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

NCT ID: NCT03391765

Last Updated: 2021-02-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-24
• Study Completion Date: 2019-12-13

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

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).

Group Type: EXPERIMENTAL

ABBV-8E12

Intervention Type: DRUG

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.

Placebo solution for IV infusion on Day 15

Intervention Type: DRUG

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.

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

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).

Group Type: EXPERIMENTAL

ABBV-8E12

Intervention Type: DRUG

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.

Placebo solution for IV infusion on Day 15

Intervention Type: DRUG

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.

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

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.

Group Type: EXPERIMENTAL

ABBV-8E12

Intervention Type: DRUG

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.

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

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.

Group Type: EXPERIMENTAL

ABBV-8E12

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Tilavonemab

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

Univ Alabama-Birmingham /ID# 165522

Birmingham, Alabama, United States

Mayo Clinic Arizona /ID# 165521

Phoenix, Arizona, United States

Cedars-Sinai Medical Center /ID# 165567

Beverly Hills, California, United States

Usc /Id# 165529

Los Angeles, California, United States

University of California, Los Angeles /ID# 165669

Los Angeles, California, United States

University of California, San /ID# 165560

San Diego, California, United States

Univ California, San Francisco /ID# 165553

San Francisco, California, United States

Rocky Mountain Movement Disorders Center /ID# 165559

Englewood, Colorado, United States

UF Center for Movement Disorde /ID# 165561

Gainesville, Florida, United States

Mayo Clinic /ID# 165554

Jacksonville, Florida, United States

University of South Florida /ID# 165556

Tampa, Florida, United States

Augusta University Medical Center /ID# 165562

Augusta, Georgia, United States

Rush University Medical Center /ID# 165527

Chicago, Illinois, United States

University of Chicago Medical /ID# 165555

Chicago, Illinois, United States

Indiana University /ID# 165519

Indianapolis, Indiana, United States

University of Kentucky Chandler Medical Center /ID# 165566

Lexington, Kentucky, United States

Mayo Clinic - Rochester /ID# 165518

Rochester, Minnesota, United States

Cleveland Clinic Lou Ruvo Cent /ID# 165538

Las Vegas, Nevada, United States

Rutgers Robert Wood Johnson /ID# 165526

New Brunswick, New Jersey, United States

Columbia Univ Medical Center /ID# 165528

New York, New York, United States

Cleveland Clinic Main Campus /ID# 165537

Cleveland, Ohio, United States

Vanderbilt Univ Med Ctr /ID# 165520

Nashville, Tennessee, United States

Kerwin Research Center /ID# 206872

Dallas, Texas, United States

McGovern Medical School /ID# 165565

Houston, Texas, United States

Q-Pharm Pty Limited /ID# 165452

Herston, Queensland, Australia

Royal Adelaide Hospital /ID# 165451

Adelaide, South Australia, Australia

Alfred Hospital /ID# 165454

Melbourne, Victoria, Australia

University of Calgary /ID# 165667

Calgary, Alberta, Canada

Toronto Western Hospital /ID# 165462

Toronto, Ontario, Canada

CHUM - Notre-Dame Hospital /ID# 165461

Montreal, Quebec, Canada

Montreal Neurological Institut /ID# 165546

Montreal, Quebec, Canada

Policlinico Agostino Gemelli /ID# 165536

Rome, Lazio, Italy

University of Catanzaro /ID# 170214

Catanzaro, , Italy

Istituto Neuro Mediterraneo IR /ID# 165533

Pozzilli, , Italy

A.O. Santa Maria /ID# 165535

Terni, , Italy

IRCCS San Camillo /ID# 201229

Venice, , Italy

National Hospital Organization Higashinagoya National Hospital /ID# 208786

Nagoya, Aichi-ken, Japan

National Hospital Organization Asahikawa Medical Center /ID# 208818

Asahikawa, Hokkaido, Japan

National Hospital Organization Utano National Hospital /ID# 208780

Kyoto, Kyoto, Japan

NHO Sendai Nishitaga National Hospital /ID# 209014

Sendai, Miyagi, Japan

Osaka University Hospital /ID# 208787

Suita-shi, Osaka, Japan

National Center of Neurology and Psychiatry /ID# 208820

Kodaira, Tokyo, Japan

Countries

United States; Australia; Canada; Italy; Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-001590-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M15-563

Identifier Type: -

Identifier Source: org_study_id