None listed
Conditions
Brief summary
Paradigm Biopharmaceuticals Ltd (Paradigm) is evaluating Pentosan Polysulfate Sodium (PPS) for the treatment of symptoms (pain and diminished function) and mitigation of underlying tissue degeneration associated with osteoarthritis (OA) of the knee.. This study is designed to measure synovial fluid biomarkers indicative of the inflammation and cartilage degradation present in symptomatic knee OA, and to determine quantitative changes in individual biomarkers resulting from treatment with PPS. The results from this study will enhance understanding of the PPS mechanism of action and will provide information on the effect of PPS on joint inflammation and on the processes responsible for OA disease progression.
Interventions
Participants will be administered twice weekly, subcutaneous (SC) injections of investigational product (IP) calculated for ideal body weight (IBW) of either:
• PPS twice weekly: 2.0 mg/kg IBW PPS twice weekly for 6 weeks
• PPS once weekly: 2.0 mg/kg IBW PPS once weekly + placebo (0.9% saline) once weekly for 6 weeks
• Placebo: placebo (0.9% saline) twice weekly for 6 weeks
Participants will visit the clinical trial centre twice weekly for 6 weeks for treatment injections. For the remaining dose
Participants will be administered twice weekly, subcutaneous (SC) injections of investigational product (IP) calculated for ideal body weight (IBW) of either: • PPS twice weekly: 2.0 mg/kg IBW PPS twice weekly for 6 weeks • PPS once weekly: 2.0 mg/kg IBW PPS once weekly + placebo (0.9% saline) once weekly for 6 weeks • Placebo: placebo (0.9% saline) twice weekly for 6 weeks Participants will visit the clinical trial centre twice weekly for 6 weeks for treatment injections. For the remaining doses, participants will attend the clinical trial centre for pre-dose assessment, dosing, and post-dosing assessment as outpatients. Patients adherence to visits will be by reminder phone calls, emails and texts.
Sponsors
Paradigm Biopharmaceuticals Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects with a clinical diagnosis of osteoarthritis in one or both knees and a radiographic diagnosis of knee osteoarthritis showing a Kellgren-Lawrence score 2, 3 or 4 Symptomatic pain for at least 6 months preceding screening Males and females aged greater than or equal to 18 years, who are willing and able to comply with study requirements Subjects must be able to provide written informed consent Body Mass Index (BMI) of 18 to 35.0 kg/m2 inclusive Females of non child-bearing potential or females and males willing to comply with medically acceptable contraceptive requirements of the study Additional inclusion criteria apply.
Exclusion criteria
Documented or reported history of increased bleeding in the absence of anticoagulant or antiplatelet drugs, or prior history of major bleeding episode in the presence of anticoagulant or antiplatelet therapy. History of idiopathic or immune-mediated thrombocytopenia including history of or laboratory-confirmed heparin-induced thrombocytopenia (HIT; positive or equivocal antibodies against platelet factor 4 [ie, PF4]). Current treatment with anticoagulants or antiplatelet drugs, excluding aspirin less than or equal to 100 mg/day. Previous treatment with PPS in any form. Currently active or recent history (within preceding 12 months) of a gastric or duodenal ulcer, or suspicion of gastrointestinal tract bleeding. Activated partial thromboplastin time [aPTT]) > upper limit of normal (ULN), platelets <150,000/µL, or liver enzyme tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT]) greater than or equal to 2 × ULN at screening. Additional exclusion criteria apply.
Outcome results
None listed