Phase 3, multicentre, randomised, placebo-controlled study evaluating the efficacy and safety of ustekinumab in patients with systemic lupus erythematosus
van Vollenhoven RF, et al. Ann Rheum Dis. 2022. Epub ahead of print. doi:10.1136/ard-2022-222858.
Phase 3 study evaluating the efficacy and safety of ustekinumab in patients with active SLE, despite receiving standard-of-care, does not achieve primary and key secondary endpoints.
Following successful phase 2 study of ustekinumab efficacy in patients with active SLE, van Vollenhoven, et al., sort to investigate ustekinumab efficacy in subsequent phase 3. However, following a prespecified interim efficacy analysis, the study was discontinued early due to lack of efficacy.