first morning void (FMV) urine sample * Estimated glomerular filtration rate (eGFR) of ≥45 mL/min/1.73 m2 * Concomitant biologic: * Patients on the belimumab or anifrolumab treatment regimens are receiving belimumab or anifrolumab (as applicable) prior to Screening or will initiate belimumab or anifrolumab (as applicable) on or before Day 1. * Patients on the obinutuzumab treatment regimen must have received at least 2 administrations of obinutuzumab prior to Screening. * Willing to take mycophenolic acid analog (MPAA), either by continuing current MPAA therapy or by initiating it on or before Day 1 * Willing to take corticosteroids, either by continuing current corticosteroids (prednisone \[or equivalent\]) or by initiating on or before Day 1 Key Exclusion Criteria: * Any B cell targeted therapy except for the concomitant biologics (belimumab and obinutuzumab) within 1 year prior to Screening unless demonstration of B cell count within the normal range * Cyclophosphamide or any calcineurin inhibitor other than voclosporin (eg, cyclosporine and tacrolimus) within 3 months prior to Screening * Any other immunosuppressive therapy except for the concomitant drugs (anifrolumab, MPAAs and oral prednisone \[or equivalent\]) and immunosuppressive agents used to treat a patient's underlying systemic lupus erythematosus (SLE), including, but not limited to, the examples below, within 30 days or 5 half-lives, whichever is longer, prior to Screening: * Anti-tumor necrosis factor (TNF) therapy (eg, adalimumab, etanercept, infliximab) * Anti-interleukin therapy (eg, risankizumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tocilizumab, dupilumab) * T cell costimulation modulator (eg, abatacept) * Intravenous immunoglobulin (IVIg) * Janus kinase (JAK) inhibitors (eg, upadacitinib) * Pregnant, breastfeeding or intending to become pregnant during the Study

Interventions

DRUG

LUPKYNIS

BIOLOGICAL

belimumab, obinutuzumab or anifrolumab

DRUG

mycophenolic acid analog (MPAA)

DRUG

corticosteroid

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Conditions

Lupus Nephritis

Locations

Purushotham & Akther Kotha MD, Inc.

La Mesa, California 91942

United States

Valerius Medical Group & Research Center of Greater Long Beach, Inc.

Los Alamitos, California 90720

United States

Swati Shah MD Rheumatology, LLC

Jacksonville, Florida 32257

United States

CTR Oakwater

Orlando, Florida 32806

United States

Parris and Associates Rheumatology

Lawrenceville, Georgia 30044

United States

Accurate Clinical Research, Inc.

Lake Charles, Louisiana 70605

United States

Arthritis and Osteoporosis Consultants of the Carolinas

Charlotte, North Carolina 28202

United States

Joint and Muscle Research Institute

Charlotte, North Carolina 28204

United States

West Tennessee Research Institute

Jackson, Tennessee 38305

United States

Novel Research LLC

Bellaire, Texas 77401

United States

Liberty Research Center

Dallas, Texas 75230

United States

Integrative Rheumatology of South Texas

Harlingen, Texas 78550

United States

Northwest Houston Arthritis Center

Houston, Texas 77090

United States

Texas Rheumatology Research Institute, LLC

Plano, Texas 75024

United States

Nephrology Leaders and Associates, PLLC

Van Vleck, Texas 77482

United States