A Study to Assess Safety and Tolerability of PCRX-201 in Subjects With Painful Osteoarthritis of the Knee
NCT ID: NCT06884865
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
135 participants
INTERVENTIONAL
2025-02-26
2032-03-31
Brief Summary
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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
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Detailed Description
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Enrollment of subjects with K-L Grade 2 or 3 will include a minimum of 4 subjects per Grade per dose group in Part A and a minimum of 8 subjects per Grade per dose group in Part B. This study does not require an equal number of subjects between K-L Grade 2 and 3. All eligible subjects will be pretreated with the same dose of methylprednisolone acetate (40 mg) on Day 1 immediately before treatment with PCRX-201 or placebo.
Part A will enroll approximately 45 subjects into 3 dose groups (15 subjects in each treatment group, stratified by K-L Grade as noted above).
Part B will enroll approximately 90 subjects into 3 groups (30 subjects in each treatment group, stratified by K-L Grade as noted above). Enrollment in Part B is dependent upon the availability of study drug developed with manufacturing process 2.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
In Part B (manufacturing process 2), subjects are randomized in a 1:1:1 ratio to Dose A, Dose B, or placebo, each with a pre-dose IA steroid of methylprednisolone acetate.
TREATMENT
QUADRUPLE
Study Groups
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Part A Dose A
Single Intra-Articular injection
Enekinragene Inzadenovec (PCRX-201)
Enekinragene Inzadenovec (PCRX-201) injection
Part A, Placebo
Single Intra-Articular injection
Placebo
Placebo injection
Part B Dose A
Single Intra-Articular injection
Enekinragene Inzadenovec (PCRX-201)
Enekinragene Inzadenovec (PCRX-201) injection
Part B Dose B
Single Intra-Articular injection
Enekinragene Inzadenovec (PCRX-201)
Enekinragene Inzadenovec (PCRX-201) injection
Part B Placebo
Part B Placebo
Placebo
Placebo injection
Part A, Dose B
Single Intra-Articular injection
Enekinragene Inzadenovec (PCRX-201)
Enekinragene Inzadenovec (PCRX-201) injection
Interventions
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Enekinragene Inzadenovec (PCRX-201)
Enekinragene Inzadenovec (PCRX-201) injection
Placebo
Placebo injection
Eligibility Criteria
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Inclusion Criteria
* 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 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
45 Years
80 Years
ALL
No
Sponsors
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Pacira Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Nino Joy, MD
Role: STUDY_DIRECTOR
Pacira Pharmaceuticals, Inc
Locations
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Osteoporosis Medical Center
Beverly Hills, California, United States
Beach Physicians Medical Group Inc.
Huntington Beach, California, United States
Horizon Clinical Research
La Mesa, California, United States
Alliance Clinical West Hills (Focus Clinical Research)
West Hills, California, United States
Arrow Clinical Trials
Daytona Beach, Florida, United States
Journey Research Inc.
Oldsmar, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Conquest Research
Winter Park, Florida, United States
Injury Care Research, LLC
Boise, Idaho, United States
Physicians Research Collaboration
Lincoln, Nebraska, United States
Excel Clinical Research
Las Vegas, Nevada, United States
NY Scientific
Brooklyn, New York, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Clinical Trials of South Carolina - Charleston
Charleston, South Carolina, United States
Clinical Trials of South Carolina - Columbia
Columbia, South Carolina, United States
Zenos Clinical Research
Dallas, Texas, United States
Epic Clinical Research
Lewisville, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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201-C-201
Identifier Type: -
Identifier Source: org_study_id
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