Trial Outcomes & Findings for Study of FX006 vs Normal Saline in Patients With Osteoarthritis of the Knee (NCT NCT02116972)

Last Updated: 2024-01-24

Results Overview

The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain"and 10 indicates "pain as bad as you can imagine."

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

310 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2024-01-24

Participant Flow

Patients were screened for study eligibility at 48 study centers in the United States (US) and Canada. Enrollment took approximately 7 months.

Subjects were screened within 21 days of being randomized

Participant milestones

Participant milestones
Measure	FX006 16 mg 102 subjects received FX006 16 mg a single 5 mL IA injection	FX006 32 mg 104 subjects received FX006 32 mg a single 5 mL IA injection	Placebo 100 subjects received normal saline as a single 5 mL IA injection
Overall Study STARTED	102	104	104
Overall Study COMPLETED	83	87	85
Overall Study NOT COMPLETED	19	17	19

Reasons for withdrawal

Reasons for withdrawal
Measure	FX006 16 mg 102 subjects received FX006 16 mg a single 5 mL IA injection	FX006 32 mg 104 subjects received FX006 32 mg a single 5 mL IA injection	Placebo 100 subjects received normal saline as a single 5 mL IA injection
Overall Study Adverse Event	4	4	1
Overall Study Withdrawal by Subject	1	1	5
Overall Study Protocol Violation	1	0	1
Overall Study Lost to Follow-up	4	3	1
Overall Study Lack of Efficacy	6	6	5
Overall Study scheduling conflicts and relocation	3	3	6

Baseline Characteristics

Study of FX006 vs Normal Saline in Patients With Osteoarthritis of the Knee

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FX006 16 mg n=102 Participants Single intra-articular injection FX006: Single intra-articular injection	FX006 32 mg n=104 Participants Single intra-articular injection FX006: Single intra-articular injection	Normal Saline n=100 Participants Single intra-articular injection Normal saline: Single intra-articular injection	Total n=306 Participants Total of all reporting groups
Age, Continuous	58.2 years STANDARD_DEVIATION 8.34 • n=5 Participants	58.7 years STANDARD_DEVIATION 8.06 • n=7 Participants	59.7 years STANDARD_DEVIATION 8.23 • n=5 Participants	58.8 years STANDARD_DEVIATION 8.20 • n=4 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	51 Participants n=7 Participants	61 Participants n=5 Participants	174 Participants n=4 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	53 Participants n=7 Participants	39 Participants n=5 Participants	132 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Randomized patients who received study drug assigned to the FX006 32 mg arm and the placebo arm

The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain"and 10 indicates "pain as bad as you can imagine."

Outcome measures

Outcome measures
Measure	FX006 32 mg n=104 Participants FX006: Single 5 mL IA injection	Placebo n=100 Participants Normal Saline: Single 5 mL IA injection	Placebo Normal Saline: Single 5 mL IA injection
Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores for 32 mg FX006 Versus Placebo	-3.08 units on a scale Standard Error 0.229	-2.50 units on a scale Standard Error 0.238	—

SECONDARY outcome

Timeframe: Baseline and Week 12

The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

Outcome measures

Outcome measures
Measure	FX006 32 mg n=104 Participants FX006: Single 5 mL IA injection	Placebo n=100 Participants Normal Saline: Single 5 mL IA injection	Placebo Normal Saline: Single 5 mL IA injection
Change From Baseline to Week 12 for WOMAC C (Function Subscale)	-1.01 units on a scale Standard Error 0.083	-0.79 units on a scale Standard Error 0.087	—

SECONDARY outcome

Timeframe: Baseline and Week 12

The Patient Global Impression of Change is a scale that aims to evaluate all aspects of participants' (patients') health and determining if there has been an improvement or not. The participant selects the one response from the response options that gives the most accurate description of his/her state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.

Outcome measures

Outcome measures
Measure	FX006 32 mg n=104 Participants FX006: Single 5 mL IA injection	Placebo n=100 Participants Normal Saline: Single 5 mL IA injection	Placebo Normal Saline: Single 5 mL IA injection
Change From Baseline to Week 12 for Patient Global Impression of Change (PGIC)	2.6 units on a scale Standard Error 0.14	2.7 units on a scale Standard Error 0.14	—

SECONDARY outcome

Timeframe: Baseline and Weeks 16, 20 and 24

Population: Randomized patients who received study drug.

The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."

