The purpose of this study is to find out if CND261 is safe and how well it works in treating patients with this type of vasculitis who have not gotten better with other treatments. The study will look at whether the treatment causes any side effects, particularly a reaction called Cytokine Release Syndrome, which happens when the immune system releases substances too quickly, and another reaction called Immune Cell Associated Neurotoxicity Syndrome, which can affect the nervous system. The study will also check if the treatment can reduce or eliminate certain antibodies in the blood called ANCA antibodies, which are linked to the disease. Specifically, the study will measure anti-PR3 antibodies in patients with one form of the disease called granulomatosis with polyangiitis and anti-MPO antibodies in patients with another form called microscopic polyangiitis.

The study is divided into two phases. In the first phase, a small number of patients will receive the treatment to check if it is safe. In the second phase, more patients will receive the treatment to learn more about safety and to see how well it works in reducing disease activity and the antibodies that cause the disease. During the study, patients will be monitored regularly for any side effects and to measure changes in their disease activity, blood tests, and quality of life. The study will track how long patients can stay off other disease-modifying medicines, whether they experience any flare-ups of their disease, and how their overall health and ability to perform daily activities change over time.

The study will involve participants who are between 18 and 80 years old and have either newly diagnosed or relapsing ANCA-associated vasculitis for which treatment with certain medications is being considered. Participants must have a positive test for specific antibodies called PR3-ANCA or MPO-ANCA and must meet certain disease activity requirements based on a scoring system called BVAS (Birmingham Vasculitis Activity Score). The study will monitor various safety measures including any unwanted effects of the treatment, changes in vital signs, physical examinations, laboratory tests, and heart function tests measured by ECG (electrocardiogram).

During the study, researchers will also look at how well the treatment works by checking if participants achieve disease remission, which means the disease becomes inactive, at different time points including week 26 and week 52. They will measure changes in kidney function using eGFR (estimated glomerular filtration rate), which shows how well the kidneys are filtering waste from the blood. Other measurements will include checking for protein in the urine using tests called UPCR (urine protein-to-creatinine ratio) and UACR (urine albumin-to-creatinine ratio), as well as looking for blood in the urine. The study will also track any disease damage over time using the Vasculitis Damage Index and monitor whether the disease comes back after achieving remission. The study is expected to run for approximately 52 weeks for each participant.

The main goal of this study is to find out if adding AMG 569 to standard treatment can help more patients achieve better kidney function after one year of treatment compared to those receiving placebo with standard treatment. Better kidney function is defined as reaching a specific level of kidney filtering ability that indicates less severe kidney disease. The study will also look at other important outcomes such as survival rates, disease activity and damage scores, how many patients achieve complete disease remission, changes in kidney function over time, protein levels in urine, how many patients need long-term dialysis, and quality of life measures. Additionally, researchers will measure various substances in blood and urine that indicate inflammation and immune system activity, and will examine kidney tissue samples to assess the degree of kidney damage.

Patients participating in this study will be followed for approximately one year and three months. During this time, they will have regular visits where their kidney function will be checked through blood and urine tests, and their overall disease activity will be assessed. The study requires a kidney biopsy, which is a procedure where a small piece of kidney tissue is removed for examination, either before joining the study or within the first month of participation. Participants will continue to receive their standard treatment for the disease while also taking either AMG 569 or placebo. The study will monitor for any side effects or complications, including infections, diabetes, liver problems, and other adverse events that may occur during the treatment period.

The purpose of the study is to assess the safety and effectiveness of the Anti-CD19 CAR-T cell therapy in patients with active, treatment-resistant ANCA-associated vasculitis. Participants in the study will receive the treatment and be monitored over a period of time to see how their condition responds. The study will be conducted in two phases, with the first phase focusing on safety and the second phase looking at both safety and how well the treatment works. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatment.

Throughout the study, participants will undergo regular check-ups and tests to monitor their health and the progress of the treatment. The study aims to provide valuable information on the potential benefits and risks of using Anti-CD19 CAR-T cell therapy for treating ANCA-associated vasculitis. This research could lead to new treatment options for patients with this challenging condition.

