NCT07225829

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (estimated)
• Sponsor: 4Moving Biotech · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Osteoarthritis
• Synovitis of Knee

Interventions

Type	Name	Description
DRUG	4P004	Single intra-articular injection in the knee joint
DRUG	Placebo (NaCl 0.9%)	Single intra-articular injection in the knee joint

Timeline

• Start date: 2025-06-17
• Primary completion: 2026-07-01
• Completion: 2026-09-01
• First posted: 2025-11-10
• Last updated: 2026-04-14

Locations

22 sites across 6 countries: United States, Canada, Denmark, France, Poland, Spain

Regulatory

• FDA-regulated drug study