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A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis
Rochester, MN
The aim of the trial is to assess the safety and efficacy of the orally-administered, selective complement C5a receptor inhibitor CCX168 (avacopan) in inducing and sustaining remission in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).
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A Study to Evaluate the Safety and Effectiveness of IFX-1 in Add-on to Standard of Care in Patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)
Rochester, MN
The purpose of this study is to investigate the safety and tolerability of two dose regimens of IFX-1 as add-on to standard of care (SOC) in subjects with GPA and MPA compared with placebo.
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PR3-AAV Resilient Remission or PRRR
Rochester, MN
The purpose of this study is to determine the proportion of patients achieving both complete remission and seronegativity for Anti-Neutrophil Cytoplasmic Antibody (ANCA) at 6 months.
The study is a double-blind, randomized, active controlled phase 2 study. It will take place at multiple sites and enroll 30 patients who have clinical diagnosis of either granulomatosis with polyangiitis or microscopic polyangiitis (PR3-AAV). It will look at the study drug, Obinutuzumab, for the treatment of these diagnosis and evaulate the safety of the drug. Subjects will be followed for 18 months after first treatment. The study will complete when all enrolled subjects are have been ...
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A Study to Evaluate the Safety and Effectiveness of IFX-1 in Add-on to Standard of Care in Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)
Scottsdale/Phoenix, AZ
The purpose of this study is to investigate the safety and tolerability of two dose regimens of IFX-1 as add-on to standard of care (SOC) in subjects with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) compared with placebo.
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Creation of a Biospecimen Repository from Patients with ANCA-associated Vasculitis
Rochester, MN
The purpose of this study is to develop a repository of serum and urine samples from patients with AAV to support future studies into the development of such biomarkers.
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Clinical Transcriptomics in Systemic Vasculitis (CUTIS)
Rochester, MN
Multi-center observational study to evaluate the histopathology and transcriptome of cutaneous lesions in patients with several different types of vasculitis.
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Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis
Rochester, MN
The purpose of this clinical trial is to determine if low dose naltrexone is effective in improving health-related quality of life (HRQoL) among patients with vasculitis. Although it is a pilot study, a placebo-controlled component is used because of the prominent placebo group effect seen in studies with self-reported subjective outcomes.
Naltrexone is an FDA approved drug (for alcoholism) that has found widespread use "off-label" to treat pain and improve quality of life at much lower doses than are used for the approved indication. There are a few scientific studies in three conditions (fibromyalgia, Crohn's disease, and multiple sclerosis) ...