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NCT07225829 · ClinicalTrials.gov registry record · Phase 2
A Trial to Investigate the Safety and Efficacy of Intra-articular 4P004 Injection in Subjects With Knee Synovitis and Osteoarthritis
A Phase 2 study of Knee Osteoarthritis and Synovitis of Knee, sponsored by 4Moving Biotech.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 129
- Enrollment target
- 20
- Study locations
NCT07225829: Recruiting Phase 2 study of Knee Osteoarthritis and Synovitis of Knee, sponsored by 4Moving Biotech.
NCT07225829 is a Phase 2 study of Knee Osteoarthritis and Synovitis of Knee that is actively recruiting participants, run by 4Moving Biotech. The registered enrollment target is 129 participants, below the 303-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (57% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07225829, a Phase 2 study of Knee Osteoarthritis and Synovitis of Knee, is actively recruiting participants, sponsored by 4Moving Biotech.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 129 participants
- Enrollment target
- 20
- Study locations
Study 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 according to Kellgren and Lawrence (KL) classification.
Primary Outcome
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 li
Conditions Studied
Interventions
- DRUG 4P004
- DRUG Placebo (NaCl 0.9%)
Study Locations (20)
Other
- Durham Bone and Joint Specialists - Ajax
- SJHC London Rheumatology Centre - London
- G.R.M.O. (Groupe de recherche en maladies osseuses) Inc - Québec
- Parker Institute Bispebjerg, Frederiksberg Hospital - Frederiksberg
- Sanos Clinic Herlev - Herlev
- CHU Montpellier - Montpellier
- ChU de Nice - Nice
- Hôpital Cochin - Paris
- Hôpital Lariboisière - Paris
- Centre Hospitalier Universitaire CHU de Reims - Hopital Maison Blanche - Reims
- Care Access Kraków - Krakow
- Centrum Medyczne Reuma Park - Warsaw
- MICS Centrum Medyczne Warszawa - Warsaw
- 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
- Hospital Universitario Marques de Valdecilla - Santander
- Clinica Nuestra Senora de la Esperanza - Santiago de Compostela
Illinois
- Northwestern University Feinberg School of Medicine - Chicago
Massachusetts
- Skylight Health Research Burlington - Burlington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2025-06-17 |
| Est. Completion | 2026-05 |
| Phase | Phase 2 |
What NCT07225829 shows while recruiting
NCT07225829 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, below the 303-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (57% lower).
The record links to 2 conditions, with Knee Osteoarthritis appearing as the primary indexed condition, and to 2 interventions - of which 4P004 is the first listed.
NCT07225829 names 20 study sites across 3 states, led by Other, Illinois, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT07225829 about?
NCT07225829 is a clinical study titled "A Trial to Investigate the Safety and Efficacy of Intra-articular 4P004 Injection 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 osteoarth...
What is the current status of trial NCT07225829?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 129 participants. The study started on 2025-06-17. Estimated completion is 2026-05.
What conditions does trial NCT07225829 study?
This clinical trial studies the following conditions: Knee Osteoarthritis, Synovitis of Knee.
What interventions are being tested in trial NCT07225829?
The interventions under investigation include: 4P004 (DRUG), Placebo (NaCl 0.9%) (DRUG).
Who is sponsoring clinical trial NCT07225829?
This trial is sponsored by 4Moving Biotech, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07225829 being conducted?
This trial has 20 study locations across Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07225829's enrollment target sits among peer trials
129 37th of 101 higher than 65 of 101 other Knee Osteoarthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Knee Osteoarthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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