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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001590-16 | EudraCT Number |
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This study was prematurely discontinued because the program for progressive supranuclear palsy was discontinued due to lack of efficacy.
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ Alabama-Birmingham /ID# 165522 | Birmingham | Alabama | 35294 | United States | ||
| Mayo Clinic Arizona /ID# 165521 |
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.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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.
All enrolled participants
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| ID | Title | Description |
|---|---|---|
| FG000 | M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mg | 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). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 21, 2019 | Nov 2, 2020 |
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|
| 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. |
|
| Baseline, Week 52 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| Cedars-Sinai Medical Center /ID# 165567 | Beverly Hills | California | 90211 | United States |
| Usc /Id# 165529 | Los Angeles | California | 90033 | United States |
| University of California, Los Angeles /ID# 165669 | Los Angeles | California | 90095 | United States |
| University of California, San /ID# 165560 | San Diego | California | 92037 | United States |
| Univ California, San Francisco /ID# 165553 | San Francisco | California | 94143-2204 | United States |
| Rocky Mountain Movement Disorders Center /ID# 165559 | Englewood | Colorado | 80113-2736 | United States |
| UF Center for Movement Disorde /ID# 165561 | Gainesville | Florida | 32607 | United States |
| Mayo Clinic /ID# 165554 | Jacksonville | Florida | 32224 | United States |
| University of South Florida /ID# 165556 | Tampa | Florida | 33612 | United States |
| Augusta University Medical Center /ID# 165562 | Augusta | Georgia | 30912-0004 | United States |
| Rush University Medical Center /ID# 165527 | Chicago | Illinois | 60612 | United States |
| University of Chicago Medical /ID# 165555 | Chicago | Illinois | 60637 | United States |
| Indiana University /ID# 165519 | Indianapolis | Indiana | 46202 | United States |
| University of Kentucky Chandler Medical Center /ID# 165566 | Lexington | Kentucky | 40536 | United States |
| Mayo Clinic - Rochester /ID# 165518 | Rochester | Minnesota | 55905-0001 | United States |
| Cleveland Clinic Lou Ruvo Cent /ID# 165538 | Las Vegas | Nevada | 89106 | United States |
| Rutgers Robert Wood Johnson /ID# 165526 | New Brunswick | New Jersey | 08901 | United States |
| Columbia Univ Medical Center /ID# 165528 | New York | New York | 10032-3725 | United States |
| Cleveland Clinic Main Campus /ID# 165537 | Cleveland | Ohio | 44195 | United States |
| Vanderbilt Univ Med Ctr /ID# 165520 | Nashville | Tennessee | 37232-0011 | United States |
| Kerwin Research Center /ID# 206872 | Dallas | Texas | 75231-4316 | United States |
| McGovern Medical School /ID# 165565 | Houston | Texas | 77054 | United States |
| Q-Pharm Pty Limited /ID# 165452 | Herston | Queensland | 4006 | Australia |
| Royal Adelaide Hospital /ID# 165451 | Adelaide | South Australia | 5000 | Australia |
| Alfred Hospital /ID# 165454 | Melbourne | Victoria | 3004 | Australia |
| University of Calgary /ID# 165667 | Calgary | Alberta | T2N 4Z6 | Canada |
| Toronto Western Hospital /ID# 165462 | Toronto | Ontario | M5T 2S8 | Canada |
| CHUM - Notre-Dame Hospital /ID# 165461 | Montreal | Quebec | H2X 0A9 | Canada |
| Montreal Neurological Institut /ID# 165546 | Montreal | Quebec | H3A 2B4 | Canada |
| Policlinico Agostino Gemelli /ID# 165536 | Rome | Lazio | 00168 | Italy |
| University of Catanzaro /ID# 170214 | Catanzaro | 88100 | Italy |
| Istituto Neuro Mediterraneo IR /ID# 165533 | Pozzilli | 86077 | Italy |
| A.O. Santa Maria /ID# 165535 | Terni | 05100 | Italy |
| IRCCS San Camillo /ID# 201229 | Venice | 30126 | Italy |
| National Hospital Organization Higashinagoya National Hospital /ID# 208786 | Nagoya | Aichi-ken | 4658620 | Japan |
| National Hospital Organization Asahikawa Medical Center /ID# 208818 | Asahikawa | Hokkaido | 070-8644 | Japan |
| National Hospital Organization Utano National Hospital /ID# 208780 | Kyoto | Kyoto | 616-8255 | Japan |
| NHO Sendai Nishitaga National Hospital /ID# 209014 | Sendai | Miyagi | 982-8555 | Japan |
| Osaka University Hospital /ID# 208787 | Suita-shi | Osaka | 565-0871 | Japan |
| National Center of Neurology and Psychiatry /ID# 208820 | Kodaira | Tokyo | 187-8551 | Japan |
| M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg |
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). |
| FG002 | M15-562 Placebo/M15-563 ABBV-8E12 2000 mg | 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. |
| FG003 | M15-562 Placebo/M15-563 ABBV-8E12 4000 mg | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Stand-Alone Dataset: data from Study M15-563 only, regardless of the treatment received in Study M15-562. Baseline is the last observation on or before the first dose of ABBV-8E12 in Study M15-563. If no baseline was recorded in Study M15-563, the last value in Study M15-562 was used as baseline.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mg | 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). |
| BG001 | M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mg | 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). |
| BG002 | M15-562 Placebo/M15-563 ABBV-8E12 2000 mg | 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. |
| BG003 | M15-562 Placebo/M15-563 ABBV-8E12 4000 mg | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | ITT dataset: all participants who received any dose of study drug in Study M15-563 and those with available data at baseline and at Week 52 | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 52 |
