Phase 3 knee osteoarthritis trial.
Paradigm Biopharmaceuticals has randomized and dosed the first participants in the Phase III clinical trial of injectable pentosan polysulfate sodium (PPS/Zilosul) for treating pain linked to knee osteoarthritis (kOA) in the US.
The randomization of the first subject in the trial was carried out at Northwestern University, Chicago, US.
Named PARA_OA_002, the adaptive, randomized, double-blinded, placebo-controlled, multicentre, international trial is assessing the variation in pain and function following subcutaneous injections of PPS versus placebo in subjects with kOA pain.
Stage 1 will include a Phase IIb dose selection and subjects will be randomized to receive one of the three iPPS dosing regimens or a placebo for six weeks.
Detecting the dose for use in stage 2 and Paradigm’s confirmatory trial, PARA_OA_003 is the primary objective of stage 1 of the trial.
The dosage will be chosen based on an optimal balance of efficacy and safety.
In stage 2 of the trial, subjects will be randomized into a 1:1 ratio to receive the selected dosing regimen of PPS or placebo for six weeks.
Variation from baseline in WOMAC pain at Day 56 is the trial’s primary endpoint.
Secondary outcomes comprise variation from baseline at various time points till day 168 in WOMAC pain and function, quality of life and patient global impression of change.
Subject screening and enrollment in eight sites in Australia and 21 of the 56 chosen sites in the US are underway.
Activation of the remaining sites in the US will progress while sites in the UK and European Union will be launched throughout this year.
Paradigm chief medical officer and interim CEO Dr Donna Skerrett said: “To have our first subjects randomized in the US is an important milestone in the OA clinical program.
“The Paradigm clinical team has been working tirelessly to initiate and activate sites throughout the US, and we are seeing a large number of subjects entering the screening phase throughout the US.”