Noosaville

Researchers are conducting a multicenter, prospective, randomized, double-blind, placebo-controlled Phase 3 study to assess the effectiveness, safety, and tolerability of a single intra-articular injection of PTP-001 (MOTYS) in adults aged 40 to 80 years with knee osteoarthritis. The study focuses on participants with mild to moderate radiographic knee OA and symptomatic knee pain, aiming to compare PTP-001 against a placebo over a 52-week period. Participants will be randomly assigned in equal numbers to receive either a single dose of PTP-001 or a placebo saline injection into the target knee on Day 1. The study includes a screening period up to 28 days before treatment, a one-day treatment phase, and a 12-month follow-up phase. A total of at least 260 participants are planned, with 130 in each treatment group. During the study, participants will undergo evaluations to measure improvements in knee function and pain at 6 months. Researchers will monitor symptoms using pain scales and collect safety data throughout the year. Participants are expected to adhere to study visit schedules, use acetaminophen as needed for knee pain, and avoid other unauthorized medications during the trial.