19May 2023
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

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

This study aimed to examine the dose-response relationship of BI 655064, an anti-CD40 monoclonal antibody, when used as an add-on treatment with mycophenolate and glucocorticoids in patients with active lupus nephritis (LN). A total of 121 patients were randomized to receive placebo or varying doses of BI 655064. The primary endpoint, complete renal response (CRR) at Week 52, did not show a clear dose-response relationship. However, a post-hoc analysis indicated a potential benefit of the 180mg dose of BI 655064 in patients with active LN. Adverse events were reported in both the BI 655064 and placebo groups, with a higher incidence of serious and severe infections in the 240mg dose group. Overall, the trial did not establish a consistent dose-response relationship for the primary endpoint.

  • #rheumatology

Like

Save

Share