Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis (NCT NCT03793010)

Last Updated: 2024-01-24

Results Overview

The change from baseline on the average Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A (pain) score at Week 12. The average WOMAC A score is calculated by taking the average of five questions with a range from 0 (no pain) to 10 (extreme pain).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

70 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2024-01-24

Participant Flow

The recruitment period for this study was from December 2018 until August 2019. The patients were enrolled at medical clinics.

Participant milestones

Participant milestones
Measure	FX006 FX006 32mg FX006: Single Intra-articular injection	Normal Saline Normal Saline Normal saline: Single Intra-articular injection
Overall Study STARTED	35	35
Overall Study Randomized But Not Dosed	2	0
Overall Study COMPLETED	7	8
Overall Study NOT COMPLETED	28	27

Reasons for withdrawal

Reasons for withdrawal
Measure	FX006 FX006 32mg FX006: Single Intra-articular injection	Normal Saline Normal Saline Normal saline: Single Intra-articular injection
Overall Study Withdrawal by Subject	5	7
Overall Study Withdrawn by Investigator or Sponsor	19	18
Overall Study Lost to Follow-up	1	2
Overall Study Patient couldn't sit still for injection	1	0
Overall Study Withdrew to pursue other treatment	1	0
Overall Study Did not meet eligibility criteria	1	0

Baseline Characteristics

Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FX006 n=33 Participants FX006 32mg FX006: Single Intra-articular injection	Normal Saline n=35 Participants Normal Saline Normal saline: Single Intra-articular injection	Total n=68 Participants Total of all reporting groups
Age, Continuous	59.6 years STANDARD_DEVIATION 9.45 • n=5 Participants	61.8 years STANDARD_DEVIATION 7.99 • n=7 Participants	60.7 years STANDARD_DEVIATION 8.73 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants	31 Participants n=7 Participants	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	26 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	33 Participants n=5 Participants	35 Participants n=7 Participants	68 Participants n=5 Participants
Body Mass Index (BMI)	30.50 kg/m2 STANDARD_DEVIATION 5.679 • n=5 Participants	31.29 kg/m2 STANDARD_DEVIATION 5.775 • n=7 Participants	30.91 kg/m2 STANDARD_DEVIATION 5.699 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: All patients who received a full dose of study drug assigned to the FX006 32 mg arm and the placebo arm were included in the analysis. 68 total patients were included in the safety analysis. 55 of 68 patients had Week 12 assessments and are included in the primary and secondary outcomes analysis.

Outcome measures

Outcome measures
Measure	FX006 n=24 Participants FX006 32mg FX006: Single Intra-articular injection	Normal Saline n=31 Participants Normal Saline Normal saline: Single Intra-articular injection
Change in WOMAC A (Pain) Score at Week 12	-1.85 score on a scale Interval -2.99 to -0.71	-2.16 score on a scale Interval -3.22 to -1.09

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients who received a full dose of study drug assigned to the FX006 32 mg arm and the placebo arm were included in the analysis. 68 total patients were included in the safety population. 55 of 68 patients had week 12 assessments and are included in the primary and secondary outcomes analysis.

Change from Baseline on the WOMAC C (function) score at Week 12. The average WOMAC C score is calculated by taking the average of seventeen questions with a range from 0 (no difficulty) to 10 (extreme difficulty).

Outcome measures

Outcome measures
Measure	FX006 n=24 Participants FX006 32mg FX006: Single Intra-articular injection	Normal Saline n=31 Participants Normal Saline Normal saline: Single Intra-articular injection
Change in WOMAC C (Function) Score at Week 12	-1.56 score on a scale Interval -2.73 to -0.4	-2.16 score on a scale Interval -3.3 to -1.03

SECONDARY outcome

Timeframe: 12 Weeks

Population: All patients who received a full dose of study drug assigned to the FX006 32 mg arm and the placebo arm were included in the analysis. 68 total patients were included in the safety population. 55 of 68 patients had week 12 assessments and are included in the primary and secondary outcomes analysis.

PGIC (Patient Global Impression of Change) at Week 12. The PGIC score has a range from 1(very much improved) to 7 (very much worse) and indicates the overall status of the patient since baseline.

