NCT03391765

An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to assess the long-term safety and efficacy of ABBV-8E12 (tilavonemab) in participants with progressive supranuclear palsy (PSP).

Detailed description

This study (M15-563) was a Phase 2, randomized, double-blind, multiple-dose, multicenter, long-term extension of NCT 02985879 (Study M15-562) in participants with progressive supranuclear palsy (PSP). Those who completed the 52-week Treatment Period in Study M15-562 and met all entry criteria were eligible for enrollment into this study. This study planned for a Treatment Period of up to 5 years and a post-treatment follow-up visit approximately 20 weeks after the last dose of study drug (including participants who prematurely discontinued treatment). All participants received ABBV-8E12 as follows: those who received placebo in Study M15-562 were randomized, in a 1:1 ratio, to either 2000 or 4000 mg; those who received ABBV-8E12 at a dose of either 2000 or 4000 mg in Study M15-562 continued on the same dose in this study. This study was prematurely discontinued because the program for progressive supranuclear palsy was discontinued due to lack of efficacy.

Conditions

• Progressive Supranuclear Palsy (PSP)

Interventions

Type	Name	Description
DRUG	ABBV-8E12	Participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW \>59 kg, 4.7 mL/min or 282 mL/hr.
DRUG	Placebo solution for IV infusion on Day 15	0.9% NaCl injection/solution for infusion 500 mL; participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW \>59 kg, 4.7 mL/min or 282 mL/hr.

Timeline

• Start date: 2018-01-24
• Primary completion: 2019-12-13
• Completion: 2019-12-13
• First posted: 2018-01-05
• Last updated: 2021-02-03
• Results posted: 2021-02-03

Locations

42 sites across 5 countries: United States, Australia, Canada, Italy, Japan

Regulatory

• FDA-regulated drug study