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Clinical Studies
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A Phase 1, Multicenter, Open-Label Study Of CC-97540 (BMS-986353), CD19-Targeted Nex-T Chimeric Antigen Receptor (CAR) T Cells, in Participants with Severe, Refractory Autoimmune Diseases: Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy or Systemic Sclerosis
Rochester, Minn.,
Jacksonville, Fla.
CC-97540, also known as BMS-986353, is an investigational CD19-specific CAR T cell
product and is being investigated in this Phase 1 open-label study in participants with
severe, refractory SLE, IIM, and SSc.
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-2) (POETYK SLE-2)
Rochester, Minn.
The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.
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An Open Label Multicenter Study to Assess the Relationship Between Data Obtained with the LuGENE® Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients with Systemic Lupus Erythematosus (SLE) (ReLATE)
Rochester, Minn.
The purpose of this study is to determine the association of the data obtained with LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE, including clinical involvement, SLEDAI score, Physician Global Assessment (PGA) and standard laboratory measures, including ANA, anti-DNA, anti-RNP and complement components C3 and C4, as well as Patient Reported Outcomes capturing pain, fatigue and Health-Related Quality of Life.
Closed for Enrollment
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A Double-Blind, Placebo-Controlled Randomized, Multicenter Study to Assess Changes in Omega-3 Index in Erythrocytes and Health Benefit After 24 Weeks of Daily Consumption of AKBM-3031 (Omega-3 Phospholipids From Krill), Followed by a 24 Week Open-Label Extension, in Patients With Systemic Lupus Erythematosus (SLE) (ORKIDS)
Rochester, Minn.
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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A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study in Healthy Subjects and Multiple Dose Study of JNJ-55920839 in Subjects with Mild to Moderate Systemic Lupus Erythematosus
Rochester, Minn.
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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Algorithm Refinement to Predict Clinical Disease Flare Through Longitudinal Assessment of Systemic Lupus Erythematosus Patients
Rochester, Minn.
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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Exploring the Connection Between Immune Check-point Inhibitor (ICI) Induced Rheumatic Diseases and Classic Rheumatologic Diseases
Rochester, Minn.
The purpose of this study is to:
- Understanding how to better predict and manage patients at high risk for rheumatic irAEs and tailor therapy without diminishing cancer treatment efficacy and,
- Further inform our understanding on the pathogenesis of classic rheumatologic diseases.
- Establish a repository of biological samples from patients with irAE and corresponding rheumatologic
.