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Glenohumeral OsteoarthritisPhase 3NCT06269705

ZILRETTA in Subjects With Shoulder Osteoarthritis

A Phase 3 study testing ZILRETTA in people with Glenohumeral Osteoarthritis, run by Pacira Pharmaceuticals, Inc at 32 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Glenohumeral Osteoarthritis
What is being tested?
ZILRETTA
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
32 sitesUnited States
Study dates
5 Feb 2024to Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • 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.
Show all 43Show fewer
  • 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
  • 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.
  • Participants with clinically relevant level of pain catastrophizing defined as Pain Catastrophizing Scale (PCS) score of ≥30 at Screening Visit.
  • Known or suspected hypersensitivity to any form of triamcinolone or PLGA.
  • Laboratory evidence of infection with human immunodeficiency virus (HIV), positive test for hepatitis B surface antigen (HBsAg), or positive for hepatitis C virus (HCV) antibodies.
  • A medical history suggesting the participant will or is likely to require a course of systemic corticosteroids during the study.
  • History or evidence of active or latent systemic fungal or mycobacterial infection (including tuberculosis) or of ocular herpes simplex.
  • History of sarcoidosis, amyloidosis, or active Cushing's syndrome.
  • Use of immunomodulators, immunosuppressives, or chemotherapeutic agents within 5 years of Screening.
  • 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.
  • History of radiation treatment involving the index shoulder girdle.
  • Active substance use/abuse (drugs or alcohol) or history of substance abuse within 12 months of Screening. Positive drug test results due to prescribed attention deficit/hyperactivity disorder (ADHD) medications with at least 6 months of stable dosing is permitted.
  • Has received a live vaccine (eg, measles, mumps, and rubella [MMR], rotavirus, yellow fever, varicella, influenza (nasal spray version only), Bacillus Calmette-Guérin [BCG], and polio) within 3 months of Baseline/Day 1.
  • Has received an inactivated vaccination (eg, flu, COVID, tetanus, tetanus/diphtheria/pertussis [Tdap], hepatitis A) within 1 week prior to the Screening Visit and local injection pain has not resolved.
  • Use of any other investigational drug, biologic, or device within 3 months of Screening Visit.
  • 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.
  • Any other clinically significant acute or chronic medical conditions (eg, asthma or chronic obstructive pulmonary disease [COPD] requiring steroid use, poorly controlled diabetes with hemoglobin A1c [HbA1c] of greater than 9.5%) that, in the judgment of the Investigator, could compromise participant safety, preclude the use of an IA corticosteroid, limit the participant's ability to complete the study, or compromise the objectives of the study.
  • Participants contraindicated to the use of acetaminophen/paracetamol (allowed rescue pain medicine) per National Product Labeling and Investigator's judgment.
  • Participant is the Investigator or any Subinvestigator, research assistant, pharmacist, study coordinator, or other staff or relative thereof directly involved in the conduct of the study.

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

United States32 sites

  • University Orthopedics Center

    Altoona, Pennsylvania, 16602

  • Orthopedic Center of Palm Beach City

    Atlantis, Florida, 33462

  • Texas Orthopedic Specialists, PLLC

    Bedford, Texas, 76021

  • First Surgical Hospital

    Bellaire, Texas, 77401

  • Injury Care Research

    Boise, Idaho, 83713

  • New England Baptist Hospital

    Boston, Massachusetts, 02120-2847

  • Medical University Health - West Ashley Medical Pavilion

    Charleston, South Carolina, 29407

  • University of Cincinnati

    Cincinnati, Ohio, 45267-0212

  • Ohio State University

    Columbus, Ohio, 43210

  • Spectrum Medical

    Danville, Virginia, 24541

  • Physicians Research Options

    Draper, Utah, 84020

  • Altoona Arthritis &amp; Osteoporosis Center - Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16653

  • El Paso Clinical Trials, LLC

    El Paso, Texas, 79935-3013

  • New York-Presbyterian Queens

    Flushing, New York, 11355-5045

  • Horizon Clinical Research

    La Mesa, California, 91942

  • Baptist Health Orthopedic Care - Miami Gardens

    Maimi, Florida, 33056

  • Infinite Clinical Research

    Miami, Florida, 33133

  • West Clinical Research

    Morehead City, North Carolina, 28557

  • Napa Pain Institute

    Napa, California, 94558

  • Ochsner Sports Medicine Institute

    New Orleans, Louisiana, 70121

  • Kansas City Bone & Joint Clinic - Overland Park

    Overland Park, Kansas, 66211

  • Stanford University - Sports Medicine Clinic

    Redwood City, California, 94063

  • Gulfcoast Research Institute

    Sarasota, Florida, 34232-6028

  • Sundance Clinical Research

    St Louis, Missouri, 63141

  • University Orthopedics Center (UOC) - State College

    State College, Pennsylvania, 16801

  • Onyx Clinical Research

    Surprise, Arizona, 85374

  • Clinical Research of West Florida

    Tampa, Florida, 33606

  • Oakland Medical Center

    Troy, Michigan, 48085-5524

  • Tucson Orthopaedic Institute (TOI) - East Office

    Tucson, Arizona, 85712

  • Alabama Orthopaedic Center- Research

    Vestavia Hills, Alabama, 35243

  • International Spine, Pain & Performance Center

    Washington D.C., District of Columbia, 20006

  • Hospital for Special Services

    West Palm Beach, Florida, 33401

Other trials in United States

About this study

Official title: A Study to Evaluate the Efficacy and Safety of ZILRETTA in Subjects With Glenohumeral Osteoarthritis

