Inclusion Criteria:
1. Written informed consent has been obtained prior to initiating any study-specific
procedures.
2. Willingness and ability to comply with the study procedures and visit schedules and
ability to follow verbal and written instructions, including eDiary questionnaire
completion requirements.
3. Subjects 50 to 80 years of age, inclusive, on the day of consent.
4. Body Mass Index (BMI) ≤40 kg/m2.
5. Symptoms (including pain) associated with OA of the index shoulder for ≥3 months prior
to Screening Visit (subject self-report is acceptable).
6. Shoulder pain due to OA for >15 days over the last month (as reported by the subject).
7. Grade 2 or 3 OA in the index glenohumeral joint based on the Samilson-Prieto
classification system as confirmed by X-ray (axillary view and true anterior-posterior
view) taken at, or within 6 months of, the Screening Visit and read by the central
reader.
8. Average daily mean pain score ≥4.0 and ≤9.0 in index shoulder (0-10 numeric rating
scale [NRS]) using the average daily ratings for at least 4 out of the 7 days prior to
Baseline/Day 1.
9. Average Shoulder Pain and Disability Index (SPADI) pain score ≥5.0 and ≤9.0 in index
shoulder prior to Baseline/Day 1.
10. Willingness to abstain from use of protocol-specified restricted medications and
therapies during the study.
11. Sexually active males or females of childbearing potential must agree to use a highly
effective method of contraception throughout the duration of the study. Females of
childbearing potential are defined as females who are not surgically sterile or
postmenopausal (defined as 12 consecutive months with no menses without an alternative
medical cause) as documented in medical history. Highly effective methods of
contraception include abstinence; oral, injected, or implanted hormonal methods of
contraception; intrauterine device or intrauterine system; condom or occlusive cap
(diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository;
or monogamous intercourse with a partner who is surgically sterile (post-vasectomy,
-hysterectomy, or -tubal ligation).
Exclusion Criteria:
Disease-related criteria. 1. Subjects who cannot washout of prohibited medications (eg, opioids, other analgesics,
and THC- and cannabidiol (CBD)-containing products) or restricted medications.
2. Has symptomatic arthritis in other joints of the index shoulder (eg, acromioclavicular
joint, sternoclavicular joint, or scapulothoracic joint), which is the primary source
of pain in the opinion of the Investigator.
3. Has symptomatic rotator cuff pathology by physical examination or evidence of cuff
tear arthropathy by radiograph.
4. Has clinical symptomatic chronic bilateral shoulder pain (any condition causing pain
in the non- index shoulder).
5. Has a subchondral bone insufficiency fracture or humeral head necrosis/collapse
(including bone infarct) in the index shoulder based on X-ray used for study
qualification.
6. Has a prior ipsilateral proximal humerus fracture or scapula fracture to the index
shoulder within 2 years of Screening Visit.
7. Has been diagnosed with adhesive capsulitis ("frozen shoulder") in the index shoulder,
within 1 year of the Screening Visit.
8. Has a previous shoulder injury (eg, dislocation or clavicle fracture) in the index
shoulder which resulted in functional limitation ≥1 month prior to the Screening
Visit.
9. Prior surgery on the index shoulder (less than 5 years), either open or arthroscopic.
Should not have any retained hardware.
10. Has an index shoulder 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. Has current or history of infection (eg, osteomyelitis) in the index shoulder or
current skin infection at injection site.
12. Has any concurrent chronic pain condition within 1 month prior to the Screening Visit
(subject self- report acceptable), including but not limited to, cervical spine pain
or conditions causing radicular pain or peripheral nerve injury/entrapment (eg,
brachial plexus injury or suprascapular nerve entrapment); diabetic neuropathy;
post-herpetic neuralgia; post-stroke pain; or fibromyalgia that may affect sensation
of the index shoulder.
13. painDETECT Questionnaire (PD-Q) score >18 during Screening Visit.
14. History or current evidence of reactive arthritis, rheumatoid arthritis, psoriatic
arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel
disease, systemic lupus erythematosus, or calcium pyrophosphate dihydrate crystal
deposition (CPPD), gout, or other autoimmune diseases.
15. Any planned surgeries in the upper limbs and/or cervical spine during the study
period, or any other surgery during the study period that would require use of a
restricted medication.
