A Study to Assess Safety and Tolerability of PCRX-201 in Subjects With Painful Osteoarthritis of the Knee

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Osteoarthritis (OA) of the Knee

In brief

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

Key facts

Study ID

NCT06884865

Run by

Pacira Pharmaceuticals, Inc

People needed

135

Starts

2025-02-26

Expected to finish

2032-07-01

Last updated by the study team

2026-08-07

Who can join

Age: 45 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Knee pain
• 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.

You may not qualify if…

• 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 is running

• Arrow Clinical Trials — Daytona Beach, Florida, United States (enrolling)
• Beach Physicians Medical Group Inc. — Huntington Beach, California, United States (enrolling)
• Physicians Research Collaboration — Lincoln, Nebraska, United States (enrolling)
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix — Phoenix, Arizona, United States
• Osteoporosis Medical Center — Beverly Hills, California, United States
• Advanced Clinical Research Center, LLC dba TriWest Research Associates, LLC — Chula Vista, California, United States
• Medvin Clinical Research - Covina — Covina, California, United States
• Horizon Clinical Research — La Mesa, California, United States
• Source Healthcare — Santa Monica, California, United States
• Alliance Clinical West Hills (Focus Clinical Research) — West Hills, California, United States
• Medvin Clinical Research - Whittier — Whittier, California, United States
• Journey Research Inc. — Oldsmar, Florida, United States
• Discovery Health Research Center - Plantation, FL — Plantation, Florida, United States
• Gulfcoast Research Institute — Sarasota, Florida, United States
• Palm Beach Research Center — West Palm Beach, Florida, United States
• Conquest Research — Winter Park, Florida, United States
• Pinnacle Trials, Inc. — Atlanta, Georgia, United States
• Rush Medical College - Division of Rheumatology — Chicago, Illinois, United States
• Accurate Clinical Research, Inc. - Lake Charles — Lake Charles, Louisiana, United States
• Best Clinical Trials, LLC — New Orleans, Louisiana, United States
• LifeBridge Health — Baltimore, Maryland, United States
• Michigan Orthopaedic and Spine Surgeons — Rochester Hills, Michigan, United States
• Excel Clinical Research — Las Vegas, Nevada, United States
• NY Scientific — Brooklyn, New York, United States
• New York University (NYU) Center for Musculoskeletal Care — New York, New York, United States

Full record on ClinicalTrials.gov

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