Pharmaceutical company Boehringer Ingelheim has begun patient enrolment in the Phase II clinical trial of BI 655064 for the treatment of lupus nephritis (LN).
Part of a collaboration between AbbVie and Boehringer Ingelheim, BI 655064 is a humanised mouse, anti-human monoclonal antibody being developed as an antagonist to CD40 present on B-cells in whole blood.
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The double-blind, randomised, placebo-controlled, multi-centre Phase II trial will enrol a total of 120 patients in North America, Western and Eastern Europe, Asia and Australia.
Trial’s coordinating principal investigator Dr David Jayne said: “This trial is of great importance for patients with lupus nephritis, since it investigates a new and promising mechanism that has the potential to both improve kidney function and control of their lupus symptoms.”
The trial is designed to assess the efficacy and safety of three different sub-cutaneous doses of the drug over a period of 52 weeks in patients with active LN class III and IV.
Boehringer Ingelheim immunology / CNS therapeutic area head Dr Jan Poth said: “Boehringer Ingelheim is dedicated to transforming lives of patients with immunological diseases.
“Our innovative trial is designed to include patients with active LN class III and IV and we are glad to be able to investigate a new potential treatment option for patients in urgent need.”
The trial’s primary endpoint is complete renal response at week 52, while other evaluations include overall systemic lupus erythematosus (SLE) symptoms, patient reported outcomes and fatigue.
Subjects participating in the trial will receive treatment with BI 655064 and standard-of-care therapy combination for one year, following which responders to therapy will be provided treatment for an additional two years.
