Knee OsteoarthritisPhase 2INFLAM MOTIONNCT07225829
A Trial to Investigate the Safety and Efficacy of Intra-articular 4P004 Injection in Subjects With Knee Synovitis and Osteoarthritis
A Phase 2 study testing 4P004 in people with Knee Osteoarthritis and Synovitis of Knee, run by 4Moving Biotech at 22 sites in 6 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Synovitis of Knee
- What is being tested?
- 4P004
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 22 sitesin 6 countries
- Study dates
- 17 Jun 2025to 19 Oct 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who have the capacity to give informed consent and who are willing to comply with all trial related procedures and assessments.
- Participants between 40 and 80 years of age.
- Female participant of childbearing potential (defined as any woman unless postmenopausal for at least one year or surgically sterile) must use highly effective methods of contraception as defined in the protocol. Highly effective contraceptive measures must be continued throughout the trial until the final visit.
- Bodyweight > 40 kg.
- Body mass index (BMI) ≥ 18.5 and ≤ 35.
- Ambulatory (single assistive devices such as canes allowed).
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- Widespread Pain Index (WPI) ≤ 4.
- Pain NRS (0-10) < 4 in the contralateral knee.
- History of OA-related pain of the TK for at least 6 months.
- Moderate to severe pain of the TK the majority of days during the last 3 months as per participant's judgement.
- Moderate to severe pain of the TK on the WOMAC Pain subscale prior to the Randomization visit (V2) complying with: a) Complete WOMAC Pain diary for at least 7 of the last 10 days prior to V2 (including V2/D1 rating which is mandatory), and b) Diary reported WOMAC Pain between 5 and 9 for at least 7 of the last 10 days.
- History of insufficient pain relief, intolerance, or contraindication to NSAIDs, and at least a history of insufficient pain relief from at least one of the following therapies: a) Acetaminophen/paracetamol, b) Opioids including tramadol, or c) Corticosteroids, hyaluronate IA injections (efficacy less than 3 months according to the patient).
- KL grade 2 to 4 on the Schuss radiograph.
- Predominant femorotibial OA based on the OA Research Society International. (OARSI) Atlas reading (Altman \& Gold, 2007).
- Presence of synovitis in the TK assessed locally using PDUS, and synovial thickness of ≥ 5 mm evaluated through a longitudinal view of the suprapatellar pouch and axial views of the medial and lateral patellofemoral pouches.
- Negative urine drug screen (performed locally): amphetamines, barbiturates, cocaine.
- CE-MRI Central reading to confirm synovitis with a synovial Semi-Quantitative (SQ) ≥ 9 or a SQ score ≥7 with at least one site with a score ≥ 2.
Who cannot join
- Pregnant or breastfeeding women.
- Significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the TK (varus > 10°, valgus > 10°) by radiography.
- Secondary OA such as joint dysplasia, aseptic osteonecrosis, joint infection, acromegaly, Paget disease, hemochromatosis, joint crystal disease or any inflammatory joint disease.
- Any known active infections including skin infections at the site injection or increased predisposition for the development of infections.
- Any partial knee replacement of the TK.
- Acute fracture or IA trauma to the TK within 12 months prior to the screening visit.
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- Major knee surgery performed within the previous 12 months or planned during the trial.
- Arthroscopy of the TK within 6 months prior to the screening visit.
- Presence of any painful conditions that could confound accurate assessment of pain from OA in the TK, such as fibromyalgia, peripheral neuropathy or vascular insufficiency.
- Treatment with systemic corticosteroids (other than IA) at a dose greater than 10 mg prednisone or the equivalent per day for more than 7 days within 4 weeks prior to the screening visit.
- Treatment of the TK with any IA injection (including corticosteroids, hyaluronic acid derivatives, Platelet Rich Plasma….) within 24 weeks prior to the screening visit.
- Any treatment with glucosamine, chondroitin sulfate, or other nutraceuticals with potential activity on OA within the previous 3 months prior to the screening visit.
- Treatment with duloxetine for OA (allowed if given for depressive disorders at stable dose since at least 3 months before V1).
- Any significant psychiatric illness unless well controlled since at least 6 months.
- Current treatment with combination of insulin and liraglutide (Xultophy®) or with GLP-1 agonist administered once a week (semaglutide, dulaglutide).
- High-risk of bleeding.
- Congestive Heart Failure stage III or IV in the New York Heart Association classification.
- History or current diagnosis of electrocardiogram ECG abnormalities indicating significant safety risk (such as ischemia, significant cardiac arrhythmias).
- Glycemia < 4.4 mmol/L (or 80 mg/dL) at screening.
