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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02985879




Registration number
NCT02985879
Ethics application status
Date submitted
1/12/2016
Date registered
7/12/2016

Titles & IDs
Public title
A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP)
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy
Secondary ID [1] 0 0
2016-001635-12
Secondary ID [2] 0 0
M15-562
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Progressive Supranuclear Palsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Neurodegenerative diseases
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - ABBV-8E12

Placebo comparator: Placebo - 0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks

Experimental: ABBV-8E12 2000 mg - Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)

Experimental: ABBV-8E12 4000 mg - Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)


Treatment: Drugs: Placebo
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.

Treatment: Drugs: 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. For participants in Cohort 2, ABBV-8E12 doses may have been decreased after the evaluation by the Data Monitoring Committee of available safety, tolerability and pharmacokinetic data.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to Week 52 in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score
Timepoint [1] 0 0
Baseline, Week 52
Primary outcome [2] 0 0
Number of Participants With Adverse Events
Timepoint [2] 0 0
From the first dose of study drug until 20 weeks following discontinuation of study drug administration have elapsed (approximately 5 half-lives), up to 80 weeks
Secondary outcome [1] 0 0
Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)
Timepoint [1] 0 0
Baseline, Week 52
Secondary outcome [2] 0 0
Clinical Global Impression of Change (CGI-C) Score at Week 52
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Mean Change From Baseline to Week 52 in Midbrain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)
Timepoint [3] 0 0
Baseline, Week 52
Secondary outcome [4] 0 0
Mean Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale (SEADL)
Timepoint [4] 0 0
Baseline, Week 52
Secondary outcome [5] 0 0
Maximum Observed Serum Concentration (Cmax) for ABBV-8E12
Timepoint [5] 0 0
First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113
Secondary outcome [6] 0 0
Time to Maximum Observed Serum Concentration (Tmax) for ABBV-8E12
Timepoint [6] 0 0
First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113
Secondary outcome [7] 0 0
Area Under the Concentration Time Curve (AUC) for ABBV-8E12
Timepoint [7] 0 0
First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113
Secondary outcome [8] 0 0
Serum Concentration of ABBV-8E12 Prior to Infusion of a Day of Dosing (Ctrough)
Timepoint [8] 0 0
First day of the Fifth Dosing Interval, Day 85
Secondary outcome [9] 0 0
Mean Change From Baseline to Week 52 in Clinical Global Impression of Severity (CGI-S) Score
Timepoint [9] 0 0
Baseline, Week 52
Secondary outcome [10] 0 0
Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Health Related Quality of Life Scale (PSP-QoL) Total Score
Timepoint [10] 0 0
Baseline, Week 52
Secondary outcome [11] 0 0
Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Staging System Score (PSP-SS) Score
Timepoint [11] 0 0
Baseline, Week 52
Secondary outcome [12] 0 0
Mean Change From Baseline to Week 52 in Third Ventricle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)
Timepoint [12] 0 0
Baseline, Week 52
Secondary outcome [13] 0 0
Mean Change From Baseline to Week 52 in Superior Cerebellar Peduncle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)
Timepoint [13] 0 0
Baseline, Week 52
Secondary outcome [14] 0 0
Mean Change From Baseline to Week 52 in Brainstem Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)
Timepoint [14] 0 0
Baseline, Week 52
Secondary outcome [15] 0 0
Mean Change From Baseline to Week 52 in Whole Brain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)
Timepoint [15] 0 0
Baseline, Week 52
Secondary outcome [16] 0 0
Mean Change From Baseline to Week 52 in Frontal Lobe Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)
Timepoint [16] 0 0
Baseline, Week 52
Secondary outcome [17] 0 0
Time to Loss of Ability to Walk Independently as Measured by Progressive Supranuclear Palsy Rating Scale (PSPRS) Item 26
Timepoint [17] 0 0
From Baseline to Week 52

Eligibility
Key inclusion criteria
Key

* Male or female participant with age 40 years or greater at the time of signed consent
* Meets the criteria for possible or probable progressive supranuclear palsy (PSP; Steele-Richardson-Olszewski Syndrome)
* Presence of PSP symptoms for less than 5 years
* Participant is able to walk 5 steps with minimal assistance (stabilization of one arm or use of cane/walker)
* Participant has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend)

Key
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants who weigh less than 44 kg (97 lbs) at screening
* Mini-Mental State Examination (MMSE) score less than 15 at screening
* Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI)
* Participant resides at a skilled nursing or dementia care facility, or admission to such a facility is planned during the study period
* Evidence of any clinically significant neurological disorder other than PSP
* The participant has a history of or currently has schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) or International Classification of Diseases (ICD-10) criteria
* Participant has had a significant illness or infection requiring medical intervention in the past 30 days

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/12/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/11/2019
Sample size
Target
Accrual to date
Final
378
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Westmead Hospital /ID# 154403 - Westmead
Recruitment hospital [2] 0 0
Q-Pharm Pty Limited /ID# 154410 - Herston
Recruitment hospital [3] 0 0
Royal Adelaide Hospital /ID# 153157 - Adelaide
Recruitment hospital [4] 0 0
Alfred Hospital /ID# 153158 - Melbourne
Recruitment hospital [5] 0 0
Neurodegenerative Disorders Re /ID# 153770 - West Perth
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4006 - Herston
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
6005 - West Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Nevada
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
Canada
State/province [19] 0 0
Alberta
Country [20] 0 0
Canada
State/province [20] 0 0
British Columbia
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
France
State/province [23] 0 0
Haute-Garonne
Country [24] 0 0
France
State/province [24] 0 0
Provence-Alpes-Cote-d Azur
Country [25] 0 0
France
State/province [25] 0 0
Bordeaux
Country [26] 0 0
France
State/province [26] 0 0
Lille
Country [27] 0 0
France
State/province [27] 0 0
Paris
Country [28] 0 0
France
State/province [28] 0 0
Strasbourg
Country [29] 0 0
Germany
State/province [29] 0 0
Nordrhein-Westfalen
Country [30] 0 0
Germany
State/province [30] 0 0
Sachsen
Country [31] 0 0
Germany
State/province [31] 0 0
Thueringen
Country [32] 0 0
Germany
State/province [32] 0 0
Hausham
Country [33] 0 0
Germany
State/province [33] 0 0
Munich
Country [34] 0 0
Italy
State/province [34] 0 0
Calabria
Country [35] 0 0
Italy
State/province [35] 0 0
Lazio
Country [36] 0 0
Italy
State/province [36] 0 0
Milano
Country [37] 0 0
Italy
State/province [37] 0 0
Milan
Country [38] 0 0
Italy
State/province [38] 0 0
Pozzilli
Country [39] 0 0
Italy
State/province [39] 0 0
Terni
Country [40] 0 0
Italy
State/province [40] 0 0
Venezia LIDO
Country [41] 0 0
Japan
State/province [41] 0 0
Aichi
Country [42] 0 0
Japan
State/province [42] 0 0
Hokkaido
Country [43] 0 0
Japan
State/province [43] 0 0
Kyoto
Country [44] 0 0
Japan
State/province [44] 0 0
Miyagi
Country [45] 0 0
Japan
State/province [45] 0 0
Niigata
Country [46] 0 0
Japan
State/province [46] 0 0
Osaka
Country [47] 0 0
Japan
State/province [47] 0 0
Tokyo
Country [48] 0 0
Spain
State/province [48] 0 0
Madrid
Country [49] 0 0
Spain
State/province [49] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02985879