A Phase 3 Study to Evaluate the Efficacy and Safety of Resiniferatoxin for Pain Due to Osteoarthritis of the Knee
A Phase 3 Study to Evaluate the Efficacy and Safety of Resiniferatoxin for Pain Due to Osteoarthritis of the Knee
This study evaluates the efficacy and safety of intra-articular injection of resiniferatoxin
 in patients with moderate to severe knee pain due to osteoarthritis.
This study is to evaluate the analgesic efficacy and safety of resiniferatoxin administered
 intra-articularly to subjects with moderate to severe knee pain due to osteoarthritis (OA).
Key Inclusion Criteria:

 -  Male or female 35 to 85 years of age (inclusive).

 -  Diagnosis of moderate to severe pain in the index knee due to OA.

 -  Pain in the non-index knee is less than pain in the index knee.

 -  Body mass index ≤40 kg/m².

 -  Experienced treatment failure with at least 2 prior categories of therapies.

 -  Able to understand and complete study-related forms and communicate with the
 Investigator and/or site staff.

 Key Exclusion Criteria:

 -  Evidence or history of a serious coagulopathy or hemostasis problem, such as inherited
 bleeding disorders or thrombocytopenia.

 -  History of or current condition of poorly controlled hypertension, QTc prolongation,
 history of risk factors for Torsades de Pointes, or family history of long QT
 syndrome; or is using concomitant medications that prolong the QT interval.

 -  Received index knee injections with corticosteroids within 30 days, or hyaluronic acid
 within 3 months, or platelet-rich plasma within 6 months prior to the injection day.

 -  Pre-existing osteonecrosis, subchondral insufficiency fracture, severe bone on bone
 OA, or knee pain attributable to disease other than OA.

 -  Instability or misalignment in the index knee.

 -  Concurrent use of opioids or indications other than knee pain.

 -  History within the past 2 years of substance abuse, including alcohol.

 -  Allergy or hypersensitivity to chili peppers, capsaicin, resiniferatoxin,
 acetaminophen, tramadol, or radiographic contrast agents.

 -  Female participants who are pregnant, planning on becoming pregnant, or currently
 breastfeeding.

 -  Any medical condition or comorbidities that, in the Investigator's opinion, could
 adversely impact study participation or safety, conduct of the study, or interfere
 with pain assessments.

 -  Sensory peripheral neuropathy that is of moderate severity or higher.

 -  Arterial or venous thrombi (including stroke), myocardial infarction, hospital
 admission for unstable angina, cardiac angioplasty, or stenting within the past 12
 months.

 -  Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related
 illness, acute or history of chronic hepatitis B or hepatitis C. Participants with
 these viral infections who are receiving or have received antiviral treatment and have
 a viral load that is undetectable are eligible.

 -  Concurrent medical or arthritic conditions that could interfere with the evaluation of
 the index knee joint including chondromalacia patellae, metabolic diseases,
 gout/pseudogout, hemochromatosis, acromegaly, fibromyalgia, rheumatoid arthritis, or
 other inflammatory arthropathies affecting the knee joint.

 -  Undergone arthroscopic surgery of the index knee within 6 months of the injection day,
 or open surgery to the index knee within 24 months of the injection day.

 -  Undergone replacement surgery of the index knee.

 -  Presence of surgical hardware or other foreign bodies in the index knee.