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A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP)

Primary Purpose

Progressive Supranuclear Palsy

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Placebo

ABBV-8E12

About this trial

This is an interventional treatment trial for Progressive Supranuclear Palsy focused on measuring PSP, Steele-Richardson-Olszewski syndrome, Tauopathy

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

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 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

Sites / Locations

University of Alabama at Birmingham - Main /ID# 144892
Mayo Clinic - Scottsdale /ID# 144893
Cedars-Sinai Medical Center /ID# 149775
Ucsd /Id# 144905
Usc /Id# 149773
University of California, Los Angeles /ID# 144896
Univ California, San Francisco /ID# 144897
Rocky Mountain Movement Disorders Center /ID# 153397
University of Florida - Archer /ID# 144906
Mayo Clinic /ID# 144911
University of South Florida /ID# 144912
Georgia Regents University /ID# 144908
Rush University Medical Center /ID# 144894
University of Chicago /ID# 148672
Indiana University /ID# 149036
University of Kentucky Chandler Medical Center /ID# 144891
Mayo Clinic - Rochester /ID# 144895
St. Luke's Hosp. of Kansas Cit /ID# 168629
Cleveland Clinic Lou Ruvo Cent /ID# 148919
Rutgers Robert Wood Johnson /ID# 144901
COLUMBIA University Medical Center /ID# 149037
Cleveland Clinic Main Campus /ID# 144885
Oregon Health and Science University /ID# 149774
Vanderbilt Univ Med Ctr /ID# 144898
Kerwin Research Center /ID# 144904
McGovern Medical School /ID# 149236
Central Texas Neurology Consul /ID# 167417
Westmead Hospital /ID# 154403
Q-Pharm Pty Limited /ID# 154410
Royal Adelaide Hospital /ID# 153157
Alfred Hospital /ID# 153158
Neurodegenerative Disorders Re /ID# 153770
University of Calgary /ID# 154393
OCT Research ULC /ID# 169688
Toronto Western Hospital /ID# 152818
Crchum /Id# 152819
Montreal Neurological Institut /ID# 156413
Hopital Universitaire Purpan /ID# 153152
Hopital de la Timone /ID# 153113
Chu de Bordeaux Hopital /Id# 153151
Hopital B Roger Salengro /ID# 153943
Hopital Pitie Salpetriere /ID# 153942
CHU Strasbourg Hautepierre Hos /ID# 206942
St. Josef-Hospital /ID# 201984
Universitaetsklinikum Leipzig /ID# 201761
Universitaetsklinikum Ulm /ID# 153155
KH Agatharied /ID# 154166
TU Uniklinik Munchen /ID# 153154
Universita di Catanzaro Magna Graecia /ID# 166322
Policlinico Agostino Gemelli /ID# 153104
IBD Center - IRCCS Istituto Clinico Humanitas /ID# 155092
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 201982
Istituto Neuro Mediterraneo IR /ID# 153106
A.O. Santa Maria /ID# 153102
IRCCS Ospedale San Camillo /ID# 153101
National Hospital Organization Higashinagoya National Hospital /ID# 201514
National Hospital Organization Asahikawa Medical Center /ID# 201585
National Hospital Organization Utano National Hospital /ID# 201979
Tohoku University Hospital /ID# 202307
NHO Sendai Nishitaga National Hospital /ID# 202132
Niigata University Medical & Dental Hospital /ID# 201680
Osaka University Hospital /ID# 201980
Juntendo University Hospital /ID# 200870
National Center of Neurology and Psychiatry /ID# 202037
Hospital General Universitario Gregorio Maranon /ID# 200876
Hosp Univ Virgen del Rocio /ID# 201039

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

ABBV-8E12 2000 mg

ABBV-8E12 4000 mg

Arm Description

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

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)

Outcomes

Primary Outcome Measures

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

Number of Participants With Adverse Events

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity from first dose of study drug until 20 weeks after the last dose. For more details on AEs please see the Adverse Event section.

Secondary Outcome Measures

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 changes in score indicate worsening from baseline.

Clinical Global Impression of Change (CGI-C) Score at 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.

Mean Change From Baseline to Week 52 in Midbrain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)

Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify midbrain atrophy. Negative changes in values indicate a reduction in volume.

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) 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 changes in values indicate a decline in health.

Maximum Observed Serum Concentration (Cmax) for ABBV-8E12

The maximum observed serum concentration after the first and the fifth doses in Cohort 1 and Cohort J1 was determined.

Time to Maximum Observed Serum Concentration (Tmax) for ABBV-8E12

The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax, the maximum plasma concentration. Tmax was measured after the first and the fifth doses in Cohort 1 and Cohort J1.

