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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
4Moving Biotech
Study ID
NCT07225829
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 4P004 — DRUG
    Single intra-articular injection in the knee joint
  • Placebo (NaCl 0.9%) — DRUG
    Single intra-articular injection in the knee joint

Study Details

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.

Key Dates

Start date
Jun 17, 2025
Status verified
Apr 2026
Primary completion
Jul 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
129 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 4P004 (2mL)
    One IA injection in the knee of 4P004 (2mL) on the day of randomization
  • Placebo Comparator: Placebo (NaCl 0.9% 2mL)
    One IA injection in the knee of Placebo (NaCl 0.9% 2mL) on the day of randomization

Primary Outcome Measure

Change from Baseline at Week 4 in the weekly average of Target Knee (TK) daily pain intensity using the WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain subscore [ Time Frame: Baseline and Week 4 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Tucson Orthopaedic InstituteTucsonArizona85712-2805
Nebojsa Skrepnik, MD
Northwestern University Feinberg School of MedicineChicagoIllinois60611
Thomas Schnitzer, MD
Skylight Health Research BurlingtonBurlingtonMassachusetts01803
Timothy McAlindon, MD

Find similar trials in Tucson, AZ

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
Tucson Orthopaedic Institute· Tucson, AZNorthwestern University Feinberg School of Medicine· Chicago, ILSkylight Health Research Burlington· Burlington, MA

Related Studies