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Progressive Supranuclear Palsy (PSP)Phase 2NCT03391765

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

A Phase 2 study testing ABBV-8E12 in people with Progressive Supranuclear Palsy (PSP), run by AbbVie at 42 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Progressive Supranuclear Palsy (PSP)
What is being tested?
ABBV-8E12
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
142 participants
Where
42 sitesin 5 countries
Study dates
24 Jan 2018to 13 Dec 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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 locations and contacts

42 sites in 5 countries.

42 sites in 5 countries

United States24 sites

  • Augusta University Medical Center /ID# 165562

    Augusta, Georgia, 30912-0004

  • Cedars-Sinai Medical Center /ID# 165567

    Beverly Hills, California, 90211

  • Univ Alabama-Birmingham /ID# 165522

    Birmingham, Alabama, 35294

  • Rush University Medical Center /ID# 165527

    Chicago, Illinois, 60612

  • University of Chicago Medical /ID# 165555

    Chicago, Illinois, 60637

  • Cleveland Clinic Main Campus /ID# 165537

    Cleveland, Ohio, 44195

  • Kerwin Research Center /ID# 206872

    Dallas, Texas, 75231-4316

  • Rocky Mountain Movement Disorders Center /ID# 165559

    Englewood, Colorado, 80113-2736

  • UF Center for Movement Disorde /ID# 165561

    Gainesville, Florida, 32607

  • McGovern Medical School /ID# 165565

    Houston, Texas, 77054

  • Indiana University /ID# 165519

    Indianapolis, Indiana, 46202

  • Mayo Clinic /ID# 165554

    Jacksonville, Florida, 32224

  • Cleveland Clinic Lou Ruvo Cent /ID# 165538

    Las Vegas, Nevada, 89106

  • University of Kentucky Chandler Medical Center /ID# 165566

    Lexington, Kentucky, 40536

  • Usc /Id# 165529

    Los Angeles, California, 90033

  • University of California, Los Angeles /ID# 165669

    Los Angeles, California, 90095

  • Vanderbilt Univ Med Ctr /ID# 165520

    Nashville, Tennessee, 37232-0011

  • Rutgers Robert Wood Johnson /ID# 165526

    New Brunswick, New Jersey, 08901

  • Columbia Univ Medical Center /ID# 165528

    New York, New York, 10032-3725

  • Mayo Clinic Arizona /ID# 165521

    Phoenix, Arizona, 85054

  • Mayo Clinic - Rochester /ID# 165518

    Rochester, Minnesota, 55905-0001

  • University of California, San /ID# 165560

    San Diego, California, 92037

  • Univ California, San Francisco /ID# 165553

    San Francisco, California, 94143-2204

  • University of South Florida /ID# 165556

    Tampa, Florida, 33612

Other trials in United States

Japan6 sites

  • National Hospital Organization Asahikawa Medical Center /ID# 208818

    Asahikawa, Hokkaido, 070-8644

  • National Center of Neurology and Psychiatry /ID# 208820

    Kodaira, Tokyo, 187-8551

  • National Hospital Organization Utano National Hospital /ID# 208780

    Kyoto, Kyoto, 616-8255

  • National Hospital Organization Higashinagoya National Hospital /ID# 208786

    Nagoya, Aichi-ken, 4658620

  • NHO Sendai Nishitaga National Hospital /ID# 209014

    Sendai, Miyagi, 982-8555

  • Osaka University Hospital /ID# 208787

    Suita-shi, Osaka, 565-0871

Other trials in Japan

Italy5 sites

  • University of Catanzaro /ID# 170214

    Catanzaro, 88100

  • Istituto Neuro Mediterraneo IR /ID# 165533

    Pozzilli, 86077

  • Policlinico Agostino Gemelli /ID# 165536

    Rome, Lazio, 00168

  • A.O. Santa Maria /ID# 165535

    Terni, 05100

  • IRCCS San Camillo /ID# 201229

    Venice, 30126

Other trials in Italy

Canada4 sites

  • University of Calgary /ID# 165667

    Calgary, Alberta, T2N 4Z6

  • CHUM - Notre-Dame Hospital /ID# 165461

    Montreal, Quebec, H2X 0A9

  • Montreal Neurological Institut /ID# 165546

    Montreal, Quebec, H3A 2B4

  • Toronto Western Hospital /ID# 165462

    Toronto, Ontario, M5T 2S8

Other trials in Canada

Australia3 sites

  • Royal Adelaide Hospital /ID# 165451

    Adelaide, South Australia, 5000

  • Q-Pharm Pty Limited /ID# 165452

    Herston, Queensland, 4006

  • Alfred Hospital /ID# 165454

    Melbourne, Victoria, 3004

Other trials in Australia

About this study

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).

