Safety and Tolerability Study of PCRX-201 Knee Injection for Adults 45 to 80 with Osteoarthritis Pain

What this Trial Is About

This trial studies the safety and tolerability of different doses of PCRX-201, an investigational injection, for adults aged 45 to 80 with painful osteoarthritis of the knee. It compares two doses of PCRX-201 to placebo over one year, assessing adverse events and exploring effects on knee pain and joint function. The study includes two parts using PCRX-201 manufactured by different processes, enrolling 135 participants with specific knee osteoarthritis grades. Participants receive a single knee injection of PCRX-201 or placebo after a steroid pretreatment with methylprednisolone acetate. The study randomly assigns subjects to dose groups stratified by knee osteoarthritis severity using X-rays and MRI or ultrasound for synovitis assessment. Part A enrolls 45 subjects Part B enrolls 90 subjects, contingent on drug availability. Both parts include careful screening and dosing procedures. Participants attend multiple clinic visits for pretreatment, injection, and follow-up assessments. Visits occur weekly, bi-weekly, and then monthly through Week 52, followed by 8 visits over the next four years. Researchers monitor adverse events, inflammation markers, antibody levels, and knee pain through questionnaires and laboratory tests. The total participation can last up to five years for long-term safety and effectiveness monitoring.

A Study to Assess Safety and Tolerability of PCRX-201 in Subjects With Painful Osteoarthritis of the Knee