Enekinragene Inzadenovec for Knee Arthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment, Enekinragene Inzadenovec (PCRX-201), for knee osteoarthritis, which can make walking and daily activities painful. Researchers aim to determine if a single injection of PCRX-201, administered at two different doses, is safe and can reduce knee pain while improving joint function. They seek individuals who have experienced knee osteoarthritis symptoms for over a year and have tried at least two other treatments without success. Participants will receive regular checkups to monitor progress over several years. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have used certain knee injections or gene therapy recently. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that enekinragene inzadenovec (PCRX-201) was safe in earlier studies. Participants who received a single injection of PCRX-201 generally tolerated it well, with no major safety issues identified. The data suggest that the treatment is safe, as it did not cause significant negative effects. This information comes from previous human trials where a single injection was administered in the knee.12345
Why are researchers excited about this trial's treatments?
Enekinragene Inzadenovec (PCRX-201) is unique because it offers a novel approach to treating knee arthritis through a single intra-articular injection that directly targets the affected area. Unlike current treatments such as NSAIDs, corticosteroids, or physical therapy, Enekinragene Inzadenovec works potentially by modulating specific genetic pathways linked to inflammation and cartilage health. This targeted mechanism could reduce side effects associated with systemic medications and provide more efficient relief. Researchers are excited about this treatment's potential to offer faster and more sustained relief from arthritis symptoms, improving the quality of life for patients.
What evidence suggests that this trial's treatments could be effective for knee arthritis?
Research has shown that enekinragene inzadenovec, also known as PCRX-201, may help treat knee osteoarthritis. Studies have found that a single injection can lead to lasting improvements in pain, stiffness, and joint function for up to three years. This trial will test different doses of PCRX-201, with some participants receiving Dose A and others receiving Dose B, to evaluate its effectiveness and safety. The treatment uses a special method to deliver helpful genes directly to the knee joint. Clinical data suggests that PCRX-201 is both effective and safe, offering a potential option for people with knee osteoarthritis. Results so far are promising, with patients experiencing significant relief and improved mobility.12678
Who Is on the Research Team?
Nino Joy, MD
Principal Investigator
Pacira Pharmaceuticals, Inc
Are You a Good Fit for This Trial?
This trial is for men and women aged 45 to 80 with painful knee osteoarthritis. Participants will receive a steroid pretreatment followed by an injection of PCRX-201 or placebo into the knee. They must be able to attend numerous clinic visits over five years for checkups and tests.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pretreatment
Participants receive a pretreatment with methylprednisolone acetate (40 mg) on Day 1
Treatment
Participants receive a single intra-articular injection of PCRX-201 or placebo and are monitored for safety and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Enekinragene Inzadenovec (PCRX-201)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pacira Pharmaceuticals, Inc
Lead Sponsor
Dr. Jonathan Slonin
Pacira Pharmaceuticals, Inc
Chief Medical Officer since 2020
BSc in Biomedical Engineering and MD from University of Miami, MBA from George Washington University
Frank D. Lee
Pacira Pharmaceuticals, Inc
Chief Executive Officer since 2024
BSc in Chemical Engineering from Vanderbilt University, MBA from Wharton Graduate School of Business