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Study on the Effects of PPV-06 and Paracetamol for Patients with Inflammatory Knee Osteoarthritis

Fast replyRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment for knee osteoarthritis, a condition that causes pain and stiffness in the knee joint. The treatment being tested is called PPV-06, which is a type of active immunotherapy. This means it is designed to help the body's immune system reduce inflammation and improve joint function. The study will also involve the use of paracetamol, a common pain reliever, and a placebo, which is a substance with no active medication.

The purpose of the study is to evaluate how well PPV-06 works in reducing pain and improving physical function in people with knee osteoarthritis. Participants in the study will receive either the new treatment, paracetamol, or a placebo. The study will be conducted over a period of time, with regular check-ups to monitor the effects of the treatment on knee pain and function. Participants will be asked to stop using other pain medications, except for paracetamol, during the study.

The study will last for several months, with the main focus on changes in pain levels and physical abilities over time. Participants will undergo assessments, including imaging tests like MRI, to measure changes in the knee joint. The study aims to provide valuable information on the safety and effectiveness of PPV-06 for treating knee osteoarthritis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit and screening
Upon joining the study, the first step involves an initial visit where eligibility is confirmed. This includes a review of medical history and a physical examination.
Participants will undergo tests such as blood tests and imaging of the knee to confirm the diagnosis of knee osteoarthritis and assess the severity of the condition.
Step 2
Randomization and baseline assessment
Participants are randomly assigned to receive either the investigational treatment PPV-06 or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.
A baseline assessment is conducted to record initial pain levels and physical function using specific scales.
Step 3
Treatment administration
The investigational treatment PPV-06 is administered as a subcutaneous injection. The frequency and duration of administration will be explained during the study visits.
Participants are allowed to use paracetamol as a rescue medication for pain relief, taken orally as needed, but must avoid other pain medications.
Step 4
Follow-up visits
Regular follow-up visits are scheduled to monitor the participant's health, pain levels, and physical function. These visits include physical examinations and may involve additional imaging or blood tests.
Participants are required to report any side effects or changes in their condition during these visits.
Step 5
Final assessment
At the end of the study period, a final assessment is conducted to evaluate changes in pain and physical function compared to the baseline.
The results of the study will be analyzed to determine the efficacy and safety of the investigational treatment.

Who can join the trial?

17 criteria

The participant has given written informed consent to participate.
The participant must have pain in the knee for most days (more than 50%) during the month before the screening visit.
At the screening visit, the participant reports typical knee pain of at least 4 out of 10 when not using medication.
The participant must have a WOMAC pain subscale score (a measure of pain) between 4 and 8 out of 10 for the knee at screening and baseline visits.
The participant is willing to stop all pain medications for osteoarthritis except for rescue medication (paracetamol) and follow the rules about using other treatments during the trial.
The participant has normal liver and kidney function, as shown by specific blood test results.
Female participants must be of non-childbearing potential, which means they are post-menopausal, have had certain surgeries, or have confirmed ovarian failure.
Male participants agree not to donate sperm and to use barrier contraception (condom) during sexual intercourse with women who can have children throughout the study and for 5 months after the last treatment.
The investigator believes that no additional benefit can be expected from changing the participant's current osteoarthritis treatment.
The participant can be male or female.
The participant must be at least 40 years old.
The participant has a BMI (Body Mass Index) between 22 and 35 kg/m² at the screening visit.
The participant has a diagnosis of knee osteoarthritis based on specific clinical and X-ray criteria, with a certain severity level.
The participant has a specific level of joint space narrowing in the knee, confirmed by an X-ray at the screening visit.
There is evidence of synovitis (inflammation of the joint lining) in the knee based on an ultrasound at the screening visit.
There is evidence of moderate to severe synovitis, with a score of at least 9 out of 22, based on an assessment at the screening visit.
The participant has not had enough pain relief with standard treatments for knee osteoarthritis in the 6 months before the screening visit.

Who cannot join the trial?

10 criteria

Participants with any other joint disease besides knee osteoarthritis cannot join the study. Osteoarthritis is a condition that affects the joints, causing pain and stiffness.
Individuals who have had a knee replacement surgery are not eligible.
People with severe heart, liver, or kidney problems cannot participate.
Participants who are currently taking part in another clinical trial are excluded.
Pregnant or breastfeeding women are not allowed to join the study.
Individuals with a history of allergic reactions to similar medications are not eligible.
Participants who have had a recent injury or surgery on the knee are excluded.
People with uncontrolled diabetes or high blood pressure cannot participate.
Individuals with a history of drug or alcohol abuse are not eligible.
Participants with any condition that the study doctors believe would make it unsafe for them to participate are excluded.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Centre Hospitalier Universitaire De Bordeaux
Bordeaux, France
Responsive
Futuremeds Sp. z o.o.
Wroclaw, Poland
Responsive
Krakowskie Centrum Medyczne Sp. z o.o.
Cracow, Poland

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Investigated drugs

PPV-06 is an active immunotherapy treatment being studied for its potential to help people with inflammatory knee osteoarthritis. This therapy is designed to work with the body's immune system to reduce pain and improve physical function in the knee. The goal of using PPV-06 is to provide relief from the discomfort and limitations caused by osteoarthritis, allowing patients to move more easily and with less pain.

What is already known about the treatment

PPV-06 – PPV-06 is an investigational medication administered as an injection, designed to treat knee osteoarthritis by reducing pain and improving physical function. Currently, it is being studied in clinical trials to assess its safety and effectiveness, and it is not yet widely available in medical practice. The main therapeutic indication for PPV-06 is inflammatory knee osteoarthritis, a condition characterized by joint pain and stiffness. At the molecular level, PPV-06 works by stimulating the body's immune system to target and reduce inflammation in the knee joint, potentially leading to pain relief and improved mobility. It falls under the pharmacological classification of active immunotherapy, which involves using the body's immune response to treat diseases.

Investigated diseases

Knee Osteoarthritis – Knee osteoarthritis is a degenerative joint disease characterized by the breakdown of cartilage in the knee joint. As the cartilage wears away, bones may begin to rub against each other, causing pain and stiffness. Over time, the joint may lose its normal shape, and bone spurs may develop. The condition often leads to decreased mobility and difficulty in performing daily activities. Synovitis, or inflammation of the joint lining, can occur, contributing to pain and swelling. The progression of the disease can also result in a reduction of cartilage thickness, particularly in the medial femorotibial compartment of the knee.