Trial Outcomes & Findings for Study to Characterize the PK and Local Extent and Duration of Exposure From FX006 in Patients With OA of the Knee (NCT NCT02637323)
NCT ID: NCT02637323
Last Updated: 2024-01-24
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
81 participants
Primary outcome timeframe
Up to 20 Weeks
Results posted on
2024-01-24
Participant Flow
Patients were screened for study eligibility at four (4) study centers in the United States (US).
Patients were enrolled sequentially with at least 10 patients per Cohort. Subjects were enrolled within 14 days of Screening.
Participant milestones
| Measure |
FX006 32 mg
63 subjects received FX006 32 mg as a single 5 mL IA injection
|
TCA IR 40 mg
18 subjects received TCA IR 40 mg as a single 1 mL IA injection
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
18
|
|
Overall Study
COMPLETED
|
61
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
FX006 32 mg
63 subjects received FX006 32 mg as a single 5 mL IA injection
|
TCA IR 40 mg
18 subjects received TCA IR 40 mg as a single 1 mL IA injection
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Study to Characterize the PK and Local Extent and Duration of Exposure From FX006 in Patients With OA of the Knee
Baseline characteristics by cohort
| Measure |
FX006 32 mg
n=63 Participants
Single 5 mL IA injection
|
TCA IR 40 mg
n=18 Participants
Single 1 mL IA injection
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 8.16 • n=5 Participants
|
61.9 years
STANDARD_DEVIATION 7.68 • n=7 Participants
|
61 years
STANDARD_DEVIATION 8.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 20 WeeksPopulation: All patients who received study drug and had synovial fluid obtained at the Synovial Fluid Visit and assayed for drug concentration levels.
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).
Outcome measures
| Measure |
FX006 32 mg
n=17 Participants
Single 5 mL IA injection
|
TCA IR 40 mg
n=8 Participants
Single 1 mL IA injection
|
|---|---|---|
|
Synovial Fluid Drug Concentrations (pg/mL) by Time Point Pooled Across FX006 Cohorts and TCA IR in Synovial Fluid
Baseline (pre-treatment)
|
1.0 pg/mL
Interval 1.0 to 1.0
|
1.0 pg/mL
Interval 1.0 to 1.0
|
|
Synovial Fluid Drug Concentrations (pg/mL) by Time Point Pooled Across FX006 Cohorts and TCA IR in Synovial Fluid
Week 1
|
231328.9 pg/mL
Interval 56460.4 to 947798.36
|
—
|
|
Synovial Fluid Drug Concentrations (pg/mL) by Time Point Pooled Across FX006 Cohorts and TCA IR in Synovial Fluid
Week 6
|
3590.0 pg/mL
Interval 32.89 to 391914.74
|
7.7 pg/mL
Interval 0.31 to 191.34
|
|
Synovial Fluid Drug Concentrations (pg/mL) by Time Point Pooled Across FX006 Cohorts and TCA IR in Synovial Fluid
Week 12
|
290.6 pg/mL
Interval 15.67 to 5390.53
|
—
|
|
Synovial Fluid Drug Concentrations (pg/mL) by Time Point Pooled Across FX006 Cohorts and TCA IR in Synovial Fluid
Week 16
|
1.0 pg/mL
Interval 1.0 to 1.0
|
—
|
|
Synovial Fluid Drug Concentrations (pg/mL) by Time Point Pooled Across FX006 Cohorts and TCA IR in Synovial Fluid
Week 20
|
1.0 pg/mL
Interval 1.0 to 1.0
|
—
|
SECONDARY outcome
Timeframe: Up to 20 WeeksPopulation: All patients who received study drug and had at least one post-baseline plasma sample obtained and assayed for drug concentration levels.
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.
