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

NCT07225829 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2026-04-14

No results posted yet for this 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.

Conditions

Interventions

DRUG

4P004

Single intra-articular injection in the knee joint

DRUG

Placebo (NaCl 0.9%)

Single intra-articular injection in the knee joint

Sponsors & Collaborators

  • 4Moving Biotech

    lead INDUSTRY

Principal Investigators

  • Francis Berenbaum, MD, PhD · 4

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-17
Primary Completion
2026-07-31
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Denmark
  • France
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07225829 on ClinicalTrials.gov