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

NCT02468583 | Terminated Phase 2 Results

• 1 other identifier: FX006-2014-007
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-traumatic Osteoarthritis of the Knee

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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."

  5-10 Weeks

Secondary Outcomes (15)

• 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

• 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

Study Arms (2)

FX006 32mg

EXPERIMENTAL

Single 5 mL intra-articular (IA) injection Extended-release formulation

Drug: FX006 32 mg

TCA IR 40 mg

ACTIVE COMPARATOR

Single 1 mL intra-articular (IA) injection Immediate-release formulation

Drug: TCA IR 40 mg

Interventions

FX006 32 mg DRUG

Experimental

Also known as: Zilretta

FX006 32mg

TCA IR 40 mg DRUG

Comparator

Also known as: Kenalog®-40, Triamcinolone Acetonide Crystalline Suspension (TAcs)

TCA IR 40 mg

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (1)

San Antonio Military Medical Center

San Antonio, Texas, 78234, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Pain

Interventions

FX006; Triamcinolone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Limitations and Caveats

This study was terminated early with only 5% of the planned study population enrolled, efficacy data were not analyzed.

Results Point of Contact

• Title: Scott Kelley, VP of Medical Affairs
• Organization: Flexion Therapeutics

skelley@flexiontherapeutics.com

781-305-7142

Study Officials

• Neil Bodick, MD

  Flexion Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: June 11, 2015
• Study Start: February 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: January 24, 2024
• Results First Posted: December 21, 2017

Record last verified: 2024-01

Locations

US (1)