placebo + standard of care (Novartis)

The 'placebo + standard of care' refers to the control intervention arm used in clinical trials conducted by Novartis for the treatment of active lupus nephritis, such as the Phase 2 trial for iptacopan (NCT05268289). In this regimen, patients receive a placebo alongside a standardized background therapy known as the 'standard of care' (SoC). The SoC typically consists of immunosuppressive agents like mycophenolate mofetil (MMF) or mycophenolate sodium (MPS) and a tapering course of corticosteroids (e.g., prednisone). Additionally, patients receive supportive care including anti-malarials (such as hydroxychloroquine) and blood pressure management with angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs). This combination is designed to manage the underlying autoimmune inflammation and provide renal protection while serving as a comparator for investigational therapies.

Other names

placebo plus standard of carePBO + SoC