Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

Male or female, aged 40 to 80 years
Symptomatic knee OA with Kellgren-Lawrence radiographic classification of 2 or 3 (mild or moderate) as assessed by the central reading facility
Target knee pain ≥ 20 and ≤ 40 out of 50 the WOMAC®NRS 3.1 pain questionnaire (sum of 5 questions) at screening and baseline
Onset of symptomatic OA of the target knee was at least 6 months prior to screening
Insufficient or failed response or intolerance to analgesics and/or non-steroidal anti-inflammatory drugs, as reported by the participant

IF FEMALE, must meet all of the following:

Not breast feeding
Not planning to become pregnant during the study
If of childbearing potential, must have a negative pregnancy test result within 72 hours prior to receiving the intra-articular injection, and must commit to the use of a highly effective form of birth control (See Appendix A) for at least 12 weeks after the injection
Willingness to remain on the same oral "rescue" (as needed) analgesic as the only pharmacologic treatment for knee pain during the study
Willingness to abstain from taking any illicit or unauthorized medications for treatment of OA or any other concurrent condition during the study
Written informed consent is obtained from the participant

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

Participant is non-ambulatory (unable to walk >50 feet without assistance)
Clinically severe obesity as defined by the National Institutes of Health (body mass target ≥40 kg/m2)
Contralateral knee pain equal to or exceeding the pain in the target knee (on the WOMAC® NRS3.1 pain questionnaire) at screening and/or baseline
Clinically significant effusion of the target knee at either the screening or baseline visits determined by physical examination (e.g., ballotable patella or positive bulge sign). Note: Participants presenting with effusion may be enrolled in the study after undergoing knee aspiration to remove excess fluid in the target joint.
Severe (excessive) malalignment of the tibial-femoral axis, assessed radiographically
Presence of active infection of the target knee or systemic infection requiring treatment within the 3 months prior to screening
Clinical diagnosis of inflammatory arthritis (e.g., rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, etc.) established by clinical history, examination, or serology

Participant is receiving, has received, or plans to receive any of the following therapies

Prior administration of hyaluronic acid, extended release corticosteroid (e.g., Zilretta®), platelet-rich plasma (PRP), or stem cell therapies by intra-articular injection(s) of the target knee within 6 months prior to screening
Prior intra-articular corticosteroid within 3 months prior to screening or into any other joint within 30 days prior to screening
Current chronic systemic use of corticosteroids in doses exceeding 10 mg prednisolone-equivalents daily
Treatment with any investigational therapy (drug, device, or biologic) within 3 months prior to screening or is planned for the duration of the study
Treatment with immunosuppressive medication or chemotherapy within the past 5 years
Chronic use of narcotics or alcohol abuse within the past 6 months prior to screening
Surgery to the target knee (including arthroscopy) within 6 months prior to receiving the intra-articular injection or planned surgery to the target knee within 6 months after the injection
Participant previously underwent arthroplasty of the target knee
Presence of joint instability or complaints of locking, intermittent limitation in range of motion, or loose body sensation, suggestive of internal derangement of the knee (either extremity)
Symptomatic OA of the non-target knee that is not responsive to paracetamol (acetaminophen) or oral nonsteroidal anti-inflammatory drugs (NSAIDs).
Diagnosis of lower extremity gout or pseudo-gout in the past 6 months
Osteonecrosis of either knee
Significant acute (within the past 3 months) injury to the target knee
History of receiving a solid organ or hematologic transplant
History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 years, except for basal or squamous cell carcinoma of the skin
History of prior radiation therapy of the target knee
History of autoimmune disease affecting the musculoskeletal system
Known (documented) history of acquired immune deficiency syndrome or human immunodeficiency virus
Any condition causing pain in or around the target knee (e.g., radiating pain, pain in another region of the ipsilateral lower extremity) that may interfere with assessment(s) of the target knee
Other chronic pain anywhere in the body that requires the chronic use of analgesic medications, such as fibromyalgia, neuropathic pain, low back pain, etc.
Presence of contraindications for use of 3 g/day of orally administered paracetamol/acetaminophen due to known hypersensitivity or hepatic impairment.
Known presence of any concurrent medical condition (e.g., hematologic renal, hepatic, cardiac, or coagulation abnormalities) that in the investigator's judgment would interfere with the required study assessments and study participation
Participant is involved in litigation (e.g., worker's compensation) for a medical condition or injury at any anatomical site