Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06269705 | RECRUITING | Glenohumeral Osteoarthritis

ZILRETTA in Subjects With Shoulder Osteoarthritis
Sponsor:

Pacira Pharmaceuticals, Inc

Brief 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 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

Condition or disease

Glenohumeral Osteoarthritis

Intervention/treatment

ZILRETTA

Placebo

Phase

PHASE3

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 150 participants
Masking : SINGLE
Masking Description : Only unblinded team (pharmacist, unblinded coordinator, drug administrator) will know the treatment assignment. A site-specific blinding plan will be developed to ensure blinding. Unblinded team will only interact with the subject at treatment and will not have any blinded roles on the study (only exception- informed consent). The subject and the assessor responsible for assessments/safety monitoring will be blinded. Site and Sponsor personnel/representatives will be blinded, with the following Sponsor/representative exceptions: unblinded monitors for performing drug accountability, unblinded clinical manager for reviewing unblinded monitoring visit reports and escalation of site unblinded issues, inventory manager for addressing product-related issues, and regulatory personnel for safety reporting. Information regarding treatment assignments will be kept securely at Sponsor.
Primary Purpose : TREATMENT
Official Title : A Study to Evaluate the Efficacy and Safety of ZILRETTA in Subjects With Glenohumeral Osteoarthritis
Actual Study Start Date : 2024-02-05
Estimated Primary Completion Date : 2026-08
Estimated Study Completion Date : 2026-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • To be included in the trial, participants must fulfill the following 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. Participants 50 to 80 years of age, inclusive, on the day of consent.
    • 4. 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.
    • 5. 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.
    • 6. 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.
    • 7. 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.
    • 8. 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).
    • 9. Willingness to abstain from use of protocol-specified restricted medications and therapies during the study.
    • 10. 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
  • Participants fulfilling at least 1 of the following criteria may not be included in the study
    • Disease-Related Criteria
    • 1. Participants who cannot washout prohibited medications (eg, opioids, other analgesics, and tetrahydrocannabinol (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 pain in the scapulothoracic region), which is the primary source of pain in the opinion of the Investigator.
    • 3. Has clinical symptomatic chronic bilateral shoulder pain (any condition causing pain in the non-index shoulder).
    • 4. 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.
    • 5. Has a prior ipsilateral proximal humerus fracture or scapula fracture to the index shoulder within 2 years of Screening Visit.
    • 6. 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.
    • 7. 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.
    • 8. Has had prior surgery on the index shoulder (less than 3 years), either open or arthroscopic. Should not have any retained hardware.
    • 9. 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.
    • 10. Has current or history of infection (eg, osteomyelitis) in the index shoulder or current skin infection at injection site.
    • 11. 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.
    • 12. painDETECT Questionnaire (PD-Q) score \>18 during Screening Visit.
    • 13. 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.
    • 14. 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
    • 15. Presence of surgical hardware or other foreign body due to open or arthroscopic cartilage transplant or bone grafting procedures in the index shoulder.
    • 16. 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.
    • 17. 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.
    • 18. 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).
    • 19. 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.
    • 20. 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.
    • 21. Any treatment with acupuncture and/or transcutaneous electrical nerve stimulation (TENS) within 3 months of Screening Visit.
    • Participant-Related Criteria
    • 22. 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.
    • 23. Participants with clinically relevant level of pain catastrophizing defined as Pain Catastrophizing Scale (PCS) score of ≥30 at Screening Visit.
    • 24. Known or suspected hypersensitivity to any form of triamcinolone or PLGA.
    • 25. 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.
    • 26. A medical history suggesting the participant will or is likely to require a course of systemic corticosteroids during the study.
    • 27. History or evidence of active or latent systemic fungal or mycobacterial infection (including tuberculosis) or of ocular herpes simplex.
    • 28. History of sarcoidosis, amyloidosis, or active Cushing's syndrome.
    • 29. Use of immunomodulators, immunosuppressives, or chemotherapeutic agents within 5 years of Screening.
    • 30. 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.
    • 31. History of radiation treatment involving the index shoulder girdle.
    • 32. 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.
    • 33. 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.
    • 34. 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.
    • 35. Use of any other investigational drug, biologic, or device within 3 months of Screening Visit.
    • 36. 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.
    • 37. 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.
    • 38. Participants contraindicated to the use of acetaminophen/paracetamol (allowed rescue pain medicine) per National Product Labeling and Investigator's judgment.
    • 39. 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.
    • ZILRETTA in Subjects With Shoulder Osteoarthritis

