Phase II, Randomized, Dose-Finding Studies of the NMDA Subunit 2B-Selective Negative Allosteric Modulator, BI 1569912, in People Living With Major Depressive Disorder
Objective: We describe 2 Phase II, multicenter, randomized, double-blind, placebo-controlled trials to provide proof of concept and dose selection for BI 1569912 for the treatment of major depressive disorder (MDD).
Methods: In the current ongoing dose-finding adjunctive trial (1447-0005, NCT06280235), 204 adults (18–65 years old) with an established MDD diagnosis and insufficient treatment response ( < 50% response to ≤4 antidepressants) in their current episode are randomized to 6 weeks’ treatment with BI 1569912 (5 mg, 10 mg, or 20 mg) or placebo once daily in addition to their existing antidepressant. Assessments include the Montgomery-Åsberg Depression Rating Scale (MADRS), Symptoms of Major Depressive Disorder Scale, safety and tolerability. Primary endpoint is change from baseline in MADRS total score at Day 8.
The planned dose-finding monotherapy trial (1447-0012) will randomize 222 adults (18–65 years old) with an established MDD diagnosis to 6 weeks’ treatment with 1 of the 3 doses of BI 1569912 or placebo once daily. Assessments will include the MADRS, safety, and tolerability. Primary endpoint will be change from baseline in MADRS total score at Week 6.
Results: The BI 1569912 adjunctive therapy trial started recruitment in March 2024 and is expected to complete in October 2025. The BI 1569912 monotherapy trial is expected to start in October 2024. The poster will present a status update on screening and recruitment of the adjunctive trial and further methodology for the monotherapy trial.
Conclusion: These trials will explore efficacy and safety of BI 1569912 in people with MDD.
Funding: Boehringer Ingelheim
