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Study on the Effects of QUC398 for Patients with Knee Osteoarthritis

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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 called QUC398 for people with knee osteoarthritis. Knee osteoarthritis is a condition where the protective cartilage in the knee joint wears down over time, leading to pain and stiffness. The study aims to see how well QUC398 can relieve pain in the knee compared to a placebo. QUC398 is given as an injection under the skin every four weeks.

Participants in the study will be randomly assigned to receive either QUC398 or a placebo. The study is designed to be "blinded," meaning that neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are unbiased. The study will last for about a year, with regular check-ups to monitor the participants' progress and any changes in their knee pain.

Throughout the study, participants will have their knee pain assessed using a scale called the Knee Injury and Osteoarthritis Outcome Score (KOOS). This will help determine if there is any improvement in pain levels. Additionally, the study will look at changes in the knee's cartilage volume using MRI scans. Safety and any side effects will also be closely monitored to ensure the well-being of all participants. The goal is to gather information on the effectiveness and safety of QUC398 as a potential treatment for knee osteoarthritis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.
Radiographic imaging is performed to assess the condition of the knee joint, specifically looking for joint space narrowing and other signs of osteoarthritis.
Step 2
Baseline measurements
Baseline measurements are taken to establish a starting point for the study. This includes the Knee Injury and Osteoarthritis Outcome Score (KOOS) and a Pain Numerical Rating Scale (NRS).
These measurements help track changes in pain and knee function throughout the study.
Step 3
Medication administration
Participants receive either QUC398 or a placebo. QUC398 is administered as a subcutaneous injection every four weeks at a dose of 300 mg.
The placebo is a solution for injection that does not contain the active substance.
Step 4
Regular follow-up visits
Regular follow-up visits are scheduled at weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52.
During these visits, changes in pain and knee function are assessed using the KOOS and NRS. Additional assessments may include MRI scans to evaluate cartilage volume.
Step 5
Safety monitoring
Throughout the study, safety is monitored through regular checks of vital signs, electrocardiograms (ECGs), and laboratory tests including blood and urine analysis.
Any adverse events or side effects are recorded and evaluated to ensure participant safety.
Step 6
Final assessment
At the end of the study, a final assessment is conducted to evaluate the overall effectiveness and safety of the treatment.
This includes a comprehensive review of all collected data, including changes in pain, knee function, and any side effects experienced during the study.

Who can join the trial?

9 criteria

Must weigh at least 50 kg (about 110 pounds) and have a body mass index (BMI) between 18 and 35. BMI is a measure of body fat based on height and weight.
Must have a Kellgren-Lawrence grade between 2 and 4 in the knee joint. This is a way to measure the severity of knee osteoarthritis using X-rays.
Must show joint space narrowing in the knee on an X-ray. This means the space between the bones in the knee is getting smaller.
Must have moderate to severe knee pain most days over the last 3 months, as judged by the participant. Pain should be rated between 5 and 9 on a scale where 0 is no pain and 10 is the worst pain.
Must have moderate to severe knee pain at the first and second screening visits, rated between 5 and 9 on the pain scale.
Must have moderate to severe knee pain in the last 7 days before the third screening visit. This should be confirmed by a pain diary filled out for at least 6 of the last 7 days, with pain rated between 5 and 9.
Must have a KOOS pain subscale score of 60 or less in the knee at the first, second, and third screening visits. KOOS is a questionnaire that measures knee pain and function.
Both men and women can participate.
Participants must be adults, as the study includes age ranges for adults.

Who cannot join the trial?

8 criteria

Having any other joint disease that affects the knees, besides knee osteoarthritis.
Having had surgery on the knee that is being studied within the last 6 months.
Using certain medications that might interfere with the study, such as strong painkillers or anti-inflammatory drugs.
Having a history of allergic reactions to similar treatments.
Being pregnant or planning to become pregnant during the study period.
Having a serious medical condition that might affect participation, like heart disease or uncontrolled diabetes.
Being unable to follow the study procedures or attend the required visits.
Participating in another clinical trial at the same time.

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Verified sites

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Centre Hospitalier Universitaire De Nice
Nice, France
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Centre Hospitalier Universitaire d’Orléans
Orléans, France
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Groupement Des Hopitaux De L'Institut Catholique De Lille
Lomme, France

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Investigated drugs

QUC398 is a medication being studied for its potential to relieve pain in patients with knee osteoarthritis. It is administered through injections under the skin every four weeks. The trial aims to evaluate how effective, safe, and tolerable this medication is for individuals experiencing symptoms of knee osteoarthritis.

What is already known about the treatment

QUC398 – This medication is administered through subcutaneous injections every four weeks. It is currently being studied in clinical trials for its effectiveness in treating knee osteoarthritis, focusing on pain relief. The main therapeutic indication is the management of pain associated with knee osteoarthritis. At the molecular level, QUC398 is believed to work by modulating specific pathways involved in inflammation and pain signaling, although the exact mechanism is still under investigation. It is classified pharmacologically as an investigational drug, as it is still undergoing research to determine its safety and efficacy.

Investigated diseases

Knee Osteoarthritis – Knee osteoarthritis is a degenerative joint disease characterized by the breakdown of cartilage in the knee joint. This condition leads to pain, stiffness, and swelling, which can worsen over time. As the cartilage wears away, bones may rub against each other, causing increased discomfort and reduced mobility. The progression of knee osteoarthritis can vary, with some individuals experiencing gradual worsening of symptoms. Factors such as age, weight, and previous joint injuries can influence the development and progression of the disease. Regular physical activity and maintaining a healthy weight can help manage symptoms and slow progression.