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Study to Characterize the Local Duration of Exposure From FX006 in Patients With Osteoarthritis of the Knee

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FX006 10 mg
FX006 40 mg
TCA IR 40 mg
Sponsored by
Flexion Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring osteoarthritis, knee, corticosteroids, triamcinolone acetonide, synovial fluid

Eligibility Criteria

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

Key Inclusion Criteria:

  • Written consent to participate in the study
  • Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
  • Has documented diagnosis of OA of the index knee made at least 6 months prior to Screening
  • Currently meets American Collage of Rheumatology Criteria (clinical and radiological) for OA
  • Index knee pain for >15 days over the last month
  • Body mass index (BMI) ≤ 40 kg/m2
  • Ambulatory and in good general health

Key Exclusion Criteria:

  • History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis
  • History of arthritides due to crystals (e.g., gout, pseudogout)
  • History of infection in the index joint
  • Clinical signs and symptoms of active knee infection or crystal disease of the index knee
  • Presence of surgical hardware or other foreign body in the index knee
  • Unstable joint (such as a torn anterior cruciate ligament) within 12 months of Screening
  • IA corticosteroid (investigational or marketed) in any joint within 6 months of Screening
  • IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
  • Oral corticosteroids (investigational or marketed) within 1 month of Screening
  • Inhaled, intranasal and topical corticosteroids (investigational or marketed) within 2 weeks of Screening
  • Any other IA investigational drug/biologic within 6 months of Screening
  • Prior use of FX006
  • Prior arthroscopic or open surgery of the index knee within 12 months of Screening
  • Planned/anticipated surgery of the index knee during the study period
  • Active or history of malignancy within the last 5 years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

FX006 10 mg

FX006 40 mg

TCA IR 40 mg

Arm Description

Single 3 mL intra-articular (IA) injection

Single 3 mL intra-articular (IA) injection

Single 1 mL intra-articular (IA) injection

Outcomes

Primary Outcome Measures

Concentration of Triamcinolone Acetonide in Synovial Fluid
Analyses of synovial fluid drug concentrations were performed using the Synovial Fluid Drug Concentration Population. Values recorded as lower limit of quantification (LLOQ) (< 50 pg/mL) were counted as half the value below limit of quantification (BLQ).

Secondary Outcome Measures

Plasma Drug Concentrations by Time
Plasma Drug Concentration Population. Analyses of plasma drug concentrations were performed using the Plasma Drug Concentration Population. Values recorded as lower limit of quantification (LLOQ) (< 10 pg/mL) were counted as half the value below limit of quantification (BLQ).

Full Information

First Posted
November 18, 2013
Last Updated
December 13, 2017
Sponsor
Flexion Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02003365
Brief Title
Study to Characterize the Local Duration of Exposure From FX006 in Patients With Osteoarthritis of the Knee
Official Title
An Open-label, Single Administration Study to Characterize the Local Duration of Exposure of Triamcinolone Acetonide From FX006 in Patients With Osteoarthritis (OA) of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study was to characterize the local duration of exposure of TCA for 2 doses of FX006 relative to 40 mg of TCA IR in patients with OA of the knee.
Detailed Description
This study was an open-label, single administration design, conducted in male and female patients ≥40 years of age with OA of the knee. Patients were enrolled sequentially with 8 patients per cohort, as follows: Cohort A: FX006 40 mg, Final Visit at Week 20 Cohort B: FX006 40 mg, Final Visit at Week 16 Cohort C: FX006 10 mg, Final Visit at Week 12 Cohort D: FX006 40 mg, Final Visit at Week 12 Cohort E: Triamcinolone acetonide immediate-release (TCA IR) 40 mg, Final Visit Week 12 Each patient was evaluated for up to 12, 16, or 20 weeks following a single IA injection depending on the assigned cohort. Following the screening visit, safety was evaluated at 3 out-patient visits and synovial fluid was collected at Day 1 for baseline measurements and the Final Visit for drug concentration measurements.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
osteoarthritis, knee, corticosteroids, triamcinolone acetonide, synovial fluid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FX006 10 mg
Arm Type
Experimental
Arm Description
Single 3 mL intra-articular (IA) injection
Arm Title
FX006 40 mg
Arm Type
Experimental
Arm Description
Single 3 mL intra-articular (IA) injection
Arm Title
TCA IR 40 mg
Arm Type
Active Comparator
Arm Description
Single 1 mL intra-articular (IA) injection
Intervention Type
Drug
Intervention Name(s)
FX006 10 mg
Intervention Description
Extended-release formulation
Intervention Type
Drug
Intervention Name(s)
FX006 40 mg
Intervention Description
Extended-release formulation
Intervention Type
Drug
Intervention Name(s)
TCA IR 40 mg
Other Intervention Name(s)
Kenalog®-40 Injection, Triamcinolone Acetonide Crystalline Suspension (TAcs)
Intervention Description
Immediate-release formulation
Primary Outcome Measure Information:
Title
Concentration of Triamcinolone Acetonide in Synovial Fluid
Description
Analyses of synovial fluid drug concentrations were performed using the Synovial Fluid Drug Concentration Population. Values recorded as lower limit of quantification (LLOQ) (< 50 pg/mL) were counted as half the value below limit of quantification (BLQ).
Time Frame
12 to 20 weeks
Secondary Outcome Measure Information:
Title
Plasma Drug Concentrations by Time
Description
Plasma Drug Concentration Population. Analyses of plasma drug concentrations were performed using the Plasma Drug Concentration Population. Values recorded as lower limit of quantification (LLOQ) (< 10 pg/mL) were counted as half the value below limit of quantification (BLQ).
Time Frame
Weeks 6, 12, 16 and 20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Written consent to participate in the study Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions Has documented diagnosis of OA of the index knee made at least 6 months prior to Screening Currently meets American Collage of Rheumatology Criteria (clinical and radiological) for OA Index knee pain for >15 days over the last month Body mass index (BMI) ≤ 40 kg/m2 Ambulatory and in good general health Key Exclusion Criteria: History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis History of arthritides due to crystals (e.g., gout, pseudogout) History of infection in the index joint Clinical signs and symptoms of active knee infection or crystal disease of the index knee Presence of surgical hardware or other foreign body in the index knee Unstable joint (such as a torn anterior cruciate ligament) within 12 months of Screening IA corticosteroid (investigational or marketed) in any joint within 6 months of Screening IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening Oral corticosteroids (investigational or marketed) within 1 month of Screening Inhaled, intranasal and topical corticosteroids (investigational or marketed) within 2 weeks of Screening Any other IA investigational drug/biologic within 6 months of Screening Prior use of FX006 Prior arthroscopic or open surgery of the index knee within 12 months of Screening Planned/anticipated surgery of the index knee during the study period Active or history of malignancy within the last 5 years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Bodick, MD
Organizational Affiliation
Flexion Therapeutics
Official's Role
Study Director
Facility Information:
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States

12. IPD Sharing Statement

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Study to Characterize the Local Duration of Exposure From FX006 in Patients With Osteoarthritis of the Knee

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