Actively Recruiting
A Trial to Investigate the Safety and Efficacy of Intra-articular 4P004 Injection in Subjects With Knee Synovitis and Osteoarthritis
Led by 4Moving Biotech · Updated on 2026-04-14
129
Participants Needed
22
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase 2a trial is an international, multicenter, randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of one single intra-articular (IA) injection of 4P004 or placebo in: * patients between 40 and 80 years of age, * with synovitis and grade 2 to 4 osteoarthritis (OA) of the knee according to Kellgren and Lawrence (KL) classification.
CONDITIONS
Official 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...
- Participants able to give informed consent and comply with study procedures
- Age between 40 and 80 years
- Female participants of childbearing potential must use effective contraception throughout the trial
- Body weight over 40 kg
- Body mass index between 18.5 and 35
- Ambulatory, allowing use of a single assistive device such as a cane
- Widespread Pain Index of 4 or less
- Pain score less than 4 in the opposite knee
- History of knee osteoarthritis pain for at least 6 months
- Moderate to severe knee pain most days during the last 3 months
- WOMAC Pain diary scores between 5 and 9 for at least 7 of the last 10 days prior to randomization
- History of insufficient pain relief, intolerance, or contraindication to NSAIDs and at least one of acetaminophen, opioids, or corticosteroid/hyaluronate injections
- Kellgren and Lawrence grade 2 to 4 on knee X-ray
- Predominant femorotibial osteoarthritis confirmed by OA Research Society International criteria
- Synovitis present in the knee with synovial thickness of 5 mm or more by ultrasound
- 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 malalignment greater than 10 degrees varus or valgus
- Secondary osteoarthritis due to other joint diseases or conditions
- Active infections including skin infections at the injection site
- Partial knee replacement
- Recent acute fracture or trauma to the knee within 12 months
- Major knee surgery within 12 months or planned during the trial
- Knee arthroscopy within 6 months
- Pain conditions that could affect pain assessment such as fibromyalgia or neuropathy
- Systemic corticosteroid treatment above specified doses within 4 weeks
- Injections in the knee within 24 weeks prior to screening
- Use of certain nutraceuticals within 3 months prior to screening
- Use of duloxetine for osteoarthritis unless stable for 3 months or more
- Significant psychiatric illness unless stable for 6 months
- Current use of specific diabetes medications
- High risk of bleeding
- Severe heart failure (NYHA stage III or IV)
- Significant ECG abnormalities
- Low blood sugar at screening
- Abnormal laboratory tests outside specified ranges
- Impaired kidney function below specified threshold
- Hypersensitivity to study drug or its components
- Contraindications to MRI or gadolinium contrast
- Other MRI-detected knee conditions that exclude participation
- Recent participation in disease-modifying osteoarthritis drug trials or other interventional trials
- Risk of falling as judged by investigator
- History of pancreatitis, thyroid cancer, specific endocrine disorders, diabetic ketoacidosis, type 1 diabetes, inflammatory bowel disease, or diabetic gastroparesis
- Use of anticoagulants within the last 10 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
Tucson Orthopaedic Institute
Tucson, Arizona, United States, 85712-2805
Actively Recruiting
2
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
3
Skylight Health Research Burlington
Burlington, Massachusetts, United States, 01803
Actively Recruiting
4
Durham Bone and Joint Specialists
Ajax, Canada
Actively Recruiting
5
SJHC London Rheumatology Centre
London, Canada
Actively Recruiting
6
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc
Québec, Canada
Not Yet Recruiting
7
Parker Institute Bispebjerg, Frederiksberg Hospital
Frederiksberg, Denmark
Actively Recruiting
8
Sanos Clinic Herlev
Herlev, Denmark
Actively Recruiting
9
CHU Montpellier
Montpellier, France
Actively Recruiting
10
ChU de Nice
Nice, France
Actively Recruiting
11
Hôpital Cochin
Paris, France
Actively Recruiting
12
Hôpital Lariboisière
Paris, France
Actively Recruiting
13
Centre Hospitalier Universitaire CHU de Reims - Hopital Maison Blanche
Reims, France
Actively Recruiting
14
Care Access Kraków
Krakow, Poland
Actively Recruiting
15
Centrum Medyczne Reuma Park
Warsaw, Poland
Actively Recruiting
16
MICS Centrum Medyczne Warszawa
Warsaw, Poland
Not Yet Recruiting
17
Clínica Gaias Santiago
A Coruña, Spain, 15702
Actively Recruiting
18
Complejo Hospitalario Universitario de A Coruna - Hospital Universitario de A Coruna
A Coruña, Spain
Actively Recruiting
19
HLA Clínica Vistahermosa
Alicante, Spain
Actively Recruiting
20
Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
Sabadell, Spain
Not Yet Recruiting
21
Clinica Nuestra Senora de la Esperanza
Santiago de Compostela, Spain
Actively Recruiting
22
Hospital Quirónsalud Sagrado Corazón
Seville, Spain
Actively Recruiting
Research Team
F
Francis Berenbaum, MD, PhD
CONTACT
O
Odile Fleurot, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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