Clinical and biomarker responses to BI 655064, an antagonistic anti-CD40 antibody, in patients with active lupus nephritis: a randomized, double-blind, placebo-controlled, phase II trial
Arthritis Rheumatol. 2023;75(11):1983–93 doi: 10.1002/art.42557.
This phase II study of BI 655064 in patients with active LN did not meet the primary endpoint of CRR at Week 52, however, post-hoc analyses suggest a potential benefit of BI 655064 180 mg in patients with active LN.
Jayne, et al. aimed to report the safety, efficacy and pharmacodynamic effects of BI 655064 in an exploratory, proof-of-concept dose-ranging trial in patients with active LN.
The observed improvement in SELENA-SLEDAI scores and patient-reported outcomes may also suggest that BI 655064 could be useful for the treatment of non-renal SLE.
