NCT04809376

Treatment Effects of Subcutaneous Injections of Pentosan Polysulfate Sodium vs Placebo in Participants With Knee OA Pain

A 2-stage, Adaptive, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Evaluate Dose and Treatment Effect of Pentosan Polysulfate Sodium Compared With Placebo in Participants With Knee Osteoarthritis Pain

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 602 (actual)
• Sponsor: Paradigm Biopharmaceuticals USA (INC) · 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 osteoarthritis pain. Study details include: * The study duration will be up to 31 weeks per participant * The treatment duration will be 6 weeks. * The visit frequency will be twice weekly during treatment. * The visit frequency will be every 4 weeks during the follow-up period.

Detailed description

This is a 2-stage, adaptive, randomized, double-blind, placebo-controlled, multicenter study that will evaluate the dose and treatment effect of PPS in participants with knee OA pain. In Stage 1 (dose selection), approximately 468 participants will be randomised 1:1:1:1 to receive 1 of 3 PPS dose regimens or placebo for 6 weeks. A minimum of 96 participants (24 within each dose group) will be assigned to the Pharmacokinetic (PK) subset. Participants in Stage 1 will be randomly allocated to receive: * 1.5 mg/kg calculated for ideal body weight (IBW) PPS twice weekly * 2 mg/kg IBW PPS once weekly + placebo once weekly * 100/150/180 mg PPS if ≤ 65 kg/ ≥ 65 kg and ≤ 90kg/ \> 90kg IBW+ placebo once weekly * placebo twice weekly In Stage 2, approximately 470 participants will be randomized 1:1 to receive the selected PPS dose regimen or placebo for 6 weeks. Approximately 150 participants (75 per group) will be assigned to the PK subset. Participants in Stage 2 will be randomly allocated to receive: * One of the 3 Stage 1 PPS dose regimens selected by the DMC * placebo twice weekly The maximum duration for each participant is approximately 31 weeks, which includes: * 7-week Screening Period from Day -45 to Day -1 * 6-week Treatment Period from Day 1 to Day 39 * 18-week Follow-up Period from Day 40 to Day 168

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	Pentosan Polysulfate Sodium twice weekly	Subcutaneous Injection, 1.5mg/kg Ideal body Weight (IBW)
DRUG	Placebo (Sodium Chloride Injection, 0.9%)	Placebo to match PPS
DRUG	Pentosan Polysulfate Sodium Fixed Dose	Subcutaneous Injection, 100/150/180 mg if \<65kg/ ≥ 65 kg and ≤ 90kg/ \>90 kg IBW
DRUG	Pentosan Polysulfate Sodium once weekly	Subcutaneous Injection, 2.0mg/kg Ideal body Weight (IBW)

Timeline

• Start date: 2021-10-19
• Primary completion: 2024-10-15
• Completion: 2025-01-06
• First posted: 2021-03-22
• Last updated: 2024-04-08

Locations

33 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study