Vera Therapeutics, Inc is starting a new clinical trial of Atacicept in Subjects With Active Lupus Nephritis (COMPASS).
The objective of the study is to evaluate the effect of atacicept compared to placebo on changes to renal response in adult subjects with LN.
The study will assess atacicept vs. placebo on the impact of renal function. Safety and patient reported outcomes will be clinically assessed. The clinical study is comprised of a 104 week double-blind treatment period, followed by a 52 week open-label treatment period and a 26 week safety follow-up period.
The clinical trial started on November 2, 2022 and will continue throughout December 15, 2028.
The patients that can participate include adult male or female able to understand,sign and date a written informed consent form, with the diagnosis of SLE 4. Biopsy- Proven Active LN 5. that requires high-dose corticosteroids and immunosuppressive therapy for the treatment of active LN 6. Besides, subject must be willing to take oral MMF for the duration of the study.
Whereas excluded will be any patient with eGFR of ≤30 mL/min/1.73 m2; having sclerosis in 50% of glomeruli on renal biopsy; with evidence of rapidly progressive glomerulonephritis; those currently requiring renal dialysis or expected to require dialysis during the study; having serum igG <7 g/L 6; having active infection or at high infectious risk.
The locations of the Vera Sites are: Alabama, United States; California, United States; Connecticut, United States; Florida, United States; Georgia, United States; Illinois, United States; Las Vegas, Nevada, United States; New Jersey, United States; New York, United States; Ohio, United States; Tennessee, United States; Texas, United States; Puerto Rico; Spain.
For more details: https://ichgcp.net/clinical-trials-registry/NCT05609812.