A Phase 3, Randomized, Double-blind, Placebo- and Active-Controlled Study of the Efficacy and Safety of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,100
- 试验地点
- 147
- 主要终点
- Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12 Compared to Placebo
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine (SUZ) in participants with pain associated with diabetic peripheral neuropathy (DPN).
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body weight greater than or equal to (≥) 45 kilogram (kg)
- •Body mass index (BMI) ≥18.0 to less than (<) 40.0 kilogram per meter square (kg/m^2)
- •Diagnosis of diabetes mellitus type 1 or type 2 by glycosylated hemoglobin A1c (HbA1c) ≤9% and the presence of bilateral pain in lower extremities due to DPN
- •Weekly average of daily NPRS score ≥4 and less than or equal to (≤) 9 with limited variation in the 7-day Baseline Period
排除标准
- •More than 3 missing daily NPRS scores during the 7-day Baseline Period
- •Any sensory abnormality (excluding DPN) as pre-specified in the protocol
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Suzetrigine (SUZ)
Participants will be randomized to receive SUZ.
干预措施: Placebo (matched to Pregabalin) (Drug)
Pregabalin
Participants will be randomized to receive Pregabalin.
干预措施: Placebo (matched to SUZ) (Drug)
Placebo
Participants will be randomized to receive placebo matched to SUZ and Pregabalin.
干预措施: Placebo (matched to SUZ) (Drug)
Placebo
Participants will be randomized to receive placebo matched to SUZ and Pregabalin.
干预措施: Placebo (matched to Pregabalin) (Drug)
Pregabalin
Participants will be randomized to receive Pregabalin.
干预措施: Pregabalin (Drug)
Suzetrigine (SUZ)
Participants will be randomized to receive SUZ.
干预措施: Suzetrigine (Drug)
结局指标
主要结局
Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12 Compared to Placebo
时间窗: From Baseline up to Week 12
次要结局
- Change From Baseline in the Medical Outcomes Study 36-item Short-form Health Status (SF 36v2) Physical Component Summary (PCS) Score at Week 12 Compared to Placebo (pooled with data from Study VX24-548-111)(From Baseline up to Week 12)
- Change From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12 Compared to Pregabalin(From Baseline up to Week 12)