Proof of Concept Study Comparing FX006 to Kenalog®-40 in Patients With Post-Traumatic Osteoarthritis of the Knee

A Double-Blind, Randomized, Parallel Group, Proof of Concept Study Comparing FX006 to Kenalog®-40 in Patients With Post-Traumatic Osteoarthritis of the Knee

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02468583

Enrollment

Registered

2015-06-11

Start date

2015-02-28

Completion date

2016-07-31

Last updated

2024-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-traumatic Osteoarthritis of the Knee

Keywords

Osteoarthritis, Post-traumatic, Knee, Pain, Corticosteroid, Intra-articular, Injection

Brief summary

This study was a double-blind, randomized, parallel group, proof of concept study comparing FX006 to Kenalog®-40 (triamcinolone acetonide injectable suspension, USP) in patients with post-traumatic osteoarthritis of the knee.

Detailed description

This study was a double-blind, randomized, parallel group, proof of concept study patients with post-traumatic osteoarthritis (PTOA) of the knee. Approximately 124 eligible patients were intended to be randomized to one of the two treatment groups (1:1) and treated with a single intra-articular (IA) injection of: * 32 mg of FX006 * 40 mg of Kenalog®-40 (triamcinolone acetonide injectable suspension, USP) Each prospective patient underwent a screening evaluation to confirm a diagnosis of PTOA of the knee and concurrence with all other eligibility criteria. Patients were be treated on Day 1 (Baseline) and returned to the clinic at Weeks 4, 8 and 12 for evaluation of safety and efficacy.

Interventions

DRUGFX006 32 mg

Experimental

DRUGTCA IR 40 mg

Comparator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

Healthy volunteers

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 ≥20 and ≤50 years of age * Diagnosis of post-traumatic OA of the knee * Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee within 6 months prior to or at Screening * 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 and therapies during the study

Exclusion criteria

* Prior osteotomy of the index knee * Any condition that could possibly confound the patient's assessment of index knee pain in the judgement of the Investigator (i.e., ipsilateral hip OA, gout, radicular low back pain and hip pain that is referred to the knee that could cause misclassifcation, pain in any other area of the lower extremeties or back that is equal to 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, or clinical signs and symptoms of active infection of the index knee * Crystal disease of the index knee within one month of Screening * Disease secondary to surgical treatment of Shatzker grade IV, V, or VI tibial plateau fractures (OTA classification C2 or C3); surgical treatment of OTA calssifcation C2 or C3 distal femur fractures; or \>2mm of articular incongruity after surgery * 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 * Prior arthroplasty of any type of the index knee or planned/anticipated surgery of the index knee during the study period * Type 1 or Type 2 diabetes requiring insulin * Women of child-bearing potential not using effective contraception or who are pregnant or nursing

Design outcomes

Primary

Measure	Time frame	Description
Average Change From Baseline in the Weekly Mean of the Average Daily (24-hour) Pain Intensity Scores Over Weeks 5 to 10	5-10 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.

Secondary

Measure	Time frame	Description
Proportion of Patients Experiencing a >20% Decrease in Pain From Baseline in Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores at Each Week	12 Weeks	—
Proportion of Patients Experiencing a >50% or >30% Decrease in Pain From Baseline in Weekly Mean of Average Daily 24-hr Pain Intensity Scores at Each Week	12 Weeks	—
Proportion of Patients Experiencing Each of >50% or >30% Decrease in Pain From Baseline in Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores at Each Week	12 Weeks	—
WOMAC A (Pain Subscale)	12 weeks	change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
WOMAC A1 (Pain on Walking Question)	12 weeks	change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
WOMAC B (Stiffness)	12 weeks	change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
WOMAC C (Function)	12 weeks	change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores, Change From Baseline to Each Week and Average Change From Baseline Over Weeks 1 to 12 and Weeks 4 to 12	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.
Knee Injury and Osteoarthritis Score (KOOS)	12 weeks	change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12
Patient Global Impression of Change (PGIC) at Weeks 4, 8 and 12	12 weeks	—
Clinical Global Impression of Change (CGIC) at Weeks 4, 8 and 12	12 weeks	—
Percent of Responders (Defined as Patients With High Improvement in Pain or Function) According to OMERACT-OARSI Criteria at Weeks 4, 8 and 12	12 weeks	—
Time to Onset of Pain Relief	Baseline to >30% improvement	Time to onset of pain relief in days is defined as the time from first dose to the first daily pain assessment showing \>30% improvement from the weekly mean of the average daily (24-hr) pain intensity scores at Baseline
Average Weekly and Total Consumption of Rescue Medication	12 weeks	—
WOMAC (Total):	12 weeks	change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12

Countries

United States

Participant flow

Participants by arm

Arm	Count
FX006 32 mg FX006: Single 5 mL IA injection	3
TCA IR 40 mg TCA IR: Single 1 mL IA injection	3
Total	6

Baseline characteristics

Characteristic	FX006 32 mg	TCA IR 40 mg	Total
Age, Continuous	43 years	40 years	42 years
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	3 Participants	3 Participants	6 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 3	0 / 3
other Total, other adverse events	2 / 3	2 / 3
serious Total, serious adverse events	0 / 3	0 / 3

Outcome results

Primary

Average Change From Baseline in the Weekly Mean of the Average Daily (24-hour) Pain Intensity Scores Over Weeks 5 to 10

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.

Time frame: 5-10 Weeks