Outcome measures

Outcome measures
Measure	FX006 32 mg n=104 Participants FX006: Single 5 mL IA injection	Placebo n=100 Participants Normal Saline: Single 5 mL IA injection	Placebo Normal Saline: Single 5 mL IA injection
Change From Baseline to Week 16 and Then Week 20 and Then Week 24 in the Weekly Mean of the Average Daily (24-hour) Pain Intensity Scores Week 16	-2.83 units on a scale Standard Error 0.2224	-2.46 units on a scale Standard Error 0.234	—
Change From Baseline to Week 16 and Then Week 20 and Then Week 24 in the Weekly Mean of the Average Daily (24-hour) Pain Intensity Scores Week 20	-2.81 units on a scale Standard Error 0.233	-2.34 units on a scale Standard Error 0.244	—
Change From Baseline to Week 16 and Then Week 20 and Then Week 24 in the Weekly Mean of the Average Daily (24-hour) Pain Intensity Scores Week 24	-2.51 units on a scale Standard Error 0.241	-2.24 units on a scale Standard Error 0.252	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 4, 8 and 12

Population: Percent of responders according to Outcomes Measures in OMERACT-OARSI strict criteria for patients assigned to FX006 16 mg arm was not a pre-specified Secondary Outcome and therefore not reported.

Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International. (OMERACT-OARSI) Responders are defined as participants with high improvement in pain or function.

Outcome measures

Outcome measures
Measure	FX006 32 mg n=104 Participants FX006: Single 5 mL IA injection	Placebo n=100 Participants Normal Saline: Single 5 mL IA injection	Placebo Normal Saline: Single 5 mL IA injection
Percent of Responders According to Outcomes Measures in OMERACT-OARSI Strict Criteria Week 4	75 Participants	51 Participants	—
Percent of Responders According to Outcomes Measures in OMERACT-OARSI Strict Criteria Week 8	73 Participants	58 Participants	—
Percent of Responders According to Outcomes Measures in OMERACT-OARSI Strict Criteria Week 12	70 Participants	57 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 12

The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5- point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

Outcome measures

Outcome measures
Measure	FX006 32 mg n=102 Participants FX006: Single 5 mL IA injection	Placebo n=100 Participants Normal Saline: Single 5 mL IA injection	Placebo Normal Saline: Single 5 mL IA injection
Change From Baseline to Week 12 for WOMAC C (Function Subscale)	-0.83 units on a scale Standard Error 0.085	-0.79 units on a scale Standard Error 0.087	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 12

Outcome measures

Outcome measures
Measure	FX006 32 mg n=102 Participants FX006: Single 5 mL IA injection	Placebo n=100 Participants Normal Saline: Single 5 mL IA injection	Placebo Normal Saline: Single 5 mL IA injection
Change From Baseline to Week 12 for Patient Global Impression of Change (PGIC)	2.5 units on a scale Standard Error 0.14	2.7 units on a scale Standard Error 0.14	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Up to Week 24

Population: Randomized patients who received study drug.

The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."Weeks 12, 16, 20, and 24 are specified as the primary and secondary endpoints for the 32 mg group and the placebo group

