NCT06917404

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 466 (estimated)
• Sponsor: Paradigm Biopharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a randomised, double-blind, placebo-controlled, multicenter study that will evaluate the dose and treatment effect of PPS in participants with knee OA pain. Participants will be randomised 1:1 to receive twice-weekly subcutaneous (SC) injections of 2 mg/kg PPS or placebo for 6 weeks. An interim analysis for a potential early conclusion is planned after approximately 50% of participants complete Day 112. The primary analysis will be conducted when all participants complete Day 112. A final analysis will be conducted when the last participant reaches Day 404. The maximum duration for each participant is up to 64 weeks, which includes * 7-week Screening Period from Day -45 to Day -1 * 6-week Treatment Period from Day 1 to Day 39 * 52-week Follow-up Period from Day 40 to Day 404

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	Pentosan Polysulfate Sodium twice weekly	Subcutaneous injection, 2 mg/kg twice weekly for 6 weeks
DRUG	Placebo	Placebo, subcutaneous injection, twice weekly for 6 weeks

Timeline

• Start date: 2025-05-29
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2025-04-08
• Last updated: 2026-03-27

Locations

48 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study