Area Under the Concentration Time Curve (AUC) for ABBV-8E12

The area under the plasma concentration-time curve (AUC; measured in µg•day/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ABBV-8E12 was estimated using non-compartmental methods after the first and the fifth doses in Cohort 1 and Cohort J1.

Serum Concentration of ABBV-8E12 Prior to Infusion of a Day of Dosing (Ctrough)

The concentration of ABBV-8E12 immediately prior to infusion of the fifth dose (Ctrough; measured in µg/mL) was estimated using non-compartmental methods in Cohort 1 and Cohort J1.

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 changes in score indicate worsening from baseline.

Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Health Related Quality of Life Scale (PSP-QoL) Total Score

The PSP-QoL is a validated patient-reported outcome measure, specifically designed to assess the quality of life of participants with PSP. There are 45 items and two subscales: physical and mental impact. Items are scored from 0 (no problem) to 4 (extreme problems). The total subscale sum scores are linearly converted into a 0 to 100 scale, and higher scores indicate a lower quality of life. Positive changes in score indicate a decline in quality of life.

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 changes in score indicate worsening from baseline.

Mean Change From Baseline to Week 52 in Third Ventricle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)

Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify third ventricle atrophy. Positive changes in values indicate an increase in volume.

Mean Change From Baseline to Week 52 in Superior Cerebellar Peduncle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)

Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify Superior cerebellar peduncle atrophy. Negative changes in values indicate a reduction in volume.

Mean Change From Baseline to Week 52 in Brainstem Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)

Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify brainstem atrophy. Negative changes in values indicate a reduction in volume.

Mean Change From Baseline to Week 52 in Whole Brain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)

Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify whole brain atrophy. Negative changes in values indicate a reduction in volume.

Mean Change From Baseline to Week 52 in Frontal Lobe Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)

Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify frontal lobe atrophy. Positive changes in values indicate an increase in volume.

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 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. 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).

Full Information

NCT ID

NCT02985879

First Posted

December 1, 2016

Last Updated

February 1, 2021

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT02985879

Brief Title

A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP)

Official Title

A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Terminated

Why Stopped

This study was prematurely discontinued because the program for progressive supranuclear palsy was discontinued due to lack of efficacy of study drug.

Study Start Date

December 12, 2016 (Actual)

Primary Completion Date

November 20, 2019 (Actual)

Study Completion Date

November 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study was to assess efficacy, safety, tolerability, and pharmacokinetics of ABBV-8E12 in participants with progressive supranuclear palsy (PSP).

Detailed Description

This was a Phase 2, randomized, double-blind, placebo-controlled, multiple dose, multicenter study consisting of a screening period of up to 8 weeks (56 days), a 52-week double-blind treatment period, and a post-treatment follow-up period of approximately 20 weeks following last study drug administration (for those participants who prematurely discontinued from treatment, declined to participate in or did not qualify for participation in a long term extension [LTE] study). At the end of the treatment period, extended treatment was available for eligible participants who completed the 52-week treatment period and entered the separate long-term extension study (NCT03391765; Study M15-563). There were 3 cohorts in the study (Cohort 1, Cohort J1, and Cohort 2). Cohort 1 had augmented safety and pharmacokinetic (PK) assessments in the first 30 participants enrolled into the global study from countries other than Japan. Cohort J1 had augmented safety and PK assessments in the first 9 participants enrolled into the study from Japan. Cohort 2 consisted of all other participants enrolled in the global study not participating in Cohort 1 or Cohort J1. This study was prematurely discontinued because the program for progressive supranuclear palsy was discontinued due to lack of efficacy of study drug.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Progressive Supranuclear Palsy

Keywords

PSP, Steele-Richardson-Olszewski syndrome, Tauopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

378 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

ABBV-8E12 2000 mg

Arm Type

Experimental

Arm Description

Arm Title

ABBV-8E12 4000 mg

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Intervention Type

Drug

Intervention Name(s)

ABBV-8E12

Other Intervention Name(s)

Tilavonemab

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline, Week 52

Title

Number of Participants With Adverse Events

Description

Time Frame

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 Measure Information:

Title

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

Description

Time Frame

Baseline, Week 52

Title

Clinical Global Impression of Change (CGI-C) Score at Week 52

Description

Time Frame

Week 52

Title

Mean Change From Baseline to Week 52 in Midbrain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)

Description

Time Frame

Baseline, Week 52

Title

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

Description

Time Frame

Baseline, Week 52

Title

Maximum Observed Serum Concentration (Cmax) for ABBV-8E12

Description

The maximum observed serum concentration after the first and the fifth doses in Cohort 1 and Cohort J1 was determined.

