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

A Phase 2, Two-Part, Randomized, Double-Blind, Active-Controlled Study to Assess the Safety and Tolerability of Enekinragene Inzadenovec (PCRX-201) in Subjects With Painful Osteoarthritis of the Knee

Phase 2 Interventional Pacira Pharmaceuticals, Inc · NCT06884865

This study is testing a new gene therapy called PCRX-201 to see if it can safely relieve knee pain in people aged 45 to 80 with osteoarthritis.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment135 (estimated)
Ages45 Years to 80 Years
SexAll
SponsorPacira Pharmaceuticals, Inc Industry-sponsored
Locations17 sites (Birmingham, Alabama and 16 other locations)
Trial IDNCT06884865 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 45 to 80 who have experienced knee pain due to osteoarthritis for at least 12 months and have not responded to previous therapies.

Not a fit: Patients with Kellgren-Lawrence Grade 4 osteoarthritis may not benefit as they are capped in enrollment and may require different treatment approaches.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective option for managing knee pain in osteoarthritis patients.

How similar studies have performed: While gene therapy for osteoarthritis is a novel approach, similar studies have shown promise in other conditions, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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.
* 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 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

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

Other protocol-defined criteria apply

Where this trial is running

Birmingham, Alabama and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Osteoarthritis of the Kneegene therapyKnee Pain Arthritis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.