Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis

Summary

The overall purpose of the study is to assess the efficacy of three different doses of BI 655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus nephritis in order to characterize the dose-response relationship within the therapeutic range, and select the target dose for phase III development.

Timeline

Start

2016-05-16

Primary completion

2020-06-23

Completion

2020-08-18

Outcome

Missed primary endpoint

paper The trial failed to demonstrate a dose-response relationship for the primary CRR endpoint. PMID 37192040 ↗

paper A dose-response relationship with CRR at week 52 was not shown PMID 37192040 ↗

Publications

• Jayne DR, Steffgen J, Romero-Diaz J, Bajema I, Boumpas DT, Noppakun K, Amano H, Gomez HM, Satirapoj B, Avihingsanon Y, Chawanasuntorapoj R, Madero M, Naumnik B, Recto R, Fagan N, Revollo I, Wu J, Visvanathan S, Furie R. 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 Nov;75(11):1983-1993. doi: 10.1002/art.42557. Epub 2023 Aug 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BI 655064	Monoclonal antibody	120 mg	Subcutaneous
Subject	BI 655064	Monoclonal antibody	180 mg	Subcutaneous
Subject	BI 655064	Monoclonal antibody	240 mg	Subcutaneous

Indications