This trial is active, not recruiting.

Condition osteoarthritis of the knee
Treatments fx006, tca ir
Phase phase 2
Sponsor Flexion Therapeutics, Inc.
Start date November 2015
End date October 2016
Trial size 60 participants
Trial identifier NCT02637323, FX006-2015-009


This is an open-label, single administration study of 40 mg of FX006 and Triamcinolone Acetonide Injectable Suspension, USP (referred to as TCA IR in the protocol) conducted in male and female patients with Osteoarthritis (OA) of the knee.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
FX006 Single intra-articular injection
fx006 Zilretta™
Sustained Release Steroid
(Active Comparator)
TCA IR Single intra-articular injection
tca ir Kenalog
Immediate Release Steroid

Primary Outcomes

Measure the concentration of triamcinolone acetonide (TCA) from FX006 and TCA IR in synovial fluid
time frame: Up to 20 Weeks
Measure the concentration of TCA from FX006 and TCA IR in blood plasma
time frame: Up to 20 Weeks

Secondary Outcomes

Incidence of treatment emergent adverse events
time frame: Up to 20 Weeks

Eligibility Criteria

Male or female participants at least 40 years old.

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 - Symptoms associated with OA of the knee for ≥ 6 months prior to Screening (patient reported is acceptable) - Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA - 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 Exclusion Criteria: - Fibromyalgia, Reiter's syndrome, 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 joint within 12 months of Screening - IA corticosteroid (investigational or marketed) in any joint within 6 months of Screening - IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening - Intravenous or Intramuscular corticosteroids (investigational or marketed) within 3 months of Screening - Oral corticosteroids (investigational or marketed) within 1 month of Screening - Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening - Any other IA investigational drug/biologic use within 6 months of Screening or 5 half-lives (whichever is longer) - Prior use of FX006 - Women of child-bearing potential not using effective contraception or who are pregnant or nursing

Additional Information

Official title An Open-label, Single Administration Study to Characterize the Systemic Pharmacokinetics and Local Extent and Duration of Exposure of Triamcinolone Acetonide From FX006 in Patients With Osteoarthritis of the Knee
Description Approximately 60 patients with OA of the knee (10 per Cohort) will be treated with a single 5mL intra-articular (IA) injection of 40 mg of FX006 or a single 1 mL injection of 40 mg of TCA IR. Patients will be enrolled sequentially into one of six cohorts. Cohorts A through E will receive 40 mg of FX006. Cohort F will receive 40 mg of TCA IR. Synovial Fluid Visits are as follows for each cohort: Cohort A: 20 Weeks, Cohort B: 16 Weeks, Cohort C: 12 Weeks, Cohort D and F: 6 Weeks, Cohort E: 1 Week. Each patient will be evaluated for safety during his/her participation in the study and plasma and synovial fluid will be collected for drug concentration measurements.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Flexion Therapeutics, Inc..