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A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof of Concept Trial to Investigate the Efficacy and Safety of Intra-articular 4P004 in Subjects With Knee Synovitis and Osteoarthritis
Led by 4Moving Biotech · Updated on 2026-04-14
129
Participants Needed
22
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates the use of a single injection of 4P004 compared to a placebo injection in patients aged 40 to 80 who have knee synovitis and moderate to severe osteoarthritis, classified as grade 2 to 4. It is a phase 2a, international, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the safety and effectiveness of this treatment for knee pain related to osteoarthritis and synovitis. Participants will receive one injection of either 4P004 or a placebo saltwater solution directly into the knee joint on the day they are randomized. The study groups consist of a 4P004 treatment arm and a placebo arm, each receiving a 2 mL intra-articular injection. This setup allows comparison of the effects of the investigational drug versus placebo over the course of the trial. During the study, participants will be closely monitored at baseline and several follow-up points up to 12 weeks. Pain intensity, knee function, and patient global assessment will be measured using tools like the WOMAC pain scale and numeric rating scales. Lab tests, blood pressure, and vital signs will also be regularly checked to track safety. The primary outcome is the change in knee pain at week 4, with additional assessments at weeks 2, 6, 8, 10, and 12 to evaluate ongoing effects and adverse events.
CONDITIONS
Brief Title
A Trial to Investigate the Safety and Efficacy of Intra-articular 4P004 Injection in Subjects With Knee Synovitis and Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give informed consent and willing to follow all trial procedures
- Aged between 40 and 80 years
- Female participants of childbearing potential must use highly effective contraception throughout the trial
- Bodyweight over 40 kg
- Body mass index between 18.5 and 35
- Able to walk, can use a single assistive device like a cane
- Widespread Pain Index of 4 or less
- Pain score less than 4 in the opposite knee
- History of osteoarthritis-related pain in the target knee for at least 6 months
- Moderate to severe pain in the target knee most days in the last 3 months
- WOMAC Pain diary scores between 5 and 9 for at least 7 of the last 10 days before randomization
- History of insufficient pain relief or intolerance to NSAIDs and at least one other therapy such as acetaminophen, opioids, or corticosteroid/hyaluronate injections
- Kellgren and Lawrence grade 2 to 4 on knee X-ray
- Predominant femorotibial osteoarthritis per OARSI Atlas
- Presence of synovitis in the target knee confirmed by ultrasound with synovial thickness 5 mm or more
- Negative urine drug screen for amphetamines, barbiturates, and cocaine
- MRI confirmation of synovitis with specific scoring criteria
You will not qualify if you...
- Pregnant or breastfeeding women
- Significant knee misalignment greater than 10 degrees varus or valgus
- Secondary osteoarthritis due to other joint diseases or infections
- Active infections including skin infection at injection site
- Partial knee replacement
- Knee fracture or trauma within 12 months
- Major knee surgery within 12 months or planned during the trial
- Knee arthroscopy within 6 months
- Other painful conditions affecting knee pain assessment like fibromyalgia
- Recent systemic corticosteroid use over 10 mg prednisone for more than 7 days within 4 weeks
- Recent intra-articular knee injections within 24 weeks
- Use of glucosamine, chondroitin, or similar supplements within 3 months
- Use of duloxetine for osteoarthritis unless stable dose for depression
- Significant psychiatric illness unless well controlled for 6 months
- Use of certain diabetes medications
- High risk of bleeding
- Severe heart failure
- Significant ECG abnormalities
- Low blood sugar at screening
- Abnormal lab values at screening such as low blood counts or elevated liver enzymes
- Reduced kidney function
- Hypersensitivity to study drug or components
- Contraindications or inability to undergo MRI
- Hypersensitivity to gadolinium contrast
- Other MRI diagnoses excluding participation
- Recent participation in disease-modifying osteoarthritis drug studies or other interventional trials
- Risk of falls
- History or current pancreatitis, thyroid cancer, certain endocrine disorders, type-1 diabetes, inflammatory bowel disease, or diabetic gastroparesis
- Recent anticoagulant treatment within 10 days
Research Team
F
Francis Berenbaum, MD, PhD
O
Odile Fleurot, MD
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