Inclusion Criteria:
Subjects must provide written informed consent prior to initiating any study
specific procedures.
2. Subjects must be willing and able to comply with the study procedures and visit
schedule and to follow verbal and written instructions.
3. Subjects must be male or female and 50 to 80 years old, inclusive, on the day
of consent.
4. Subjects must have a body mass index (BMI) ≤40 kg/m2 at Screening. 5. Subjects
must exhibit symptoms associated with unilateral or bilateral hip OA for at
least 6 months prior to Screening.
6. Subjects with unilateral or bilateral hip pain must have an 24-hour average
pain score (based on a numerical rating scale [NRS]) between ≥5.0 and ≤9.0 for
the index hip and <5 in contralateral hip at Screening.
7. Subjects must have K-L Grade 2 or 3 in the index hip (ie, the hip identified by
the Investigator as appropriate for injection) confirmed by X ray obtained
during Screening or within ≤6 months prior to the Screening visit.
8. Subjects must have an index hip examination indicating the index hip and the
intended injection site area are free of any signs of local or joint infection
at Day 1/Baseline. Subjects must also not have a history of infection (eg,
osteomyelitis) in the index hip or injection site.
9. Sexually active subjects of child-bearing potential (SOCBP; defined as neither
surgically sterile nor postmenopausal, ie, age >45 years and no menstrual
periods for at least 1 year without an alternative medical cause) must agree to
use, from Screening through 14 weeks postinjection for biologically female
subjects and through 23 weeks postinjection for biologically male subjects, a
highly effective method of contraception, defined as one of the following:
abstinence; oral, injected, or implanted hormonal methods of contraception;
intrauterine device or intrauterine contraceptive system; condom or occlusive
cap (diaphragm or cervical/vault caps) with spermicidal
foam/gel/film/cream/suppository; or sexual intercourse only with biological
male ≥6 months post-vasectomy.
Exclusion Criteria:
Subjects who are pregnant, nursing, lactating, or plan to become, or their
partner plans to become, pregnant during the study.
2. Subjects with a history of hypersensitivity to triamcinolone acetonide, PLGA,
or lidocaine.
3. Subjects with hypersensitivity or allergy to Omnipaque 300 or iodine. 4.
Subjects contraindicated to the use of acetaminophen/paracetamol (allowed
rescue pain medicine) per National Product Labeling and Investigator's
judgment.
5. Subjects currently taking coumadin or have taken coumadin for ≥3 weeks prior to
Day 1/Baseline.
6. Subjects with a history of or active significant concomitant illness (known or
suspected) including, but not limited to:
- - Inflammatory joint disease, eg, rheumatoid arthritis, seronegative
spondyloarthropathy, ankylosing spondylitis, psoriatic arthritis, reactive
arthritis, inflammatory-bowel disease associated inflammatory arthritis.
- - Systemic inflammatory disease, eg, polymyalgia rheumatica, systemic lupus
erythematosus.
- - Sarcoidosis or amyloidosis.
- - Malignancy requiring systemic therapy within the past 5 years (excludes basal
cell carcinoma or cervical cancer treated only with surgical removal more than
1 year prior).
- - Other autoimmune disease.
7. Subjects who have had any previous substantial hip
injury (eg, hip dislocation, partial or complete hip fraction), which resulted
in functional limitation or immobilization within 3 months prior to Screening.
8. Subjects who have had prior surgery of the index hip either open or
arthroscopic within 5 years of Screening.
9. Subjects with any retained hardware or foreign body in the index hip. 10.
Subjects with an index hip with major dysplasia or congenital abnormality,
osteochondritis dissecans, acromegaly, ochronosis, hemochromatosis,
Wilson's disease, primary osteochondromatosis, chondrolysis from a pain
pump, or a history of avascular necrosis with secondary OA.
11. Subjects with a diagnosis of other disorders in the index hip that can
cause pain or any concurrent chronic joint, muscle, or nerve pain
condition within 1 month prior to Screening (subject self-report
acceptable), including but not limited to, back spine pain or conditions
causing femoral nerve, obturator nerve, and sciatic nerve
injury/entrapment; trochanteric bursitis; diabetic neuropathy of lower
extremities; post-herpetic neuralgia; post-stroke pain; or fibromyalgia
that may affect sensation of the index hip.
12. Subjects who have used corticosteroids (any route of administration: IA
intrabursal, intratendinous, intravenous [IV], intramuscular [IM], oral,
intranasal, or inhaled) within 3 months of Screening except occasional
(non-daily use <1 month) topical steroid use within 1 month prior to
dosing. Treatment in another joint during this timeframe is exclusionary.
