Enekinragene Inzadenovec for Knee Arthritis

Recruiting at 16 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Pacira Pharmaceuticals, Inc

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if a single knee injection of different doses (Dose A and Dose B) of an investigation product PCRX-201, following steroid pretreatment, is safe and tolerable in male of female patients 45 to 80 years old with osteoarthritis of the knee. It will also learn how the body reacts to the PCRX-201 injection and how effective the treatment is. Researchers will compare Dose A and Dose B of PCRX-201 versus placebo from Week 1 through Week 52 to assess adverse events. Researchers will also explore how PCRX-201 may impact knee pain and joint function over time. Participants will be asked to * Visit the clinic for pretreatment and drug administration * Visit the clinic for checkups and tests: 1. Screening through Week 52: intially weekly, bi-weekly, later monthly 2. Week 53 through Week 260 (Year 5): 8 visits throughout the period

Research Team

Nino Joy, MD

Principal Investigator

Pacira Pharmaceuticals, Inc

Eligibility Criteria

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

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Exclusion Criteria

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

Subjects are unable to undergo MRI with contrast MRI

Subjects with X-ray or MRI exclusionary events

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Trial Timeline

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

Treatment Details

Interventions

Enekinragene Inzadenovec (PCRX-201) (Virus Therapy)

Trial OverviewThe 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.

Participant Groups

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B Dose BExperimental Treatment1 Intervention