Outcome measures

Outcome measures
Measure	FX006 32 mg n=102 Participants FX006: Single 5 mL IA injection	Placebo n=104 Participants Normal Saline: Single 5 mL IA injection	Placebo n=100 Participants Normal Saline: Single 5 mL IA injection
Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores Week 10	-2.88 units on a scale Standard Error 0.229	-3.17 units on a scale Standard Error 0.224	-2.44 units on a scale Standard Error 0.233
Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores Week 11	-2.78 units on a scale Standard Error 0.234	-3.18 units on a scale Standard Error 0.229	-2.48 units on a scale Standard Error 0.238
Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores Week 12	-2.59 units on a scale Standard Error 0.234	-3.08 units on a scale Standard Error 0.229	-2.50 units on a scale Standard Error 0.238
Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores Week 13	-2.68 units on a scale Standard Error 0.234	-3.12 units on a scale Standard Error 0.229	-2.43 units on a scale Standard Error 0.239
Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores Week 14	-2.38 units on a scale Standard Error 0.235	-2.83 units on a scale Standard Error 0.229	-2.48 units on a scale Standard Error 0.239
Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores Week 15	-2.38 units on a scale Standard Error 0.225	-2.91 units on a scale Standard Error 0.219	-2.44 units on a scale Standard Error 0.229
Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores Week 1	-2.04 units on a scale Standard Error 0.177	-1.96 units on a scale Standard Error 0.175	-1.24 units on a scale Standard Error 0.178
Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores Week 2	-2.88 units on a scale Standard Error 0.218	-2.75 units on a scale Standard Error 0.216	-1.65 units on a scale Standard Error 0.220
Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores Week 3	-2.90 units on a scale Standard Error 0.228	-2.91 units on a scale Standard Error 0.226	-1.74 units on a scale Standard Error 0.231
Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores Week 4	-3.05 units on a scale Standard Error 0.228	-3.20 units on a scale Standard Error 0.226	-1.84 units on a scale Standard Error 0.232
Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores Week 5	-3.28 units on a scale Standard Error 0.222	-3.39 units on a scale Standard Error 0.219	-2.05 units on a scale Standard Error 0.225
Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores Week 6	-3.27 units on a scale Standard Error 0.225	-3.29 units on a scale Standard Error 0.222	-2.20 units on a scale Standard Error 0.229
Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores Week 7	-3.14 units on a scale Standard Error 0.233	-3.13 units on a scale Standard Error 0.230	-2.28 units on a scale Standard Error 0.237
Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores Week 8	-3.08 units on a scale Standard Error 0.237	-3.04 units on a scale Standard Error 0.234	-2.33 units on a scale Standard Error 0.242
Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores Week 9	-3.09 units on a scale Standard Error 0.233	-3.24 units on a scale Standard Error 0.229	-2.39 units on a scale Standard Error 0.237
Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores Week 16	-2.30 units on a scale Standard Error 0.231	-2.83 units on a scale Standard Error 0.224	-2.46 units on a scale Standard Error 0.234
Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores Week 17	-2.32 units on a scale Standard Error 0.237	-2.71 units on a scale Standard Error 0.229	-2.41 units on a scale Standard Error 0.240
Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores Week 18	-2.32 units on a scale Standard Error 0.240	-2.73 units on a scale Standard Error 0.232	-2.34 units on a scale Standard Error 0.242
Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores Week 19	-2.27 units on a scale Standard Error 0.241	-2.76 units on a scale Standard Error 0.233	-2.28 units on a scale Standard Error 0.243
Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores Week 20	-2.27 units on a scale Standard Error 0.241	-2.81 units on a scale Standard Error 0.233	-2.34 units on a scale Standard Error 0.244
Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores Week 21	-2.21 units on a scale Standard Error 0.246	-2.71 units on a scale Standard Error 0.237	-2.38 units on a scale Standard Error 0.248
Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores Week 22	-2.41 units on a scale Standard Error 0.249	-2.53 units on a scale Standard Error 0.240	-2.30 units on a scale Standard Error 0.251
Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores Week 23	-2.33 units on a scale Standard Error 0.258	-2.40 units on a scale Standard Error 0.249	-2.25 units on a scale Standard Error 0.260
Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores Week 24	-2.38 units on a scale Standard Error 0.249	-2.51 units on a scale Standard Error 0.241	-2.24 units on a scale Standard Error 0.252

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Weeks 4, 8, 16, 20 and 24 (Week 12 data is represented in the secondary outcome measure)

Population: Change from baseline to each of Weeks 4, 8, 16, 20, and 24 in WOMAC-C-function for patients assigned to FX006 16 mg arm was not a pre-specified Secondary Outcome and therefore not reported

Outcome measures

Outcome measures
Measure	FX006 32 mg n=104 Participants FX006: Single 5 mL IA injection	Placebo n=100 Participants Normal Saline: Single 5 mL IA injection	Placebo Normal Saline: Single 5 mL IA injection
Change From Baseline to Each of Weeks 4, 8, 16, 20, and 24 in WOMAC-C-function Week 4	-1.16 units on a scale Standard Error 0.079	-0.66 units on a scale Standard Error 0.082	—
Change From Baseline to Each of Weeks 4, 8, 16, 20, and 24 in WOMAC-C-function Week 8	-1.09 units on a scale Standard Error 0.082	-0.74 units on a scale Standard Error 0.085	—
Change From Baseline to Each of Weeks 4, 8, 16, 20, and 24 in WOMAC-C-function Week 16	-0.94 units on a scale Standard Error 0.083	-0.84 units on a scale Standard Error 0.086	—
Change From Baseline to Each of Weeks 4, 8, 16, 20, and 24 in WOMAC-C-function Week 20	-0.87 units on a scale Standard Error 0.082	-0.84 units on a scale Standard Error 0.085	—
Change From Baseline to Each of Weeks 4, 8, 16, 20, and 24 in WOMAC-C-function Week 24	-0.89 units on a scale Standard Error 0.083	-0.80 units on a scale Standard Error 0.086	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 24

Population: Change from baseline to each of Weeks 4, 8, 12, 16, 20, and 24 in WOMAC-A pain for patients assigned to FX006 16 mg arm was not a pre-specified Secondary Outcome and therefore not reported.

