Phase 2Active, not recruitingAge-related condition
A Trial to Investigate the Safety and Efficacy of Intra-articular 4P004 Injection in Subjects With Knee Synovitis and Osteoarthritis (INFLAM MOTION)
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 (Industry)
- Enrolment
- 129 planned
- Conditions
- Knee Osteoarthritis; Synovitis of Knee
- Interventions
- 4P004; Placebo (NaCl 0.9%)
- Ages
- adults, older adults
- Registry
- NCT07225829, CTIS2024-518916-38-00
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- 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
History
Study completion expected
Last registry update
Primary completion
Registered
Started