RecruitingPhase 2NCT07225829

A Trial to Investigate the Safety and Efficacy of Intra-articular 4P004 Injection in Subjects With Knee Synovitis and Osteoarthritis

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


Sponsor

4Moving Biotech

Enrollment

129 participants

Start Date

Jun 17, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 4P004 and a drug called Placebo (NaCl 0.9%) for people with knee osteoarthritis and synovitis of knee. The study is currently recruiting participants at 22 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG4P004

Single intra-articular injection in the knee joint

DRUGPlacebo (NaCl 0.9%)

Single intra-articular injection in the knee joint


Locations(22)

Tucson Orthopaedic Institute

Tucson, Arizona, United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Skylight Health Research Burlington

Burlington, Massachusetts, United States

Durham Bone and Joint Specialists

Ajax, Canada

SJHC London Rheumatology Centre

London, Canada

G.R.M.O. (Groupe de recherche en maladies osseuses) Inc

Québec, Canada

Parker Institute Bispebjerg, Frederiksberg Hospital

Frederiksberg, Denmark

Sanos Clinic Herlev

Herlev, Denmark

CHU Montpellier

Montpellier, France

ChU de Nice

Nice, France

Hôpital Cochin

Paris, France

Hôpital Lariboisière

Paris, France

Centre Hospitalier Universitaire CHU de Reims - Hopital Maison Blanche

Reims, France

Care Access Kraków

Krakow, Poland

Centrum Medyczne Reuma Park

Warsaw, Poland

MICS Centrum Medyczne Warszawa

Warsaw, Poland

Clínica Gaias Santiago

A Coruña, Spain

Complejo Hospitalario Universitario de A Coruna - Hospital Universitario de A Coruna

A Coruña, Spain

HLA Clínica Vistahermosa

Alicante, Spain

Corporacio Sanitaria Parc Tauli - Hospital de Sabadell

Sabadell, Spain

Clinica Nuestra Senora de la Esperanza

Santiago de Compostela, Spain

Hospital Quirónsalud Sagrado Corazón

Seville, Spain

View Full Details on ClinicalTrials.gov

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NCT07225829


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