- Clinically significant abnormal laboratory test at screening, in particular: haemoglobin <10 g/dL, white blood cell <3000/µL (3.0 Giga/L), absolute neutrophil count <1000/µL (1.0 Giga/L), platelets count <100,000/µL (100 Giga/L), alanine aminotransferase or aspartate aminotransferase >2.5 upper limit of normal (ULN), total bilirubin >1.5 ULN, lipasemia >1 ULN.
- Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2, using Chronic Kidney Disease - EPIdemiology (CKD EPI) 2021 Formula.
- Any other abnormal laboratory results that the Investigator believes should preclude the subject's participation in the trial.
- History of hypersensitivity to IMP or excipients (liraglutide or disodium phosphate dihydrate, propylene glycol, phenol).
- Any contraindication for MRI (cardiac pacemaker, deep brain stimulators, intraocular metal, cerebral aneurysm clips, recent stents, cochlear implants, neurostimulators and implantable pumps) or inability to undergo MRI (e.g., body size, leg not fitting in the coil, claustrophobia).
- History of hypersensitivity reactions to a gadolinium-based contrast agent.
- Any CE-MRI Central reading additional diagnoses: posterior meniscal root tears, subchondral insufficiency fractures, osteonecrosis, malignant bone marrow infiltration, solid tumours, and traumatic fracture or bone bruise using ROAMES (Roemer et al., 2020).
- Previous participation in clinical research with a disease-modifying OA drug during the last 2 years.
- Participation in an interventional clinical research trial within 3 months before screening.
- Participants who, in the investigator's judgement, are at risk of falling.
- Participants with a history, or current diagnosis, of pancreatitis, thyroid cancer (including medullary thyroid carcinoma), multiple endocrine neoplasia type-2 (MEN2), diabetic ketoacidosis, type-1 diabetes mellitus (T1DM), inflammatory bowel disease, or diabetic gastroparesis.
- Participants currently, or within the last 10 days, taking any anticoagulant treatment.
Trial locations and contacts
22 sites in 6 countries.
22 sites in 6 countries
Spain6 sites
Clínica Gaias Santiago
A Coruña, 15702
Complejo Hospitalario Universitario de A Coruna - Hospital Universitario de A Coruna
A Coruña
HLA Clínica Vistahermosa
Alicante
Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
Sabadell
Clinica Nuestra Senora de la Esperanza
Santiago de Compostela
Hospital Quirónsalud Sagrado Corazón
Seville
France5 sites
CHU Montpellier
Montpellier
ChU de Nice
Nice
Hôpital Cochin
Paris
Hôpital Lariboisière
Paris
Centre Hospitalier Universitaire CHU de Reims - Hopital Maison Blanche
Reims
United States3 sites
Skylight Health Research Burlington
Burlington, Massachusetts, 01803
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Tucson Orthopaedic Institute
Tucson, Arizona, 85712-2805
Canada3 sites
Durham Bone and Joint Specialists
Ajax
SJHC London Rheumatology Centre
London
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc
Québec
Poland3 sites
Care Access Kraków
Krakow
Centrum Medyczne Reuma Park
Warsaw
MICS Centrum Medyczne Warszawa
Warsaw
Denmark2 sites
Parker Institute Bispebjerg, Frederiksberg Hospital
Frederiksberg
Sanos Clinic Herlev
Herlev
About this study
Official title: 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
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
- Knee Osteoarthritis, Synovitis of Knee
- Being tested
- 4P004, Placebo (NaCl 0.9%)
- Keywords
- OA, Knee OA, Liraglutide, Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4P004Drug
Also called Liraglutide
Single intra-articular injection in the knee joint
Placebo (NaCl 0.9%)Drug
Single intra-articular injection in the knee joint
| Study group | Role | What they receive |
|---|---|---|
| 4P004 (2mL) | Experimental | One IA injection in the knee of 4P004 (2mL) on the day of randomization Receives: Drug: 4P004 |
| Placebo (NaCl 0.9% 2mL) | Placebo comparator | One IA injection in the knee of Placebo (NaCl 0.9% 2mL) on the day of randomization Receives: Drug: Placebo (NaCl 0.9%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline at Week 4 in the weekly average of Target Knee (TK) daily pain intensity using the WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain subscore
The WOMAC is a questionnaire widely used in the evaluation of knee osteoarthritis. It contains 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items). Scores are calculated for each subscale and summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for all three subscales gives a total WOMAC score.
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: Baseline and Week 4
Secondary outcomes (15)
Change from Baseline at Week 2, Week 6, Week 8, Week 10 and Week 12 in the weekly average of TK (Target Knee) daily pain intensity using the WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain subscore
The WOMAC is a questionnaire widely used in the evaluation of knee osteoarthritis. It contains 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items). Scores are calculated for each subscale and summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for all three subscales gives a total WOMAC score.
