Table of Contents
- Trial overview
- Who is being studied
- Study design and phase
- What the study measures
- Treatment groups in the trial
- What the main terms mean
Trial overview
The available trial data show one study of His203-Crm197 in people with inflammatory knee osteoarthritis.[1] The study is a phase 2 trial, which means it is testing the treatment in a patient group to learn more about safety and possible benefit.[1]
The trial is authorised and planned to enroll 204 participants.[1] It is an interventional study, so researchers give a study treatment and then measure the results.[1]
Who is being studied
The target condition is knee osteoarthritis, specifically inflammatory knee osteoarthritis.[1] The brief summary says the study is evaluating whether PPV-06 can help with pain and physical function in participants with knee OA.[1]
The source data do not list extra entry rules such as age limits, disease severity, or other health conditions.[1] Because of that, the clearest patient group described in the trial record is adults with knee osteoarthritis who fit the study criteria used by the trial team.[1]
Study design and phase
This study is described as randomized, double-blind, placebo-controlled, and multicenter.[1] Randomized means participants are placed into groups by chance.[1] Double-blind means neither the participants nor the study team knows who receives the active treatment or the placebo during the study.[1]
Placebo-controlled means one group gets a look-alike treatment with no active study drug, so results can be compared fairly.[1] Multicenter means the study is being run at more than one site.[1]
The phase 2 design is important because it usually follows early testing and focuses on whether the treatment may help the condition in a more careful way.[1] In this trial, the main goal is to assess both safety and efficacy, meaning whether the treatment works and whether it can be used safely in the study setting.[1]
What the study measures
The primary outcomes are changes from the start of the study to Week 54 in two parts of the WOMAC score.[1] WOMAC is a standard questionnaire used in osteoarthritis research to measure symptoms and daily function.[1]
The first main outcome is the pain subscale, which includes 5 items.[1] The second main outcome is the physical function subscale, which includes 17 items.[1] These outcomes help researchers see whether treatment changes pain and the ability to do everyday activities over time.[1]
Treatment groups in the trial
The intervention list includes His203-Crm197 as PPV-06 given by subcutaneous injection, matching placebo, and Panodil, filmovertrukne tabletter, given by mouth.[1] The source data do not explain in detail how these are used together, but they show the treatment options being studied in the trial.[1]
PPV-06 / His203-Crm197: the active study treatment listed in the trial record.[1]
Matching placebo: a comparison treatment that looks like the study treatment but is not active.[1]
Panodil, filmovertrukne tabletter: an oral medicine listed in the intervention section of the study record.[1]
What the main terms mean
Safety means whether the treatment can be given without causing unacceptable problems in the study population.[1] Efficacy means whether the treatment helps with the condition being studied.[1]
Primary outcome means the main result the researchers are watching most closely.[1] In this trial, the main results are pain and physical function at Week 54, using the WOMAC questionnaire.[1]
Subscale means a smaller part of a larger score or questionnaire.[1] Here, the WOMAC score is split into a pain part and a physical function part so the researchers can study each area separately.[1]
