The purpose of this study is to measure the change in pain and function with subcutaneous injections of pentosan polysulfate sodium (PPS) compared with subcutaneous injections of placebo in participants with knee OA pain.
Study details include:
* The study duration will be up to 64 weeks. * The treatment duration will be 6 weeks. * The visit frequency will be twice weekly during treatment. * The visit/contact frequency will be every 4-6 weeks during the 52-week Follow-up period. * Approximately 466 participants will be enrolled into this study.
Participant must be ≥18 years of age inclusive, at the time of signing the informed consent.
Clinical diagnosis of OA in the index knee by American College of Rheumatology 1986 criteria.
Radiographic diagnosis (confirmed by radiologist) of knee OA classified K-L grade 2, 3, or 4 on standing anterior-posterior X-ray of the index knee.
Participant is unresponsive for at least 6 months preceding Screening to any two combinations of OA therapies (one from each A and B) within the last 12 months that include: A.) conservative non-pharmacologic therapy (exercise, weight loss, physical therapy) or simple analgesics (e.g., acetaminophen) and B.) pharmacological treatment (topical or oral NSAIDs [or cyclooxygenase (COX) inhibitor], or intra-articular [IA] injections), or participant is unable to take NSAIDs because of contraindication or inability to tolerate.
History of idiopathic or immune-mediated thrombocytopenia including history of HIT with or without thrombosis.
History of major bleeding disorders including haemophilia.
Currently active or recent history (within preceding 12 months) of a gastric or duodenal ulcer, or suspicion of gastrointestinal tract bleeding.
Recent cerebral bleeding or operation on brain, spine, or eyes within 12 months of Day 1.