Study S000091

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

ClinicalTrials.gov record

Registration

Registration: NCT07225829
Acronym: INFLAM MOTION
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: DOUBLE
Status: ACTIVE_NOT_RECRUITING
Enrollment: 129
Start: 2025-06-17
Primary completion: 2026-08-31
Lead sponsor: 4Moving Biotech
Conditions: Knee Osteoarthritis; Synovitis of Knee
Interventions: DRUG:4P004; DRUG:Placebo (NaCl 0.9%)
Results posted: FALSE
Individual participant data sharing: UNDECIDED
Secondary identifiers: CTIS:2024-518916-38-00

Registered 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 [Baseline and Week 4]

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