A Double-Blind, Placebo-Controlled Assessment of the Tolerability and Efficacy of XT-150 for the Treatment of Moderate to Severe Pain Due to Osteoarthritis of the Knee
This is a Phase 2 safety and efficacy study of XT-150 in adult participants experiencing moderate to severe pain due to osteoarthritis of the knee.
• Symptomatic disease due to osteoarthritis, defined as a WOMAC Pain score ≥ 8 (worst possible = 20)
• Focused Analgesia Selection Test will be used to determine whether patients can report pain with sufficient consistency to enter the clinical trial
• Males and females between 45 and 85 years of age, inclusive
• Kellgren-Lawrence grading of 2 or 3 within the last 6 months
• Stable analgesic regimen during the 4 weeks prior to enrollment
• In the judgment of the Investigator, acceptable general medical condition
• Life expectancy \>6 months
• Male and female participants who are heterosexually active and not surgically sterile must agree to use effective contraception, including abstinence, for the duration of the study
• Have suitable knee joint anatomy for intra-articular injection
⁃ Willing and able to return for the follow-up (FU) visits
⁃ Able to read and understand study instructions, and willing and able to comply with all study procedures