3-year, Open-Label Study Evaluating Safety, Tolerability, and Efficacy of Lorecivivint in Knee Osteoarthritis
brief summary
This study is designed as a 3-year, multicenter, open-label study evaluating the safety, tolerability, and efficacy of intra-articular (IA) Lorecivivint (LOR) in subjects with osteoarthritis of the knee in a real-world setting.
detailed description
At Day 1, after a screening period of up to 14 days, subjects will receive an IA injection of 0.07 mg LOR into one or both knees, followed by a 36-month evaluation period.
Clinic visits will be scheduled at Day 1, and Months 3, 12, 24, and 36 \[End of study (EOS)\] or Early Termination (ET).
All Patient Reported Outcome (PRO) measurements, including Western Ontario and McMaster University Osteoarthritis Index (WOMAC), and Pain Numeric Rating Scale (NRS), as well as safety evaluations will be conducted at each clinic visit. An additional phone follow-up visit for safety will occur 4 weeks after the injection on Day 1.
Study was terminated by Sponsor based on a business decision not due to safety. The study report was finalized without any statistical analysis.
official title
A 3-Year, Multicenter, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Intra-articular Lorecivivint in Subjects With Osteoarthritis of the Knee in a Real-World Setting (STRIDES-EXTRA)