The study is divided into two parts. In the first part, participants will receive either the combination of rituximab and cyclophosphamide or just cyclophosphamide to see which is more effective in achieving complete remission of the disease. In the second part, the study will look at how well rituximab works when given in two different ways: as an injection under the skin or as an infusion into a vein. This part will focus on maintaining remission, which means keeping the disease under control after it has been reduced or stopped.

Throughout the study, researchers will also look at genetic factors that might influence how the disease develops and how patients respond to treatment. The study will last for several years, allowing researchers to gather comprehensive data on the effectiveness and safety of the treatments. Participants will be monitored regularly to assess their health and any changes in their condition.

The purpose of the study is to compare the effectiveness of using rituximab alone versus a combination of rituximab and cyclophosphamide in maintaining remission, which means keeping the disease under control without symptoms. Participants will receive these treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will last for up to two years, during which the number of rituximab infusions needed to maintain remission will be evaluated. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments.

Throughout the study, researchers will monitor various aspects, such as the time it takes for certain antibodies related to the disease to become undetectable, the duration of immune cell depletion, and any side effects experienced by participants. The study will also assess the quality of life and disease activity in participants. This information will help determine the best treatment approach for managing ANCA-associated vasculitis and improving patient outcomes.

Participants in the study may also receive standard treatments for vasculitis, including rituximab, cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, and glucocorticoids. These medications help control inflammation and suppress the immune system to manage the disease. The treatment period will last for 60 months, during which patients will take either avacopan or placebo along with their other medications.

Throughout the study, doctors will monitor patients’ health, checking for any side effects and measuring how well the treatment works. They will pay special attention to liver function, allergic reactions, and infections. They will also track improvements in kidney function and overall quality of life. This information will help determine if avacopan is safe and effective for long-term use in treating this type of vasculitis.

The purpose of this research is to determine if taking corticosteroid medication twice per day, instead of once daily, leads to better control of blood sugar levels. During the study, participants will receive Aprednislon tablets and will wear a special device that continuously monitors their blood sugar levels. The total treatment period lasts 14 days.

The study will track how long blood sugar levels stay within a healthy range throughout the day. Additional measurements will include various blood tests to monitor the effectiveness of treatment and its impact on overall health. Participants will also complete questionnaires about their quality of life during the study period.

The medications being studied include rituximab, azathioprine, prednisone, and mycophenolate mofetil. Rituximab is given as an injectable solution, while azathioprine, prednisone, and mycophenolate mofetil are taken orally in tablet form. The purpose of the study is to determine if stopping immunosuppressive therapy is better for patients with end-stage renal disease and ANCA vasculitis compared to continuing the standard maintenance therapy. The study will follow participants for 24 months to observe any severe events such as major relapses, severe infections, or death.

Participants in the study will be randomly assigned to either continue their current immunosuppressive therapy or to stop it. The study will monitor the health of the participants over the course of two years to see which approach leads to better outcomes. This research aims to provide valuable information on the best treatment approach for patients with these serious conditions.

Participants in the study will be divided into groups to receive either a continued low dose of prednisone or a placebo, which is a substance with no active medication, to compare the effects on maintaining remission. The study will last for about 30 months, during which the participants’ health will be monitored to see if they remain free of disease symptoms. The goal is to determine if continuing prednisone helps prevent the return of symptoms better than stopping it after a short period.

Throughout the study, participants will receive regular check-ups to monitor their health and any potential side effects. The study will also track the occurrence of any disease flare-ups, which are periods when symptoms return or worsen. This research is important for understanding how to best manage ANCA-associated vasculitis and improve long-term outcomes for patients living with these conditions.

The purpose of the study is to see if adding pioglitazone to the usual treatment can help reduce kidney damage in patients with ANCA-associated vasculitis. The study will last for about six months, during which participants will receive the treatment and have regular check-ups to monitor their kidney function and overall health. The study will also look at how the treatment affects the quality of life and any side effects that may occur.

Participants in the study will receive either pioglitazone or a placebo, which is a substance with no active medication, along with their standard treatment. The study will involve regular visits to the clinic for assessments and to ensure the safety and effectiveness of the treatment. The goal is to find out if pioglitazone can provide additional benefits in managing ANCA-associated vasculitis and improving kidney outcomes.