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: Baseline, Week 2, Week 6, Week 8, Week 10 and Week 12
Change from Baseline at Week 2, Week 4, Week 8 and Week 12 in the NRS (Numeric Rating Scale) pain (scale 0-10) in a nominated pain aggravating activity
The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time, using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable.
Measured: Baseline, Week 2, Week 4, Week 8 and Week 12
Change from Baseline at Week 2, Week 4, Week 8 and Week 12 in WOMAC (Western Ontario and McMaster Universities Arthritis Index) subscores and total score
The WOMAC is a questionnaire widely used in the evaluation of knee osteoarthritis. It contains 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items). Scores are calculated for each subscale and summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for all three subscales gives a total WOMAC score.
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: Baseline, Week 2, Week 4, Week 8 and Week 12
Change from Baseline at Week 2, Week 4, Week 8 and Week 12 in the Patient Global Assessment of Osteoarthritis (PGA-OA)
The PGA-OA is a 1-item questionnaire designed to assess the participant's impression of disease severity adapted from Guy et al., 1976, to the specific disease as a Patient-reported Outcome measurement "Considering all the ways your knee osteoarthritis affects you, how are you doing these last seven days ?".
PGA-OA is measured on a 5-point Likert scale, with higher scores indicating worse symptoms (1= "very good" to 5 = "very poor").
Measured: Baseline, Week 2, Week 4, Week 8 and Week 12
Percentage (%) of OMERACT-OARSI Responders at Week 2, Week 4, Week 8 and Week 12
Measured: Week 2, Week 4, Week 8 and Week 12
Incidence and severity of TEAEs (Treatment-Emergent Adverse Events) during the trial
Measured: From randomization to end of trial, up to 12 weeks
Absolute changes from Baseline in clinical laboratory assessment - hematology parameter: total blood cells count (in cell/L)
Measured: From randomization to end of trial (up to 12 weeks)
Absolute changes from Baseline in clinical laboratory assessments - hematology parameter: hemoglobin (in g/L)
Measured: From randomization to end of trial (up to 12 weeks)
Absolute changes from Baseline in clinical laboratory assessment - blood chemistry: AST (in U/L)
Measured: From randomization to end of trial (up to 12 weeks)
Absolute changes from Baseline in clinical laboratory assessment - blood chemistry: ALT (in U/L)
Measured: From randomization to end of trial (up to 12 weeks)
Absolute changes from Baseline in clinical laboratory assessment - blood chemistry: lipase (in U/L)
Measured: From randomization to end of trial (up to 12 weeks)
Absolute changes from Baseline in clinical laboratory assessment - blood chemistry: fasting glycemia (in mmol/L)
Measured: From randomization to end of trial (up to 12 weeks)
Absolute changes from Baseline in clinical laboratory assessment - blood chemistry: total bilirubin (in umol/L)
Measured: From randomization to end of trial (up to 12 weeks)
Absolute changes from Baseline in Vital signs: systolic and diastolic blood pressure (BP)
Measured: From randomization to end of trial (up to 12 weeks)
Absolute changes from Baseline in Vital signs: pulse rate
Measured: From randomization to end of trial (up to 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start17 Jun 2025
- Primary completion31 Aug 2026
- Study completion19 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of one hundred and twenty-nine (129) participants will be randomized in the trial, and enrolled in two arms. Participants in the active arm will receive one intra-articular (IA) injection of 4P004 (2mL), while the placebo arm will receive 2mL of NaCl 0.9%. Randomization ratio will be 2:1 (4P004:Placebo).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- 4Moving Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francis Berenbaum, MD, PhD, Study chair, 4
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225829
- Sponsor's protocol ID
- 4MB-4P004-P-INFLAM
- Other IDs
- 2024-518916-38-00
- Acronym
- INFLAM MOTION
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07225829
- Acronym / sponsor ID
- INFLAM MOTION / 4MB-4P004-P-INFLAM
- Conditions
- Knee Osteoarthritis, Synovitis of Knee
- Keywords
- OA, Knee OA, Liraglutide, Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- 4Moving BiotechIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 19 Oct 2026 (actual)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A total of one hundred and twenty-nine (129) participants will be randomized in the trial, and enrolled in two arms. Participants in the active arm will receive one intra-articular (IA) injection of 4P004 (2mL), while the placebo arm will receive 2mL of NaCl 0.9%. Randomization ratio will be 2:1 (4P004:Placebo).
| Arm | Type | Receives |
|---|---|---|
| 4P004 (2mL) | Experimental | Drug: 4P004One IA injection in the knee of 4P004 (2mL) on the day of randomization |
| Placebo (NaCl 0.9% 2mL) | Placebo comparator | Drug: Placebo (NaCl 0.9%)One IA injection in the knee of Placebo (NaCl 0.9% 2mL) on the day of randomization |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Participants who have the capacity to give informed consent and who are willing to comply with all trial related procedures and assessments.
