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
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 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
Parallel
Enekinragene Inzadenovec (PCRX-201)
Biological/VaccineEnekinragene Inzadenovec (PCRX-201) injection
Placebo
Biological/VaccinePlacebo injection
6
Treatment groupsSee each treatment group below.
Incidence (number and percent) of treatment-emergent adverse events (TEAEs) for PCRX-201 Dose A and Dose B versus placebo from Week 1 through Week 52
Incidence (number and percent) of adverse events of special interest (AESIs) for PCRX-201 Dose A and Dose B versus placebo from Week 1 through Week 52
Incidence (number and percent) of serious adverse events (SAEs) for PCRX-201 Dose A and Dose B versus placebo from Week 1 through Week 52
Real-time quantitative polymerase chain reaction (qPCR) measurement profile in plasma of PCRX-201 Dose A and Dose B from postdose through Week 8
Real-time qPCR measurement profile of skin swab samples from Baseline through Week 4.
Assessment of the levels of neutralizing antibodies (NAbs), high-sensitivity C-reactive protein (hs-CRP), and biomarkers of inflammation (eg, interleukin [IL]- 1, cytokines [tumor necrosis factor alpha (TNFα), IL-1β, IL-6, IL-10], and chemokines [IL-8])
Absolute change from baseline in Average Daily Knee Pain (Numerical Rating Scale [NRS]) for PCRX-201 Dose A and Dose B versus placebo.
Click on the lead sponsor to view all of their trials.
