In short
Clinical trials are investigating His203-Crm197 in people with inflammatory knee osteoarthritis. These studies aim to check safety and how well the treatment works for pain and physical function. The main focus is on adults with knee osteoarthritis in a phase 2 study.
Key points
- Clinical trials of His203-Crm197 are focused on inflammatory knee osteoarthritis. The main study is a phase 2, randomized, double-blind, placebo-controlled, multicenter trial. It is designed to assess safety and efficacy, especially changes in pain and physical function. The trial plans to enroll 204 participants. The main outcome measures use the WOMAC questionnaire over 54 weeks. This research is aimed at people with knee osteoarthritis.
Trial overview
The available trial data show one study of His203-Crm197 in people with inflammatory knee osteoarthritis. 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.
The trial is authorised and planned to enroll 204 participants. It is an interventional study, so researchers give a study treatment and then measure the results.
Who is being studied
The target condition is knee osteoarthritis, specifically inflammatory knee osteoarthritis. The brief summary says the study is evaluating whether PPV-06 can help with pain and physical function in participants with knee OA.
The source data do not list extra entry rules such as age limits, disease severity, or other health conditions. 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.
Study design and phase
This study is described as randomized, double-blind, placebo-controlled, and multicenter. Randomized means participants are placed into groups by chance. Double-blind means neither the participants nor the study team knows who receives the active treatment or the placebo during the study.
Placebo-controlled means one group gets a look-alike treatment with no active study drug, so results can be compared fairly. Multicenter means the study is being run at more than one site.
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. 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.
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. WOMAC is a standard questionnaire used in osteoarthritis research to measure symptoms and daily function.
The first main outcome is the pain subscale, which includes 5 items. The second main outcome is the physical function subscale, which includes 17 items. These outcomes help researchers see whether treatment changes pain and the ability to do everyday activities over time.
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. The source data do not explain in detail how these are used together, but they show the treatment options being studied in the trial.
- PPV-06 / His203-Crm197: the active study treatment listed in the trial record.
- Matching placebo: a comparison treatment that looks like the study treatment but is not active.
- Panodil, filmovertrukne tabletter: an oral medicine listed in the intervention section of the study record.
What the main terms mean
Safety means whether the treatment can be given without causing unacceptable problems in the study population. Efficacy means whether the treatment helps with the condition being studied.
Primary outcome means the main result the researchers are watching most closely. In this trial, the main results are pain and physical function at Week 54, using the WOMAC questionnaire.
Subscale means a smaller part of a larger score or questionnaire. Here, the WOMAC score is split into a pain part and a physical function part so the researchers can study each area separately.