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

Pacira

Status and phase

Completed

Phase 2

Conditions

Osteoarthritis, Hip

Treatments

Drug: FX006 32 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT04065074

FX006-2019-017

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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