Virus Therapy

Enekinragene Inzadenovec for Knee Arthritis

Huntington Beach, CA

Phase 2

Recruiting

Research Sponsored by Pacira Pharmaceuticals, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must have K-L Grade 2, 3, or 4 in the index knee based on X-rays performed during Screening and confirmed by trained radiographers at a central facility before enrollment

Subjects must be male or female and 45 to 80 years old, inclusive, at Screening

Must not have

Subjects have any active systemic or local infection, including infection of the index knee

Subjects have used any approved or investigational IA drug/biologic in index knee within 6 months of Screening (eg, hyaluronic acid, platelet rich plasma, stem cells, prolotherapy, and amniotic fluid injection)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial will test if a single knee injection of different doses of an investigational product called PCRX-201 is safe and effective for treating knee osteoarthritis in patients aged 45 to

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Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored from Week 1 through Week 52 for any adverse events related to the single knee injection of PCRX-201 following steroid pretreatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My knee arthritis is moderate to severe according to recent X-rays.

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I am between 45 and 80 years old.

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I've had knee pain for more than 15 days in the last month.

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My knee and the area for injection show no signs of infection.

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My daily knee pain score is between 5 and 9.

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My knee is swollen and has been confirmed by an ultrasound.

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I have knee pain, am over 50, or have stiffness, noise, or bone spurs in my knee.

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My MRI shows I have moderate or severe joint inflammation.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any active infections, including in my knee.

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I haven't had knee injections with any treatment like stem cells or PRP in the last 6 months.

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My knee has been unstable due to an injury within the last year.

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I have not had gene therapy, like IL-1Ra, in the last 3 years.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B Dose BExperimental Treatment1 Intervention