Read the 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.

Being tested
ABBV-8E12, Placebo solution for IV infusion on Day 15
Keywords
Tauopathy, Steele-Richardson-Olszewski Syndrome, PSP
Medical subject headings
Supranuclear Palsy, Progressive, Tauopathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABBV-8E12Drug

    Also called Tilavonemab

    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 15Drug

    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.

Study groups in NCT03391765
Study groupRoleWhat they receive
M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mgExperimentalIntravenous (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).
Receives: Drug: ABBV-8E12; Drug: Placebo solution for IV infusion on Day 15
M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mgExperimentalIntravenous (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).
Receives: Drug: ABBV-8E12; Drug: Placebo solution for IV infusion on Day 15
M15-562 Placebo/M15-563 ABBV-8E12 2000 mgExperimentalIntravenous (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.
Receives: Drug: ABBV-8E12
M15-562 Placebo/M15-563 ABBV-8E12 4000 mgExperimentalIntravenous (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.
Receives: Drug: ABBV-8E12

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 52

Secondary outcomes (7)

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

    The Unified Parkinson's Disease Rating Scale (UPDRS) is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions related to Activities of Daily Living, and ranges from 0-52. Higher scores are associated with more disability. Positive values indicate worsening from baseline.

    Measured: Baseline, Week 52

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

    The Clinical Global Impression of Change (CGI-C) score is a clinician's rating scale for assessing Global Improvement of Change. The CGI-C rates improvement by 7 categories: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), very much worse (7). The CGI-C score ranges from 1 to 7, with lower scores indicating improvement.

    Measured: Baseline, Week 52

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

    The Schwab and England Activities of Daily Living (SEADL) scale consists of ten items intended to evaluate the daily life activities of a participant. The SEADL is composed of two sections: the first is a self-reported questionnaire in which participants grade their own daily life activities, such as dressing, using the toilet, resting, eating, and social activities (subjective assessment), and the second is an assessment of motor functions, such as postural balance, speaking, rigidity, and tremors, conducted by a clinician (objective assessment). It is a percentage scale divided into deciles, and the results are reported between 0% (bedridden) and 100% (healthy). Negative values indicate worsening from baseline.

    Measured: Baseline, Week 52

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

    The CGI-S is a clinician's rating of disease severity. The CGI-S rates severity of illness on a 7-point scale, using a range of responses from 1 (normal) through 7 (the most severely ill). This rating is based upon observed and reported symptoms, behavior, and function in the past 7 days. Positive values indicate worsening from baseline.

    Measured: Baseline, Week 52

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

    The PGI-C is a participant's rating of the change in their PSP-related symptoms since initiation of study drug. Participants rated their change in status using the following 7-point scale: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse.

    Measured: Baseline, Week 52

  6. Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Staging System Score (PSP-SS) Score

    The Progressive Supranuclear Palsy Rating Scale (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 four 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. The PSP-SS score is a composite of the dysphagia and gait items from the PSPRS. Positive values indicate worsening from baseline.

    Measured: Baseline, Week 52

  7. Time to Loss of Ability to Walk Independently as Measured by Progressive Supranuclear Palsy Rating Scale (PSPRS) Item 26

    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 four 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. Item 26 pertains to gait, scored as either 0 (normal); 1 (slightly wide-based or irregular or slight pulsion on turns); 2 (must walk slowly or occasionally use walls or helper to avoid falling, especially on turns); 3 (must use assistance all or almost all the time); or 4 (unable to walk, even with walker; may be able to transfer).

    Measured: From Baseline to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2018
  2. Study start24 Jan 2018
  3. Primary completion13 Dec 2019
  4. Study completion13 Dec 2019

Why it stopped: This study was prematurely discontinued because the program for progressive supranuclear palsy was discontinued due to lack of efficacy.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03391765
Sponsor's protocol ID
M15-563
Other IDs
2017-001590-16, 2017
Status last verified
Feb 2021
First submitted
2 Jan 2018
Last updated
3 Feb 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABBV-8E12 in people with Progressive Supranuclear Palsy (PSP), run by AbbVie at 42 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Japan, Italy, Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score From Baseline to Week 52 (time frame: Baseline, Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03391765.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.

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