Study to Evaluate the Effect of FX006 on Synovial Inflammation in Patients With OA of the Knee

• Status: Completed
• Trial end date: 2020-03-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Flexion Therapeutics, Inc.
• Treatments: FX006

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