Clinical Trials

The purpose of this study is to identify genes that increase the risk of developing vasculitis, a group of severe diseases that feature inflammation of blood vessels. Results of these studies will provide vasculitis researchers with insight into the causes of these diseases and generate new ideas for diagnostic tests and therapies, and will be of great interest to the larger communities of researchers investigating vasculitis and other autoimmune, inflammatory, and vascular diseases.

Vasculitis is group of diseases where inflammation of blood vessels is the common feature. Patients typically present with fever, fatigue, weakness and muscle and joint aches. These symptoms are very common among many different diseases, not just vasculitis. A clustering of other symptoms, physical examination findings, blood tests, radiology and biopsy help make the diagnosis. There are currently no criteria to help doctors make a diagnosis of vasculitis when a patient presents with these non specific symptoms and they are reliant on previous experience and disease definitions. One of the aims of this project is to develop diagnostic criteria for ...

Rituximab is now established as an effective drug for anti-neutrophil cytoplasmic antibody (ANCA) vasculitis following major European and US trials reported in 2010. After a time, its effect wears off and the disease can return. This occurs in at least half of patients within 2 years of receiving Rituximab. A preliminary study in Cambridge has suggested that repeating rituximab every six months stops the disease returning and is safe. The RITAZAREM trial will find out whether repeating rituximab stops vasculitis returning and whether it works better than the older treatments, azathioprine or methotrexate. It will also tell us how long ...

This is a prospective pilot study to determine the utility of MRI and high resolution intracranial vessel wall imaging for the diagnosis and disease activity assessment of intracranial vasculitis.

Multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of abatacept to achieve sustained glucocorticoid-free remission in patients with relapsing non-severe granulomatosis with polyangiitis (Wegener's) (GPA) . Participants will be randomized 1:1 to receive either abatacept 125 mg or placebo administered by subcutaneous injection once a week. Participants will continue on study treatment for a minimum of 12 months unless they experience a disease relapse or disease flare. Participants who experience a non-severe disease relapse, non-severe disease worsening, or who have not achieved remission by month 6 will have the option of entering an open-label trial period whereby they would ...

This study is a multi-center randomized controlled trial to evaluate the effects of using low-dose prednisone as compared to stopping prednisone treatment entirely. Participants will be randomized 1:1 to taper their prednisone dose down to 5 mg/day or to 0 mg/day for the duration of the study (approximately six months) or until a study endpoint.

The primary purpose of this study is to evaluate the effectiveness and safety of mavrilimumab (KPL-301) versus placebo, co-administered with a 26-week corticosteroid taper, for maintaining sustained remission for 26 weeks in subjects with new onset or relapsing/refractory giant cell arteritis (GCA).

The purpose of this study is to evaluate the effectiveness and safety of RoActemra/Actemra (tocilizumab) for the treatment of patients who have giant cell arteritis.

The primary objective of the study is to evaluate the effectiveness of depemokimab 200 mg SC every 26 weeks compared with mepolizumab 300 mg SC every 4 weeks in participants with relapsing or refractory EGPA receiving Standard of Care (SoC) therapy with the endpoint of remission (i.e., a Birmingham Vasculitis Activity Score (BVAS)=0 and a dose of oral corticosteroids (OCS) ≤ 4mg/day) at both Week 36 and Week 52.

The aim of this study is to investigate the effectiveness and safety of depemokimab 200 mg (administered as 100 mg x 2) SC injections every 26 weeks compared with mepolizumab 300 mg (administered as 100 mg x 3) SC injections every 4 weeks in ...

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 ...

The purpose of this study is to gain more insight about the role of matrix metalloproteinase (MMP)-9 and -12 in the vascular remodeling in temporal arteries with giant cell arteritis (GCA), determine if their serum levels could be useful for diagnosis and/or follow up of patients with GCA, and determine if s single nucleotide polymorphisms (SNPs) of MMP-9 and/or MMP-12 could prove to be useful for diagnosis or prognosis.

The purpose of this study is to determine the effectiveness of abatacept in Giant Cell Arteritis (GCA).  Patients who have newly diagnosed or relapsing GCA within 8 weeks prior to screening will be randomized to receive subcutaneous abatacept or placebo.  All patients will receive glucocorticoids (GC) which will be tapered and discontinued by week 26 according to a standardized schedule. Patients who achieve remission will remain on their blinded assignment for 12 months at which time abatacept/placebo will be stopped. Patients who do not achieve remission by Month 3, who experience a relapse within the first 12 months, or who are ...

This is a randomized, double blind, active-controlled, parallel group, multicenter 52-week Phase 3 study to compare the efficacy and safety of benralizumab 30 mg versus mepolizumab 300 mg administered by subcutaneous (SC) injection every 4th week in patients with relapsing or refractory EGPA on corticosteroid therapy with or without stable immunosuppressive therapy. All patients who complete the 52-week double-blind treatment period on IP may be eligible to continue into an open label extension (OLE) period. The OLE period is intended to allow each patient at least 1 year of treatment with open-label benralizumab 30 mg administered SC every 4th ...

The purpose of this study is to find out if advanced ultrasound studies can be used to make a diagnosis of giant cell arteritis. Ultimately, we hope to be able to offer non-invasive diagnostic options as an alternative to biopsy to future patients who are being evaluated for giant cell arteritis.

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.

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.

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).

Multi-center sequential multiple assignment randomized trial comparing the effectiveness of three different standard of care treatment options for patients with isolated skin vasculitis.

The purpose of this study is to evaluate the effectiveness and safety of Benralizumab compared to Mepolizumab to treat Eosinophilic Granulomatosis with Polyangiitis (EGPA) in patients receiving standard of care (SOC) therapy.

Multi-center observational study to evaluate the histopathology and transcriptome of cutaneous lesions in patients with several different types of vasculitis.

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) ...

The purpose of the study is to learn more about inflammatory diseases of the central nervous system (CNS) by collecting patient information, blood sample (which contain a person’s genes, DNA) and other available tissue samples.

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.

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. 

The purpose of this study is to assess the safety of mesenchymal stem cells in patients with Interstitial Lung Disease (ILD) associated with Connective Tissue Disorders (CTD).

The purpose of  this study is to determine the usefulness of palliative care consultations by a specialty physician and a pulmonologist for patients who have advanced lung disease.

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.