An Open-Label Study to Evaluate the Effect of the Administration of FX006 on Synovial Inflammation in Patients With Osteoarthritis of the Knee

FX006-2017-014

This is an open-label study assessing the effect of the administration of a single intra-articular (IA) injection of FX006 32 mg on synovial volume in patients with osteoarthritis (OA) of the knee.

2018-04-24

2019-11-08

2020-03-09

Completed

Early phase I

129

Inclusion Criteria: * Written consent to participate in the study * Male or female ≥ 40 years of age * Body mass index (BMI) ≤ 40 kg/m\^2 * Ambulatory and in good general health * Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions * Willing to abstain from use of protocol-restricted medications during the study * Symptoms associated with OA of the index knee for ≥ 6 months prior to Screening (patient self-report is acceptable) * Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA * Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee based on X-ray performed during Screening (centrally read) Exclusion Criteria: * Any inflammatory arthritis including reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, gout or secondary OA from gout * History of infection or crystal disease in the index knee joint * Unstable index knee joint (such as a torn anterior cruciate ligament) within 12 months of Screening * Surgery or arthroscopy of the index knee within 12 months of Screening * IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening * IA treatment of the index knee with hyaluronic acid (investigational or marketed) within 6 months of Screening * IV or IM corticosteroids (investigational or marketed) within 3 months of Screening * Oral corticosteroids (investigational or marketed) within 1 month of Screening * Any other IA drug/biologic in the index knee within 6 months of Screening or 5 half-lives (whichever is longer) (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy and amniotic fluid injection) * Prior administration of FX006 * eGFR results \<40 mL/minute * Any contraindication to MRI Scanning (e.g., presence of certain ferromagnetic foreign bodies or electronic devices including most cardiac pacemakers, claustrophobia) * Known hypersensitivity to any form of radiographic contrast * Females who are pregnant or nursing or plan to become pregnant during the study; men who plan to conceive during the study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 129, 'type': 'ACTUAL'}}

2024-01-24