Outcome measures

Outcome measures
Measure	FX006 32 mg n=104 Participants FX006: Single 5 mL IA injection	Placebo n=100 Participants Normal Saline: Single 5 mL IA injection	Placebo Normal Saline: Single 5 mL IA injection
Change From Baseline to Each of Weeks 4, 8, 12, 16, 20, and 24 in WOMAC-A Pain Week 4	-1.11 units on a scale Standard Error 0.080	-0.64 units on a scale Standard Error 0.082	—
Change From Baseline to Each of Weeks 4, 8, 12, 16, 20, and 24 in WOMAC-A Pain Week 8	-1.09 units on a scale Standard Error 0.083	-0.71 units on a scale Standard Error 0.087	—
Change From Baseline to Each of Weeks 4, 8, 12, 16, 20, and 24 in WOMAC-A Pain Week 12	-0.98 units on a scale Standard Error 0.080	-0.81 units on a scale Standard Error 0.083	—
Change From Baseline to Each of Weeks 4, 8, 12, 16, 20, and 24 in WOMAC-A Pain Week 16	-0.95 units on a scale Standard Error 0.083	-0.80 units on a scale Standard Error 0.087	—
Change From Baseline to Each of Weeks 4, 8, 12, 16, 20, and 24 in WOMAC-A Pain Week 20	-0.89 units on a scale Standard Error 0.083	-0.84 units on a scale Standard Error 0.086	—
Change From Baseline to Each of Weeks 4, 8, 12, 16, 20, and 24 in WOMAC-A Pain Week 24	-0.91 units on a scale Standard Error 0.084	-0.78 units on a scale Standard Error 0.086	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Weeks 4, 8, 16, 20, and 24 (Week 12 data reported in secondary outcome measure)

Population: Change from baseline to each of Weeks 4, 8, 16, 20, and 24 in PGIC for patients assigned to FX006 16 mg arm was not a pre-specified Secondary Outcome and therefore not reported.

Outcome measures

Outcome measures
Measure	FX006 32 mg n=104 Participants FX006: Single 5 mL IA injection	Placebo n=100 Participants Normal Saline: Single 5 mL IA injection	Placebo Normal Saline: Single 5 mL IA injection
Change From Baseline to Each of Weeks 4, 8, 16, 20, and 24 in PGIC Week 4	2.2 units on a scale Standard Error 0.13	3.0 units on a scale Standard Error 0.13	—
Change From Baseline to Each of Weeks 4, 8, 16, 20, and 24 in PGIC Week 8	2.4 units on a scale Standard Error 0.14	2.8 units on a scale Standard Error 0.14	—
Change From Baseline to Each of Weeks 4, 8, 16, 20, and 24 in PGIC Week 16	2.8 units on a scale Standard Error 0.16	2.7 units on a scale Standard Error 0.16	—
Change From Baseline to Each of Weeks 4, 8, 16, 20, and 24 in PGIC Week 20	2.9 units on a scale Standard Error 0.15	2.8 units on a scale Standard Error 0.16	—
Change From Baseline to Each of Weeks 4, 8, 16, 20, and 24 in PGIC Week 24	2.7 units on a scale Standard Error 0.16	3.1 units on a scale Standard Error 0.16	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 24 Weeks after administration of study treatment

Population: Time to onset of pain relief for patients assigned to FX006 16 mg arm was not a pre-specified Secondary Outcome and therefore not reported.

Time to onset of pain relief in days is defined as the time from administration of study treatment to the first pain assessment showing \>30% improvement from the weekly average daily pain score at baseline.

Outcome measures

Outcome measures
Measure	FX006 32 mg n=104 Participants FX006: Single 5 mL IA injection	Placebo n=100 Participants Normal Saline: Single 5 mL IA injection	Placebo Normal Saline: Single 5 mL IA injection
Time to Onset of Pain Relief	4 days Interval 3.0 to 8.0	8 days Interval 5.0 to 17.0	—