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
Read the detailed description

This is a multi-center, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of ZILRETTA in subjects with glenohumeral OA. This study will be conducted at approximately 25 study sites in the United States. Subjects will be screened to confirm the diagnosis of OA and eligibility based on the Inclusion and Exclusion Criteria. Approximately 150 male or female subjects, 50 to 80 years of age inclusive, will be enrolled, randomized to 1 of 2 treatment groups (2:1), and treated with a single IA injection of either:

  • Treatment Arm: 32 mg ZILRETTA,
  • Treatment Arm: placebo (normal saline). ZILRETTA, or normal saline placebo will be administered as a single IA injection with a 24-week follow-up period with a primary endpoint at Week 12.

The study will involve a Screening period (a minimum of 10 days, up to a maximum of 35 days), pre-treatment phase, dosing at Baseline/Day 1, and 8 additional outpatient visits at Weeks 2, 4, 8, 12, 16, 20, and 24/End of Study (EOS) during the study.

At specified times throughout the study, subjects will undergo physical examinations, index shoulder assessments, and index shoulder X-rays; blood will be collected for laboratory safety tests; and vital signs will be collected.

Information regarding adverse events (AEs) and prior and concomitant medications and treatments will be collected from the time of signing the Informed Consent Form (ICF) through the Week 24/EOS visit. Information regarding rescue medication usage, Average and Worst daily Pain score (0-10 Numeric Rating Scale (NRS); 0 = no pain, 10 = worst possible pain) in the index shoulder, and Sleep Interference (SI) will be completed daily via an electronic diary (eDiary) and reviewed for compliance by site staff at each study visit.

At the Screening Visit, subjects will be registered in the eDiary and receive instructions on its use. Subjects will complete accurate pain reporting (APR) and placebo response reduction (PRR) training prior to completing all questionnaires.

Being tested
ZILRETTA, Placebo
Keywords
Glenohumeral Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZILRETTADrug

    IA injection of 32 mg ZILRETTA

  • PlaceboOther

    Also called Normal Saline

    IA injection of placebo (normal saline)

Study groups in NCT06269705
Study groupRoleWhat they receive
ZILRETTAExperimental100 subjects will receive 32 mg ZILRETTA
Receives: Drug: ZILRETTA
PlaceboPlacebo comparator50 subjects will receive normal saline placebo
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline on the Worst Daily Pain (24-hr) mean score (0-10 Numeric Rating Scale (NRS); 0 = no pain, 10 = worst possible pain) at Week 12 for ZILRETTA relative to placebo

    Measured: Week 12

Secondary outcomes (7)

  1. Change from Baseline on the Worst Daily Pain (24-hr) mean score (0-10 Numeric Rating Scale (NRS); 0 = no pain, 10 = worst possible pain) at Week 12 for ZILRETTA relative to TCA-IR

    Measured: Week 12

  2. Change from Baseline on the Worst Daily Pain (24-hr) mean score (0-10 Numeric Rating Scale (NRS); 0 = no pain, 10 = worst possible pain) at Week 18 for ZILRETTA relative to TCA-IR

    Measured: Week 18

  3. Change from Baseline on the Worst Daily Pain (24-hr) mean score (0-10 Numeric Rating Scale (NRS); 0 = no pain, 10 = worst possible pain) at Week 2 for ZILRETTA relative to placebo

    Measured: Week 2

  4. Change from Baseline on the Worst Daily Pain (24-hr) mean score (0-10 Numeric Rating Scale (NRS); 0 = no pain, 10 = worst possible pain) at Week 4 for ZILRETTA relative to placebo

    Measured: Week 4

  5. Change from Baseline on the Worst Daily Pain (24-hr) mean score (0-10 Numeric Rating Scale (NRS); 0 = no pain, 10 = worst possible pain) at Week 8 for ZILRETTA relative to placebo

    Measured: Week 8

  6. Change from Baseline at Week 12 on the Shoulder Pain and Disability Index (SPADI) total score and subscales (0-10 Numeric Rating Scale (NRS); 0 = no pain, 10 = worst possible pain) for ZILRETTA relative to placebo

    Measured: Week 12

  7. Change from Baseline at Week 12 on the SPADI total score and subscales (0-10 Numeric Rating Scale (NRS); 0 = no pain, 10 = worst possible pain) for ZILRETTA relative to TCA-IR

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2024
  2. Study start5 Feb 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06269705
Sponsor's protocol ID
006-C-301
Status last verified
May 2026
First submitted
13 Feb 2024
Last updated
29 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ZILRETTA in people with Glenohumeral Osteoarthritis, run by Pacira Pharmaceuticals, Inc at 32 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline on the Worst Daily Pain (24-hr) mean score (0-10 Numeric Rating Scale (NRS); 0 = no pain, 10 = worst possible pain) at Week 12 for ZILRETTA relative to placebo (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06269705.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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