Not recruiting

Study on the Effects of DFV890 for Pain Relief in Patients with Knee Osteoarthritis

Fast replyRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 common condition that causes pain and stiffness in the knee joint. The treatment being tested is called DFV890, which is taken as a film-coated tablet. The study will compare the effects of DFV890 to a placebo, which looks like the treatment but does not contain the active ingredient.

The purpose of the study is to determine how effective DFV890 is in relieving knee pain in people with knee osteoarthritis. Participants in the study will take either DFV890 or a placebo for a period of 12 weeks. During this time, researchers will monitor changes in knee pain and other symptoms using a specific scoring system. The study will also look at the safety and tolerability of DFV890, which means checking for any side effects or adverse reactions.

Throughout the study, participants will have regular check-ups to assess their knee condition and overall health. This will include various tests and measurements, such as blood tests and imaging techniques like MRI (Magnetic Resonance Imaging), to evaluate the level of inflammation in the knee. The study aims to provide valuable information on whether DFV890 can be a beneficial treatment option for those suffering from 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 assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes checking age, weight, body mass index (BMI), and specific health markers such as high sensitivity C-reactive protein levels and knee pain scores.
A detailed medical history and physical examination are performed to ensure the presence of knee osteoarthritis and to assess the severity of the condition.
Step 2
Randomization and baseline measurements
Participants are randomly assigned to one of two groups: one receiving the active medication DFV890 and the other receiving a placebo.
Baseline measurements are taken, including the Knee injury and Osteoarthritis Outcome Score (KOOS) pain sub-scale and other health indicators.
Step 3
Medication administration
Participants in the active group receive DFV890 in the form of film-coated tablets for oral use. The dosage is determined by the study protocol.
Participants in the placebo group receive tablets that look identical to the active medication but contain no active ingredients.
Step 4
Follow-up assessments
Regular follow-up assessments are conducted at weeks 2, 4, 8, and 12 to monitor changes in knee pain and other health parameters.
These assessments include measuring changes in the KOOS pain sub-scale, synovitis activity levels, and other health markers such as C-reactive protein levels and neutrophil counts.
Step 5
Final evaluation
At week 12, a final evaluation is conducted to assess the overall efficacy and safety of the treatment.
This includes a comprehensive review of all collected data, including any adverse events, changes in pain levels, and other health indicators.

Who can join the trial?

7 criteria

Participants must be men or women who are between 50 and 80 years old on the day they sign the consent form.
Participants must weigh at least 50 kg and have a body mass index (BMI) between 18 and 35. BMI is a measure that uses your weight and height to estimate if you have a healthy body weight.
Participants must have a high sensitivity C-reactive protein (hsCRP) level of 1.8 mg/L or higher. hsCRP is a blood test that measures inflammation in the body.
Participants must have knee osteoarthritis with pain levels between 5 and 9 on a scale from 0 to 10, where 10 is the worst pain, for most days in the last 3 months.
Participants must have a score of 60 or less on the KOOS pain sub-scale for the affected knee. This is a questionnaire that measures knee pain.
Participants must have knee osteoarthritis that is classified as K&L grade 2 or 3. This is a way to describe the severity of the condition using X-rays.
Participants must have active inflammation in the knee joint lining, shown by a contrast-enhanced MRI (CE-MRI) scan. This is a special imaging test that helps detect inflammation in the knee.

Who cannot join the trial?

10 criteria

Patients who have had a knee replacement surgery cannot participate.
Individuals with other types of arthritis, like rheumatoid arthritis, are not eligible.
People who have had a recent injury to the knee, such as a fracture or ligament tear, are excluded.
Participants who are currently taking certain medications that might interfere with the study are not allowed.
Individuals with severe heart, liver, or kidney problems cannot join the study.
Pregnant or breastfeeding women are not eligible to participate.
Patients with a history of drug or alcohol abuse are excluded.
Anyone who has participated in another clinical trial within the last 30 days is not eligible.
Individuals with a known allergy to the study medication or similar drugs cannot participate.
People with uncontrolled diabetes or high blood pressure are excluded.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Ambenet GmbH Das Ambulante Behandlungsnetz
Verified
Leipzig, Germany
Charite Research Organisation GmbH
Verified
Berlin, Germany
Spitalul Clinic Judetean De Urgenta Cluj
Responsive
Cluj Napoca, Romania

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

DFV890 is a medication being studied for its potential to relieve pain in patients with knee osteoarthritis. The trial aims to assess how effective DFV890 is in reducing pain compared to a placebo. Participants in the study receive DFV890 to see if it can improve their knee pain over a 12-week period, as measured by a specific pain scoring system.

What is already known about the treatment

DFV890 – DFV890 is administered orally in the form of tablets. It is currently being studied in clinical trials to assess its effectiveness and safety for treating knee osteoarthritis, a condition characterized by joint pain and stiffness. The main therapeutic indication for DFV890 is to relieve pain associated with knee osteoarthritis. At the molecular level, DFV890 works by inhibiting specific inflammatory pathways that contribute to pain and swelling in the joints. It is classified pharmacologically as an anti-inflammatory agent.

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.