NCT04476108已完成2 期
Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY3016859 for the Treatment of Diabetic Peripheral Neuropathic Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 29
- 主要终点
- Change From Baseline in Average Pain Intensity as Measured by the NRS
研究概览
简要总结
This study is being done to test the safety and efficacy of the study drug LY3016859 for the treatment of diabetic peripheral neuropathic pain. This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain.
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
- Double (Participant, Investigator)
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
- •Have a visual analog scale (VAS) pain value ≥40 and <95 during screening.
- •Have a history of daily pain for at least 12 weeks based on participant report or medical history.
- •Have a value of ≤30 on the pain catastrophizing scale.
- •Have a body mass index <40 kilograms per meter squared (kg/m²) (inclusive).
- •Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation.
- •Are willing to discontinue all medications taken for chronic pain conditions for the duration of the study.
- •Have daily symmetrical foot pain secondary to peripheral neuropathy present for at least 6 months and as diagnosed through use of the Michigan Neuropathy Screening Instrument Part B ≥3 (©University of Michigan).
- •Have a history and current diagnosis of type 1 or type 2 diabetes mellitus.
- •Have stable glycemic control as indicated by a glycated hemoglobin ≤11 at time of screening.
- •Are men, or women able to abide by reproductive and contraceptive requirements.
排除标准
- •Have second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia.
- •Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques).
- •Have surgery planned during the study for any reason, related or not to the disease state under evaluation.
- •Have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.
- •There is an inability to rule out other causative or confounding sources of pain in the primary condition under study.
- •Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
- •Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association).
- •Have congenital QT prolongation or QT interval corrected for heart rate using Fridericia's formula (QTcF) interval measurement >450 milliseconds (msec) for male participants, >470 msec for female participants, or >480 msec for participants with bundle branch block.
- •Have any clinically important abnormality at screening, as determined by investigator, in physical or neurological examination, vital signs, electrocardiogram (ECG), or clinical laboratory test results that could be detrimental to the participant or could compromise the study.
- •Have a positive human immunodeficiency virus (HIV) test result at screening.
- •Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
- •Have an intolerance to acetaminophen or paracetamol or any of its excipients.
- •Have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.
- •Have a current drug-induced neuropathy, for example, due to some types of chemotherapy, or other types of peripheral neuropathy.
- •Have known hereditary motor, sensory or autonomic neuropathies.
- •Have an estimated glomerular filtration rate (eGFR) of less than 70 milliliters/minute/1.73m² during screening.
- •Have any clinically serious or unstable cardiovascular, musculoskeletal disorder, gastrointestinal, endocrinologic, hematologic, hepatic, metabolic, urologic, pulmonary, dermatologic, immunologic, or ophthalmologic disease within 3 months of baseline.
- •Have megaloblastic anemia or combined degeneration of the spinal cord.
- •Have received any antibodies against nerve growth factor (NGF), or antibodies against EGFR, or EGFR tyrosine kinase inhibitors.
- •Have a history of allergic reactions to monoclonal antibodies, or clinically significant multiple or severe drug allergies, including but not limited to erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis.
- •Have a history or presence of uncontrolled asthma, eczema, significant atopy, significant hereditary angio-edema or common variable immune deficiency.
- •Have fibromyalgia
研究组 & 干预措施
750 Mg-500 mg LY3016859
Experimental
Participants received LY3016859 every 2 weeks with 750 mg as starting dose followed by 500 mg intravenous (IV) infusion for a total of 4 doses.
干预措施: LY3016859 (Drug)
Placebo
Placebo Comparator
Participants received LY3016859 every 2 weeks with 750 mg as starting dose followed by 500 mg IV infusion for a total of 4 doses.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Average Pain Intensity as Measured by the NRS
时间窗: Baseline, up to Week 8
The NRS was used during the preliminary data entry period and daily throughout the study to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine. Posterior mean change from baseline, 95% credible interval (CrI) was derived using Bayesian mixed model repeated measures.
次要结局
- Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change(Baseline, up to Week 8)
- Change From Baseline Assessment to Endpoint on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale)(Baseline, up to Week 8)
- Change From Baseline for Worst Pain Intensity as Measured by NRS(Baseline, up to Week 8)
- Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Total Interference Score(Baseline, up to Week 8)
- Change From Baseline on the Visual Analog Scale (VAS) for Pain(Baseline, up to Week 8)
- Total Amount of Rescue Medication Use as Measured by Average Dosage Per Week(Baseline up to Week 8)
- Change From Baseline on the EuroQol-5D 5 Level Questionnaire (EQ-5D-5L) (United States)(Baseline, up to Week 8)
研究者
研究点 (29)
Loading locations...
相似试验
已完成
2 期
Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Chronic Low Back PainChronic Low-back PainNCT04529096Eli Lilly and Company149
终止
2 期
Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Diabetic Peripheral Neuropathic PainDiabetic Peripheral Neuropathic PainNCT04707157Eli Lilly and Company68
已完成
2 期
Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Chronic Low Back PainChronic Low-back PainNCT04874636Eli Lilly and Company153
已完成
2 期
A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Diabetic Peripheral Neuropathic Pain (NP05).Diabetic Peripheral Neuropathic PainNCT05620576Eli Lilly and Company131
已完成
2 期
Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Diabetic Peripheral Neuropathic PainDiabetic Peripheral Neuropathic PainNCT05177094Eli Lilly and Company155