Study to Evaluate a Procedure for Intra-articular Injection of FX006 in Patients With Osteoarthritis of the Hip
Condition: Osteoarthritis, Hip
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Intervention: FX006 32 mg
Intervention description: Extended-release 32 mg FX006 IA injection
Intervention MeSH terms: FX006
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Hip; Intra-articular; Injection

Summary:

      This is a multi-center, single-arm, open-label study of FX006 in patients with hip OA. A
      maximum number of approximately 30 patients may be enrolled in this protocol. All enrolled
      patients will receive a single intra-articular (IA) injection of FX006.
    

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 consent

          -  Body Mass Index (BMI) ≤ 40 kg/m^2

          -  Has a documented clinical diagnosis of unilateral or bilateral hip OA for at least six
             months

          -  Kellgren-Lawrence (KL) Grade 2 or 3 in the index hip as confirmed by local read of
             X-ray obtained during Screening or ≤ 6 months of Screening visit

          -  Has clinically significant pain in the index hip

        Exclusion Criteria:

          -  Has a history of hypersensitivity to triamcinolone acetonide, PLGA or lidocaine

          -  Is receiving anticoagulants (including warfarin, dabigatran, rivaroxaban, apixaban or
             low molecular weight heparin, ritonavir or cobicistat)

          -  Has had any previous surgery on the index hip

          -  Presence of surgical hardware or other foreign body in the index hip

          -  Has a history of infection of the index hip

          -  Has a diagnosis of other disorders in the index hip that can cause pain

          -  Has received any intra-articular injection in the index hip of corticosteroids,
             investigational (including FX006) or marketed (including Zilretta®) within the 3
             months prior to Screening

          -  Has had trauma to the index hip in the past 3 months requiring immobilization

          -  Has a history or evidence of active or latent systemic fungal or mycobacterial
             infection (including tuberculosis), or of ocular herpes simplex

          -  Has within the past 3 months received corticosteroids by mouth, or by parenteral
             injection. Multiple courses or chronic intermittent use of inhaled, intranasal, or
             topical steroids is also exclusionary. Single courses of 14 days or less by those
             routes are permitted

          -  Has, at screening, or any time prior to day of scheduled injection (Day 1), clinical
             suspicion of local or systemic infection, including any infection in the index leg.

          -  Has a history of or active significant concomitant illness (known or suspected)

          -  Any bacterial or viral infection requiring parental antibiotics within 4 weeks of Day
             1 or oral antibiotics within 2 weeks of Day 1

          -  Is a woman who is pregnant, nursing, lactating, or plans to become pregnant during the
             study

          -  Is a man who plans to conceive during the study