Lupus & antiphospholipid syndrome
Efficacy, pharmacokinetics and safety of iscalimab (CFZ533) in patients with proliferative lupus nephritis: a randomised, double-blind, placebo-controlled, phase II study
Primary result · Relative improvement from baseline in proteinuria (UPCR)Result — go to the resultReduction in UPCR to baseline 42.1%Authors' conclusion
Iscalimab showed a significant improvement in proteinuria (UPCR) in patients with active LN.
Study context
- Population
- Patients with SLE and biopsy-proven active proliferative lupus nephritis (LN)31 (54.4%) completed
- Participants
- 57 patients
- Comparison
- IV iscalimab 10 mg/kg vs placebo for 24 weeks on top of standard-of-care (SoC) for LN
- Iscalimabn = 39
- Placebon = 18reference
- Primary endpoint
- Ratio from baseline in urinary protein-to-creatinine ratio (UPCR)
- Follow-up
- Week 24
Methodological detailsphase II, double-blind, placebo-controlled, multicentre, 2:1 randomisation, add-on to SoC
- Phase II
- Double-blind
- Placebo-controlled
- Multicentre
- 2:1 randomisation
- Add-on to SoC
Primary result
As reported in the abstract
Relative improvement from baseline in proteinuria (UPCR)
Reduction in urinary protein-to-creatinine ratio (UPCR) to baseline
42.1%
By group
Safety
SAEs · up to 49 weeks
SAEs Iscalimab 7 · Placebo 4
- Serious AEs (SAEs): patients with ≥1 SAE
Adverse events (AEs)
- Most AEs mild to moderate in both arms
Original publication
Efficacy, pharmacokinetics and safety of iscalimab (CFZ533) in patients with proliferative lupus nephritis: a randomised, double-blind, placebo-controlled, phase II study. RMD Open. Published 14 August 2025. doi:10.
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