A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP)

Summary

The purpose of this study was to assess efficacy, safety, tolerability, and pharmacokinetics of ABBV-8E12 in participants with progressive supranuclear palsy (PSP).

Timeline

Start

2016-12-12

Primary completion

2019-11-20

Completion

2019-11-20

Outcome

Missed primary endpoint

Stopped: “This study was prematurely discontinued because the program for progressive supranuclear palsy was discontinued due to lack of efficacy of study drug.”

registry analysis (superiority test); Placebo vs ABBV-8E12 2000mg; p =0.998; LS Mean Difference 0.0 (95% CI -2.63 to 2.63) NCT02985879 ↗

registry analysis (superiority test); Placebo vs ABBV-8E12 4000mg; p =0.464; LS Mean Difference 1.0 (95% CI -1.63 to 3.58) NCT02985879 ↗

paper No beneficial treatment effects were recorded. PMID 33609476 ↗

Publications

• Hoglinger GU, Litvan I, Mendonca N, Wang D, Zheng H, Rendenbach-Mueller B, Lon HK, Jin Z, Fisseha N, Budur K, Gold M, Ryman D, Florian H; Arise Investigators. Safety and efficacy of tilavonemab in progressive supranuclear palsy: a phase 2, randomised, placebo-controlled trial. Lancet Neurol. 2021 Mar;20(3):182-192. doi: 10.1016/S1474-4422(20)30489-0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tilavonemab	Monoclonal antibody	2000 mg	Intravenous
Subject	Tilavonemab	Monoclonal antibody	4000 mg	Intravenous

Indications