Trial Outcomes & Findings for Study to Characterize the Local Duration of Exposure From FX006 in Patients With Osteoarthritis of the Knee (NCT NCT02003365)
NCT ID: NCT02003365
Last Updated: 2024-01-24
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
12 to 20 weeks
Results posted on
2024-01-24
Participant Flow
This study took place at 3 centers across the United States. Enrollment took approximately 2 months.
Subjects were screened for eligibility within 14 days of being enrolled
Participant milestones
| Measure |
FX006 10 mg
10 subjects received FX006 10 mg as a single 3 mL IA injection
|
FX006 40 mg
30 Subjects received FX006 40 mg as a single 3 mL IA injection
|
TCA IR 40 mg
10 subjects received TCA IR 40 mg as a single 1 mL IA injection
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
30
|
10
|
|
Overall Study
COMPLETED
|
10
|
30
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
FX006 10 mg
10 subjects received FX006 10 mg as a single 3 mL IA injection
|
FX006 40 mg
30 Subjects received FX006 40 mg as a single 3 mL IA injection
|
TCA IR 40 mg
10 subjects received TCA IR 40 mg as a single 1 mL IA injection
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
Study to Characterize the Local Duration of Exposure From FX006 in Patients With Osteoarthritis of the Knee
Baseline characteristics by cohort
| Measure |
FX006 10 mg
n=10 Participants
Single 3 mL IA injection
|
FX006 40 mg
n=30 Participants
Single 3 mL IA injection
|
TCA IR 40 mg
n=10 Participants
Single 1 mL IA injection
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.5 years
n=5 Participants
|
62.8 years
n=7 Participants
|
61.6 years
n=5 Participants
|
62.15 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 to 20 weeksPopulation: All patients who received study drug and had synovial fluid obtained at the Final Visit were included in the Synovial Fluid Drug Concentration Population.
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).
Outcome measures
| Measure |
FX006 10 mg
n=8 Participants
Single 3 mL IA injection.
|
FX006 40 mg
n=15 Participants
Single 3 mL IA injection.
|
TCA IR 40 mg
n=5 Participants
Single 1 mL IA injection.
|
|---|---|---|---|
|
Concentration of Triamcinolone Acetonide in Synovial Fluid
Week 12
|
477.5 pg/mL
Interval 166.41 to 1369.91
|
923.7 pg/mL
Interval 74.24 to 11492.46
|
250.1 pg/mL
Interval 0.16 to 380930.9
|
|
Concentration of Triamcinolone Acetonide in Synovial Fluid
Week 16
|
NA pg/mL
For the 10 mg group of FX006 patients were only followed until week 12.
|
224.3 pg/mL
Interval 37.42 to 1344.7
|
NA pg/mL
TCA IR 40 mg group patients were only followed until week 12.
|
|
Concentration of Triamcinolone Acetonide in Synovial Fluid
Week 20
|
NA pg/mL
For the 10 mg group of FX006 patients were only followed until week 12.
|
33.3 pg/mL
Interval 20.28 to 54.74
|
NA pg/mL
TCA IR 40 mg group patients were only followed until week 12.
|
SECONDARY outcome
Timeframe: Weeks 6, 12, 16 and 20Plasma 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).
Outcome measures
| Measure |
FX006 10 mg
n=10 Participants
Single 3 mL IA injection.
|
FX006 40 mg
n=30 Participants
Single 3 mL IA injection.
|
TCA IR 40 mg
n=10 Participants
Single 1 mL IA injection.
|
|---|---|---|---|
|
Plasma Drug Concentrations by Time
Week 6
|
26.5 pg/mL
Interval 15.09 to 46.59
|
100.1 pg/mL
Interval 76.05 to 131.8
|
21.1 pg/mL
Interval 5.76 to 77.13
|
|
Plasma Drug Concentrations by Time
Week 12
|
6.6 pg/mL
Interval 4.26 to 10.26
|
8.9 pg/mL
Interval 3.97 to 19.79
|
9.4 pg/mL
Interval 1.86 to 47.4
|
|
Plasma Drug Concentrations by Time
Week 16
|
NA pg/mL
For the 10 mg group of FX006 patients were only followed until week 12.
|
26.4 pg/mL
Interval 8.75 to 79.64
|
NA pg/mL
For the TCA IR 40 mg group patients were only followed until week 12.
|
|
Plasma Drug Concentrations by Time
Week 20
|
NA pg/mL
For the 10 mg group of FX006 patients were only followed until week 12.
|
10.1 pg/mL
Interval 4.21 to 24.48
|
NA pg/mL
For the TCA IR 40 mg group patients were only followed until week 12.
|
Adverse Events
FX006 10 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
FX006 40 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
TCA IR
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FX006 10 mg
n=10 participants at risk
Single 3 mL IA injection
|
FX006 40 mg
n=30 participants at risk
Single 3 mL IA injection
|
TCA IR
n=10 participants at risk
Single 1 mL IA injection
|
|---|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/10 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
0.00%
0/30 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
|
Injury, poisoning and procedural complications
Food Poisoning
|
0.00%
0/10 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
0.00%
0/30 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
Other adverse events
| Measure |
FX006 10 mg
n=10 participants at risk
Single 3 mL IA injection
|
FX006 40 mg
n=30 participants at risk
Single 3 mL IA injection
|
TCA IR
n=10 participants at risk
Single 1 mL IA injection
|
|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/10 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
0.00%
0/30 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
|
Gastrointestinal disorders
Abdominal Pain
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
0.00%
0/30 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
0.00%
0/10 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
|
General disorders
Tenderness
|
0.00%
0/10 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
0.00%
0/30 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
20.0%
2/10 • Number of events 2 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
0.00%
0/30 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
0.00%
0/10 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
|
Infections and infestations
Viral Infection
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
0.00%
0/30 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
0.00%
0/10 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
|
Injury, poisoning and procedural complications
Food Poisoning
|
0.00%
0/10 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
0.00%
0/30 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
|
Injury, poisoning and procedural complications
Frostbite
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
0.00%
0/30 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
0.00%
0/10 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
10.0%
3/30 • Number of events 3 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
20.0%
2/10 • Number of events 2 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/10 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
0.00%
0/30 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/10 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
3.3%
1/30 • Number of events 1 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/10 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
0.00%
0/30 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/10 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
0.00%
0/30 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
0.00%
0/30 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/10 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
0.00%
0/30 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
3.3%
1/30 • Number of events 1 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
0.00%
0/10 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/10 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
0.00%
0/30 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
0.00%
0/30 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
0.00%
0/10 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
|
Infections and infestations
Oral Herpes
|
10.0%
1/10 • Number of events 1 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
0.00%
0/30 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
0.00%
0/10 • Adverse Events were monitored/assessed from post-injection on Day 1 through 12 weeks for FX006 10 mg and TCA IR groups and up to 20 weeks for FX006 40 mg groups.
|
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