Trial Outcomes & Findings for Study to Compare Exposure of TA Following Administration of Either FX006 or TAcs in Patients With Bilateral Knee OA (NCT NCT03378076)

Last Updated: 2024-01-24

Results Overview

Plasma drug concentrations (pg/mL) by Time Point across FX006 and TAcs treatment arms in plasma. For the PK analysis and individual concentration vs. time plots, a concentration that is BLOQ is assigned a value of zero if it occurs in a profile before the first measurable concentration. If a BLOQ value occurs after a measurable concentration in a profile and is followed by a value above the lower limit of quantification, then the BLOQ is treated as missing data. If a BLOQ value occurs at the end of the collection interval (after the last quantifiable concentration) it is set to zero. If two BLOQ values occur in succession after Cmax, the profile is deemed to have terminated at the first BLOQ value and any subsequent concentrations are set to zero for PK calculations

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

43 days

Results posted on

2024-01-24

Participant Flow

Participant milestones

Participant milestones
Measure	FX006 32 mg 12 subjects received FX006 32 mg as a single 5 mL IA injection into each knee for a total of total 64 mg dose	TAcs IR 40 mg 12 subjects received TAcs 40 mg as a single 5 mL IA injection into each knee for a total 80 mg dose
Overall Study STARTED	12	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Compare Exposure of TA Following Administration of Either FX006 or TAcs in Patients With Bilateral Knee OA

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FX006 64 mg n=12 Participants Single 5 mL IA injection into each knee	TAcs IR 80mg n=12 Participants Single 5 mL IA injection into each knee	Total n=24 Participants Total of all reporting groups
Age, Continuous	61.8 years STANDARD_DEVIATION 6.45 • n=93 Participants	61.6 years STANDARD_DEVIATION 8.17 • n=4 Participants	61.7 years STANDARD_DEVIATION 7.20 • n=27 Participants
Sex: Female, Male Female	10 Participants n=93 Participants	9 Participants n=4 Participants	19 Participants n=27 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=93 Participants	12 Participants n=4 Participants	22 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) White	10 Participants n=93 Participants	10 Participants n=4 Participants	20 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Body Mass Index (BMI)	33.31 kg/m^2 STANDARD_DEVIATION 3.669 • n=93 Participants	30.35 kg/m^2 STANDARD_DEVIATION 4.955 • n=4 Participants	31.83 kg/m^2 STANDARD_DEVIATION 4.524 • n=27 Participants

PRIMARY outcome

Timeframe: 43 days

Population: All patients who received 2 IA injections (one in each knee) of study drug, completed scheduled sampling, and had sufficient plasma concentration data

Outcome measures

Outcome measures
Measure	FX006 32 mg n=12 Participants Two 5 mL IA injections (total dose of 64 mg)	TAcs 40 mg n=12 Participants Two 1mL IA injections (total dose of 80 mg)
Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma Day 1- Hour 1	1801.5 pg/mL Interval 1261.5 to 2572.77	4507.9 pg/mL Interval 1205.43 to 16857.74
Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma Day 1 - Hour 2	1893.6 pg/mL Interval 1328.58 to 2698.84	5140.1 pg/mL Interval 1327.67 to 19899.79
Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma Day 1 - Hour 3	1958.1 pg/mL Interval 1336.54 to 2868.86	5443.8 pg/mL Interval 1357.81 to 21825.9
Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma Day 1 - Hour 4	2013.8 pg/mL Interval 1381.39 to 2935.59	5454.2 pg/mL Interval 1409.98 to 21098.36
Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma Day 1 - Hour 5	1914.4 pg/mL Interval 1291.93 to 2836.82	5338.9 pg/mL Interval 1366.93 to 20852.59
Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma Day 1 - Hour 6	1900.2 pg/mL Interval 1293.77 to 2790.96	5430.6 pg/mL Interval 1442.24 to 20448.57
Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma Day 1 - Hour 8	1928.1 pg/mL Interval 1288.45 to 2885.17	5199.0 pg/mL Interval 1418.52 to 19054.8
Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma Day 1 - Hour 10	1839.8 pg/mL Interval 1241.72 to 2725.96	4948.8 pg/mL Interval 1392.07 to 17593.31
Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma Day 1 - Hour 12	1793.9 pg/mL Interval 1247.06 to 2580.66	4507.8 pg/mL Interval 1294.51 to 15697.14
Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma Day 2 - Hour 24	1948.8 pg/mL Interval 1349.93 to 2813.36	4185.4 pg/mL Interval 1614.39 to 10850.75
Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma Day 8	1397.0 pg/mL Interval 1073.13 to 1818.65	450.8 pg/mL Interval 230.66 to 880.92
Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma Day 15	956.2 pg/mL Interval 759.23 to 1204.25	428.7 pg/mL Interval 231.92 to 792.29
Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma Day 29	445.8 pg/mL Interval 313.12 to 634.8	334.6 pg/mL Interval 182.45 to 613.8
Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma Day 43	265.8 pg/mL Interval 199.56 to 354.03	241.0 pg/mL Interval 119.11 to 487.54

PRIMARY outcome

Timeframe: 43 days

Population: All patients who received study drug (injection in at least one knee).

