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

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
FX006 32 mg
Sponsored by
Flexion Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Knee, Pain, Intra-articular, Injection, Corticosteroid

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • TriWest Research Associates, LLC
  • Biosolutions Research
  • Dream Team Clinical Research (formerly located in Anaheim)
  • Dream Team Clinical Research
  • Tampa Bay Medical Research, Inc.
  • Rush University Medical Center
  • Duke University Medical Center
  • Altoona Center for Clinical Research
  • PMG Research, Inc. d/b/a PMG Research of Knoxville
  • University of Leeds

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FX006 32 mg

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mean Absolute Change in Synovial Volume at 6 Weeks
Mean absolute change from baseline at 6 weeks in synovial volume (mm^3) as measured by MRI and read by a central imaging vendor. The least squares mean changes are estimated using a mixed effects model for repeated measures with fixed effects for study time point, study site, baseline score and baseline femur bone volume (mm^3) and a random effect for patient.
Mean Standardized Change in Synovial Volume (SV) at 24 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.
Mean Absolute Change in Synovial Volume at 24 Weeks
Mean absolute change (mm^3) from baseline at 24 weeks in synovial volume (mm^3) as measured by MRI and read by a central imaging vendor. The least squares mean changes are estimated using a mixed effects model for repeated measures with fixed effects for study time point, study site, baseline score and baseline femur bone volume (mm^3) and a random effect for patient.

Full Information

First Posted
May 8, 2018
Last Updated
January 13, 2022
Sponsor
Flexion Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03529942
Brief Title
Study to Evaluate the Effect of FX006 on Synovial Inflammation in Patients With OA of the Knee
Official Title
An Open-Label Study to Evaluate the Effect of the Administration of FX006 on Synovial Inflammation in Patients With Osteoarthritis of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 24, 2018 (Actual)
Primary Completion Date
November 8, 2019 (Actual)
Study Completion Date
March 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Flexion Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. The study will be conducted in male and female patients who are ≥ 40 years of age. Eligible patients who provide written consent and meet all entry criteria will undergo initial ultrasound examination and MRI with contrast of the index knee, and then receive a single IA injection of FX006 administered to the index knee at Baseline/Day 1. Patients will return to the clinic at Weeks 6 and 24 for an MRI with contrast of the index knee and other assessments. Patients must also have a blood sample drawn for Estimated Glomerular Filtration Rate (eGFR) testing within 30 days prior to the scheduled MRIs. In addition, a patient questionnaire will be administered and adverse events (AEs) and concomitant medication updates will be collected via telephone at Weeks 12 and 18.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Osteoarthritis, Knee, Pain, Intra-articular, Injection, Corticosteroid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FX006 32 mg
Arm Type
Experimental
Arm Description
Single intra-articular (IA) injection of FX006 32 mg
Intervention Type
Drug
Intervention Name(s)
FX006 32 mg
Other Intervention Name(s)
Zilretta
Intervention Description
Extended-release 32 mg FX006 IA injection
Primary Outcome Measure Information:
Title
Mean Standardized Change in Synovial Volume (SV) at 6 Weeks
Description
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.
Time Frame
Baseline to Week 6
Secondary Outcome Measure Information:
Title
Mean Absolute Change in Synovial Volume at 6 Weeks
Description
Mean absolute change from baseline at 6 weeks in synovial volume (mm^3) as measured by MRI and read by a central imaging vendor. The least squares mean changes are estimated using a mixed effects model for repeated measures with fixed effects for study time point, study site, baseline score and baseline femur bone volume (mm^3) and a random effect for patient.
Time Frame
Baseline to Week 6
Title
Mean Standardized Change in Synovial Volume (SV) at 24 Weeks
Description
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.
Time Frame
Baseline to Week 24
Title
Mean Absolute Change in Synovial Volume at 24 Weeks
Description
Mean absolute change (mm^3) from baseline at 24 weeks in synovial volume (mm^3) as measured by MRI and read by a central imaging vendor. The least squares mean changes are estimated using a mixed effects model for repeated measures with fixed effects for study time point, study site, baseline score and baseline femur bone volume (mm^3) and a random effect for patient.
Time Frame
Baseline to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Kelley, MD
Organizational Affiliation
Flexion Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
TriWest Research Associates, LLC
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
Biosolutions Research
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Dream Team Clinical Research (formerly located in Anaheim)
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Dream Team Clinical Research
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Tampa Bay Medical Research, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
PMG Research, Inc. d/b/a PMG Research of Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37938
Country
United States
Facility Name
University of Leeds
City
Leeds
ZIP/Postal Code
LS7 4SA
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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