Study to Characterize the PK and Local Extent and Duration of Exposure From FX006 in Patients With OA of the Knee

NCT02637323 | Completed Phase 2 Results

• 1 other identifier: FX006-2015-009
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 4

Brief Summary

The objectives of this study were to characterize the local extent and duration of exposure of TA from FX006 and TCA IR, characterize the systemic PK of FX006 and TCA IR, and assess the safety and general tolerability of a single 5 mL IA injection of 32 mg FX006 relative to 40 mg of TCA IR in patients with OA of the knee.

Conditions

Osteoarthritis of the Knee

Keywords

osteoarthritis; knee; pain; corticosteroid; intra-articular; injection

Outcome Measures

Primary Outcomes (1)

• Synovial Fluid Drug Concentrations (pg/mL) by Time Point Pooled Across FX006 Cohorts and TCA IR in Synovial Fluid

  All baseline (pre-treatment) values and all post-baseline values recorded as below LLOQ (\<50 pg/mL) were set to zero. Geometric mean summary statistics were computed on adjusted concentration values. One (1) was added to each concentration value observed. BLQ values for the computation of geometric mean are included in the summary with a value of 1 (0+1).

  Up to 20 Weeks

Secondary Outcomes (1)

• Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort

  Up to 20 Weeks

Other Outcomes (1)

• Plasma Pharmacokinetic Parameters for FX006 and TCA IR

  Up to 20 Weeks

Study Arms (2)

FX006 32 mg

EXPERIMENTAL

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

Drug: FX006 32 mg

TCA IR 40 mg

ACTIVE COMPARATOR

Commercially available triamcinolone acetonide, single 1 mL intra-articular (IA) injection Immediate-release formulation

Drug: TCA IR 40

Interventions

FX006 32 mg DRUG

Single 5 mL IA injection

Also known as: Zilretta

FX006 32 mg

TCA IR 40 DRUG

Single 1 mL IA injection

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

TCA IR 40 mg

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written consent to participate in the study
• Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
• Symptoms associated with OA of the knee for ≥ 6 months prior to Screening (patient reported is acceptable)
• Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA
• Index knee pain for \>15 days over the last month (as reported by the patient)
• Body mass index (BMI) ≤ 40 kg/m2
• Ambulatory and in good general health

You may not qualify if:

• Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
• History of infection in the index knee joint
• Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening
• Presence of surgical hardware or other foreign body in the index knee
• Unstable joint within 12 months of Screening
• IA corticosteroid (investigational or marketed) in any joint within 6 months of Screening
• IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
• Intravenous or Intramuscular corticosteroids (investigational or marketed) within 3 months of Screening
• Oral corticosteroids (investigational or marketed) within 1 month of Screening
• Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening
• Any other IA investigational drug/biologic use within 6 months of Screening or 5 half-lives (whichever is longer)
• Prior use of FX006
• Women of child-bearing potential not using effective contraception or who are pregnant or nursing

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (4)

Unknown Facility

Canoga Park, California, 91303, United States

Location

Unknown Facility

San Diego, California, 92103, United States

Location

Unknown Facility

Hialeah, Florida, 33012, United States

Location

Unknown Facility

Duncansville, Pennsylvania, 16635, United States

Location

Related Links

• Osteoarthritis and Cartilage Journal Full Text Article

MeSH Terms

Conditions

Osteoarthritis, Knee; 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

Subsequent to completion of clinical studies extensive testing was performed to assess the actual FX006 dose delivered. It was determined that the FX006 delivered dose to the patient from an FX006 40 mg vial is 32 mg.

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: December 22, 2015
• Study Start: November 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 24, 2024
• Results First Posted: January 12, 2018

Record last verified: 2024-01

Locations

US (4)