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

AbbVie

Status and phase: Terminated; Phase 2

Conditions: Progressive Supranuclear Palsy (PSP)

Treatments: Drug: Placebo solution for IV infusion on Day 15; Drug: ABBV-8E12

Study type: Interventional

Funder types: Industry

Identifiers

NCT03391765

M15-563

2017-001590-16 (EudraCT Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 142 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant completed the 52-week treatment period in Study M15-562 (NCT02985879)
• In the opinion of the investigator, the participant was compliant during participation in Study M15-562 (NCT02985879)
• Participant has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend)

Exclusion criteria

• Participants who weigh less than 44 kg (97 lbs) at the time of study entry
• Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI)
• Participant has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results
• More than 8 weeks have elapsed since the participant received his/her last dose of study drug in Study M15-562 (NCT02985879)
• Participant is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the participant is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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142 participants in 4 patient groups

M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mg

Experimental group

Description:

Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).

Treatment:

Drug: Placebo solution for IV infusion on Day 15

Drug: ABBV-8E12

M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg

Experimental group

Description:

Intravenous (IV) infusions of 4000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).

Treatment:

Drug: Placebo solution for IV infusion on Day 15

Drug: ABBV-8E12

M15-562 Placebo/M15-563 ABBV-8E12 2000 mg

Experimental group

Description:

Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1, Day 15, and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength.

Treatment:

Drug: ABBV-8E12

M15-562 Placebo/M15-563 ABBV-8E12 4000 mg

Experimental group

Description:

Intravenous (IV) infusions of 4000 mg ABBV-8E12 at Day 1, Day 15, and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength.

Treatment:

Drug: ABBV-8E12