EUCTR2018-002523-42-DK进行中（未招募）1 期
A randomised, double-blind, placebo-controlled, dose-response study of the efficacy and safety of MEDI7352 in subjects with painful diabetic neuropathy
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 272
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male, or postmenopausal or surgically sterile female, 18 to 80 years of age
- •Post-menopausal women must have had = 12 months of spontaneous amenorrhea and a negative pregnancy test within 7 days of treatment. Surgically sterile women must have had a hysterectomy, bilateral ovariectomy (oophorectomy), or bilateral tubal ligation
- •Males who are biologically capable of having children must use of adequate contraception for the duration of the treatment period and for 3 months after the last administration of study drug
- •Body mass index of =42 kg/m2
- •Chronic PDN persistent for 6 months or longer not adequately controlled by standard of care treatments
- •Pain (beginning in the feet and with relatively symmetrical onset for 6 months or greater) due to bilateral peripheral neuropathy caused by either type 1 or type 2 diabetes mellitus, with bilateral decrease or absent reflexes at the ankles, or bilateral decrease of a sensory sign in the distal lower extremities
- •Mean pain intensity score =4, as measured on an 11 point NRS for a minimum of 7 days prior to Day 1
- •Willing and able to discontinue all NSAID or COX-2 analgesic therapy during study
- •Subjects taking medication for the treatment of PDN consistent with standard of care which has been stable for at least 3 months and are willing to maintain this dosing regimen for the duration of the study and use only protocol specified rescue medications
- •Treatment for non-excluded medical conditions must be stable for at least 28 days before Day 1 and expected to remain stale for the duration of the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 163
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 109
排除标准
- •Treatment with another biologic therapeutic agent
- •Previous treatment with any form of anti-NGF or anti-TNF therapy
- •Participation in another clinical study within 60 days or 5 half lves prior to screening
- •Plasma donation within 28 days of screening or any blood donation or blood loss >500 mL within 2 months of screening
- •Allogeneic bone marrow or stem cell transplant
- •Non-leukocyte-depleted whole blood transfusion within 120 days of the genetic research sample collection, if participating in the optional genetic research
- •Poor venous access such that IV drug delivery would be difficult
- •Involvement in the planning and/or conduct of the study
- •Presence of other clinically significant neuropathy (eg, hereditary neuropathy, inflammatory neuropathy) or other clinically significant disorder (eg, nerve compression injury) involving abnormal peripheral sensation, with an aetiology considered to be distinct from that of PDN, and likely to interfere with assessment of peripheral nerve function
- •History of osteonecrosis, rapidly progressing OA, subchondral insufficiency fractures, neurogenic arthropathy, or analgesia-induced arthropathy
- •Diagnosis of clinically significant OA currently affecting a major joint in the upper or lower extremity or axial spine; or other degenerative disease affecting any joint where there is an identified risk of osteonecrosis, rapidly progressing OA, subchondral insufficiency fractures, neurogenic arthropathy or analgesia-induced arthropathy
- •Chronic pain condition, other than PDN, likely to interfere with the evaluation of PDN pain
- •Major psychiatric disorder likely to confound interpretation of drug effect, affect pain assessment or ability to complete the study
- •Significant cardiovascular disease, congestive heart failure, clinically significant stenosis or occlusion of a carotid or vertebral artery or clinically significant arrhythmias
- •Significant or chronic lung disease, including severe or unstable COPD or severe or unstable asthma
- •Known or suspected systemic infection, including HIV, HBV, HCV, or tuberculosis
- •History or evidence of any significant autoimmune disease or disorder, including inflammatory bowel disease, multiple sclerosis, or systemic lupus erythematosus
- •History of severe allergy/hypersensitivity reactions or history of hypersensitivity to immunisations or immunoglobulins
- •History of cancer within 5 years except non-metastatic basal cell carcinoma of the skin, carcinoma in situ of the cervix, or non-progressive prostate cancer
- •Transient ischaemic attack or stroke in the last 3 years
- •History of alcohol or recreational drug dependence within 2 years except nicotine dependence
- •Myocardial infarction, hospitalisation for unstable angina or arrhythmia or unexplained syncope within 1 year
- •Clinically important infection, including chronic, persistent, or acute infection, within 3 months of screening or between screening and randomisation
- •Current serious or unstable clinically important illness, including avascular necrosis, respiratory, cardiovascular, gastrointestinal, endocrinologic (excluding well-controlled type 1 or type 2 diabetes), immunologic, haematologic, neurologic, or other major disease likely to detieriorate or affect ability to complete the study
- •Any significant medical or surgical procedure or trauma within 28 days of Day 1, or planned to be undertaken within the timeframe of the clinical trial, that will likely affect the subject’s safety or ability to complete the study, or the scientific integrity
研究者
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