Intervention: Kenalog
Trial phase: Phase 3
SMILES: CC1(C)OC2CC3C4CCC5=CC(=O)C=CC5(C)C4(F)C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: FX006 32mg

FX006: Single Intra-articular injection
Eligibility criteria:
Inclusion Criteria:

Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
Patients 40 to 80 years of age, inclusive, on the day of randomization (Day 1)
Body Mass Index (BMI) ≤ 40 kg/m2
Symptoms associated with OA of the index hip for ≥ 3 months prior to Screening visit
Currently meet the American College of Radiology (ACR) Criteria (clinical and radiological) for OA of the index hip
Kellgren-Lawrence (KL) Grade 2 or 3 in the index hip as confirmed by X-ray during Screening visit (centrally read)
Qualifying mean score on the WOMAC A and C (0-10 NRS scale)
Agree to maintain the similar activity level throughout the study
Willingness to abstain from use of restricted medications

Exclusion Criteria:

Patients who cannot washout of prohibited medications
Diagnosed as secondary OA in the index hip including but not limited to articular fracture, major dysplasia or congenital abnormality, osteochondritis dissecans, acromegaly, ochronosis, hemochromatosis, Wilson's disease, or primary osteochondromatosis, etc.
Ipsilateral chronic knee pain
Sciatica
Atrophic osteoarthritis, femoral head necrosis and/or collapse, or subchondral bone insufficiency fracture in the index hip joint determined via central reading
Current or history of infection in the index hip (e.g. osteomyelitis) or current skin infection at injection site
Trauma or surgeries (e.g., arthroscopy, knee surgery) of lower limbs within 52 weeks with sequelae, etc.
History or current evidence of reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease, systemic lupus erythematosus or other autoimmune diseases
Any planned surgeries in the lower limbs during the study period, or any other surgery during the study period that would require use of a restricted medication
Presence of surgical hardware or other foreign body in the index hip
Planned/anticipated surgery of the index hip or any other surgery that would require use of a restricted medication during the study period
IA corticosteroid of any joint within 3 months of Screening visit (investigational or marketed, including FX006)
IA treatment of index hip with any of the following agents within 6 months of Screening: any biologic agent or hyaluronic acid (investigational or marketed)
IV or IM 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 visit
Planned or expected changes to lifestyle with regard to physical activity, physical therapy, acupuncture, transcutaneous electrical nerve stimulation (TENS), or bracing within 1 month prior to Screening and changes throughout the duration of the study
Women of child-bearing potential (not surgically sterile or post-menopausal for at least 1 year as documented in medical history) not using a highly effective method or who are pregnant or nursing