Study to Compare Exposure of TA Following Administration of Either FX006 or TAcs in Patients With Bilateral Knee OA
Condition: Bilateral Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: FX006 32 mg; TAcs 40 mg
Intervention description: Drug: Extended-release 32 mg FX006 IA injection into each knee (total 64 mg dose); Drug: Immediate-release 40mg TAcs IA injection into each knee (total 80 mg dose)
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; FX006; Triamcinolone diacetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Knee; Corticosteroid; Bilateral; Pain; Intra-articular; Injection

Summary:

      This is a randomized, open-label, parallel group study to compare systemic exposure of
      triamcinolone acetonide following administration into both knees of either FX006 or TAcs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written consent to participate in the study

          -  Male or female greater than or equal to 40 years of age

          -  Symptoms consistent with OA in both knees for greater than or equal to 6 months prior
             to Screening (patient reported is acceptable)

          -  Currently meets ACR Criteria (clinical and radiological) for OA in both knees

          -  Knee pain in both knees for greater than 15 days over the last month (as reported by
             the patient)

          -  Body mass index (BMI) less than or equal to 40 kg/m2

          -  Morning serum cortisol result within normal range at Screening (5-23 mcg/dL or 138-635
             nmol/dL)

          -  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

        Exclusion Criteria:

          -  Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis,
             or arthritis associated with inflammatory bowel disease

          -  History of infection in either knee joint

          -  Clinical signs and symptoms of active knee infection or crystal disease in either knee
             within 1 month of Screening

          -  Unstable joint (such as a torn anterior cruciate ligament) in either knee within 12
             months of Screening

          -  Presence of surgical hardware or other foreign body in either knee

          -  Surgery or arthroscopy of either knee within 12 months of Screening

          -  IA treatment of any joint with any of the following agents within six (6) months of
             Screening: any corticosteroid preparation (investigational or marketed, including
             FX006), any biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells,
             prolotherapy, amniotic fluid injection; investigational or marketed).

          -  IA treatment in either knee with hyaluronic acid (investigational or marketed) within
             6 months of Screening

          -  Parenteral or oral corticosteroids (investigational or marketed) within 3 months of
             Screening

          -  Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2
             weeks of Screening

          -  Females who are pregnant or nursing or plan to become pregnant during the study; men
             who plan to conceive during the study