Study to Compare Exposure of TA Following Administration of Either FX006 or TAcs in Patients With Bilateral Knee OA

• Status: Completed
• Trial end date: 2018-03-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Flexion Therapeutics, Inc.
• Treatments: FX006; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

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