Clinical Trials

Date: 2016-05-11

Type of information: Initiation of the trial

phase: 2

Announcement: initiation of the trial

Company: Boehringer Ingelheim (Germany)

Product: BI 655064

Action mechanism: monoclonal antibody. BI 655064 is an antagonistic anti-CD40 antibody. About BI 655064* BI 655064* is a humanized mouse anti-human monoclonal antibody which is purely antagonistic against CD40. BI 655064 binds human CD40 on B cells present in whole blood [5]. BI 655064 has been well tolerated in toxicology studies up to 26 weeks at doses higher than those deemed clinically relevant. In addition, BI 655064 has been evaluated in healthy volunteers [6], patients with rheumatoid arthritis [7] and patients with immune thrombocytopenia, supporting further clinical development. BI 655064 has been discovered and developed at Boehringer Ingelheim’s Immunology research laboratories and is part of a global collaboration of AbbVie and Boehringer Ingelheim, announced in March 2016. AbbVie gained rights to BI 655064, currently in Phase 2 development. Boehringer Ingelheim will retain responsibility for further development of BI 655064, and AbbVie may elect to advance the program after completion of certain undisclosed clinical achievements.

Disease: lupus nephritis

Therapeutic area: Autoimmune diseases – Inflammatory diseases

Country: Australia, Austria, Canada, Czech Republic, France, Germany, Greece, Hong Kong, Italy, Japan, Republic of Korea, Poland, Portugal, Spain, Thailand, Turkey, UK, USA

Trial details: 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 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. (NCT02770170 )

Latest news:

• • On May 10, 2017, Boehringer Ingelheim announced that a Phase II trial will test BI 655064 in lupus nephritis. The treatment approach investigated in this trial evaluates the efficacy and safety of the antibody BI 655064 that specifically blocks the CD40 receptor. The CD40 receptor is increased in patients with class III and class IV lupus nephritis. CD40 receptors are located on various immune and other cells, which are responsible for unwanted immune responses that play a role in causing systemic lupus erythematosus and lupus nephritis. Therefore, targeting the CD40 receptor may be a potential treatment option.
• In the trial, eligible patients with lupus nephritis will be offered 1 year treatment with BI 655064 in combination with standard of care therapy and responders to therapy at 1 year will be offered to have additional 2 years of treatment. The trial is a worldwide trial recruiting patients in North America, Western- and Eastern Europe, Asia and Australia.  About the trial This double-blind, randomised, placebo-controlled trial will evaluate the efficacy and safety of three different doses of BI 655064 in comparison to placebo as sub-cutaneous injections over 52 weeks for patients with active LN class III and IV. All patients will receive background therapy according to treatment guidelines. The primary endpoint is complete renal response at week 52. Other clinical evaluations include assessment of overall SLE symptoms, patient reported outcomes and fatigue.
• • On May 11, 2016, a Phase 2 trial sponsored by Boehringer Ingelheim was published on the NIH website ClinicalTrials.gov for BI 655064.

Is general: Yes