Study to Evaluate the Effect of FX006 on Synovial Inflammation in Patients With OA of the Knee
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Inflammation
Intervention: FX006 32 mg
Intervention description: Extended-release 32 mg FX006 IA injection
Intervention MeSH terms: FX006
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Knee; Pain; Intra-articular; Injection; Corticosteroid

Summary:

      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.
    

Eligibility criteria:

        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