Previous or concomitant treatment-related criteria. 16. Presence of surgical hardware or other foreign body due to open or arthroscopic
cartilage transplant or bone grafting procedures in the index shoulder.
17. Use of muscle relaxants (eg, cyclobenzaprine, tetrazepam, and diazepam) and topical
therapies (eg, NSAIDs, CBD oil, capsaicin, lidocaine patches, or other local
treatments) applied to the index shoulder.
18. The use corticosteroids as follows:
- - IA corticosteroid in the index shoulder within 3 months of Screening Visit.
- - Intrabursal and intratendinous corticosteroids in the index shoulder within 6
months of Screening Visit.
- - Intravenous (IV), Intramuscular (IM), or epidural corticosteroids within 6 months
of Screening.
- - Oral corticosteroids within 1 month of Screening.
19. IA treatment of index shoulder with any of the following agents within 6 months of
Screening: hyaluronic acid (investigational or marketed) or any biologic agent (eg,
platelet rich plasma [PRP] injection, stem cells, prolotherapy, and amniotic
fluid-derived product).
20. Significant changes with regard to physical activity, physical therapy, or lifestyle
within 1 month of the Screening Visit, or any planned changes throughout the duration
of the study.
21. Use of selective serotonin/norepinephrine reuptake inhibitors (SSRIs/SNRIs) (eg,
fluoxetine, fluvoxamine, citalopram, escitalopram, sertraline, duloxetine, and
venlafaxine, milnacipran) if the dose is not stable for at least 3 months prior to
Screening Visit and must remain stable throughout the study.
22. Any treatment with acupuncture and/or transcutaneous electrical nerve stimulation
(TENS) within 3 months of Screening Visit.
Subject-related criteria. 23. Females who are pregnant or nursing or plan to become pregnant within 12 months after
dosing; men whose partner plans to conceive within 12 months after dosing.
24. Subjects with clinically relevant level of pain catastrophizing defined as Pain
Catastrophizing Scale (PCS) score of ≥30 at Screening Visit.
25. Known or suspected hypersensitivity to any form of triamcinolone or PLGA.
26. Laboratory evidence of infection with human immunodeficiency virus (HIV), positive
test for hepatitis B surface antigen (HBsAg), or positive serology for hepatitis C
virus (HCV) with positive test for HCV ribonucleic acid (RNA) on recent testing.
27. A medical history suggesting the subject will or is likely to require a course of
systemic corticosteroids during the study.
28. History or evidence of active or latent systemic fungal or mycobacterial infection
(including tuberculosis) or of ocular herpes simplex.
29. History of sarcoidosis, amyloidosis or active Cushing's syndrome.
30. Use of immunomodulators, immunosuppressives, or chemotherapeutic agents within 5 years
of Screening.
31. Active or history of malignancy within 5 years of Screening, with the exception of
resected basal cell carcinoma, squamous cell carcinoma of the skin, or effectively
managed cervical carcinoma.
32. History of radiation treatment involving the index shoulder girdle.
33. Active substance abuse (drugs or alcohol) or history of substance abuse within the
past 12 months of Screening.
34. Has received a live vaccine within 3 months of Baseline/Day 1.
35. Has received vaccination within 1 week prior to the Screening Visit and local
injection pain has not resolved.
36. Use of any other investigational drug, biologic, or device within 3 months of
Screening Visit.
37. Any bacterial or viral infection requiring IV antibiotics within 4 weeks of
Baseline/Day 1 or oral antibiotics within 2 weeks of Baseline/Day 1.
38. Any other clinically significant acute or chronic medical conditions (eg, poorly
controlled diabetes with hemoglobin A1c [HbA1c] of greater than 9.5%) that, in the
judgment of the Investigator, could compromise subject safety, preclude the use of an
IA corticosteroid, limit the subject's ability to complete the study, or compromise
the objectives of the study.
39. Subjects contraindicated to the use of acetaminophen/paracetamol (allowed rescue pain
medicine) per National Product Labeling and Investigator's judgment.
40. Investigator or any subinvestigator, research assistant, pharmacist, study
coordinator, or other staff or relative thereof directly involved in the conduct of
the study.
