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Study to Characterize the PK and Local Extent and Duration of Exposure From FX006 in Patients With OA of the Knee

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FX006 32 mg
TCA IR 40
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, pain, corticosteroid, intra-articular, injection

Eligibility Criteria

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

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
  • Symptoms associated with OA of the knee for ≥ 6 months prior to Screening (patient reported is acceptable)
  • Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA
  • Index knee pain for >15 days over the last month (as reported by the patient)
  • Body mass index (BMI) ≤ 40 kg/m2
  • Ambulatory and in good general health

Exclusion Criteria:

  • Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
  • History of infection in the index knee joint
  • Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening
  • Presence of surgical hardware or other foreign body in the index knee
  • Unstable joint 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
  • Intravenous or Intramuscular corticosteroids (investigational or marketed) within 3 months of Screening
  • Oral corticosteroids (investigational or marketed) within 1 month of Screening
  • Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening
  • Any other IA investigational drug/biologic use within 6 months of Screening or 5 half-lives (whichever is longer)
  • Prior use of FX006
  • Women of child-bearing potential not using effective contraception or who are pregnant or nursing

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FX006 32 mg

TCA IR 40 mg

Arm Description

Single 5 mL intra-articular (IA) injection Extended-release formulation

Commercially available triamcinolone acetonide, single 1 mL intra-articular (IA) injection Immediate-release formulation

Outcomes

Primary Outcome Measures

Synovial Fluid Drug Concentrations (pg/mL) by Time Point Pooled Across FX006 Cohorts and TCA IR in Synovial Fluid
All baseline (pre-treatment) values and all post-baseline values recorded as below LLOQ (<50 pg/mL) were set to zero. Geometric mean summary statistics were computed on adjusted concentration values. One (1) was added to each concentration value observed. BLQ values for the computation of geometric mean are included in the summary with a value of 1 (0+1).

Secondary Outcome Measures

Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort
All baseline (pre-treatment) values and all post-baseline values that are recorded as below LLOQ were set to zero for analysis and were included in the descriptive mean calculations. Values below LLOQ were not included in geometric mean calculations.

Full Information

First Posted
December 7, 2015
Last Updated
December 13, 2017
Sponsor
Flexion Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02637323
Brief Title
Study to Characterize the PK and Local Extent and Duration of Exposure From FX006 in Patients With OA of the Knee
Official Title
An Open-label, Single Administration Study to Characterize the Systemic Pharmacokinetics and Local Extent and Duration of Exposure of Triamcinolone Acetonide From FX006 in Patients With Osteoarthritis of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (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 objectives of this study were to characterize the local extent and duration of exposure of TA from FX006 and TCA IR, characterize the systemic PK of FX006 and TCA IR, and assess the safety and general tolerability of a single 5 mL IA injection of 32 mg FX006 relative to 40 mg of TCA IR in patients with OA of the knee.
Detailed Description
This study employed an open-label, single administration design and was conducted in male and female patients ≥40 years of age with OA of the knee. Patients were enrolled sequentially with at least 10 patients per cohort as follows: Cohort A: FX006 32 mg, Final Visit at Week 20 Cohort B: FX006 32 mg, Final Visit at Week 16 Cohort C: FX006 32 mg, Final Visit at Week 12 Cohort D: FX006 32 mg, Final Visit at Week 6 Cohort E: FX006 32 mg, Final Visit at Week 1 Cohort F: TCA IR 40 mg, Final Visit Week 6 Each patient was screened to confirm eligibility and assigned to a cohort on Day 1/baseline. Each patient was evaluated for safety during his/her participation in the study at 6, 12, 16, or 20 weeks following a single IA injection depending on the assigned Cohort, and plasma and synovial fluid was collected for drug concentration measurements. Safety and tolerability was assessed by physical examinations, index knee examinations, vital signs, clinical laboratory evaluations, and adverse events (AEs). No efficacy assessments were employed in this study.

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, pain, corticosteroid, intra-articular, injection

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
FX006 32 mg
Arm Type
Experimental
Arm Description
Single 5 mL intra-articular (IA) injection Extended-release formulation
Arm Title
TCA IR 40 mg
Arm Type
Active Comparator
Arm Description
Commercially available triamcinolone acetonide, single 1 mL intra-articular (IA) injection Immediate-release formulation
Intervention Type
Drug
Intervention Name(s)
FX006 32 mg
Other Intervention Name(s)
Zilretta
Intervention Description
Single 5 mL IA injection
Intervention Type
Drug
Intervention Name(s)
TCA IR 40
Other Intervention Name(s)
Kenalog®-40 Injection, Triamcinolone Acetonide Crystalline Suspension (TAcs)
Intervention Description
Single 1 mL IA injection
Primary Outcome Measure Information:
Title
Synovial Fluid Drug Concentrations (pg/mL) by Time Point Pooled Across FX006 Cohorts and TCA IR in Synovial Fluid
Description
All baseline (pre-treatment) values and all post-baseline values recorded as below LLOQ (<50 pg/mL) were set to zero. Geometric mean summary statistics were computed on adjusted concentration values. One (1) was added to each concentration value observed. BLQ values for the computation of geometric mean are included in the summary with a value of 1 (0+1).
Time Frame
Up to 20 Weeks
Secondary Outcome Measure Information:
Title
Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort
Description
All baseline (pre-treatment) values and all post-baseline values that are recorded as below LLOQ were set to zero for analysis and were included in the descriptive mean calculations. Values below LLOQ were not included in geometric mean calculations.
Time Frame
Up to 20 Weeks
Other Pre-specified Outcome Measures:
Title
Plasma Pharmacokinetic Parameters for FX006 and TCA IR
Time Frame
Up to 20 Weeks

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 Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions Symptoms associated with OA of the knee for ≥ 6 months prior to Screening (patient reported is acceptable) Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA Index knee pain for >15 days over the last month (as reported by the patient) Body mass index (BMI) ≤ 40 kg/m2 Ambulatory and in good general health Exclusion Criteria: Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease History of infection in the index knee joint Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening Presence of surgical hardware or other foreign body in the index knee Unstable joint 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 Intravenous or Intramuscular corticosteroids (investigational or marketed) within 3 months of Screening Oral corticosteroids (investigational or marketed) within 1 month of Screening Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening Any other IA investigational drug/biologic use within 6 months of Screening or 5 half-lives (whichever is longer) Prior use of FX006 Women of child-bearing potential not using effective contraception or who are pregnant or nursing
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
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States

12. IPD Sharing Statement

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Study to Characterize the PK and Local Extent and Duration of Exposure From FX006 in Patients With OA of the Knee

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