135 Participants Needed

Enekinragene Inzadenovec for Knee Arthritis

Recruiting at 17 trial locations
LR
BA
Overseen ByBassil Aish
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Pacira Pharmaceuticals, Inc
Must be taking: Steroids
Prior Safety DataThis treatment has passed at least one previous human trial

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?

NJ

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

I have had knee pain from arthritis for over a year.
Subjects must be willing and able to comply with the study procedures and visit schedule and able to follow verbal and written instructions
Subjects must have a body mass index (BMI) ≤40 kg/m2 at Screening
See 10 more

Exclusion Criteria

Subjects are unable to undergo MRI with contrast MRI
Subjects with X-ray or MRI exclusionary events
I do not have any active infections, including in my knee.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Pretreatment

Participants receive a pretreatment with methylprednisolone acetate (40 mg) on Day 1

1 day
1 visit (in-person)

Treatment

Participants receive a single intra-articular injection of PCRX-201 or placebo and are monitored for safety and tolerability

52 weeks
Weekly, bi-weekly, then monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

208 weeks
8 visits throughout the period

What Are the Treatments Tested in This Trial?

Interventions

  • Enekinragene Inzadenovec (PCRX-201)
Trial Overview The study is testing two different doses of PCRX-201, an investigational drug, against a placebo in patients with knee osteoarthritis. The focus is on safety, tolerability, how the body reacts to it, and its effectiveness in reducing pain and improving joint function over one year.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B Dose BExperimental Treatment1 Intervention
Group II: Part B Dose AExperimental Treatment1 Intervention
Group III: Part A, Dose BExperimental Treatment1 Intervention
Group IV: Part A Dose AExperimental Treatment1 Intervention
Group V: Part B PlaceboPlacebo Group1 Intervention
Group VI: Part A, PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pacira Pharmaceuticals, Inc

Lead Sponsor

Trials
142
Recruited
14,300+
Headquarters
Tampa, USA
Known For
Non-opioid Pain Management
Top Products
Exparel, Zilretta, iovera
Dr. Jonathan Slonin profile image

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

Citations

Release details... -- Data demonstrates sustained clinical improvements in pain, stiffness and function for up to 156 weeks following a single ...
PCRX-201 High-Capacity Adenovirus Serotype 5 Gene ...PCRX-201 High-Capacity Adenovirus Serotype 5 Gene Therapy Demonstrates Sustained Clinical Efficacy and Safety in Patients With Knee Osteoarthritis [abstract].
Release detailsPacira BioSciences to Present 3-Year Data Demonstrating Sustained Pain and Function Improvements in Knee Osteoarthritis with Investigational ...
Derek Jackson, BS, MA, on Evaluating Gene Therapy ...Pacira Biosciences is currently evaluating enekinragene inzadenovec (PCRX-201), an investigational high-capacity adenovirus (HCAd) vector gene therapy intended ...
Pacira BioSciences Reports 3-Year Sustained Efficacy Data ...Pacira BioSciences will present 3-year data from its Phase 1 trial of PCRX-201 gene therapy at the American College of Rheumatology ...
Pacira BioSciences to Present 3-Year Data Demonstrating ...Pacira BioSciences to Present 3-Year Data Demonstrating Sustained Pain and Function Improvements in Knee Osteoarthritis with Investigational ...
Enekinragene Inzadenovec for Knee ArthritisPrior Safety DataThis treatment has passed at least one previous human trial ... Participants receive a single intra-articular injection of PCRX-201 or placebo ...
enekinragene inzadenovec (PCRX-201) / GQ Bio Therap, ...A Study to Assess Safety and Tolerability of PCRX-201 in Subjects With Painful Osteoarthritis of the Knee ... data suggest the IA PCRX201 has an acceptable safety ...
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