- Participants between 40 and 80 years of age.
- Female participant of childbearing potential (defined as any woman unless postmenopausal for at least one year or surgically sterile) must use highly effective methods of contraception as defined in the protocol. Highly effective contraceptive measures must be continued throughout the trial until the final visit.
- Bodyweight > 40 kg.
- Body mass index (BMI) ≥ 18.5 and ≤ 35.
Key exclusion criteria (31 listed)
- Pregnant or breastfeeding women.
- Significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the TK (varus > 10°, valgus > 10°) by radiography.
- Secondary OA such as joint dysplasia, aseptic osteonecrosis, joint infection, acromegaly, Paget disease, hemochromatosis, joint crystal disease or any inflammatory joint disease.
- Any known active infections including skin infections at the site injection or increased predisposition for the development of infections.
- Any partial knee replacement of the TK.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4P004Also: LiraglutideSingle intra-articular injection in the knee joint | Drug | 4P004 (2mL) |
| Placebo (NaCl 0.9%)Single intra-articular injection in the knee joint | Drug | Placebo (NaCl 0.9% 2mL) |
Primary outcome
Change from Baseline at Week 4 in the weekly average of Target Knee (TK) daily pain intensity using the WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain subscore
Time frame: Baseline and Week 4
The WOMAC is a questionnaire widely used in the evaluation of knee osteoarthritis. It contains 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items). Scores are calculated for each subscale and summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for all three subscales gives a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
15 secondary outcomes
Change from Baseline at Week 2, Week 6, Week 8, Week 10 and Week 12 in the weekly average of TK (Target Knee) daily pain intensity using the WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain subscore
Time frame: Baseline, Week 2, Week 6, Week 8, Week 10 and Week 12
Change from Baseline at Week 2, Week 4, Week 8 and Week 12 in the NRS (Numeric Rating Scale) pain (scale 0-10) in a nominated pain aggravating activity
Time frame: Baseline, Week 2, Week 4, Week 8 and Week 12
Change from Baseline at Week 2, Week 4, Week 8 and Week 12 in WOMAC (Western Ontario and McMaster Universities Arthritis Index) subscores and total score
Time frame: Baseline, Week 2, Week 4, Week 8 and Week 12
Change from Baseline at Week 2, Week 4, Week 8 and Week 12 in the Patient Global Assessment of Osteoarthritis (PGA-OA)
Time frame: Baseline, Week 2, Week 4, Week 8 and Week 12
Percentage (%) of OMERACT-OARSI Responders at Week 2, Week 4, Week 8 and Week 12
Time frame: Week 2, Week 4, Week 8 and Week 12
Incidence and severity of TEAEs (Treatment-Emergent Adverse Events) during the trial
Time frame: From randomization to end of trial, up to 12 weeks
Absolute changes from Baseline in clinical laboratory assessment - hematology parameter: total blood cells count (in cell/L)
Time frame: From randomization to end of trial (up to 12 weeks)
Absolute changes from Baseline in clinical laboratory assessments - hematology parameter: hemoglobin (in g/L)
Time frame: From randomization to end of trial (up to 12 weeks)
Absolute changes from Baseline in clinical laboratory assessment - blood chemistry: AST (in U/L)
Time frame: From randomization to end of trial (up to 12 weeks)
Absolute changes from Baseline in clinical laboratory assessment - blood chemistry: ALT (in U/L)
Time frame: From randomization to end of trial (up to 12 weeks)
Absolute changes from Baseline in clinical laboratory assessment - blood chemistry: lipase (in U/L)
Time frame: From randomization to end of trial (up to 12 weeks)
Absolute changes from Baseline in clinical laboratory assessment - blood chemistry: fasting glycemia (in mmol/L)
Time frame: From randomization to end of trial (up to 12 weeks)
Absolute changes from Baseline in clinical laboratory assessment - blood chemistry: total bilirubin (in umol/L)
Time frame: From randomization to end of trial (up to 12 weeks)
Absolute changes from Baseline in Vital signs: systolic and diastolic blood pressure (BP)
Time frame: From randomization to end of trial (up to 12 weeks)
Absolute changes from Baseline in Vital signs: pulse rate
Time frame: From randomization to end of trial (up to 12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis Berenbaum, MD, PhD study chair
4
22 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 4P004 in people with Knee Osteoarthritis and Synovitis of Knee, run by 4Moving Biotech at 22 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Spain, France, United States, Canada, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline at Week 4 in the weekly average of Target Knee (TK) daily pain intensity using the WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain subscore (time frame: Baseline and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.