A study of MEDI7352 in painful diabetic neuropathy
- Conditions
- Painful diabetic neuropathyMedDRA version: 20.0Level: PTClassification code 10012680Term: Diabetic neuropathySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2018-002523-42-ES
- Lead Sponsor
- AstraZenecaAB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 271
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 108
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy of MEDI7352 versus placebo on chronic pain in subjects with painful diabetic neuropathy (PDN) currently taking standard of care medication for their PDN pain.;Secondary Objective: To assess the safety and tolerability of MEDI7352 in subjects with PDN<br>To assess the pharmacokinetics , pharmacodynamics and immunogenicity of MEDI7352 in subjects with PDN<br>To characterise the dose-response relationship of MEDI7352 on chronic pain in subjects with PDN;Primary end point(s): Change in the weekly average of the average daily NRS pain scores from the baseline of MEDI7352 compared to placebo;Timepoint(s) of evaluation of this end point: Week 12
- Secondary Outcome Measures
Name Time Method