ZILRETTA in Subjects With Shoulder Osteoarthritis

NCT06269705 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 006-C-301
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 32

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

Conditions

Glenohumeral Osteoarthritis

Keywords

Glenohumeral Osteoarthritis

Outcome Measures

Primary Outcomes (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

  Week 12

Secondary Outcomes (7)

• 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

  Week 12

• 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

  Week 18

• 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

  Week 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 4 for ZILRETTA relative to placebo

  Week 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 8 for ZILRETTA relative to placebo

  Week 8

Study Arms (2)

ZILRETTA

EXPERIMENTAL

100 subjects will receive 32 mg ZILRETTA

Drug: ZILRETTA

Placebo

PLACEBO COMPARATOR

50 subjects will receive normal saline placebo

Other: Placebo

Interventions

ZILRETTA DRUG

IA injection of 32 mg ZILRETTA

ZILRETTA

Placebo OTHER

IA injection of placebo (normal saline)

Also known as: Normal Saline

Placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (32)

Alabama Orthopaedic Center- Research

Vestavia Hills, Alabama, 35243, United States

RECRUITING

Onyx Clinical Research

Surprise, Arizona, 85374, United States

RECRUITING

Tucson Orthopaedic Institute (TOI) - East Office

Tucson, Arizona, 85712, United States

RECRUITING

Horizon Clinical Research

La Mesa, California, 91942, United States

RECRUITING

Napa Pain Institute

Napa, California, 94558, United States

RECRUITING

Stanford University - Sports Medicine Clinic

Redwood City, California, 94063, United States

RECRUITING

International Spine, Pain & Performance Center

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

RECRUITING

Orthopedic Center of Palm Beach City

Atlantis, Florida, 33462, United States

COMPLETED

Baptist Health Orthopedic Care - Miami Gardens

Maimi, Florida, 33056, United States

RECRUITING

Infinite Clinical Research

Miami, Florida, 33133, United States

RECRUITING

Gulfcoast Research Institute

Sarasota, Florida, 34232-6028, United States

RECRUITING

Clinical Research of West Florida

Tampa, Florida, 33606, United States

ACTIVE NOT RECRUITING

Hospital for Special Services

West Palm Beach, Florida, 33401, United States

RECRUITING

Injury Care Research

Boise, Idaho, 83713, United States

RECRUITING

Kansas City Bone & Joint Clinic - Overland Park

Overland Park, Kansas, 66211, United States

RECRUITING

Ochsner Sports Medicine Institute

New Orleans, Louisiana, 70121, United States

RECRUITING

New England Baptist Hospital

Boston, Massachusetts, 02120-2847, United States

RECRUITING

Oakland Medical Center

Troy, Michigan, 48085-5524, United States

RECRUITING

Sundance Clinical Research

St Louis, Missouri, 63141, United States

RECRUITING

New York-Presbyterian Queens

Flushing, New York, 11355-5045, United States

RECRUITING

West Clinical Research

Morehead City, North Carolina, 28557, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45267-0212, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

University Orthopedics Center

Altoona, Pennsylvania, 16602, United States

RECRUITING

Altoona Arthritis & Osteoporosis Center - Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16653, United States

RECRUITING

University Orthopedics Center (UOC) - State College

State College, Pennsylvania, 16801, United States

RECRUITING

Medical University Health - West Ashley Medical Pavilion

Charleston, South Carolina, 29407, United States

RECRUITING

Texas Orthopedic Specialists, PLLC

Bedford, Texas, 76021, United States

RECRUITING

First Surgical Hospital

Bellaire, Texas, 77401, United States

RECRUITING

El Paso Clinical Trials, LLC

El Paso, Texas, 79935-3013, United States

RECRUITING

Physicians Research Options

Draper, Utah, 84020, United States

COMPLETED

Spectrum Medical

Danville, Virginia, 24541, United States

RECRUITING

MeSH Terms

Interventions

Triamcinolone; Saline Solution

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Nino Joy, MD

  Pacira Pharmaceuticals, Inc

  STUDY DIRECTOR

Central Study Contacts

Jack Castaneda

CONTACT

973-435-4288; jack.castaneda@pacira.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 21, 2024
• Study Start: February 5, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 3, 2025

Record last verified: 2025-10

Locations

US (32)