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

NCT03391765 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: M15-5632017-001590-16
• Study Type: interventional
• Target: 142
• Locations: 5 countries
• Sites: 42

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).

Conditions

Progressive Supranuclear Palsy (PSP)

Keywords

Tauopathy; Steele-Richardson-Olszewski Syndrome; PSP

Outcome Measures

Primary Outcomes (1)

• Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score From Baseline to Week 52

  The PSPRS consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for six items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. Positive values indicate worsening from baseline.

  Baseline, Week 52

Secondary Outcomes (7)

• Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)

  Baseline, Week 52

• Change in Clinical Global Impression of Severity (CGI-C) Score From Baseline to Week 52

  Baseline, Week 52

• Mean Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale (SEADL)

  Baseline, Week 52

• Mean Change From Baseline to Week 52 in Clinical Global Impression of Severity (CGI-S) Score

  Baseline, Week 52

• Patient Global Impression of Change Score (PGI-C) Score From Baseline to Week 52

  Baseline, Week 52

Study Arms (4)

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

EXPERIMENTAL

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).

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

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

EXPERIMENTAL

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).

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

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

EXPERIMENTAL

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.

Drug: ABBV-8E12

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

EXPERIMENTAL

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.

Drug: ABBV-8E12

Interventions

ABBV-8E12 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.

Also known as: Tilavonemab

M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mg; M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg; M15-562 Placebo/M15-563 ABBV-8E12 2000 mg; M15-562 Placebo/M15-563 ABBV-8E12 4000 mg

Placebo solution for IV infusion on Day 15 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 2000 mg/M15-563 ABBV-8E12 2000 mg; M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (42)

Univ Alabama-Birmingham /ID# 165522

Birmingham, Alabama, 35294, United States

Location

Mayo Clinic Arizona /ID# 165521

Phoenix, Arizona, 85054, United States

Location

Cedars-Sinai Medical Center /ID# 165567

Beverly Hills, California, 90211, United States

Location

Usc /Id# 165529

Los Angeles, California, 90033, United States

Location

University of California, Los Angeles /ID# 165669

Los Angeles, California, 90095, United States

Location

University of California, San /ID# 165560

San Diego, California, 92037, United States

Location

Univ California, San Francisco /ID# 165553

San Francisco, California, 94143-2204, United States

Location

Rocky Mountain Movement Disorders Center /ID# 165559

Englewood, Colorado, 80113-2736, United States

Location

UF Center for Movement Disorde /ID# 165561

Gainesville, Florida, 32607, United States

Location

Mayo Clinic /ID# 165554

Jacksonville, Florida, 32224, United States

Location

University of South Florida /ID# 165556

Tampa, Florida, 33612, United States

Location

Augusta University Medical Center /ID# 165562

Augusta, Georgia, 30912-0004, United States

Location

Rush University Medical Center /ID# 165527

Chicago, Illinois, 60612, United States

Location

University of Chicago Medical /ID# 165555

Chicago, Illinois, 60637, United States

Location

Indiana University /ID# 165519

Indianapolis, Indiana, 46202, United States

Location

University of Kentucky Chandler Medical Center /ID# 165566

Lexington, Kentucky, 40536, United States

Location

Mayo Clinic - Rochester /ID# 165518

Rochester, Minnesota, 55905-0001, United States

Location

Cleveland Clinic Lou Ruvo Cent /ID# 165538

Las Vegas, Nevada, 89106, United States

Location

Rutgers Robert Wood Johnson /ID# 165526

New Brunswick, New Jersey, 08901, United States

Location

Columbia Univ Medical Center /ID# 165528

New York, New York, 10032-3725, United States

Location

Cleveland Clinic Main Campus /ID# 165537

Cleveland, Ohio, 44195, United States

Location

Vanderbilt Univ Med Ctr /ID# 165520

Nashville, Tennessee, 37232-0011, United States

Location

Kerwin Research Center /ID# 206872

Dallas, Texas, 75231-4316, United States

Location

McGovern Medical School /ID# 165565

Houston, Texas, 77054, United States

Location

Q-Pharm Pty Limited /ID# 165452

Herston, Queensland, 4006, Australia

Location

Royal Adelaide Hospital /ID# 165451

Adelaide, South Australia, 5000, Australia

Location

Alfred Hospital /ID# 165454

Melbourne, Victoria, 3004, Australia

Location

University of Calgary /ID# 165667

Calgary, Alberta, T2N 4Z6, Canada

Location

Toronto Western Hospital /ID# 165462

Toronto, Ontario, M5T 2S8, Canada

Location

CHUM - Notre-Dame Hospital /ID# 165461

Montreal, Quebec, H2X 0A9, Canada

Location

Montreal Neurological Institut /ID# 165546

Montreal, Quebec, H3A 2B4, Canada

Location

Policlinico Agostino Gemelli /ID# 165536

Rome, Lazio, 00168, Italy

Location

University of Catanzaro /ID# 170214

Catanzaro, 88100, Italy

Location

Istituto Neuro Mediterraneo IR /ID# 165533

Pozzilli, 86077, Italy

Location

A.O. Santa Maria /ID# 165535

Terni, 05100, Italy

Location

IRCCS San Camillo /ID# 201229

Venice, 30126, Italy

Location

National Hospital Organization Higashinagoya National Hospital /ID# 208786

Nagoya, Aichi-ken, 4658620, Japan

Location

National Hospital Organization Asahikawa Medical Center /ID# 208818

Asahikawa, Hokkaido, 070-8644, Japan

Location

National Hospital Organization Utano National Hospital /ID# 208780

Kyoto, Kyoto, 616-8255, Japan

Location

NHO Sendai Nishitaga National Hospital /ID# 209014

Sendai, Miyagi, 982-8555, Japan

Location

Osaka University Hospital /ID# 208787

Suita-shi, Osaka, 565-0871, Japan

Location

National Center of Neurology and Psychiatry /ID# 208820

Kodaira, Tokyo, 187-8551, Japan

Location

MeSH Terms

Conditions

Supranuclear Palsy, Progressive; Tauopathies

Interventions

tilavonemab

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Neurodegenerative Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 5, 2018
• Study Start: January 24, 2018
• Primary Completion: December 13, 2019
• Study Completion: December 13, 2019
• Last Updated: February 3, 2021
• Results First Posted: February 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

Locations

US (24); CA (4); IT (5); AU (3); JP (6)