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| 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. | ITT dataset: all participants who received any dose of study drug in Study M15-563 and those with available data at baseline and at Week 52 | Posted | Mean | Standard Deviation | units on a scale | 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. | ITT dataset: all participants who received any dose of study drug in Study M15-563 and those with available data at baseline and at Week 52 | Posted | Mean | Standard Deviation | units on a scale | 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. | ITT dataset: all participants who received any dose of study drug in Study M15-563 and those with available data at baseline and at Week 52 | Posted | Mean | Standard Deviation | units on a scale | 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. | ITT dataset: all participants who received any dose of study drug in Study M15-563 and those with available data at baseline and at Week 52 | Posted | Mean | Standard Deviation | units on a scale | 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. | ITT dataset: all participants who received any dose of study drug in Study M15-563 and those with available data at baseline and at Week 52 | Posted | Mean | Standard Deviation | units on a scale | 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. | ITT dataset: all participants who received any dose of study drug in Study M15-563 and those with available data at baseline and at Week 52 | Posted | Mean | Standard Deviation | units on a scale | 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). | ITT dataset: all participants who received any dose of study drug in Study M15-563 and those with available data | Posted | Median | 95% Confidence Interval | days | From Baseline to Week 52 |
|
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 20 weeks following discontinuation of study drug administration have elapsed (approximately 5 half-lives), up to 98 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study is administered until 20 weeks (approximately 5 half-lives) have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mg | 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). | 5 | 51 | 10 | 51 | 18 | 51 |
| EG001 | M15-562 ABBV-8E12 4000 mg /M15-563 ABBV-8E12 4000 mg | 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). | 5 | 45 | 10 | 45 | 16 | 45 |
| EG002 | M15-562 Placebo/M15-563 ABBV-8E12 2000 mg | 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. | 1 | 23 | 3 | 23 | 6 | 23 |
| EG003 | M15-562 Placebo/M15-563 ABBV-8E12 4000 mg | 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. | 2 | 23 | 7 | 23 | 16 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CARDIAC ARREST | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CARDIO-RESPIRATORY ARREST | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| COMPLICATION ASSOCIATED WITH DEVICE | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DEATH | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| KLEBSIELLA INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| POST PROCEDURAL SEPSIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| CERVICAL VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| CLAVICLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| COLORECTAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| LETHARGY | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PARTIAL SEIZURES | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PROGRESSIVE SUPRANUCLEAR PALSY | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| APNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| CHEST INJURY | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| LIP INJURY | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| SKIN ABRASION | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| SKIN LACERATION | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 15, 2019 | Nov 2, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D013494 | Supranuclear Palsy, Progressive |
| D024801 | Tauopathies |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D009886 | Ophthalmoplegia |
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D019636 | Neurodegenerative Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000628586 | tilavonemab |
Not provided
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Native Hawaiian or other Pacific Islander |
|
| Multiple |
|
| OG002 |
| M15-562 Placebo/M15-563 ABBV-8E12 2000 mg |
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. |
| OG003 | M15-562 Placebo/M15-563 ABBV-8E12 4000 mg | 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. |
|
|
| OG002 |
| M15-562 Placebo/M15-563 ABBV-8E12 2000 mg |
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. |
| OG003 | M15-562 Placebo/M15-563 ABBV-8E12 4000 mg | 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. |
|
|
| OG002 | M15-562 Placebo/M15-563 ABBV-8E12 2000 mg | 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. |
| OG003 | M15-562 Placebo/M15-563 ABBV-8E12 4000 mg | 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. |
|
|
| M15-562 Placebo/M15-563 ABBV-8E12 2000 mg |
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. |
| OG003 | M15-562 Placebo/M15-563 ABBV-8E12 4000 mg | 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. |
|
|
| M15-562 Placebo/M15-563 ABBV-8E12 2000 mg |
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. |
| OG003 | M15-562 Placebo/M15-563 ABBV-8E12 4000 mg | 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. |
|
|
| OG002 | M15-562 Placebo/M15-563 ABBV-8E12 2000 mg | 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. |
| OG003 | M15-562 Placebo/M15-563 ABBV-8E12 4000 mg | 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. |
|
|
| OG002 | M15-562 Placebo/M15-563 ABBV-8E12 2000 mg | 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. |
| OG003 | M15-562 Placebo/M15-563 ABBV-8E12 4000 mg | 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. |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|