Study to Evaluate the Effect of FX006 on Synovial Inflammation in Patients With OA of the Knee

NCT03529942 | Completed Phase 3 Results FDA Drug

• 1 other identifier: FX006-2017-014
• Study Type: interventional
• Target: 129
• Locations: 2 countries
• Sites: 10

Brief Summary

This is an open-label study assessing the effect of the administration of a single intra-articular (IA) injection of FX006 32 mg on synovial volume in patients with osteoarthritis (OA) of the knee.

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis; Knee; Pain; Intra-articular; Injection; Corticosteroid

Outcome Measures

Primary Outcomes (1)

• Mean Standardized Change in Synovial Volume (SV) at 6 Weeks

  Synovial volume (mm\^3) as measured by MRI and read by a central imaging vendor. Standardization was performed by dividing the model-derived least squares means and corresponding confidence intervals by the adjusted standard deviation (SD). Therefore, the mean standardized change represents the change in synovial volume expressed in standard deviation units.

  Baseline to Week 6

Secondary Outcomes (3)

• Mean Absolute Change in Synovial Volume at 6 Weeks

  Baseline to Week 6

• Mean Standardized Change in Synovial Volume (SV) at 24 Weeks

  Baseline to Week 24

• Mean Absolute Change in Synovial Volume at 24 Weeks

  Baseline to Week 24

Study Arms (1)

FX006 32 mg

EXPERIMENTAL

Single intra-articular (IA) injection of FX006 32 mg

Drug: FX006 32 mg

Interventions

FX006 32 mg DRUG

Extended-release 32 mg FX006 IA injection

Also known as: Zilretta

FX006 32 mg

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written consent to participate in the study
• Male or female ≥ 40 years of age
• Body mass index (BMI) ≤ 40 kg/m\^2
• Ambulatory and in good general health
• Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions
• Willing to abstain from use of protocol-restricted medications during the study
• Symptoms associated with OA of the index knee for ≥ 6 months prior to Screening (patient self-report is acceptable)
• Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA
• Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee based on X-ray performed during Screening (centrally read)

You may not qualify if:

• Any inflammatory arthritis including reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, gout or secondary OA from gout
• History of infection or crystal disease in the index knee joint
• Unstable index knee joint (such as a torn anterior cruciate ligament) within 12 months of Screening
• Surgery or arthroscopy of the index knee within 12 months of Screening
• IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
• IA treatment of the index knee with hyaluronic acid (investigational or marketed) within 6 months of Screening
• IV or IM corticosteroids (investigational or marketed) within 3 months of Screening
• Oral corticosteroids (investigational or marketed) within 1 month of Screening
• Any other IA drug/biologic in the index knee within 6 months of Screening or 5 half-lives (whichever is longer) (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy and amniotic fluid injection)
• Prior administration of FX006
• eGFR results \<40 mL/minute
• Any contraindication to MRI Scanning (e.g., presence of certain ferromagnetic foreign bodies or electronic devices including most cardiac pacemakers, claustrophobia)
• Known hypersensitivity to any form of radiographic contrast
• Females who are pregnant or nursing or plan to become pregnant during the study; men who plan to conceive during the study

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (10)

TriWest Research Associates, LLC

El Cajon, California, 92020, United States

Location

Biosolutions Research

La Mesa, California, 91942, United States

Location

Dream Team Clinical Research (formerly located in Anaheim)

Pomona, California, 91767, United States

Location

Dream Team Clinical Research

Pomona, California, 91767, United States

Location

Tampa Bay Medical Research, Inc.

Clearwater, Florida, 33761, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

PMG Research, Inc. d/b/a PMG Research of Knoxville

Knoxville, Tennessee, 37938, United States

Location

University of Leeds

Leeds, LS7 4SA, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Pain

Interventions

FX006; Triamcinolone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; 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

Limitations and Caveats

One patient experienced procedural anxiety during the placement of the syringe on the inserted needle and did not receive the full dose of FX006. This patient is still counted in the safety population.

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

  Flexion Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: May 18, 2018
• Study Start: April 24, 2018
• Primary Completion: November 8, 2019
• Study Completion: March 9, 2020
• Last Updated: January 24, 2024
• Results First Posted: December 8, 2020

Record last verified: 2024-01

Locations

GB (1); US (9)