Outcome measures
| Measure |
FX006 32 mg
n=60 Participants
Single 5 mL IA injection
|
TCA IR 40 mg
n=18 Participants
Single 1 mL IA injection
|
|---|---|---|
|
Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort
Day 1 - Hour 1
|
670.0 pg/mL
Interval 558.42 to 803.97
|
6968.8 pg/mL
Interval 3329.0 to 14588.36
|
|
Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort
Day 1 - Hour 2
|
736.5 pg/mL
Interval 630.01 to 861.03
|
8494.7 pg/mL
Interval 3954.18 to 18248.99
|
|
Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort
Day 1 - Hour 4
|
759.5 pg/mL
Interval 641.69 to 898.87
|
9628.8 pg/mL
Interval 4420.47 to 20973.81
|
|
Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort
Day 1 - Hour 6
|
747.1 pg/mL
Interval 630.45 to 885.28
|
9314.3 pg/mL
Interval 4423.76 to 19611.37
|
|
Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort
Day 1 - Hour 8
|
740.2 pg/mL
Interval 625.13 to 876.36
|
8421.3 pg/mL
Interval 4166.33 to 17021.86
|
|
Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort
Day 1 - Hour 10
|
720.7 pg/mL
Interval 611.37 to 849.66
|
7439.3 pg/mL
Interval 3845.19 to 14392.79
|
|
Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort
Day 1 - Hour 12
|
706.6 pg/mL
Interval 600.15 to 831.91
|
6678.7 pg/mL
Interval 3535.07 to 12617.78
|
|
Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort
Day 2 - Hour 24
|
836.4 pg/mL
Interval 703.47 to 994.33
|
4991.1 pg/mL
Interval 2851.47 to 8736.28
|
|
Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort
Week 1
|
600.9 pg/mL
Interval 382.79 to 943.25
|
—
|
|
Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort
Week 6
|
118.6 pg/mL
Interval 99.93 to 140.87
|
149.4 pg/mL
Interval 69.7 to 320.32
|
|
Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort
Week 12
|
53.7 pg/mL
Interval 30.46 to 94.74
|
—
|
|
Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort
Week 16
|
73.8 pg/mL
Interval 28.74 to 189.31
|
—
|
|
Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort
Week 20
|
108.2 pg/mL
Interval 2.3 to 5090.25
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 20 WeeksOutcome measures
Outcome data not reported
Adverse Events
FX006 32 mg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
TCA IR 40 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FX006 32 mg
n=63 participants at risk
Single 5 mL intra-articular injection
FX006: Sustained Release Steroid
|
TCA IR 40 mg
n=18 participants at risk
Commercially available triamcinolone acetonide, single 1 mL intra-articular injection
TCA IR: Immediate Release Steroid
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.6%
1/63 • Number of events 1 • Adverse Events were collected following IA administration on Baseline/Day 1 up to 20 weeks.
|
0.00%
0/18 • Adverse Events were collected following IA administration on Baseline/Day 1 up to 20 weeks.
|
Other adverse events
| Measure |
FX006 32 mg
n=63 participants at risk
Single 5 mL intra-articular injection
FX006: Sustained Release Steroid
|
TCA IR 40 mg
n=18 participants at risk
Commercially available triamcinolone acetonide, single 1 mL intra-articular injection
TCA IR: Immediate Release Steroid
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
1.6%
1/63 • Number of events 1 • Adverse Events were collected following IA administration on Baseline/Day 1 up to 20 weeks.
|
0.00%
0/18 • Adverse Events were collected following IA administration on Baseline/Day 1 up to 20 weeks.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
1.6%
1/63 • Number of events 1 • Adverse Events were collected following IA administration on Baseline/Day 1 up to 20 weeks.
|
0.00%
0/18 • Adverse Events were collected following IA administration on Baseline/Day 1 up to 20 weeks.
|
|
Investigations
Weight Increased
|
1.6%
1/63 • Number of events 1 • Adverse Events were collected following IA administration on Baseline/Day 1 up to 20 weeks.
|
0.00%
0/18 • Adverse Events were collected following IA administration on Baseline/Day 1 up to 20 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
1/63 • Number of events 1 • Adverse Events were collected following IA administration on Baseline/Day 1 up to 20 weeks.
|
0.00%
0/18 • Adverse Events were collected following IA administration on Baseline/Day 1 up to 20 weeks.
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral Pain Syndrome
|
1.6%
1/63 • Number of events 1 • Adverse Events were collected following IA administration on Baseline/Day 1 up to 20 weeks.
|
0.00%
0/18 • Adverse Events were collected following IA administration on Baseline/Day 1 up to 20 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.6%
1/63 • Number of events 1 • Adverse Events were collected following IA administration on Baseline/Day 1 up to 20 weeks.
|
0.00%
0/18 • Adverse Events were collected following IA administration on Baseline/Day 1 up to 20 weeks.
|
|
Vascular disorders
Hypertension
|
3.2%
2/63 • Number of events 2 • Adverse Events were collected following IA administration on Baseline/Day 1 up to 20 weeks.
|
0.00%
0/18 • Adverse Events were collected following IA administration on Baseline/Day 1 up to 20 weeks.
|
|
Vascular disorders
Flushing
|
0.00%
0/63 • Adverse Events were collected following IA administration on Baseline/Day 1 up to 20 weeks.
|
11.1%
2/18 • Number of events 2 • Adverse Events were collected following IA administration on Baseline/Day 1 up to 20 weeks.
|
Additional Information
Scott Kelley, VP of Medical Affairs
Flexion Therapeutics
Phone: 781-305-7142
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place