A Phase 3, Randomised, Double-Blind, Placebo-Controlled Multi-Centre Study to Evaluate the Treatment Effect of Pentosan Polysulfate Sodium Compared to Placebo in Participants With Knee Osteoarthritis Pain
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.
• Average daily pain (ADP) numerical rating scale (NRS) score of 4-9 in the index knee at Screening.
• Baseline average weekly ADP NRS score of 4-9 in the index knee in the 7 days prior to randomization.
• No more than one 24-hr average pain score (0-10 NRS) reported as 10 during the 7 days prior to Day 1.
• Body mass index of ≥18.0 to ≤39.0 kg/m2.
• Female subjects of childbearing potential and Male subjects must agree to comply with protocol specified contraceptive requirements
⁃ Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
⁃ Completion of at least 11 out of 14 ADP NRS scores for at least 14 days prior to randomisation.
⁃ Current non-pharmacologic treatment regimen for knee OA (excluding knee brace) must be stable for at least 2 weeks before Day 1 and remain stable throughout the study. Participant must be willing to abstain from starting a new or changing their non-pharmacologic treatment regimen for the duration of the study.
⁃ Willing to stop treatment with oral and topical NSAIDs, and all other systemic pain medications (except allowed rescue medication) from 2 weeks before Day 1 to end of study.
⁃ Agrees to use acetaminophen/paracetamol or topical analgesics (topical NSAIDs are prohibited) as rescue therapy if required.