Key Inclusion Criteria:
- 40-80 years old and in general good health, apart from knee osteoarthritis (OA)
- Ambulatory (single assistive devices such as canes allowed if needed less than 50% of the time)
- Diagnosis of femorotibial OA in the target knee by standard American College of Rheumatology criteria
Key Exclusion Criteria:
- Pregnant women, breastfeeding women, and women who are not post-menopausal
- Significant malalignment of anatomical axis of the target knee
- Partial or complete joint replacement in either knee
Full Study Name
A Phase III, 28-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Injection of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subject (IRB no. 0000358)
This study focuses on individuals with knee osteoarthritis who are 40-80 years old. Osteoarthritis (OA) is a type of arthritis that occurs when protective cartilage at the ends of bones wears down. The purpose of the study is to evaluate the safety and effectiveness of an experimental drug called SM04690, given as a single knee injection, to treat the most painful knee of osteoarthritis patients.
SM04690 is designed to influence the Wnt pathway, which is a network of switches in the body that helps the body determine the types of cells to make and regulates both cell and organ function. Participants will be randomly assigned to one of two treatment groups. One group will receive SM04690, and the other group will receive placebo (inactive substance).