Study of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee

Phase 3

Completed

Brief Summary: The purpose of this study was to assess the safety and efficacy of FX006 for the treatment of pain in patients with osteoarthritis of the knee.

Detailed Description: This study was a double-blind, randomized, single dose design. The study was conducted in male and female patients ≥40 years of age with OA of the knee. Approximately 450 patients with OA of the knee were randomized to 1 of 3 treatment groups (1:1:1) and treated with a single IA injection of:

* 32 mg FX006,

* normal saline (placebo), or

* 40 mg TCA IR.

Randomization was stratified by weekly mean of the average daily (24-hour) pain intensity (ADP) scores at baseline, with the following classifications: 5 to \<6, 6 to \<7, and ≥7.

Each patient was evaluated for a total of 24 weeks following a single IA injection. Following screening, safety and efficacy were evaluated at 7 out-patient visits (Days 1 \[baseline\], Weeks 4, 8, 12, 16, 20, and 24). The study was expected to enroll in approximately 6 months.

Recruitment & Eligibility

Inclusion Criteria

Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
Male or female >=40 years of age
Has symptoms associated with OA of the index knee for at least 6 months prior to Screening
Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA
Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee per Screening X-ray
Index knee pain for > 15 days over the last month
Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)
Body mass index (BMI) ≤ 40 kg/m2
Willingness to abstain from use of restricted medications

Exclusion Criteria

Any condition that could possibly confound the patient's assessment of index knee pain in judgement of the investigator (i.e., iIpsilateral hip OA, gout, radicular low back pain and hip pain that is referred to the knee that could cause misclassification, pain in any other area of the lower extremities or back that is equal or greater than the index knee pain)
Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease
History of infection in the index knee
Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening
Unstable joint within 12 months of screening
IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
Intramuscular (IM) or oral corticosteroids (investigational or marketed) within 1 month of Screening
Any other IA investigational drug/biologic within 6 months of Screening
Prior use of FX006
Women of child-bearing potential not using effective contraception or who are pregnant or nursing

Arm && Interventions

Group	Intervention	Description
Normal Saline	Placebo	Single 5 mL intra-articular (IA) injection
TCA IR 40 mg	TCA IR 40	Single 1 mL intra-articular (IA) injection TCA IR 40 mg: Immediate-release formulation
FX006 32mg	FX006	Single 5 mL intra-articular (IA) injection Extended-release Formulation

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain (ADP) Intensity Scores for 32 mg FX006 Versus Placebo	Baseline and 12 Weeks	The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."

Secondary Outcome Measures

Name	Time	Method
Area Under the Effect Curve (AUE) of Change From Baseline in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to Placebo	Baseline to 12 Weeks	The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."
AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR	Baseline to 12 Weeks	The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Change From Baseline to Week 12 in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR	Baseline through 12 Weeks	The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."
AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 24 for FX006 Relative to Placebo	Baseline to 24 Weeks	The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."