Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis
Condition: Osteoarthritis, Hip
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Intervention: FX006; Normal saline
Intervention description: Single Intra-articular injection; Single Intra-articular injection
Intervention MeSH terms: FX006
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-blind, Placebo-controlled, Parallel-group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Hip; Pain; Intra-articular; Injection

Summary:

      This is a two-part, multi-center, randomized, double-blind, placebo-controlled,
      parallel-group study in patients with hip OA. Approximately 70 patients will be enrolled in
      Part I and approximately 440 patients will be enrolled in Part II of the study. In each part,
      patients will be randomized to one of two treatment groups (1:1) and treated with a single IA
      injection of either 32 mg FX006 or normal saline.
    

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