Study to Evaluate the Efficacy and Safety of FX006 in Patients With Glenohumeral Osteoarthritis or Shoulder Adhesive Capsulitis

NCT ID: NCT04160091

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-07
• Study Completion Date: 2020-06-15

Brief Summary

This is a double-blind study to evaluate the efficacy and safety of FX006 in patients with glenohumeral osteoarthritis (OA) or shoulder adhesive capsulitis (AC).

Detailed Description

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in separate cohorts of patients with a documented history of either glenohumeral OA or shoulder AC. Glenohumeral OA and shoulder AC patients will be randomized to receive a single intra-articular injection of either FX006 or placebo (saline) in a 1:1 ratio to the index shoulder with a 24-week Treatment Evaluation Period. Glenohumeral OA patients will be stratified by Baseline average daily shoulder pain with movement score according to the following classifications: 5.0 to <7.0 or ≥7.0 to 9.0 (0 to 10 numeric rating scale [NRS]). Shoulder AC patients will be stratified by Baseline average daily shoulder pain with movement score according to the following classifications: 5.0 to <7.0 or ≥7.0 to 9.0 (0 to 10 NRS), and by pain duration since onset (1 to 3 months, inclusive, or >3 to ≤6 months). A Home Exercise Program will be implemented 3 days following injection for shoulder AC patients.

Conditions

Osteoarthritis of the Shoulder; Adhesive Capsulitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

FX006 32mg in Glenohumeral OA Population

Single intra-articular (IA) injection

Group Type: EXPERIMENTAL

FX006

Intervention Type: DRUG

Single intra-articular injection

Normal Saline in Glenohumeral OA Population

Single intra-articular (IA) injection

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

Single intra-articular injection

FX006 32mg in Adhesive Capsulitis Population

Single intra-articular (IA) injection

Group Type: EXPERIMENTAL

FX006

Intervention Type: DRUG

Single intra-articular injection

Normal Saline in Adhesive Capsulitis Population

Single intra-articular (IA) injection

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

Single intra-articular injection

Interventions

FX006

Single intra-articular injection

Intervention Type: DRUG

Normal Saline

Single intra-articular injection

Intervention Type: DRUG

Other Intervention Names

Zilretta

Eligibility Criteria

Inclusion Criteria

Glenohumeral OA:

• Male or female, 35 to 80 years of age, inclusive, on the day of consent.
• Painful symptoms associated with OA of the index glenohumeral joint for ≤3 months prior to the Screening Visit.
• 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 the Screening Visit.

Shoulder AC:

• Male or female, 35 to 80 years of age, inclusive, on the day of consent.
• Pain associated with AC of the index joint for ≥1 month but ≤ 6 months prior to the Screening Visit.
• Limitations on both active and passive ROM ≥25% in at least 2 directions (e.g., forward flexion, abduction, and internal and external rotation assessed in a standardized protocol) compared with the contralateral shoulder or with normal values.
• No X-ray evidence of OA of the index shoulder (axillary view and true anterior-posterior view) at the Screening Visit.
• Agrees to complete a standardized, protocol-specified shoulder Home Exercise Program (HEP) starting 3 days after injection until the End of Study (EOS) Visit.

Both:

• Written consent to participate in the study
• Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions
• (BMI) ≤ 40 kg/m2
• Average daily mean shoulder pain with movement score ≥5.0 and ≤9.0 in the index shoulder (0 to 10 NRS) using the average daily ratings for at least 5 out of the 7 days prior to Day 1.
• Shoulder pain present >15 days in the month prior to the Screening Visit
• Willing to complete a washout of protocol-specified excluded medications 7 days prior to Day 1 and abstain from use of protocol-specified excluded medications throughout the study
• Willing to abstain from nonpharmacological therapies for the index joint for 2 weeks prior to Day 1 and throughout the study.

