Granulomatosis with Polyangiitis (GPA) Clinical Trials

Granulomatosis with Polyangiitis is a systemic necrotizing vasculitis affecting small and medium blood vessels, characterized by the triad of granulomatous inflammation, necrotizing vasculitis, and glomerulonephritis. The disease results from ANCA-associated immune mechanisms, with most patients positive for c-ANCA (anti-PR3 antibodies). The pathophysiology involves abnormal T cell and B cell function leading to generation of anti-PR3 autoantibodies and activated neutrophils that trigger vessel inflammation.

The most common symptoms of Granulomatosis with Polyangiitis include Sinusitis and upper respiratory symptoms with nasal crusting and bleeding, Cough and hemoptysis (coughing up blood), Shortness of breath from pulmonary involvement, Hematuria (blood in urine) and proteinuria from kidney involvement, Joint pain and skin rashes, among others. An estimated 3 in 100,000 people in the United States, according to MedlinePlus Genetics. Symptoms can range from mild to severe and may vary between individuals.

Trial Friend lists all active clinical trials for Granulomatosis with Polyangiitis from ClinicalTrials.gov, with eligibility criteria translated into plain English. Patients can filter by trial phase and recruitment status, search by location, and use the Match Me tool to score trials against their profile. Rituximab has been FDA approved for GPA since 2011, given with steroids, and the Rituxan label now covers adults and children 2 years and older, which makes it a standard treatment rather than an experimental one. Tavneos (avacopan), a pill that blocks the C5a receptor, was approved in October 2021 as an add-on for adults with severe active GPA or microscopic polyangiitis.

Yes. Rituximab (Rituxan, and biosimilar versions such as Truxima) is FDA approved with steroids for GPA and microscopic polyangiitis; the Rituxan label covers adults and children 2 years and older. Tavneos (avacopan) is approved as an add-on for adults with severe active GPA or MPA, but on April 27, 2026 the FDA's drug center proposed withdrawing that approval, saying the main study's results were manipulated and citing liver injury cases with fatal outcomes. Tavneos stays on the market until the FDA Commissioner decides or the company removes it, and no final decision had been published by November 3, 2026.

The exact cause of Granulomatosis with Polyangiitis is not fully understood. It is not caused by a single gene; inherited variants raise risk, and immune, environmental or other triggers are thought to set it off. ANCA-associated autoimmune vasculitis; HLA-DPB1*04:01 is the strongest risk allele but there is no diagnostic gene test. An estimated 3 in 100,000 people in the United States, according to MedlinePlus Genetics. Research is ongoing to better understand the disease mechanism.

No single gene test diagnoses Granulomatosis with Polyangiitis. The diagnosis rests on clinical findings and laboratory or imaging results; genetic variants shift risk rather than cause the disease. ANCA-associated autoimmune vasculitis; HLA-DPB1*04:01 is the strongest risk allele but there is no diagnostic gene test.

Some trials collect genetic samples for research or check specific risk markers. The Genetic Testing section of this page shows any tests listed in the NIH Genetic Testing Registry, which for this condition are usually research or risk-marker tests rather than diagnostic ones.

Eligibility for Granulomatosis with Polyangiitis clinical trials depends on factors like age, diagnosis, treatment history, and overall health. Each trial sets its own inclusion and exclusion criteria. Trial Friend translates these requirements from medical language into plain English so patients can review them more easily. The Match Me tool can score your profile against active trials to help identify studies that may be a fit.

Participating in a Granulomatosis with Polyangiitis clinical trial typically involves scheduled visits, medical tests, and close monitoring by a research team. Depending on the study phase, you may receive an investigational treatment, a placebo, or the current standard of care. Trials may last from a few weeks to several years. Study participation is voluntary, and you can withdraw at any time.