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

NCT04160091 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: FX006-2018-016
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 27

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).

Conditions

Osteoarthritis of the Shoulder; Adhesive Capsulitis

Keywords

Osteoarthritis; Adhesive Capsulitis; Shoulder; Pain; Intra-articular; Injection; Steroid

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve of the Change From Baseline in the Weekly Mean of the Daily Shoulder Pain With Movement

  The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "No pain" and 10 indicates "Worst possible pain."

  Baseline to 8 weeks

Secondary Outcomes (5)

• Change From Baseline in the Weekly Mean of the Average Daily Shoulder Pain With Movement Score

  Baseline to 12 weeks

• Change From Baseline in the SPADI Pain Subscale at Week 12

  Baseline to 12 weeks

• Change From Baseline in the SPADI Disability Subscale at Week 12

  Baseline to 12 weeks

• Patient Global Impression of Change (PGIC) Score at Week 12

  Baseline to 12 weeks

• Change From Baseline in the Range of Motion (ROM) of Active External Rotation at Week 12

  Baseline to 12 weeks

Study Arms (4)

FX006 32mg in Glenohumeral OA Population

EXPERIMENTAL

Single intra-articular (IA) injection

Drug: FX006

Normal Saline in Glenohumeral OA Population

PLACEBO COMPARATOR

Single intra-articular (IA) injection

Drug: Normal Saline

FX006 32mg in Adhesive Capsulitis Population

EXPERIMENTAL

Single intra-articular (IA) injection

Drug: FX006

Normal Saline in Adhesive Capsulitis Population

PLACEBO COMPARATOR

Single intra-articular (IA) injection

Drug: Normal Saline

Interventions

FX006 DRUG

Single intra-articular injection

Also known as: Zilretta

FX006 32mg in Adhesive Capsulitis Population; FX006 32mg in Glenohumeral OA Population

Normal Saline DRUG

Single intra-articular injection

Normal Saline in Adhesive Capsulitis Population; Normal Saline in Glenohumeral OA Population

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead
• Medpace, Inc.: collaborator

Study Sites (27)

Central Research Associates

Birmingham, Alabama, 35205, United States

Location

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 35235, United States

Location

Affinity Orthopedic Specialists

Birmingham, Alabama, 35243, United States

Location

Coastal Clinical Research, Inc.

Mobile, Alabama, 36608, United States

Location

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Tucson Orthopaedic Institute

Tucson, Arizona, 85712, United States

Location

TriWest Research Associates

El Cajon, California, 92020, United States

Location

CORE Orthopedic Medical Center

Encinitas, California, 92924, United States

Location

BioSolutions Clinical Research Center

La Mesa, California, 91924, United States

Location

Mountain View Clinical Research Center

Denver, Colorado, 80209, United States

Location

Coastal Orthopaedics and Sports Medicine

Bradenton, Florida, 34209, United States

Location

South Lake Pain Institute

Clermont, Florida, 34711, United States

Location

Universal Axon Clinical Research

Homestead, Florida, 33030, United States

Location

Precision Clinical Research

Lauderdale Lakes, Florida, 33319, United States

Location

Infinite Clinical Research

Miami, Florida, 33133, United States

Location

Jewitt Orthopedic Center

Orlando, Florida, 32822, United States

Location

Gulfcoast Research Institute

Sarasota, Florida, 34232, United States

Location

Better Health Clinical Research, Inc.

Newnan, Georgia, 30265, United States

Location

Professional Research Network of Kansas, LLC

Wichita, Kansas, 67205, United States

Location

Arthritis and Rheumatism Associates PC

Wheaton, Maryland, 20902, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

M3 Emerging Medical Research

Durham, North Carolina, 22704, United States

Location

University Orthopedics Center

Altoona, Pennsylvania, 16602, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Texas Orthopedic Specialists

Bedford, Texas, 76021, United States

Location

Centex Studies, Inc.

Houston, Texas, 77058, United States

Location

Spectrum Medical, Inc.

Danville, Virginia, 24541, United States

Location

MeSH Terms

Conditions

Bursitis; Osteoarthritis; Pain

Interventions

FX006; Triamcinolone; Saline Solution

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Arthritis; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

This study was terminated early by the Sponsor due to the COVID-19 pandemic. Summary statistics were calculated for available data, but given that only approximately 8% of the planned study population had enrolled and there no conclusions can be drawn from this study.

Results Point of Contact

• Title: David Golod, Vice President, Clinical Operations
• Organization: Flexion Therapeutics, Inc.

dgolod@flexiontherapeutics.com

(781) 305-7572

Study Officials

• Scott Kelley, MD

  Pacira Pharmaceuticals, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 12, 2019
• Study Start: November 7, 2019
• Primary Completion: June 15, 2020
• Study Completion: June 15, 2020
• Last Updated: January 24, 2024
• Results First Posted: November 30, 2021

Record last verified: 2024-01

Locations

US (27)