Efficacy and Safety of MT-5547 in Patients With Osteoarthritis Accompanied by Moderate to Severe Pain

Inclusion Criteria

Additional screening criteria check may apply for qualification:

• Male and female Japanese patients, 40 years to 85 years at the time written informed consent is obtained.
• Patients who have been diagnosed with osteoarthritis (OA) of the knee or hip based on the American College of Rheumatology (ACR) criteria.
• Patients with an evaluated joint (knee or hip) with a K-L (Kellgren-Lawrence) score of ≥2 based on the X-ray test performed.
• Moderate to severe pain in the evaluated joint, defined as a WOMAC pain score of ≥4 (mean of the 5 items), on the WOMAC assessments.
• Patients who satisfy both 1) and 2) below.
• Inadequate OA pain relief from at least 1 oral NSAID.
• Intolerance to or inadequate OA pain relief from at least 1 opioid (including combination drugs), or unwillingness to take opioid therapy.
• Patients who agree to not change their current lifestyle (daily living activities and exercise) throughout the study.
• Patients who are able to complete post-operative follow-up for any joint replacement surgery that is performed during the study.
• Body mass index at screening ≤39.
• Patient who are able to understand and answer endpoint questions used in the study.

Exclusion Criteria

Additional screening criteria check may apply for qualification:

• Presence of symptoms of carpal tunnel syndrome within 6 months before screening.
• Patients who cannot undergo MRI.
• Trauma to the index joint within 3 months prior to screening.
• Presence or history of inflammatory joint diseases other than OA, Paget's disease of the spine, pelvis or femur, multiple sclerosis, fibromyalgia, vertebral tumors or infections, or renal osteodystrophy.
• Presence or history, confirmed by imaging, of arthropathy, neuropathic joint arthropathy, hip dislocation, knee dislocation, extensive subchondral cyst, marked bone destruction or bone loss, or pathologic fractures.
• Autonomic neuropathy diagnosed in the assessment of autonomic nerve symptoms performed at screening, or baseline.
• Presence or history of orthostatic hypotension at the orthostatic hypotension assessments performed at screening, prerandomization, or baseline.
• Presence or history of autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathy such as reflex sympathetic dystrophy at screening.
• Presence or history of chronic familial dysautonomia.
• Intolerance to naproxen.
• Systemic (excluding topical, intranasal, ophthalmic, and inhaled formulations) corticosteroids within 4 weeks prior to screening.
• Intra-articular corticosteroids in the evaluated joint within 12 weeks prior to screening, or in any other joint within 4 weeks prior to screening.
• Received an intra-articular injection of hyaluronic acid in any joint within the period specified for each medicine prior to screening.
• Resting heart rate of 100 bpm at screening, or baseline.
• Presence or history of 2nd or 3rd degree heart block, 1st degree heart block with abnormal QRS, or bifascicular block by ECG assessment at screening.
• Non-compliance with the Numerical rating scale (NRS) recording (average pain on walking in the evaluated joint over 1 day) during the pre-treatment observation period.
• Women who are pregnant, breast-feeding, or may be pregnant.
• Use of an anti-Nerve growth factor (anti-NGF) antibody in the past, or apparent hypersensitivity or intolerance to anti-NGF antibodies.