Arthritis Clinical Trials

⁃ Participants must meet all of the inclusion criteria listed below to be eligible for the study:

• Age 64 years or above.

• Diagnosis of primary femorotibial knee OA.

• Radiographic evidence of knee OA defined as Kellgren-Lawrence (KL) grade 2 or 3 in the index knee.

• Participants who are intolerant to, or have failed to adequately respond to at least 2 OA therapies.

• Index knee pain assessed during the screening period and following wash-out of pain medications.

• Willingness to abstain from prohibited medications/treatments during the trial.

• Women who are postmenopausal (≥12 months natural amenorrhea without alternative cause) or surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).

• Male participants with partners of childbearing potential, who are not surgically sterile (vasectomy) for at least 6 months prior to randomization, must use condoms with spermicide in addition to their partner's contraception from randomization and for 90 days after last dose.