Study to Evaluate a Procedure for Intra-articular Injection of FX006 in Patients With Osteoarthritis of the Hip

Study Overview
=================
Brief 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.

Detailed Description
-----------------
This is a multi-center, single-arm, open-label study in patients with hip OA to evaluate a procedure for intra-articular injection 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 on Day 1 and be followed for 8 weeks.

Official Title
-----------------
A Single-arm, Open-label Study to Evaluate a Procedure for Intra-articular (IA) Injection of FX006 in Patients With Osteoarthritis (OA) of the Hip

Conditions
-----------------
Osteoarthritis, Hip

Intervention / Treatment
-----------------
* Drug: FX006 32 mg


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FX006 32 mg<br>Single intra-articular (IA) injection of FX006 32 mg | Drug: FX006 32 mg<br>* Extended-release 32 mg FX006 IA injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Successful Study Drug Administrations | Successful study drug administration, defined as Injector reporting complete study drug administration. | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Hip, Intra-articular, Injection