Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease

Phase 2 Terminated 654 enrolled Biogen

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of the placebo-controlled period is to evaluate the safety and tolerability of BIIB092 in participants with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or with mild AD. The secondary objectives of the placebo-controlled period are to evaluate the efficacy of multiple doses of BIIB092 in slowing cognitive and functional impairment in participants with MCI due to AD or with mild AD, and to evaluate the immunogenicity of BIIB092 after multiple doses in participants with MCI due to AD or with mild AD. The primary objective of the long-term extension period is to evaluate the long-term safety and tolerability of BIIB092 in participants with MCI due to AD or with mild AD.

Timeline

Start: 2018-05-03
Primary completion: 2021-08-30
Completion: 2021-08-30

Outcome

Missed primary endpoint

Stopped: “The study (NCT03352557) was terminated based on lack of efficacy following the placebo-controlled period readout.”

release “Gosuranemab did not meet its primary efficacy endpoint of change from baseline at week 78 on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)” biogen.com ↗

release “Based on these results, the TANGO study has been terminated. Biogen will discontinue clinical development of gosuranemab.” biogen.com ↗

Publications

Shulman M, Kong J, O'Gorman J, Ratti E, Rajagovindan R, Viollet L, Huang E, Sharma S, Racine AM, Czerkowicz J, Graham D, Li Y, Hering H, Haeberlein SB. TANGO: a placebo-controlled randomized phase 2 study of efficacy and safety of the anti-tau monoclonal antibody gosuranemab in early Alzheimer's disease. Nat Aging. 2023 Dec;3(12):1591-1601. doi: 10.1038/s43587-023-00523-w. Epub 2023 Nov 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	gosuranemab	Monoclonal antibody	125 mg	Intravenous
Subject	gosuranemab	Monoclonal antibody	375 mg	Intravenous
Subject	gosuranemab	Monoclonal antibody	600 mg	Intravenous
Subject	gosuranemab	Monoclonal antibody	2000 mg	Intravenous