Time Frame

First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113

Title

Time to Maximum Observed Serum Concentration (Tmax) for ABBV-8E12

Description

Time Frame

First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113

Title

Area Under the Concentration Time Curve (AUC) for ABBV-8E12

Description

Time Frame

First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113

Title

Serum Concentration of ABBV-8E12 Prior to Infusion of a Day of Dosing (Ctrough)

Description

The concentration of ABBV-8E12 immediately prior to infusion of the fifth dose (Ctrough; measured in µg/mL) was estimated using non-compartmental methods in Cohort 1 and Cohort J1.

Time Frame

First day of the Fifth Dosing Interval, Day 85

Title

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

Description

Time Frame

Baseline, Week 52

Title

Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Health Related Quality of Life Scale (PSP-QoL) Total Score

Description

Time Frame

Baseline, Week 52

Title

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

Description

Time Frame

Baseline, Week 52

Title

Mean Change From Baseline to Week 52 in Third Ventricle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)

Description

Time Frame

Baseline, Week 52

Title

Mean Change From Baseline to Week 52 in Superior Cerebellar Peduncle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)

Description

Time Frame

Baseline, Week 52

Title

Mean Change From Baseline to Week 52 in Brainstem Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)

Description

Time Frame

Baseline, Week 52

Title

Mean Change From Baseline to Week 52 in Whole Brain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)

Description

Time Frame

Baseline, Week 52

Title

Mean Change From Baseline to Week 52 in Frontal Lobe Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)

Description

Time Frame

Baseline, Week 52

Title

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

Description

Time Frame

From Baseline to Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AbbVie Inc.

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

University of Alabama at Birmingham - Main /ID# 144892

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Facility Name

Mayo Clinic - Scottsdale /ID# 144893

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85259

Country

United States

Facility Name

Cedars-Sinai Medical Center /ID# 149775

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

Ucsd /Id# 144905

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Facility Name

Usc /Id# 149773

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

University of California, Los Angeles /ID# 144896

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Univ California, San Francisco /ID# 144897

City

San Francisco

State/Province

California

ZIP/Postal Code

94143-2204

Country

United States

Facility Name

Rocky Mountain Movement Disorders Center /ID# 153397

City

Englewood

State/Province

Colorado

ZIP/Postal Code

80113-2736

Country

United States

Facility Name

University of Florida - Archer /ID# 144906

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Name

Mayo Clinic /ID# 144911

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Facility Name

University of South Florida /ID# 144912

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Georgia Regents University /ID# 144908

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

Facility Name

Rush University Medical Center /ID# 144894

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

University of Chicago /ID# 148672

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637-1443

Country

United States

Facility Name

Indiana University /ID# 149036

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

University of Kentucky Chandler Medical Center /ID# 144891

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

Facility Name

Mayo Clinic - Rochester /ID# 144895

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905-0001

Country

United States

Facility Name

St. Luke's Hosp. of Kansas Cit /ID# 168629

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64111

Country

United States

Facility Name

Cleveland Clinic Lou Ruvo Cent /ID# 148919

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Facility Name

Rutgers Robert Wood Johnson /ID# 144901

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08901

Country

United States

Facility Name

COLUMBIA University Medical Center /ID# 149037

City

New York

State/Province

New York

ZIP/Postal Code

10032-3725

Country

United States

Facility Name

Cleveland Clinic Main Campus /ID# 144885

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Oregon Health and Science University /ID# 149774

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Vanderbilt Univ Med Ctr /ID# 144898

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232-0011

Country

United States

Facility Name

Kerwin Research Center /ID# 144904

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231-4316

Country

United States

Facility Name

McGovern Medical School /ID# 149236

City

Houston

State/Province

Texas

ZIP/Postal Code

77054

Country

United States

Facility Name

Central Texas Neurology Consul /ID# 167417

City

Round Rock

State/Province

Texas

ZIP/Postal Code

78681

Country

United States

Facility Name

Westmead Hospital /ID# 154403

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Q-Pharm Pty Limited /ID# 154410