Outcome measures

Outcome measures
Measure	FX006 n=24 Participants FX006 32mg FX006: Single Intra-articular injection	Normal Saline n=31 Participants Normal Saline Normal saline: Single Intra-articular injection
PGIC Score at Week 12	3.4 score on a scale Interval 2.7 to 4.1	3.4 score on a scale Interval 2.8 to 4.1

Adverse Events

FX006

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Normal Saline

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

David Golod, Vice President, Clinical Operations

Flexion Therapeutics, Inc.

Phone: (781) 305-7572

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	FX006 n=33 participants at risk FX006 32mg FX006: Single Intra-articular injection	Normal Saline n=35 participants at risk Normal Saline Normal saline: Single Intra-articular injection
Blood and lymphatic system disorders Thrombocytopenia	3.0% 1/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	0.00% 0/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Gastrointestinal disorders Dry Mouth	3.0% 1/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	0.00% 0/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Gastrointestinal disorders Dyspepsia	0.00% 0/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	2.9% 1/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Gastrointestinal disorders Dysphagia	6.1% 2/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	0.00% 0/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Gastrointestinal disorders Peptic Ulcer	0.00% 0/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	2.9% 1/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
General disorders Adhesion	0.00% 0/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	2.9% 1/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
General disorders Chest Discomfort	3.0% 1/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	0.00% 0/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
General disorders Thirst	0.00% 0/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	2.9% 1/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Hepatobiliary disorders Cholelithiasis	0.00% 0/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	2.9% 1/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Immune system disorders Hypersensitivity	0.00% 0/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	2.9% 1/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Infections and infestations Bronchitis	3.0% 1/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	2.9% 1/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Infections and infestations Gastroenteritis Viral	3.0% 1/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	0.00% 0/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Infections and infestations Hordeolum	0.00% 0/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	2.9% 1/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Infections and infestations Influenza	0.00% 0/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	2.9% 1/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Infections and infestations Pharyngitis	0.00% 0/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	2.9% 1/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Infections and infestations Sinusitis	0.00% 0/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	2.9% 1/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	2.9% 1/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Injury, poisoning and procedural complications Arthropod Bite	3.0% 1/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	0.00% 0/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Injury, poisoning and procedural complications Fall	0.00% 0/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	2.9% 1/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Injury, poisoning and procedural complications Repetitive Strain Injury	3.0% 1/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	0.00% 0/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Investigations Blood Glucose Increased	3.0% 1/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	0.00% 0/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Investigations Blood Pressure Diastolic Increased	3.0% 1/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	2.9% 1/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Investigations Blood Pressure Increased	6.1% 2/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	2.9% 1/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Investigations Hepatic Enzyme Increased	3.0% 1/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	0.00% 0/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Investigations Weight Increased	6.1% 2/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	0.00% 0/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Investigations White Blood Cell Count Decreased	3.0% 1/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	0.00% 0/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Metabolism and nutrition disorders Decreased Apetite	0.00% 0/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	2.9% 1/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Metabolism and nutrition disorders Diabetes Mellitus	3.0% 1/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	0.00% 0/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	2.9% 1/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Musculoskeletal and connective tissue disorders Arthralgia	24.2% 8/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	2.9% 1/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Musculoskeletal and connective tissue disorders Back Pain	3.0% 1/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	2.9% 1/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.00% 0/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	2.9% 1/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.00% 0/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	2.9% 1/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Nervous system disorders Headache	0.00% 0/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	2.9% 1/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Nervous system disorders Lumbar Radiculopathy	6.1% 2/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	0.00% 0/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Renal and urinary disorders Renal Cyst	0.00% 0/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	2.9% 1/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Respiratory, thoracic and mediastinal disorders Cough	3.0% 1/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	0.00% 0/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Skin and subcutaneous tissue disorders Intertrigo	3.0% 1/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	0.00% 0/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Skin and subcutaneous tissue disorders Rash	0.00% 0/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	2.9% 1/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Vascular disorders Hot Flush	0.00% 0/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	2.9% 1/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.
Vascular disorders Hypertension	0.00% 0/33 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.	2.9% 1/35 • Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.