A Study to Investigate the Treatment Effect of Subcutaneous Injections of Pentosan Polysulfate Sodium Compared With Placebo in Adult Participants With Knee Osteoarthritis Pain.

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis, Knee

In brief

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.

Key facts

Study ID

NCT06917404

Run by

Paradigm Biopharmaceuticals Ltd.

People needed

466

Starts

2025-05-29

Expected to finish

2027-07-01

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Spinal anaesthesia within 14 days of Day 1.
• Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy, or other moderate to severe pain disorder that may confound assessments or self-evaluation of the pain associated with osteoarthritis. Participants with a present (current) history of sciatica are not eligible for participation. Participants with a history of sciatica who have been asymptomatic for ≥3 months and who have no evidence of radiculopathy or sciatic neuropathy on thorough neurologic examination are eligible for participation.
• History of other disease that may involve the index knee, including inflammatory joint disease such as rheumatoid arthritis (RA), seronegative spondyloarthropathy (e.g., ankylosing spondylitis, psoriatic arthritis, inflammatory bowel disease-related arthropathy), crystalline disease (e.g., gout), endocrinopathies, metabolic joint diseases, lupus erythematosus, joint infections, Paget's disease, or tumours.
• History of hypersensitivity to PPS, heparin or heparin-like drugs, or drugs of a similar chemical or pharmacological class.
• Predisposition to hypersensitivity due to multiple (2 or more) atopic diseases (such as atopic eczema, asthma, and chronic allergic rhinitis and/or rhinoconjunctivitis) or multiple (2 or more) severe allergies.
• Allergy or contraindication to tetracosactide (Synacthen®), cosyntropin (Cortrosyn®).
• Allergy or contraindication to gadolinium.
• Chronic medical conditions including but not limited to those stated below requiring medical regime changes within 60 days before Day 1.
• Concurrent unstable peripheral, cardiac, and cerebral vascular disease, poorly controlled chronic obstructive pulmonary disease and asthma, coagulopathies, uncontrolled neurological conditions, active tuberculosis, active infections, symptomatic cardiac arrhythmias, adrenal insufficiency (primary or central), nephrotic syndrome, cirrhosis (Child-Pugh stage B or C), Gilbert syndrome, uncontrolled diabetes, and uncontrolled hypothyroidism or hyperthyroidism, or mental or emotional disorders that preclude reliable study participation.
• History of pituitary irradiation or recent (within 1 year) history of transsphenoidal surgery.
• Any cancer within the previous 5 years, except for basal cell carcinomas.
• History or current autoimmune polyglandular syndromes.
• Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete the study per the protocol.
• Current treatment with anticoagulants or antiplatelet drugs within 2 weeks before Day 1, excluding aspirin ≤150 mg/day.
• Previous treatment with PPS in any form.
• Current or recent (within 90 days before Day 1) immunosuppressive or immunomodulatory (with immunosuppressive effects) systemic therapy including but not limited to oral, inhaled, intranasal, intra-articular (IA) and topical corticosteroids (occasional use of topical, inhaled or intranasal corticosteroids is acceptable).
• Use of NSAIDs with 2 weeks before Day 1.
• Use of opioids within 6 weeks before Day 1.
• Use of glucosamine or chondroitin within 6 weeks before Day 1.
• Use of bisphosphonates and denosumab within 12 weeks before Day 1.
• Use of iloprost within 12 weeks before Day 1.

Where it is running

• Del Sol Research Management, LLC — Tucson, Arizona, United States (enrolling)
• Orange County Research Institute — Anaheim, California, United States (enrolling)
• Core Healthcare Group — Cerritos, California, United States (enrolling)
• Triwest Research Center — Chula Vista, California, United States (enrolling)
• Seaside Medical Group — Oceanside, California, United States (enrolling)
• Paragon RX Clinical — Santa Ana, California, United States (enrolling)
• Encompass Clinical Research — Spring Valley, California, United States (enrolling)
• Focus Clinical Research — West Hills, California, United States (enrolling)
• Clinical Research of West Florida - Clearwater — Clearwater, Florida, United States (enrolling)
• GNP Research — Cooper City, Florida, United States (enrolling)
• Arrow Clinical Trials — Daytona Beach, Florida, United States (enrolling)
• AGA Clinical Trials — Hialeah, Florida, United States (enrolling)
• Evolution Clinical Trials — Miami, Florida, United States (enrolling)
• Well Pharma Medical Research — Miami, Florida, United States (enrolling)
• K2 Medical Research — Orlando, Florida, United States (enrolling)
• Progressive Medical Research — Port Orange, Florida, United States (enrolling)
• Phoenix Clinical Research — Tamarac, Florida, United States (enrolling)
• Conquest Research — Winter Park, Florida, United States (enrolling)
• Chicago Clinical Research, Inc — Chicago, Illinois, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• Sinai Hospital of Baltimore — Baltimore, Maryland, United States (enrolling)
• Profound Research — Farmington Hills, Michigan, United States (enrolling)
• Insight Research Institute — Flint, Michigan, United States (enrolling)
• Rochester Medical Group — Rochester Hills, Michigan, United States (enrolling)
• Onyx Clinical Research-Peoria — Peoria, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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