Assessing the safety of PCRX-201 for knee osteoarthritis pain relief

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and tolerability of a gene therapy product, PCRX-201, administered via a single knee injection in patients aged 45 to 80 with painful osteoarthritis of the knee. Participants will receive either PCRX-201 at different doses or a placebo, following a steroid pretreatment, and will be monitored for adverse events and changes in knee pain and joint function over a period of 52 weeks. The study will involve regular clinic visits for assessments and will stratify participants based on the severity of their osteoarthritis as classified by Kellgren-Lawrence grades.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 be male or female and 45 to 80 years old, inclusive, at Screening.
* Subjects must exhibit symptoms associated with osteoarthritis of the index knee for ≥12 months before Screening (subject self-reporting is acceptable).
* Subjects must have index knee pain for \>15 days over the last month before Screening (subject self-reporting is acceptable).
* Subjects must have received 2 or more failed 2 or more therapies: Restricted physical activity as per Osteoarthritis Research Society International (OARSI) core level recommendation, ie, "structured land-based exercise" (this may include physical therapy), and failure of an additional type of conservative therapy for OA of the index knee, eg, nonselective NSAIDs or COX-2 inhibitors, in the past 12 months.
* Subjects must have a body mass index (BMI) ≤40 kg/m2 at Screening.
* Subjects must have an index knee examination indicating the index knee and the intended injection site area are free of any signs of local or joint infection at Baseline.
* Subjects must have an index knee Average Daily Knee Pain (NRS) between ≥5.0 and ≤9.0 at Screening and Baseline.
* Sexually active subjects of child-bearing potential (SOCBP) and their partners must agree to use effective birth control while in the study
* Subjects must have active synovitis in the index knee as determined by ultrasound Doppler (Part A only) For Part B, participants must have active synovitis in the index knee as determined by contrast-enhanced MRI.
* Subjects must exhibit American College of Rheumatology Criteria (clinical and radiological) for osteoarthritis as follows:

  1. Knee pain
  2. At least 1 of the following:

  i. Age \>50 years ii. Morning stiffness \<30 minutes iii. Crepitus on knee motion c. Osteophytes
* Subjects must have K-L Grade 2, 3, or 4 (Part A) or K-L Grade 2 or 3 (Part B) in the index knee based on X-rays performed during Screening and confirmed by trained radiographers at a central facility before enrollment
* Subjects need to show the presence of moderate or severe synovitis based on 11-point synovitis score using contrast-enhanced MRI (Part A). For Part B, participants need to show the presence of synovitis ≥5 on the Guermazi synovitis scoring scale using contrast-enhanced MRI to be enrolled.

Exclusion Criteria:

* Subjects have any current or prior diagnosis of autoimmune connective tissue disorders, secondary OA conditions, benign synovial tumors, gout/pseudogout, reactive arthritis, RA, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease.
* Subjects have any active systemic or local infection, including infection of the index knee
* Subjects are unable to undergo MRI with contrast MRI
* Subjects with X-ray or MRI exclusionary events
* Subjects have an unstable index knee joint (eg, torn anterior cruciate ligament) within 12 months of Screening
* 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)
* Subjects are receiving or have received any gene therapy treatment (eg, IL-1Ra) in the past 3 years
* Subjects have used IA steroids ≤3 months before screening
* For Part B, subjects with any surgery related tot he index knee.

Other protocol-defined criteria apply

Where it's running

• Beach Physicians Medical Group Inc.
  Huntington Beach, California, United States Recruiting
• Arrow Clinical Trials
  Daytona Beach, Florida, United States Recruiting
• Physicians Research Collaboration
  Lincoln, Nebraska, United States Recruiting
• Flourish Research - Birmingham
  Birmingham, Alabama, United States Not yet recruiting
• Alabama Clinical Therapeutics, LLC
  Birmingham, Alabama, United States Withdrawn
• OrthoArizona
  Phoenix, Arizona, United States Not yet recruiting

Study contacts

• Study coordinator: Lisa Ramsay, MA
• Email: lisa.ramsay@pacira.com
• Phone: 973-451-4019

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.