Safety analyses were conducted using the safety population. Analyses of adverse events will be performed for those events that are considered treatment emergent, where treatment emergent is defined as any adverse event with onset after the administration of study medication in the first knee through the end of the study or any event that was present at baseline but worsened in intensity through the end of the study. Severity of Adverse events were graded by the Principal Investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The grading went from Grade 1 (Mild) to Grade 5 (Death related to AE).

Outcome measures

Outcome measures
Measure	FX006 32 mg n=12 Participants Two 5 mL IA injections (total dose of 64 mg)	TAcs 40 mg n=12 Participants Two 1mL IA injections (total dose of 80 mg)
Incidence of Treatment Emergent Adverse Events Patients with TEAE Grade 1	6 participants	3 participants
Incidence of Treatment Emergent Adverse Events Patients with TEAE Grade 2	1 participants	2 participants
Incidence of Treatment Emergent Adverse Events Patients with TEAE Grade 3	1 participants	0 participants
Incidence of Treatment Emergent Adverse Events Patients with TEAE Grade 4	0 participants	0 participants
Incidence of Treatment Emergent Adverse Events Patients with TEAE Grade 5	0 participants	0 participants

Adverse Events

FX006 32 mg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

TAcs 40 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Scott Kelley, Chief Medical Officer

Flexion Therapeutics

Phone: 781-305-7142

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	FX006 32 mg n=12 participants at risk Two 5 mL intra-articular injection FX006: Sustained Release Steroid	TAcs 40 mg n=12 participants at risk Commercially available triamcinolone acetonide, two 1 mL intra-articular injection TAcs: Immediate Release Steroid
Gastrointestinal disorders Haemorrhoids	0.00% 0/12 • Adverse Events were collected following IA administration through the final study visit at 43 days.	8.3% 1/12 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit at 43 days.
Gastrointestinal disorders Vomiting	8.3% 1/12 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit at 43 days.	0.00% 0/12 • Adverse Events were collected following IA administration through the final study visit at 43 days.
General disorders Fatigue	0.00% 0/12 • Adverse Events were collected following IA administration through the final study visit at 43 days.	8.3% 1/12 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit at 43 days.
General disorders Injection Site Pain	8.3% 1/12 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit at 43 days.	0.00% 0/12 • Adverse Events were collected following IA administration through the final study visit at 43 days.
General disorders Vessel Puncture Site Haematoma	8.3% 1/12 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit at 43 days.	0.00% 0/12 • Adverse Events were collected following IA administration through the final study visit at 43 days.
Immune system disorders Food Allergy	0.00% 0/12 • Adverse Events were collected following IA administration through the final study visit at 43 days.	8.3% 1/12 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit at 43 days.
Infections and infestations Bronchitis	16.7% 2/12 • Number of events 2 • Adverse Events were collected following IA administration through the final study visit at 43 days.	0.00% 0/12 • Adverse Events were collected following IA administration through the final study visit at 43 days.
Infections and infestations Nasopharyngitis	8.3% 1/12 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit at 43 days.	0.00% 0/12 • Adverse Events were collected following IA administration through the final study visit at 43 days.
Infections and infestations Sinusitis	0.00% 0/12 • Adverse Events were collected following IA administration through the final study visit at 43 days.	8.3% 1/12 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit at 43 days.
Investigations Neutrophil Count Decreased	8.3% 1/12 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit at 43 days.	0.00% 0/12 • Adverse Events were collected following IA administration through the final study visit at 43 days.
Investigations White Blood Cell Count Decreased	8.3% 1/12 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit at 43 days.	0.00% 0/12 • Adverse Events were collected following IA administration through the final study visit at 43 days.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/12 • Adverse Events were collected following IA administration through the final study visit at 43 days.	16.7% 2/12 • Number of events 2 • Adverse Events were collected following IA administration through the final study visit at 43 days.
Musculoskeletal and connective tissue disorders Back Pain	8.3% 1/12 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit at 43 days.	0.00% 0/12 • Adverse Events were collected following IA administration through the final study visit at 43 days.
Musculoskeletal and connective tissue disorders Fibromyalgia	0.00% 0/12 • Adverse Events were collected following IA administration through the final study visit at 43 days.	8.3% 1/12 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit at 43 days.
Musculoskeletal and connective tissue disorders Joint Swelling	0.00% 0/12 • Adverse Events were collected following IA administration through the final study visit at 43 days.	8.3% 1/12 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit at 43 days.
Nervous system disorders Headache	8.3% 1/12 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit at 43 days.	8.3% 1/12 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit at 43 days.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	8.3% 1/12 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit at 43 days.	0.00% 0/12 • Adverse Events were collected following IA administration through the final study visit at 43 days.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/12 • Adverse Events were collected following IA administration through the final study visit at 43 days.	8.3% 1/12 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit at 43 days.
Vascular disorders Hot Flush	8.3% 1/12 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit at 43 days.	0.00% 0/12 • Adverse Events were collected following IA administration through the final study visit at 43 days.