A Phase 2 Study to Evaluate the Safety and Efficacy of RTA 901 in Patients With Diabetic Peripheral Neuropathic Pain
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 209
- 试验地点
- 68
- 主要终点
- Change From Baseline in Average Daily Pain Intensity as Assessed by the Numeric Pain Rating Scale (NPRS) at Week 12
研究概览
简要总结
This is a 2-part, randomized, placebo-controlled, double-blind, Phase 2 study to evaluate the safety, tolerability, efficacy, and pharmacokinetics (PK) of RTA 901 in qualified participants with Diabetic Peripheral Neuropathic Pain (DPNP). Each study part will be randomized into 3 treatment arms; 2 different doses of RTA 901 and RTA 901-maching placebo. The doses of RTA 901 in Part 2 will be selected based on the Exposure-Response (E-R) analyses of data from Part 1. A total of 384 participants will be randomized in this study. Each part will have 192 participants, with 64 participants randomized 1:1:1 to each treatment arm.
The duration of each part of the study will be approximately 20 weeks, including a Screening period of up to 2 weeks, a Run-in-period of 2 weeks, a Treatment period of 12 weeks, and a Follow-up period of 4 weeks. All participants in Part 1 and Part 2 of the study will follow the same visit and assessment schedule. Eligibility will be assessed during the Screening and Run-in-periods.
详细描述
Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) at least 1 year prior to Screening
- •Clinical diagnosis of DPNP defined as symptomatic distal symmetric polyneuropathy (secondary to diabetes) in the lower extremities, which may include symptoms of pain that is burning, lancinating, tingling, or shooting (electric shock-like). Pain in the lower extremities may occur with paresthesia or dysesthesia (unpleasant sensations of burning). Neuropathic pain may be accompanied by an exaggerated response to painful stimuli (hyperalgesia) and pain evoked by light touch or contact, eg, with socks, shoes, and bedclothes (allodynia);
- •NPRS pain intensity score ≥ 4 on an 11-point scale at Screening
- •A score ≥ 2.5 on the Michigan Neuropathy Screening Instrument (MNSI) Part B
排除标准
- •Has neuropathy from a cause other than T1DM or T2DM
- •Has a condition other than DPNP that could confound the assessment of pain (eg, fibromyalgia or regional pain caused by lumbar or cervical compression);
- •Diabetic foot ulceration or infection within 90 days prior to Screening
- •Prior participation in a study with RTA 901;
- •NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Part 1 RTA 901 Dose 1
Participants will receive study drug, once daily (QD), during the 2-week Run-in Period. Following randomization, the participants will receive a dose of RTA 901, QD, for a 12-week treatment duration.
干预措施: RTA 901 (Drug)
Part 1 RTA 901 Dose 2
Participants will receive study drug, QD, during the 2-week Run-in Period. Following randomization, the participants will receive a dose of RTA 901, QD, for a 12-week treatment duration.
干预措施: RTA 901 (Drug)
Part 1 RTA 901-Matching Placebo
Participants will receive study drug, QD, during the 2-week Run-in Period. Following randomization, the participants will receive a dose of RTA 901-matching placebo, QD, for a 12-week treatment duration.
干预措施: RTA 901-Matching Placebo (Drug)
Part 2 RTA 901 Dose 1
Participants will receive study drug, QD, during the 2-week Run-in Period. Following randomization, the participants will receive a dose of RTA 901, QD, for a 12-week treatment duration.
干预措施: RTA 901 (Drug)
Part 2 RTA 901 Dose 2
Participants will receive study drug, QD, during the 2-week Run-in Period. Following randomization, the participants will receive a dose of RTA 901, QD, for a 12-week treatment duration.
干预措施: RTA 901 (Drug)
Part 2 RTA 901-Matching Placebo
Participants will receive study drug, QD, during the 2-week Run-in Period. Following randomization, the participants will receive a dose of RTA 901-matching placebo, QD, for a 12-week treatment duration.
干预措施: RTA 901-Matching Placebo (Drug)
结局指标
主要结局
Change From Baseline in Average Daily Pain Intensity as Assessed by the Numeric Pain Rating Scale (NPRS) at Week 12
时间窗: Baseline, Week 12
The NPRS of pain intensity is a numeric scale, ranging from 0 (representing no pain at all) to 10 (representing the worst pain imaginable). The participant will select a whole number (0 to 10) that best indicates the intensity of his/her pain in the past 24 hours. Lower scores indicate less pain.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During and Following the Treatment Period
时间窗: From the first day of dosing up to end of follow-up period (Week 16)
Number of Participants With Clinically Significant Abnormality in Physical Examinations
时间窗: Baseline up to Week 16
Number of Participants With Clinically Significant Abnormality in Vital Sign
时间窗: Baseline up to Week 16
Number of Participants With Clinically Significant Abnormality in Electrocardiogram (ECG)
时间窗: Baseline up to Week 16
Number of Participants With Clinically Significant Abnormality in Clinical Laboratory Measurement
时间窗: Baseline up to Week 16
Number of Participants With Clinically Significant Abnormality in Body Weight
时间窗: Baseline up to Week 16
次要结局
- Number of Participants who Achieved at Least a 30% Decrease From Baseline in the Average NPRS Score at Week 12(Week 12)
- Number of Participants who Achieved at Least a 50% Decrease From Baseline in the Average NPRS Score at Week 12(Week 12)
- Number of Participants Using Rescue Medications During the Treatment Period(Up to Week 12)
- Amount of Rescue Medications Used During the Treatment Period(Up to Week 12)
- Duration of Rescue Medications Used During the Treatment Period(Up to Week 12)
- Change From Baseline in the Average Daily Sleep Interference Scale (DSIS) score at Week 12(Baseline, Week 12)