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

Browse trials for

• Supranuclear Palsy, Progressive 171
• Tauopathies 75

Keywords

• Tauopathy
• Steele-Richardson-Olszewski Syndrome
• PSP

Supranuclear Palsy, Progressive

171 studies on the registry are indexed under Supranuclear Palsy, Progressive; 51 are open to participants now.

This study's enrollment of 142 is above the median of 43 across 102 interventional studies indexed under Supranuclear Palsy, Progressive.

Lead sponsor

AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.

Study arms

• Experimental
  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).

  Drug: ABBV-8E12 · Drug: Placebo solution for IV infusion on Day 15

• Experimental
  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).

  Drug: ABBV-8E12 · Drug: Placebo solution for IV infusion on Day 15

• Experimental
  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.

  Drug: ABBV-8E12

• Experimental
  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.

  Drug: ABBV-8E12

Interventions

• DrugABBV-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.

  Also known as: Tilavonemab

• DrugPlacebo 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.

Primary outcomes

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

   The PSPRS consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for six items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. Positive values indicate worsening from baseline.

   Time frame: Baseline, Week 52

Secondary outcomes

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

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

   Time frame: Baseline, Week 52

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

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

   Time frame: Baseline, Week 52

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

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

   Time frame: Baseline, Week 52

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

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

   Time frame: Baseline, Week 52

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

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

   Time frame: Baseline, Week 52

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

   The Progressive Supranuclear Palsy Rating Scale (PSPRS) consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for four items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. The PSP-SS score is a composite of the dysphagia and gait items from the PSPRS. Positive values indicate worsening from baseline.

   Time frame: Baseline, Week 52

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

   The PSPRS consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for four items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. Item 26 pertains to gait, scored as either 0 (normal); 1 (slightly wide-based or irregular or slight pulsion on turns); 2 (must walk slowly or occasionally use walls or helper to avoid falling, especially on turns); 3 (must use assistance all or almost all the time); or 4 (unable to walk, even with walker; may be able to transfer).

   Time frame: From Baseline to Week 52

Baseline characteristics

Study documents

• Study protocol ↗ · Feb 21, 2019
• Statistical analysis plan ↗ · Aug 15, 2019

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

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

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.

Data sharing details ↗ · www.abbvie.com