ZILRETTA in Subjects With Shoulder Osteoarthritis

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Glenohumeral Osteoarthritis

In brief

Primary Objective: To assess the efficacy of ZILRETTA on pain following an intra-articular (IA) injection in subjects with glenohumeral osteoarthritis (OA) relative to normal saline placebo Secondary Objective: * To assess the efficacy of ZILRETTA on pain following an IA injection in subjects with glenohumeral OA relative to triamcinolone acetonide injectable suspension, and normal saline placebo * To assess the safety of ZILRETTA in subjects with glenohumeral OA relative to normal saline placebo

Key facts

Study ID

NCT06269705

Run by

Pacira Pharmaceuticals, Inc

People needed

150

Starts

2024-02-05

Expected to finish

2026-12-01

Last updated by the study team

2026-05-29

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• To be included in the trial, participants must fulfill the following criteria:
• Written informed consent has been obtained prior to initiating any study-specific procedures.
• 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.
• Participants 50 to 80 years of age, inclusive, on the day of consent.
• Body mass index (BMI) does not prohibit proper identification of bony landmarks and/or otherwise prohibit the ability to properly inject into the shoulder joint per Principal Investigator's (PI's) judgment.
• Participants with shoulder pain and glenohumeral arthritis with or without rotator cuff pathology (eg, rotator cuff inflammation, partial rotator cuff tear [non-to-mild superior subluxation of the humeral head on X-ray] may be included). Participants with positive Neer and Hawkins-Kennedy tests on index shoulder exam should be excluded. Participants who have complete or irreparable rotator cuff tear should not be included.
• Grade 1, 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.
• 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.
• Average Shoulder Pain and Disability Index (SPADI) pain score ≥4.0 and ≤9.0 in index shoulder during the Screening and Pretreatment Phase (average score) as calculated and reported in the electronic Clinical Outcomes Assessment (eCOA).
• Willingness to abstain from use of protocol-specified restricted medications and therapies during the study.
• 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).

You may not qualify if…

• Participants fulfilling at least 1 of the following criteria may not be included in the study:
• Disease-Related Criteria
• Participants who cannot washout prohibited medications (eg, opioids, other analgesics, and tetrahydrocannabinol (THC)- and cannabidiol (CBD)-containing products) or restricted medications.
• Has symptomatic arthritis in other joints of the index shoulder (eg, acromioclavicular joint, sternoclavicular joint, or pain in the scapulothoracic region), which is the primary source of pain in the opinion of the Investigator.
• Has clinical symptomatic chronic bilateral shoulder pain (any condition causing pain in the non-index shoulder).
• 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.
• Has a prior ipsilateral proximal humerus fracture or scapula fracture to the index shoulder within 2 years of Screening Visit.
• Has current diagnosis of adhesive capsulitis ("frozen shoulder") in the index shoulder or previous diagnosis within 1 year of the Screening Visit and is still not resolved.
• Has a previous substantial shoulder injury or trauma (eg, glenohumeral dislocation or clavicle fracture) in the index shoulder which resulted in functional limitation within 3 months prior to the Screening Visit.
• Has had prior surgery on the index shoulder (less than 3 years), either open or arthroscopic. Should not have any retained hardware.
• 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 or any other anatomic variation or disease that, in the opinion of the Investigator, could interfere with either the injection procedure or the study outcome.
• Has current or history of infection (eg, osteomyelitis) in the index shoulder or current skin infection at injection site.
• Has any concurrent chronic joint, muscle, or nerve pain condition within 1 month prior to the Screening Visit (participant 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 of upper extremities; post-herpetic neuralgia; post-stroke pain; or fibromyalgia that may affect sensation of the index shoulder.
• painDETECT Questionnaire (PD-Q) score >18 during Screening Visit.
• 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.
• 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
• Presence of surgical hardware or other foreign body due to open or arthroscopic cartilage transplant or bone grafting procedures in the index shoulder.
• Use of muscle relaxants (eg, cyclobenzaprine, tetrazepam, and diazepam) or oral/topical therapies (eg, nonsteroidal anti-inflammatory drugs [NSAIDs], CBD oil, capsaicin, lidocaine patches, or other local treatments) applied to the index shoulder within 1 month prior to Screening Visit or within 5 half-lives of last dose.
• The use of corticosteroids (any route of administration: IA, intrabursal, intratendinous, intravenous [IV], intramuscular [IM], oral, or inhaled) within 3 months of Screening Visit except occasional (non-daily use <1 month) topical and intranasal steroid use within 1 month prior to dosing. Treatment in another joint during this timeframe is exclusionary.
• IA treatment of index shoulder with any of the following agents within 6 months or 5 half-lives 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).
• 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.
• Use of selective serotonin reuptake inhibitors (SSRIs)/serotonin and norepinephrine reuptake inhibitors (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.
• Any treatment with acupuncture and/or transcutaneous electrical nerve stimulation (TENS) within 3 months of Screening Visit.
• Participant-Related Criteria

Where it is running

• Alabama Orthopaedic Center- Research — Vestavia Hills, Alabama, United States
• Onyx Clinical Research — Surprise, Arizona, United States
• Tucson Orthopaedic Institute (TOI) - East Office — Tucson, Arizona, United States
• Horizon Clinical Research — La Mesa, California, United States
• Napa Pain Institute — Napa, California, United States
• Stanford University - Sports Medicine Clinic — Redwood City, California, United States
• International Spine, Pain & Performance Center — Washington D.C., District of Columbia, United States
• Orthopedic Center of Palm Beach City — Atlantis, Florida, United States
• Baptist Health Orthopedic Care - Miami Gardens — Maimi, Florida, United States
• Infinite Clinical Research — Miami, Florida, United States
• Gulfcoast Research Institute — Sarasota, Florida, United States
• Clinical Research of West Florida — Tampa, Florida, United States
• Hospital for Special Services — West Palm Beach, Florida, United States
• Injury Care Research — Boise, Idaho, United States
• Kansas City Bone & Joint Clinic - Overland Park — Overland Park, Kansas, United States
• Ochsner Sports Medicine Institute — New Orleans, Louisiana, United States
• New England Baptist Hospital — Boston, Massachusetts, United States
• Oakland Medical Center — Troy, Michigan, United States
• Sundance Clinical Research — St Louis, Missouri, United States
• New York-Presbyterian Queens — Flushing, New York, United States
• West Clinical Research — Morehead City, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• University Orthopedics Center — Altoona, Pennsylvania, United States
• Altoona Arthritis &amp; Osteoporosis Center - Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States

Full record on ClinicalTrials.gov

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