Study of ONT01 Drug Safety and Effectiveness in Adults with Lupus Nephritis or Systemic Lupus Erythematosus

What this Trial Is About

Researchers are studying ONT01, a drug being evaluated for its safety and tolerability in people with Lupus Nephritis LN and Systemic Lupus Erythematosus SLE. The study aims to see how ONT01, when combined with common lupus treatments like mycophenolate mofetil, affects lupus symptoms. This early phase 1 study will enroll 61 participants to better understand ONT01s effects in these conditions. Participants will take ONT01 orally twice daily, about 12 hours apart, under fasting conditions with water. The tablets must be swallowed whole. The study focuses on patients with active non-renal SLE or active LN, including specific lupus nephritis classifications confirmed by kidney biopsy and urine protein measurements. The treatment period and dosing schedule are designed to assess safety and biological effects. During the study, participants will be monitored from enrollment until 18 weeks for adverse events and study completion or withdrawal. Researchers will also measure lupus and nephritis biomarkers up to day 28 to evaluate biological response. Participants will undergo clinical assessments and laboratory tests, including kidney function and protein levels in urine, to track the treatments impact. Safety and tolerability are key outcomes throughout the study duration.

Safety and Efficacy of ONT01 in Lupus