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

Phase 3

Completed

Brief 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

Detailed Description: This study is an open-label, repeat administration design of 32 mg FX006. The study will be conducted in male and female patients ≥ 40 years of age with symptomatic OA of the knee.

Eligible patients will be offered participation to receive an initial intra-articular (IA) injection of FX006 administered to the index knee at Day 1.

Patients who receive an initial injection of FX006 will return at Weeks 4 and 8 before being evaluated at 12, 16, 20 and 24 weeks for repeat administration. At the first evaluation where the patient has been determined to meet repeat administration eligibility criteria, the patient will be eligible to receive a second IA injection of FX006.

Patients who are eligible to receive a second injection will be evaluated for a total of 52 weeks post initial injection at: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52, regardless of the time at which they receive their second injection. In addition, X-rays will be completed at Screening and Week 52 or End of Study (EOS) for assessment of safety.

Patients that do not benefit from the initial treatment as determined by evaluation at Week 12 will complete the study at the Week 12 follow-up visit.

Patients who are not eligible for a second injection of FX006 after evaluation at Weeks 12, 16, 20, and 24 will complete the study at the Week 24 follow-up visit.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
FX006 32 mg	FX006 32 mg	Single intra-articular injection

Primary Outcome Measures

Name	Time	Method
Total Number of Treatment Emergent Adverse Events (TEAEs) in Patients With Symptomatic Osteoarthritis (OA) of the Knee Who Received Two Doses of 32 mg FX006	Up to 52 Weeks	Analyses of adverse events (AE) were performed for events considered treatment-emergent (TE) in patients who received two doses of 32 mg FX006. TE was defined as any AE with onset after administration of the 1st dose of study drug or any event present at baseline but worsened in intensity through the study. Severity was graded by the PI using the Common Terminology Criteria for AEs Version 4.0. Grading went from Grade 1 (Mild) to Grade 5 (Death Related to AE).

Secondary Outcome Measures

Name	Time	Method

Locations (17): Tampa Bay Medical Research
🇺🇸
Clearwater, Florida, United States
Cedars-Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Dream Team Clinical Research
🇺🇸
Anaheim, California, United States
Duke University
🇺🇸
Durham, North Carolina, United States
Tucson Orthopedic
🇺🇸
Tucson, Arizona, United States
Hope Clinical Research
🇺🇸
Canoga Park, California, United States
New England Baptist Hospital
🇺🇸
Dedham, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸
Chestnut Hill, Massachusetts, United States
Rochester Clinical Research
🇺🇸
Rochester, New York, United States
Coastal Carolina Research Center
🇺🇸
Mount Pleasant, South Carolina, United States
Harbor-UCLA Medical Center
🇺🇸
Torrance, California, United States
Artemis Institute for Clinical Research
🇺🇸
San Diego, California, United States
The Andrews Institute
🇺🇸
Gulf Breeze, Florida, United States
PMG Research of Knoxville
🇺🇸
Knoxville, Tennessee, United States
Altoona Center for Clinical Research
🇺🇸
Duncansville, Pennsylvania, United States
Ochsner Sports Medicine Institute
🇺🇸
New Orleans, Louisiana, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States