A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase 3 Study of Intra-Articular Administration of an Allogeneic Human Placental Tissue Particulate (PTP-001) for the Treatment of Knee Osteoarthritis
This is a multicenter, prospective, randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of intra-articular administration of PTP-001 (MOTYS) for the treatment of knee osteoarthritis. The purpose of the trial is to evaluate the efficacy, safety, and tolerability of a single intra-articular injection of PTP-001 compared to placebo over a 52-week period in participants with radiographic and symptomatic knee OA.
• Males and females aged 40 to 80 years.
• Presenting with symptomatic knee OA with Kellgren-Lawrence (KL) radiographic classification of 2 or 3 (mild or moderate), as assessed by the central reading facility.
• Primary source of pain throughout the body is due to OA in the target knee.
• Target knee pain ≥ 20 and ≤ 40 out of 50 on the WOMAC® numerical rating scale (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, failed response, or intolerance to analgesics and / or non-steroidal anti-inflammatory drugs (NSAIDs), as reported by the participant.
• If female, must meet all of the following:
∙ Not breast feeding,
‣ Not planning to become pregnant during the study,
‣ Must abstain from ova / egg donation 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 for at least 90 days after the injection.
• Willing to remain on the same oral rescue (as needed) analgesic as the only pharmacologic treatment for knee pain during the study.
• Willing to abstain from taking any illicit or unauthorized medications for treatment of OA or any other concurrent condition during the study.
⁃ Willing to comply with post-injection restrictions.
⁃ Written informed consent is obtained from the participant.