A Randomized, Open-label, Parallel Group Study in Patients With Bilateral Knee Osteoarthritis Comparing the Systemic Exposure of Triamcinolone Acetonide Following Administration Into Both Knees of Either Extended-release FX006 or Immediate-release TAcs (Triamcinolone Acetonide Suspension)

FX006-2017-012

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.

2017-12-06

2018-03-14

2018-03-14

Completed

Early phase I

24

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}

2024-01-24