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Biomarker, Clinical, P2 data, Journal, IO biomarker: 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. (Pubmed Central) - May 16, 2023 The trial failed to demonstrate a dose-response relationship for the primary CRR endpoint. Post-hoc analyses suggest a potential benefit of BI 655064 180mg in patients with active LN.
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Trial completion: An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis (clinicaltrials.gov) - Jul 30, 2021 P2, N=69, Completed, BI 655064 has favorable target-mediated drug disposition (TMDD)-saturation pharmacokinetics, consistent with that of a high-quality therapeutic monoclonal antibody. Active, not recruiting --> Completed
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Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis (clinicaltrials.gov) - Nov 4, 2020 P2, N=69, Active, not recruiting, Active, not recruiting --> Recruiting Recruiting --> Active, not recruiting | N=170 --> 69 | Trial completion date: Dec 2022 --> Aug 2021 | Trial primary completion date: Oct 2022 --> May 2021
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Biomarker, Clinical, P2a data, Journal, IO Biomarker: Effects of BI 655064, an antagonistic anti-CD40 antibody, on clinical and biomarker parameters in patients with active rheumatoid arthritis: a randomised, double-blind, placebo-controlled, phase IIa study. (Pubmed Central) - Jan 30, 2020 P1 Trial primary completion date: Dec 2019 --> Jun 2020 Although blockade of the CD40-CD40L pathway with BI 655064 in MTX-IR patients with RA resulted in marked changes in clinical and biological parameters, including reductions in activated B-cells, autoantibody production and inflammatory and bone resorption markers, with a favourable safety profile, clinical efficacy was not demonstrated in this small phase IIa study.
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Trial completion date, Trial primary completion date: An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis (clinicaltrials.gov) - Oct 1, 2019 P2, N=150, Recruiting, These findings support further investigation of BI 655064 as a potential treatment for autoimmune diseases. Trial completion date: Jun 2022 --> Dec 2022 | Trial primary completion date: Mar 2022 --> Oct 2022
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Enrollment open, Enrollment change, Trial primary completion date: An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis (clinicaltrials.gov) - Jan 26, 2018 P2, N=150, Recruiting, Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting | N=60 --> 150 | Trial primary completion date: Aug 2020 --> Mar 2022
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Enrollment closed: Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effects of Multiple Rising Subcutaneous Doses of BI 655064 in Healthy Volunteers and in Rheumatoid Arthritis Patients With Prior Inadequate Response to Methotrexate Therapy (clinicaltrials.gov) - Jan 8, 2015 P1, N=106, Active, not recruiting, Active, not recruiting --> Completed Recruiting --> Active, not recruiting
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