Study to Assess the Safety of Repeat Administration of FX006 Administered to Patients With Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: FX006 32 mg
Intervention description: Single intra-articular injection
Intervention MeSH terms: FX006
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 208.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Knee; Pain; Steroid; Intra-articular; Injection

Summary:

      This is an Open-label Study to Assess the Safety of Repeat Dose of FX006 Administered to
      Patients with Osteoarthritis (OA) of the Knee
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written consent to participate in the study

          -  Willingness and ability to comply with the study procedures and visit schedules and
             ability to follow verbal and written instructions

          -  Male or female ≥ 40 years of age

          -  Symptoms associated with OA of the index knee for ≥ 6 months prior to Screening

          -  Currently meets American College of Rheumatology (ACR) Criteria (clinical and
             radiological) for OA

          -  Kellgren-Lawrence (KL) Grade 2, 3 or 4 in the index knee based on X-ray performed
             during Screening

          -  Qualifying score for WOMAC A at Screening and Day 1/Baseline

          -  Index knee pain for >15 days over the last month (as reported by the patient)

          -  Body mass index (BMI) ≤ 40 kg/m2

          -  Ambulatory and in good general health

          -  Willingness to abstain from use of protocol-restricted medications during the study

        Exclusion Criteria:

          -  Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis,
             or arthritis associated with inflammatory bowel disease

          -  History of infection in the index knee joint

          -  Clinical signs and symptoms of active knee infection or crystal disease of the index
             knee within 1 month of Screening

          -  Presence of surgical hardware or other foreign body in the index knee

          -  Unstable index knee joint (such as a torn anterior cruciate ligament) within 12 months
             of Screening

          -  IA corticosteroid (investigational or marketed) in index knee within 3 months of
             Screening

          -  IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of
             Screening

          -  IV or intramuscular (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 use 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

          -  Women of child-bearing potential not using effective contraception or who are pregnant
             or nursing