    Location Details

    NCT06269705

    Please Choose a site

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    United States, alabama

    Alabama Orthopaedic Center- Research

    Vestavia Hills, alabama, United States, 35243

    RECRUITING

    United States, Arizona

    Onyx Clinical Research

    Surprise, arizona, United States, 85374

    RECRUITING

    United States, Arizona

    Tucson Orthopaedic Institute (TOI) - East Office

    Tucson, arizona, United States, 85712

    RECRUITING

    United States, California

    Horizon Clinical Research

    The Table, California, United States, 91942

    RECRUITING

    United States, California

    Napa Pain Institute

    Napa, California, United States, 94558

    RECRUITING

    United States, California

    Stanford University - Sports Medicine Clinic

    Redwood City, California, United States, 94063

    RECRUITING

    United States, District of Columbia

    International Spine, Pain & Performance Center

    Washington D.C., District of Columbia, United States, 20006

    COMPLETED

    United States, Florida

    Orthopedic Center of Palm Beach City

    Atlantis, florida, United States, 33462

    RECRUITING

    United States, Florida

    Baptist Health Orthopedic Care - Miami Gardens

    Find out, florida, United States, 33056

    RECRUITING

    United States, Florida

    Infinite Clinical Research

    Miami, florida, United States, 33133

    RECRUITING

    United States, Florida

    Gulfcoast Research Institute

    Sarasota, florida, United States, 34232-6028

    ACTIVE NOT RECRUITING

    United States, Florida

    Clinical Research of West Florida

    Tampa, florida, United States, 33606

    RECRUITING

    United States, Florida

    Hospital for Special Services

    West Palm Beach, florida, United States, 33401

    RECRUITING

    United States, Idaho

    Injury Care Research

    Boise, Idaho, United States, 83713

    RECRUITING

    United States, Kansas

    Kansas City Bone & Joint Clinic - Overland Park

    Overland Park, Kansas, United States, 66211

    RECRUITING

    United States, Louisiana

    Ochsner Sports Medicine Institute

    New Orleans, Louisiana, United States, 70121

    RECRUITING

    United States, Massachusetts

    New England Baptist Hospital

    Boston, Massachusetts, United States, 02120-2847

    RECRUITING

    United States, road cancer

    Oakland Medical Center

    Troy, road cancer, United States, 48085-5524

    RECRUITING

    United States, Missouri

    Sundance Clinical Research

    St Louis, Missouri, United States, 63141

    RECRUITING

    United States, New York

    New York-Presbyterian Queens

    Flushing, New York, United States, 11355-5045

    RECRUITING

    United States, North Carolina

    West Clinical Research

    Morehead City, North Carolina, United States, 28557

    RECRUITING

    United States, Ohio

    University of Cincinnati

    Cincinnati, Ohio, United States, 45267-0212

    RECRUITING

    United States, Ohio

    Ohio State University

    Columbus, Ohio, United States, 43210

    RECRUITING

    United States, Pennsylvania

    University Orthopedics Center

    Altoona, Pennsylvania, United States, 16602

    RECRUITING

    United States, Pennsylvania

    Altoona Arthritis & Osteoporosis Center - Altoona Center for Clinical Research

    Duncansville, Pennsylvania, United States, 16653

    RECRUITING

    United States, Pennsylvania

    University Orthopedics Center (UOC) - State College

    State College, Pennsylvania, United States, 16801

    RECRUITING

    United States, South Carolina

    Medical University Health - West Ashley Medical Pavilion

    Charleston, South Carolina, United States, 29407

    RECRUITING

    United States, Texas

    Texas Orthopedic Specialists, PLLC

    Bedford, Texas, United States, 76021

    RECRUITING

    United States, Texas

    First Surgical Hospital

    Bellaire, Texas, United States, 77401

    RECRUITING

    United States, Texas

    El Paso Clinical Trials, LLC

    El Paso, Texas, United States, 79935-3013

    COMPLETED

    United States, Utah

    Physicians Research Options

    Draper, Utah, United States, 84020

    RECRUITING

    United States, Virginia

    Spectrum Medical

    Danville, Virginia, United States, 24541