Apply to Trial

Compensation: Varies

Number of Visits: 10

Duration: 52 weeks

135 Participants Needed

Enekinragene Inzadenovec for Knee Arthritis

Recruiting at 17 trial locations

Overseen ByBassil Aish

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Pacira Pharmaceuticals, Inc

Must be taking: Steroids

Must not be taking: IA drugs, Gene therapy

Disqualifiers: Autoimmune disorders, Infections, Unstable knee, others

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.¹ ² ³ ⁴ ⁵

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.¹ ² ⁶ ⁷ ⁸

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

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?

Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B Dose BExperimental Treatment1 Intervention