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A Study to Assess Omega-3 Replacement With Krill Oil in Disease Management of System Lupus Erythematosus (SLE)
Rochester, MN
The purpose of this study is to test the hypothesis that subjects with active System Lupus Erythematosus (SLE) will benefit from correcting their omega-3 deficiency. This will be an add-on to standard of care medication.
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Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus
Rochester, MN
This is a multi-center, double-blind, randomized, Phase 2b trial to evaluate the efficacy of atacicept in subjects with systemic lupus erythematosus (SLE).
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Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Patients Who Participated in ADDRESS II)
Rochester, MN
This is a multicenter, double-blind, Phase 2b, long-term extension (LTE) to the ADDRESS II core trial (EMR 700461-023) (NCT01972568), to evaluate long-term safety and tolerability of atacicept in subjects with systemic lupus erythematosus (SLE). The Week 24 visit of ADDRESS II core trial will coincide with the Day 1 visit of this LTE trial.
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Complement Activation Signatures and Treatment in Systemic Lupus Erythematosus
Rochester, MN
The purpose of this study to look at certain blood proteins known as complement proteins in the whole blood of patients with systemic lupus erythematosus (SLE or lupus). We propose that the levels of these proteins will A) predict lupus disease activity, B) provide information regarding efficacy of treatment, and c) provide SLE diagnostic information.
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A Study of the Safety and Tolerability of JNJ-55920839, Either as a Single Ascending Dose in Healthy Individuals or as Multiple Doses for Patients who have Mild to Moderate Systemic Lupus Erythematosus
Rochester, MN
The purpose of this study is to assess the safety and tolerability of JNJ-55920839 either as a single ascending intravenous (IV) dose administration in healthy participants or multiple IV dose administrations in patients with mild to moderate Systemic Lupus Erythematosus.
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A Study of Clinical Disease Flare Through Assessment of Systemic Lupus Erythematosus Patients
Rochester, MN
The purpose of this study is to focus on following a prospective cohort of 30 patients with classified SLE for the collection of demographic, clinical (disease activity), and laboratory data that can be used to provide well- characterized biological samples for future assessment of mechanisms of immune dysregulation that lead to clinical disease flare, including a distinct subset of SLE-associated, immune pathway alterations that inform a predictive algorithm. A successful outcome of this proposal will allow for the development of an optimized soluble mediator score, encompassing a distinct subset of informative biomarkers, ready for clinical testing.
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A Study of the Biological Characteristics of Lupus
Rochester, MN
The purpose of this study is to understand the characteristics associated with lupus, to assist the early development of new treatments for human lupus and Sjögren's syndrome.
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A Study to Characterize Functional Biomarkers of Systemic Lupus Erythematosus (SLE)
Scottsdale/Phoenix, AZ
The purpose of this study is to investigate syndecan-1 expression levels on immune cells, especially pDCs, in systemic lupus erythematosus (SLE) patients by flow cytometry, the role of syndecan-1 expressed by SLE patient pDCs in IFN expression, and the role of patient serum in syndecan-1 surface expression on pDCs.
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Daratumumab to Treat Active Lupus Nephritis
Rochester, MN
The purpose of this study is to assess the effectiveness and safety of daratumumab in inducing complete or partial remission in patients with active class III or IV (± V) lupus nephritis (LN) as measured by change in proteinuria and serum creatinine.
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LUPKYNIS US Registry Trial
Jacksonville, FL
This observational study is a registry designed to assess the utilization and effectiveness of LUPKYNIS in adult patients with lupus nephritis (LN) in the United States (US).
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Aurinia Renal Response in Active Lupus With Voclosporin
Rochester, MN
The purpose of this study is to assess the efficacy of voclosporin compared with placebo in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis.
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Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V
Jacksonville, FL; Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the effectiveness, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment in Participants With Active Lupus Nephritis Class III-IV, +/- V.
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Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis
Jacksonville, FL
The purpose of this trial is to evaluate the effectiveness, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active Lupus Nephritis (LN).
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A Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis
Rochester, MN
The purpose of this study is to evaluate the effectiveness, safety, and pharmacokinetics of obinutuzumab compared with placebo in patients with International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis (LN) when added on to standard-of-care therapy consisting of mycophenolate mofetil (MMF) and corticosteroids.
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A Study of Inhaled GB002 for Treatment of WHO Group I Pulmonary Arterial Hypertension
Jacksonville, FL
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and biomarkers of inhaled GB002 in adults with World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH).
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Immunological Consequences of COVID-19 Vaccination in Patients with Rheumatic Diseases
Rochester, MN
This research trial will study the immune respone to COVID-19 vaccination in patients with rheumatic diseases.
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Biospecimens Resource for Glomerular and Tubulo-interstitial Diseases
Rochester, MN
This study is being done to create a "resource" of samples that can be used to improve our ability to diagnose and treat MN, IgAN, MPGN, FSGS/MCD, Lupus Nephritis, AAV, other glomerular tubulo-interstitial disease.
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Exploring the Role of B-cell Activating Factor Receptor (BAFFR)-based Chimeric Antigen Receptor T-cell (CAR T) in BAFFR-expressing B-cell Hematologic Malignancies and Autoimmune Rheumatologic Disorders
Jacksonville, FL
The purposes of this study are to explore the therapeutic efficacy of BAFFR-CAR T cells in BAFFR-expressing B-cell hematologic malignancies including large B-cell, mantle cell and follicular lymphoma, chronic lymphocytic leukemia (CLL) and B-cell acute lymphoblastic leukemia (B-cell ALL) using primary tumor and/or patient derived xenograft models, and to explore the therapeutic efficacy of BAFFR-CAR T cells in autoimmune rheumatologic diseases including systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis using primary samples and/or patient derived xenograft models.