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

NCT ID: NCT02468583

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-07-31

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.

Conditions

Post-traumatic Osteoarthritis of the Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

FX006 32mg

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

Group Type: EXPERIMENTAL

FX006 32 mg

Intervention Type: DRUG

Experimental

TCA IR 40 mg

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

Group Type: ACTIVE_COMPARATOR

TCA IR 40 mg

Intervention Type: DRUG

Comparator

Interventions

FX006 32 mg

Experimental

Intervention Type: DRUG

TCA IR 40 mg

Comparator

Intervention Type: DRUG

Other Intervention Names

Zilretta; Kenalog®-40; Triamcinolone Acetonide Crystalline Suspension (TAcs)

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neil Bodick, MD

Role: STUDY_DIRECTOR

Flexion Therapeutics

Locations

San Antonio Military Medical Center

San Antonio, Texas, United States

Countries

United States

Other Identifiers

FX006-2014-007

Identifier Type: -

Identifier Source: org_study_id