Roche, Genentech Now Recruiting Lupus Nephritis Patients for Clinical Trial Testing Gazyva
A Phase 2 study assessing Gazyva (obinutuzumab) plus mycophenolate mofetil (MMF) or mycophenolic acid (MPA) as a treatment for lupus nephritis patients is currently enrolling participants.
The Phase 2 NOBILITY trial (NCT02550652) will be conducted by Roche and Genentech to determine if the combination is better at treating kidney inflammation in lupus patients than MMF alone.
Lupus nephritis affects up to 60 percent of adult and 80 percent of pediatric lupus patients. The condition is characterized by excess inflammation in the kidneys caused by lupus. If not controlled, lupus nephritis can lead to kidney failure.
Genentech researchers recently showed that severe kidney inflammation is associated with increased hospitalizations and higher mortality rates among lupus patients.
They presented their study, “Lupus nephritis is associated with increased rates of hospitalization and in-hospital mortality compared with non-renal lupus and matched controls: an analysis of insurance claims data,” during the 2017 Annual European Congress of Rheumatology in Madrid.
It also revealed that adults and children with lupus nephritis had a higher burden of comorbidities than those without the disease. While lupus patients without kidney manifestations had a higher mortality rate than matched controls, the highest rates were found among lupus nephritis patients. Treating lupus nephritis should thus be a priority among lupus researchers and clinicians.
Gazyva is an antibody that recognizes the CD20 protein, found mainly in immune B-cells. While the drug is approved to treat B-cell leukemias and lymphomas, its mechanism of action suggests that it could be used to prevent excess inflammation in auto-immune diseases.
Indeed, a recent lupus study showed that Gazyva is twice as effective as Rituxan (rituximab), which is commonly used to treat lupus.
NOBILITY was designed to evaluate the safety and efficacy of intravenous Gazyva in combination with MMF or MPA, two immunosuppressive drugs. The study, which is now enrolling participants, is underway at 68 clinical sites worldwide. It aims to include 120 adult lupus patients with confirmed proliferative class III or IV lupus nephritis.
The study’s main goal is to determine if Gazyva increases the proportion of participants achieving complete renal responses at week 52. Secondary measures include overall response rate, partial renal response rate, and several immunological parameters, such as number of immune B and T-cells, production of antibodies targeting obinutuzumab and anti-dsDNA levels. Researchers will also analyze overall stability and distribution of Gazyva in the body.