Efficacy and Safety of MEDI7352 in Subjects With Painful Diabetic Neuropathy

This is an interventional treatment trial for Painful Diabetic Neuropathy Read More

Key Inclusion criteria:

• Male, or postmenopausal or surgically sterile female, 18 to 80 years of age
• Body mass index of ≤42 kg/m2.
• Chronic PDN persistent for 6 months or longer, not adequately controlled by standard of care treatments.
• mean pain intensity score of ≥4, as measured on an 11-point (0-10) NRS
• willing and able to discontinue all NSAID or COX-2 analgesic therapy
• currently be taking medication for the treatment of PDN. Subjects should be taking at least one of the first-line medications (consistent with regional or local standard of care guidelines for PDN)

Key Exclusion criteria:

• 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 that is considered to be distinct from that of PDN, and that is likely to interfere with assessment of peripheral nerve function, as judged by the investigator.
• 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 extremity (shoulder, elbow, or wrist) or lower extremity (hip, knee, or ankle) or axial spine; or other degenerative disease affecting any joint in subjects for whom, in the opinion of the investigator, 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, that is likely to interfere with the evaluation of the subject's PDN pain, as judged by the investigator
• Haemoglobin A1C greater than 8.5% (>8.5%).