Exclusion Criteria

• Has both glenohumeral OA and shoulder AC
• Has bilateral AC
• Has bilateral glenohumeral OA with glenohumeral OA pain of the shoulder contralateral to the index shoulder >3.0 (0 to 10 NRS) within 1 month prior to the Screening Visit
• Has a history of arthritis in other joints of the index shoulder (as confirmed by medical history and physical exam)
• Has a history or suspicion of full thickness rotator cuff tear in the index shoulder within 6 months of the Screening Visit
• Has symptomatic partial rotator cuff tear, tendinopathy, tendonitis, or bursitis in the index shoulder within 6 months of the Screening Visit
• Has a subchondral bone insufficiency fracture or humeral head necrosis/collapse in the index shoulder
• Shoulder AC patients only: Has a history of shoulder surgery or radiotherapy
• Glenohumeral OA patients only: Has a previous shoulder injury with functional limitation ≥1 month or surgery within 52 weeks of the Screening Visit
• Has an index shoulder with major dysplasia or congenital abnormality, osteochondritis dissecans, acromegaly, ochronosis, hemochromatosis, Wilson's disease, or primary osteochondromatosis, or a history of avascular necrosis with secondary OA
• Has current or history of infection in the index shoulder or current skin infection at injection site
• Has a concurrent chronic pain condition with a pain score >3.0 (0 to 10 NRS) within 1 month prior to the Screening Visit
• Has a history or current evidence of reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease, systemic lupus erythematosus, calcium pyrophosphate dihydrate crystal deposition disease (CPPD), or other autoimmune diseases
• Has any planned surgeries in the upper limbs during the study or any other surgery during the study that would require use of a restricted medication
• Has surgical hardware or other foreign body present in the index shoulder
• Has received an IA corticosteroid of any joint within 3 months of the Screening Visit
• Has received an IA treatment of the index shoulder with any of the following agents within 6 months of the Screening Visit
• Has received intravenous (IV), intrabursal, intratendinous, intramuscular (IM) or epidural corticosteroids within 3 months of the Screening Visit
• Has received oral corticosteroids within 1 month of the Screening Visit
• Has received inhaled, intranasal, or topical corticosteroids within 2 weeks of the Screening Visit
• Has had significant changes to lifestyle with regard to physical activity and lifestyle within 1 month of the Screening Visit or any planned changes throughout the duration of the study
• Has known hypersensitivity to TA or PLGA
• Has laboratory evidence of infection with (HIV), a positive test for hepatitis B surface antigen (HBsAg), or positive serology for hepatitis C virus (HCV) with positive test for HCV ribonucleic acid
• Has an electrocardiogram (ECG) abnormality
• Has uncontrolled diabetes as indicated by a hemoglobin A1c of >8% (>59 mmol/mol).
• Has a history of sarcoidosis or amyloidosis
• Has a history of or active Cushing's syndrome
• Has used chemotherapeutic agents, immunomodulators, or immunosuppressants within 5 years of the Screening Visit
• Has current or history of malignancy within 5 years prior to the Screening Visit, except for basal or squamous cell carcinoma of the skin or cervical carcinoma in situ that has been treated successfully.
• Has active substance use disorder or history of substance use disorder within 12 months prior to the Screening Visit
• Has received a live or live attenuated vaccine within 3 months of the Screening Visit
• Has used any other investigational drug, biologic, or device within 3 months of the Screening Visit
• Has any infection requiring IV antibiotics 4 weeks prior to Day 1 or oral antibiotics 2 weeks prior to Day 1
• Has a contraindication to the use of acetaminophen
• Is a female that is pregnant or nursing or plans to become pregnant during the study; or is a male who plans to inseminate a partner or donate sperm during the study

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medpace, Inc.

INDUSTRY

Sponsor Role: collaborator

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Kelley, MD

Role: STUDY_DIRECTOR

Pacira Pharmaceuticals, Inc

Locations

Central Research Associates

Birmingham, Alabama, United States

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, United States

Affinity Orthopedic Specialists

Birmingham, Alabama, United States

Coastal Clinical Research, Inc.

Mobile, Alabama, United States

Arizona Research Center

Phoenix, Arizona, United States

Tucson Orthopaedic Institute

Tucson, Arizona, United States

TriWest Research Associates

El Cajon, California, United States

CORE Orthopedic Medical Center

Encinitas, California, United States

BioSolutions Clinical Research Center

La Mesa, California, United States

Mountain View Clinical Research Center

Denver, Colorado, United States

Coastal Orthopaedics and Sports Medicine

Bradenton, Florida, United States

South Lake Pain Institute

Clermont, Florida, United States

Universal Axon Clinical Research

Homestead, Florida, United States

Precision Clinical Research

Lauderdale Lakes, Florida, United States

Infinite Clinical Research

Miami, Florida, United States

Jewitt Orthopedic Center

Orlando, Florida, United States

Gulfcoast Research Institute

Sarasota, Florida, United States

Better Health Clinical Research, Inc.

Newnan, Georgia, United States

Professional Research Network of Kansas, LLC

Wichita, Kansas, United States

Arthritis and Rheumatism Associates PC

Wheaton, Maryland, United States

Hassman Research Institute

Berlin, New Jersey, United States

M3 Emerging Medical Research

Durham, North Carolina, United States

University Orthopedics Center

Altoona, Pennsylvania, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Texas Orthopedic Specialists

Bedford, Texas, United States

Centex Studies, Inc.

Houston, Texas, United States

Spectrum Medical, Inc.

Danville, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

FX006-2018-016

Identifier Type: -

Identifier Source: org_study_id