An Open-label Study to Assess the Safety of Repeat Administration of FX006 to Patients With Osteoarthritis of the Knee

FX006-2016-011

This is an Open-label Study to Assess the Safety of Repeat Dose of FX006 Administered to Patients with Osteoarthritis (OA) of the Knee

2017-02-20

2018-07-19

2018-07-19

Completed

Early phase I

208

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 208, 'type': 'ACTUAL'}}

2024-01-24