A Study to Assess Safety and Tolerability of PCRX-201 in Subjects With Painful Osteoarthritis of the Knee
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 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
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 enrolled. Subjects will be randomly assigned to a treatment dose group, stratified by Kellgren-Lawrence (K-L) Grade, in both parts of the study. Enrollment of subjects with K-L Grade 4 will be capped at 4 subjects per dose group in Part A and 8 subjects per dose group in Part B.
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.
official title
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