City

Herston

State/Province

Queensland

ZIP/Postal Code

4006

Country

Australia

Facility Name

Royal Adelaide Hospital /ID# 153157

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Alfred Hospital /ID# 153158

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

Facility Name

Neurodegenerative Disorders Re /ID# 153770

City

West Perth

State/Province

Western Australia

ZIP/Postal Code

6005

Country

Australia

Facility Name

University of Calgary /ID# 154393

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4Z6

Country

Canada

Facility Name

OCT Research ULC /ID# 169688

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1Y 1Z9

Country

Canada

Facility Name

Toronto Western Hospital /ID# 152818

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 2S8

Country

Canada

Facility Name

Crchum /Id# 152819

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 0A9

Country

Canada

Facility Name

Montreal Neurological Institut /ID# 156413

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 2B4

Country

Canada

Facility Name

Hopital Universitaire Purpan /ID# 153152

City

Toulouse

State/Province

Haute-Garonne

ZIP/Postal Code

31059

Country

France

Facility Name

Hopital de la Timone /ID# 153113

City

Marseille CEDEX 05

State/Province

Provence-Alpes-Cote-d Azur

ZIP/Postal Code

13385

Country

France

Facility Name

Chu de Bordeaux Hopital /Id# 153151

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

Hopital B Roger Salengro /ID# 153943

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

Hopital Pitie Salpetriere /ID# 153942

City

Paris

ZIP/Postal Code

75651

Country

France

Facility Name

CHU Strasbourg Hautepierre Hos /ID# 206942

City

Strasbourg

ZIP/Postal Code

67200

Country

France

Facility Name

St. Josef-Hospital /ID# 201984

City

Bochum

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

44791

Country

Germany

Facility Name

Universitaetsklinikum Leipzig /ID# 201761

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04103

Country

Germany

Facility Name

Universitaetsklinikum Ulm /ID# 153155

City

Ulm

State/Province

Thueringen

ZIP/Postal Code

89081

Country

Germany

Facility Name

KH Agatharied /ID# 154166

City

Hausham

ZIP/Postal Code

83734

Country

Germany

Facility Name

TU Uniklinik Munchen /ID# 153154

City

Munich

ZIP/Postal Code

80802

Country

Germany

Facility Name

Universita di Catanzaro Magna Graecia /ID# 166322

City

Catanzaro

State/Province

Calabria

ZIP/Postal Code

88100

Country

Italy

Facility Name

Policlinico Agostino Gemelli /ID# 153104

City

Rome

State/Province

Lazio

ZIP/Postal Code

00168

Country

Italy

Facility Name

IBD Center - IRCCS Istituto Clinico Humanitas /ID# 155092

City

Rozzano

State/Province

Milano

ZIP/Postal Code

20089

Country

Italy

Facility Name

Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 201982

City

Milan

ZIP/Postal Code

20133

Country

Italy

Facility Name

Istituto Neuro Mediterraneo IR /ID# 153106

City

Pozzilli

ZIP/Postal Code

86077

Country

Italy

Facility Name

A.O. Santa Maria /ID# 153102

City

Terni

ZIP/Postal Code

05100

Country

Italy

Facility Name

IRCCS Ospedale San Camillo /ID# 153101

City

Venezia LIDO

ZIP/Postal Code

30126

Country

Italy

Facility Name

National Hospital Organization Higashinagoya National Hospital /ID# 201514

City

Nagoya-shi

State/Province

Aichi

ZIP/Postal Code

4658620

Country

Japan

Facility Name

National Hospital Organization Asahikawa Medical Center /ID# 201585

City

Asahikawa

State/Province

Hokkaido

ZIP/Postal Code

070-8644

Country

Japan

Facility Name

National Hospital Organization Utano National Hospital /ID# 201979

City

Kyoto City

State/Province

Kyoto

ZIP/Postal Code

616-8255

Country

Japan

Facility Name

Tohoku University Hospital /ID# 202307

City

Sendai-shi

State/Province

Miyagi

ZIP/Postal Code

980-8574

Country

Japan

Facility Name

NHO Sendai Nishitaga National Hospital /ID# 202132

City

Sendai

State/Province

Miyagi

ZIP/Postal Code

982-8555

Country

Japan

Facility Name

Niigata University Medical & Dental Hospital /ID# 201680

City

Niigata-shi

State/Province

Niigata

ZIP/Postal Code

951-8520

Country

Japan

Facility Name

Osaka University Hospital /ID# 201980

City

Suita-shi

State/Province

Osaka

ZIP/Postal Code

565-0871

Country

Japan

Facility Name

Juntendo University Hospital /ID# 200870

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

113-8431

Country

Japan

Facility Name

National Center of Neurology and Psychiatry /ID# 202037

City

Kodaira

State/Province

Tokyo

ZIP/Postal Code

187-8551

Country

Japan

Facility Name

Hospital General Universitario Gregorio Maranon /ID# 200876

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Hosp Univ Virgen del Rocio /ID# 201039

City

Sevilla

ZIP/Postal Code

41001

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

IPD Sharing Time Frame

Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.

IPD Sharing 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.

IPD Sharing URL

https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

Citations:

PubMed Identifier

33609476

Citation

Hoglinger GU, Litvan I, Mendonca N, Wang D, Zheng H, Rendenbach-Mueller B, Lon HK, Jin Z, Fisseha N, Budur K, Gold M, Ryman D, Florian H; Arise Investigators. Safety and efficacy of tilavonemab in progressive supranuclear palsy: a phase 2, randomised, placebo-controlled trial. Lancet Neurol. 2021 Mar;20(3):182-192. doi: 10.1016/S1474-4422(20)30489-0.

Results Reference

derived

Learn more about this trial

A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP)

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