SI-613 Study for Knee Osteoarthritis

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Repeated Intra-Articular Injection of SI-613 in Patients With Osteoarthritis of the Knee

The objective of the study is to evaluate the efficacy and safety of intra-articular injections of SI-613 compared with placebo for knee OA.

Inclusion Criteria:

• Provides their written informed consent.
• Has a diagnosis at the time of screening of OA of the knee according to American College of Rheumatology (ACR) criteria
• Is willing to switch to using acetaminophen as a rescue medication

Exclusion Criteria:

• Has a body mass index (BMI) greater than or equal to 40 kg/m2 at screening.
• Secondary OA
• Is a female subject who is pregnant or lactating.
• Is currently hospitalized or has a planned hospitalization during the life of the study.