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

Progressive Supranuclear Palsy (PSP) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03391765
• Other study ID #: M15-563
• Secondary ID: 2017-001590-16
• Status: Terminated
• Phase: Phase 2
• Start date: January 24, 2018
• Est. completion date: December 13, 2019

Study information

• Verified date: February 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 142
• Est. completion date: December 13, 2019
• Est. primary completion date: December 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Progressive Supranuclear Palsy (PSP)
• Supranuclear Palsy, Progressive

Intervention

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.
• 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.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital /ID# 165451	Adelaide	South Australia
Australia	Q-Pharm Pty Limited /ID# 165452	Herston	Queensland
Australia	Alfred Hospital /ID# 165454	Melbourne	Victoria
Canada	University of Calgary /ID# 165667	Calgary	Alberta
Canada	Montreal Neurological Institut /ID# 165546	Montreal	Quebec
Canada	CHUM - Notre-Dame Hospital /ID# 165461	Montréal	Quebec
Canada	Toronto Western Hospital /ID# 165462	Toronto	Ontario
Italy	University of Catanzaro /ID# 170214	Catanzaro
Italy	Istituto Neuro Mediterraneo IR /ID# 165533	Pozzilli
Italy	Policlinico Agostino Gemelli /ID# 165536	Rome	Lazio
Italy	A.O. Santa Maria /ID# 165535	Terni
Italy	IRCCS San Camillo /ID# 201229	Venice
Japan	National Hospital Organization Asahikawa Medical Center /ID# 208818	Asahikawa	Hokkaido
Japan	National Center of Neurology and Psychiatry /ID# 208820	Kodaira	Tokyo
Japan	National Hospital Organization Utano National Hospital /ID# 208780	Kyoto City	Kyoto
Japan	National Hospital Organization Higashinagoya National Hospital /ID# 208786	Nagoya-shi	Aichi
Japan	NHO Sendai Nishitaga National Hospital /ID# 209014	Sendai	Miyagi
Japan	Osaka University Hospital /ID# 208787	Suita-shi	Osaka
United States	Augusta University Medical Center /ID# 165562	Augusta	Georgia
United States	Cedars-Sinai Medical Center /ID# 165567	Beverly Hills	California
United States	Univ Alabama-Birmingham /ID# 165522	Birmingham	Alabama
United States	Rush University Medical Center /ID# 165527	Chicago	Illinois
United States	University of Chicago Medical /ID# 165555	Chicago	Illinois
United States	Cleveland Clinic Main Campus /ID# 165537	Cleveland	Ohio
United States	Kerwin Research Center /ID# 206872	Dallas	Texas
United States	Rocky Mountain Movement Disorders Center /ID# 165559	Englewood	Colorado
United States	UF Center for Movement Disorde /ID# 165561	Gainesville	Florida
United States	McGovern Medical School /ID# 165565	Houston	Texas
United States	Indiana University /ID# 165519	Indianapolis	Indiana
United States	Mayo Clinic /ID# 165554	Jacksonville	Florida
United States	Cleveland Clinic Lou Ruvo Cent /ID# 165538	Las Vegas	Nevada
United States	University of Kentucky Chandler Medical Center /ID# 165566	Lexington	Kentucky
United States	University of California, Los Angeles /ID# 165669	Los Angeles	California
United States	Usc /Id# 165529	Los Angeles	California
United States	Vanderbilt Univ Med Ctr /ID# 165520	Nashville	Tennessee
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	Mayo Clinic Arizona /ID# 165521	Phoenix	Arizona
United States	Mayo Clinic - Rochester /ID# 165518	Rochester	Minnesota
United States	University of California, San /ID# 165560	San Diego	California
United States	Univ California, San Francisco /ID# 165553	San Francisco	California
United States	University of South Florida /ID# 165556	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Italy,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline, Week 52
Secondary	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.	Baseline, Week 52
Secondary	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.	Baseline, Week 52
Secondary	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.	Baseline, Week 52
Secondary	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.	Baseline, Week 52
Secondary	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.	Baseline, Week 52
Secondary	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).	From Baseline to Week 52