Status:
RECRUITING
A Study to Assess Safety and Tolerability of PCRX-201 in Subjects With Painful Osteoarthritis of the Knee
Lead Sponsor:
Pacira Pharmaceuticals, Inc
Conditions:
Osteoarthritis (OA) of the Knee
Eligibility:
All Genders
45-80 years
Phase:
PHASE2
Brief Summary
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 tolerabl...
Detailed Description
The study will consist of two parts, Part A and Part B, which will use PCRX-201 from two different manufacturing processes. A total of 135 eligible subjects, with painful OA of the index knee will be ...
Eligibility Criteria
Inclusion
- 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:
- 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 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
- 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
Key Trial Info
Start Date :
February 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2032
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT06884865
Start Date
February 26 2025
End Date
March 1 2032
Last Update
June 26 2025
Active Locations (17)
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1
Osteoporosis Medical Center
Beverly Hills, California, United States, 90211
2
Beach Physicians Medical Group Inc.
Huntington Beach, California, United States, 92647
3
Horizon Clinical Research
La Mesa, California, United States, 91942
4
Alliance Clinical West Hills (Focus Clinical Research)
West Hills, California, United States, 91307