PCRX-201 (enekinragene inzadenovec)
Safety and Tolerability of PCRX-201 for Patients With Painful Osteoarthritis of the Knee
Summary1
Condition: Knee osteoarthritis
Treatment: PCRX-201, placebo
Male & Female
Age Range: 45–80 years
17 Locations
Phase 2
What is this study about?
- This study is exploring a potential new treatment, PCRX-201, for people aged 45–80 who have knee osteoarthritis (OA), a condition that causes joint pain, stiffness, and reduced mobility. The goal is to learn whether PCRX-201, given as a single knee injection after a standard steroid pretreatment, is safe, well tolerated, and effective in easing pain and improving joint function. Researchers also want to understand how the body reacts to PCRX-201 over time and how it compares with a placebo (an inactive injection).
What treatment is being studied?
- The treatment being studied is PCRX-201, an investigational injectable medicine designed to help reduce knee pain and inflammation caused by osteoarthritis1
- How it works: PCRX-201 is injected directly into the knee joint, where it may help protect the joint and reduce symptoms over time1
- How it’s given: Participants receive one injection of either PCRX-201 or a placebo1
What will happen during the study?
- About 135 participants with knee osteoarthritis will take part in this study, which is divided into two parts. Each participant will be randomly assigned to receive one of three treatments: PCRX-201 Dose A, PCRX-201 Dose B, or a placebo. Before receiving the study injection, each participant will be given a small dose of a steroid (methylprednisolone acetate) to help reduce inflammation. Participants will visit the clinic regularly and attend follow-up visits over several years to monitor long-term safety and results. Throughout the study, participants will be closely monitored for any side effects and asked to report knee pain, function, and overall well-being1
How can I learn more?
If you’d like to learn more about this study or find out whether you may be eligible to participate, talk to your healthcare provider, reach out to the study team at your local research center or contact lisa.ramsay@pacira.com.
Recruitment Locations
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