An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 142
- 试验地点
- 42
- 主要终点
- Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score From Baseline to Week 52
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant completed the 52-week treatment period in Study M15-562 (NCT02985879)
- •In the opinion of the investigator, the participant was compliant during participation in Study M15-562 (NCT02985879)
- •Participant has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend)
排除标准
- •Participants who weigh less than 44 kg (97 lbs) at the time of study entry
- •Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI)
- •Participant has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results
- •More than 8 weeks have elapsed since the participant received his/her last dose of study drug in Study M15-562 (NCT02985879)
- •Participant is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the participant is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations
研究组 & 干预措施
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).
干预措施: ABBV-8E12 (Drug)
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).
干预措施: Placebo solution for IV infusion on Day 15 (Drug)
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).
干预措施: ABBV-8E12 (Drug)
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).
干预措施: Placebo solution for IV infusion on Day 15 (Drug)
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.
干预措施: ABBV-8E12 (Drug)
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.
干预措施: ABBV-8E12 (Drug)
结局指标
主要结局
Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score From Baseline to Week 52
时间窗: Baseline, 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.
次要结局
- Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)(Baseline, Week 52)
- Change in Clinical Global Impression of Severity (CGI-C) Score From Baseline to Week 52(Baseline, Week 52)
- Mean Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale (SEADL)(Baseline, Week 52)
- Mean Change From Baseline to Week 52 in Clinical Global Impression of Severity (CGI-S) Score(Baseline, Week 52)
- Patient Global Impression of Change Score (PGI-C) Score From Baseline to Week 52(Baseline, Week 52)
- Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Staging System Score (PSP-SS) Score(Baseline, Week 52)
- Time to Loss of Ability to Walk Independently as Measured by Progressive Supranuclear Palsy Rating Scale (PSPRS) Item 26(From Baseline to Week 52)