Adverse Events

FX006 16 mg

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

FX006 32 mg

Serious events: 3 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FX006 16 mg n=102 participants at risk Single 5 mL IA injection	FX006 32 mg n=104 participants at risk Single 5 mL IA injection	Placebo n=100 participants at risk Single 5 mL IA injection
Cardiac disorders Myocardial Infarction	0.00% 0/102 • Adverse Events were collected following IA administration through the final study visit. A total of 310 subjects were randomized to a treatment assignment but only 306 enrolled subjects received their randomized treatment. Four (4) subjects randomized to placebo arm were were not treated.	0.96% 1/104 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit. A total of 310 subjects were randomized to a treatment assignment but only 306 enrolled subjects received their randomized treatment. Four (4) subjects randomized to placebo arm were were not treated.	0.00% 0/100 • Adverse Events were collected following IA administration through the final study visit. A total of 310 subjects were randomized to a treatment assignment but only 306 enrolled subjects received their randomized treatment. Four (4) subjects randomized to placebo arm were were not treated.
Injury, poisoning and procedural complications Femur Fracture	0.98% 1/102 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit. A total of 310 subjects were randomized to a treatment assignment but only 306 enrolled subjects received their randomized treatment. Four (4) subjects randomized to placebo arm were were not treated.	0.00% 0/104 • Adverse Events were collected following IA administration through the final study visit. A total of 310 subjects were randomized to a treatment assignment but only 306 enrolled subjects received their randomized treatment. Four (4) subjects randomized to placebo arm were were not treated.	0.00% 0/100 • Adverse Events were collected following IA administration through the final study visit. A total of 310 subjects were randomized to a treatment assignment but only 306 enrolled subjects received their randomized treatment. Four (4) subjects randomized to placebo arm were were not treated.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/102 • Adverse Events were collected following IA administration through the final study visit. A total of 310 subjects were randomized to a treatment assignment but only 306 enrolled subjects received their randomized treatment. Four (4) subjects randomized to placebo arm were were not treated.	0.96% 1/104 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit. A total of 310 subjects were randomized to a treatment assignment but only 306 enrolled subjects received their randomized treatment. Four (4) subjects randomized to placebo arm were were not treated.	0.00% 0/100 • Adverse Events were collected following IA administration through the final study visit. A total of 310 subjects were randomized to a treatment assignment but only 306 enrolled subjects received their randomized treatment. Four (4) subjects randomized to placebo arm were were not treated.
Musculoskeletal and connective tissue disorders Rheumatoid Arthritis	0.00% 0/102 • Adverse Events were collected following IA administration through the final study visit. A total of 310 subjects were randomized to a treatment assignment but only 306 enrolled subjects received their randomized treatment. Four (4) subjects randomized to placebo arm were were not treated.	0.96% 1/104 • Number of events 1 • Adverse Events were collected following IA administration through the final study visit. A total of 310 subjects were randomized to a treatment assignment but only 306 enrolled subjects received their randomized treatment. Four (4) subjects randomized to placebo arm were were not treated.	0.00% 0/100 • Adverse Events were collected following IA administration through the final study visit. A total of 310 subjects were randomized to a treatment assignment but only 306 enrolled subjects received their randomized treatment. Four (4) subjects randomized to placebo arm were were not treated.

Other adverse events

Other adverse events
Measure	FX006 16 mg n=102 participants at risk Single 5 mL IA injection	FX006 32 mg n=104 participants at risk Single 5 mL IA injection	Placebo n=100 participants at risk Single 5 mL IA injection
Musculoskeletal and connective tissue disorders Arthralgia	9.8% 10/102 • Number of events 10 • Adverse Events were collected following IA administration through the final study visit. A total of 310 subjects were randomized to a treatment assignment but only 306 enrolled subjects received their randomized treatment. Four (4) subjects randomized to placebo arm were were not treated.	7.7% 8/104 • Number of events 8 • Adverse Events were collected following IA administration through the final study visit. A total of 310 subjects were randomized to a treatment assignment but only 306 enrolled subjects received their randomized treatment. Four (4) subjects randomized to placebo arm were were not treated.	16.0% 16/100 • Number of events 16 • Adverse Events were collected following IA administration through the final study visit. A total of 310 subjects were randomized to a treatment assignment but only 306 enrolled subjects received their randomized treatment. Four (4) subjects randomized to placebo arm were were not treated.
Musculoskeletal and connective tissue disorders Joint Swelling	3.9% 4/102 • Number of events 4 • Adverse Events were collected following IA administration through the final study visit. A total of 310 subjects were randomized to a treatment assignment but only 306 enrolled subjects received their randomized treatment. Four (4) subjects randomized to placebo arm were were not treated.	4.8% 5/104 • Number of events 5 • Adverse Events were collected following IA administration through the final study visit. A total of 310 subjects were randomized to a treatment assignment but only 306 enrolled subjects received their randomized treatment. Four (4) subjects randomized to placebo arm were were not treated.	5.0% 5/100 • Number of events 5 • Adverse Events were collected following IA administration through the final study visit. A total of 310 subjects were randomized to a treatment assignment but only 306 enrolled subjects received their randomized treatment. Four (4) subjects randomized to placebo arm were were not treated.

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