A Trial to Investigate the Safety and Efficacy of Intra-articular 4P004 Injection in Subjects With Knee Synovitis and Osteoarthritis (NCT07225829)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Tucson Orthopaedic Institute — Tucson, Arizona
Age range: 40 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (22 Sites)
- Tucson Orthopaedic Institute — Tucson, Arizona
- Northwestern University Feinberg School of Medicine — Chicago, Illinois
- Skylight Health Research Burlington — Burlington, Massachusetts
- 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,
- Clínica Gaias Santiago — A Coruña,
- 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,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Knee Osteoarthritis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.