Also, subjects who will require any steroid use while they are in the
study are ineligible.
13. Subjects who have received IA treatment in the index hip with any of the
following agents within the 6 months or 5 half-lives prior to Screening:
any biologic agent (eg, platelet rich plasma, stem cells, prolotherapy,
amniotic fluid) or hyaluronic acid (investigational or marketed).
14. Subjects with a history of or evidence of active or latent systemic fungal
or mycobacterial infection (including tuberculosis), or of ocular herpes
simplex.
15. Subjects who have received a live vaccine (eg, measles, mumps, and rubella
[MMR], varicella, influenza [nasal spray version only], Bacillus
Calmette-Guérin [BCG], and polio) within 3 months prior to Screening.
16. Subjects who have received an inactivated vaccination (eg, flu, COVID,
tetanus, tetanus/diphtheria/pertussis [Tdap], hepatitis A) within 1 week
prior to Screening and local injection pain has not resolved.
17. Subjects with diabetes mellitus with hemoglobin A1c (HbA1c) >8.5% at
Screening.
18. Subjects with evidence of positive hepatitis B surface antigen (HBsAg) or
hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune subjects
(ie, HBsAg-negative and hepatitis B antibody-positive) may, however, be
included.
Note: Subjects who are negative for HBsAg, but positive for HBcAb, would be considered
eligible if the absence of HBV DNA is confirmed by HBV DNA polymerase chain reaction
reflex testing.
19. Subjects with chronic hepatitis C virus (HCV) (ie, positive HCV antibody [HCVAb] and
HCV RNA).
Note: Subjects who are HCVAb-positive without evidence of HCV RNA may be considered
eligible (spontaneous viral clearance or previously treated and cured [defined as no
evidence of HCV RNA at least 3 months prior to Day 1/Baseline]).
20. Subjects with laboratory evidence of infection with human immunodeficiency virus
(HIV).
21. Subjects who have any infection requiring parenteral antibiotics within 4 weeks of
Day 1/Baseline or oral antibiotics within 2 weeks of Day 1/Baseline.
22. Subjects with active substance use disorder (drugs or alcohol) or history of
substance use disorder within 12 months prior to Screening. Positive amphetamine
results due to prescribed attention deficit/hyperactivity disorder (ADHD)
medications with at least 6 months of stable dosing is permitted.
23. Subjects who use muscle relaxants (eg, cyclobenzaprine, tetrazepam, and diazepam) or
oral/topical therapies (eg, nonsteroidal anti-inflammatory drugs [NSAIDs],
cannabidiol [CBD] oil, capsaicin, lidocaine patches, or other local treatments)
applied to the index hip within 1 month prior to Screening or within 5 half-lives of
last dose.
24. Subjects who use selective serotonin reuptake inhibitors (SSRIs)/serotonin and
norepinephrine reuptake inhibitors (SNRIs) (eg, fluoxetine, fluvoxamine, citalopram,
escitalopram, sertraline, duloxetine, venlafaxine, and milnacipran) if the dose is
not stable for at least 3 months prior to Screening. Subject must remain on a stable
dose throughout the study.
25. Subjects using immunomodulators, immunosuppressives, or chemotherapeutic agents or
have used any within 5 years of Screening.
26. Subjects using any other investigational drug, biologic, or device or have used any
within 3 months of Screening.
27. Subjects who cannot washout prohibited medications (eg, opioids, other analgesics,
and tetrahydrocannabinol [THC]- and CBD-containing products) or restricted
medications.
28. Subjects who have any abnormal laboratory value(s) at Screening that, in the opinion
of the Investigator (or other authorized clinical staff), precludes study
participation.
29. Subjects with any other clinically significant acute or chronic pain condition that,
in the judgment of the Investigator and in consultation with the Medical Monitor
(MM) and/or sponsor, would or could compromise (or convey increased risk of) subject
safety, limit the subject's ability to complete the study, and/or compromise the
objectives of the study.
30. Subjects with any other clinically significant acute or chronic medical conditions
(eg, autoimmune disorder; asthma/chronic obstructive pulmonary disease [COPD], or
allergies requiring steroid use; bleeding disorder; other major hematological
conditions, cardiac, renal, metabolic, gastrointestinal, neurologic, or psychiatric
disease) that, in the judgment of the Investigator and/or in consultation with the
MM, would preclude the use of the study drug or IA corticosteroids or that could
compromise (or convey increased risk of) subject safety, limit the subject's ability
to complete the study, and/or compromise the objectives of the study.
31. Subjects are the Investigator or any Sub-Investigator, research assistant,
pharmacist, study coordinator, other staff, or relative thereof directly involved in
the conduct of the study.
