- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02637323
Study to Characterize the PK and Local Extent and Duration of Exposure From FX006 in Patients With OA of the Knee
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Canoga Park, California, United States, 91303
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San Diego, California, United States, 92103
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Florida
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Hialeah, Florida, United States, 33012
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Pennsylvania
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Duncansville, Pennsylvania, United States, 16635
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FX006 32 mg
Single 5 mL intra-articular (IA) injection Extended-release formulation
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Single 5 mL IA injection
Other Names:
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Active Comparator: TCA IR 40 mg
Commercially available triamcinolone acetonide, single 1 mL intra-articular (IA) injection Immediate-release formulation
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Single 1 mL IA injection
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Synovial Fluid Drug Concentrations (pg/mL) by Time Point Pooled Across FX006 Cohorts and TCA IR in Synovial Fluid
Time Frame: Up to 20 Weeks
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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).
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Up to 20 Weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort
Time Frame: Up to 20 Weeks
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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.
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Up to 20 Weeks
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma Pharmacokinetic Parameters for FX006 and TCA IR
Time Frame: Up to 20 Weeks
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Up to 20 Weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Neil Bodick, MD, Flexion Therapeutics
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Osteoarthritis, Knee
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
- FX006
Other Study ID Numbers
- FX006-2015-009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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