Study to Assess the Safety of Repeat Administration of FX006 Administered to Patients With Osteoarthritis of the Knee

• Status: Completed
• Trial end date: 2018-07-19
• Target enrollment: 0
• Participant gender: All

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

• 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

• 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