Study to Compare Exposure of TA Following Administration of Either FX006 or TAcs in Patients With Bilateral Knee OA

NCT03378076 | Completed Phase 2 Results FDA Drug

• 1 other identifier: FX006-2017-012
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

This is a randomized, open-label, parallel group study to compare systemic exposure of triamcinolone acetonide following administration into both knees of either FX006 or TAcs.

Conditions

Bilateral Knee Osteoarthritis

Keywords

Osteoarthritis; Knee; Corticosteroid; Bilateral; Pain; Intra-articular; Injection

Outcome Measures

Primary Outcomes (2)

• Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma

  Plasma drug concentrations (pg/mL) by Time Point across FX006 and TAcs treatment arms in plasma. For the PK analysis and individual concentration vs. time plots, a concentration that is BLOQ is assigned a value of zero if it occurs in a profile before the first measurable concentration. If a BLOQ value occurs after a measurable concentration in a profile and is followed by a value above the lower limit of quantification, then the BLOQ is treated as missing data. If a BLOQ value occurs at the end of the collection interval (after the last quantifiable concentration) it is set to zero. If two BLOQ values occur in succession after Cmax, the profile is deemed to have terminated at the first BLOQ value and any subsequent concentrations are set to zero for PK calculations

  43 days

• Incidence of Treatment Emergent Adverse Events

  Safety analyses were conducted using the safety population. Analyses of adverse events will be performed for those events that are considered treatment emergent, where treatment emergent is defined as any adverse event with onset after the administration of study medication in the first knee through the end of the study or any event that was present at baseline but worsened in intensity through the end of the study. Severity of Adverse events were graded by the Principal Investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The grading went from Grade 1 (Mild) to Grade 5 (Death related to AE).

  43 days

Study Arms (2)

FX006 32 mg

EXPERIMENTAL

Two intra-articular (IA) injections of FX006 32 mg (total dose of 64 mg)

Drug: FX006 32 mg

TAcs 40 mg

ACTIVE COMPARATOR

Two intra-articular (IA) injections of TAcs 40 mg (total dose of 80 mg)

Drug: TAcs 40 mg

Interventions

FX006 32 mg DRUG

Drug: Extended-release 32 mg FX006 IA injection into each knee (total 64 mg dose)

Also known as: Zilretta

FX006 32 mg

TAcs 40 mg DRUG

Drug: Immediate-release 40mg TAcs IA injection into each knee (total 80 mg dose)

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

TAcs 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
• Male or female greater than or equal to 40 years of age
• Symptoms consistent with OA in both knees for greater than or equal to 6 months prior to Screening (patient reported is acceptable)
• Currently meets ACR Criteria (clinical and radiological) for OA in both knees
• Knee pain in both knees for greater than 15 days over the last month (as reported by the patient)
• Body mass index (BMI) less than or equal to 40 kg/m2
• Morning serum cortisol result within normal range at Screening (5-23 mcg/dL or 138-635 nmol/dL)
• Ambulatory and in good general health
• Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions.
• Willing to abstain from use of protocol-restricted medications during the study

You may not qualify if:

• Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
• History of infection in either knee joint
• Clinical signs and symptoms of active knee infection or crystal disease in either knee within 1 month of Screening
• Unstable joint (such as a torn anterior cruciate ligament) in either knee within 12 months of Screening
• Presence of surgical hardware or other foreign body in either knee
• Surgery or arthroscopy of either knee within 12 months of Screening
• IA treatment of any joint with any of the following agents within six (6) months of Screening: any corticosteroid preparation (investigational or marketed, including FX006), any biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy, amniotic fluid injection; investigational or marketed).
• IA treatment in either knee with hyaluronic acid (investigational or marketed) within 6 months of Screening
• Parenteral or oral corticosteroids (investigational or marketed) within 3 months of Screening
• Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening
• Females who are pregnant or nursing or plan to become pregnant during the study; men who plan to conceive during the study

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (3)

LA Biomed at Harbor-UCLA Medical Center

Torrance, California, 90509, United States

Location

Rochester Clinical Research

Rochester, New York, 14609, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Related Publications (1)

• Kivitz A, Kwong L, Shlotzhauer T, Lufkin J, Cinar A, Kelley S. A randomized, phase IIa study to assess the systemic exposure of triamcinolone acetonide following injection of extended-release triamcinolone acetonide or traditional triamcinolone acetonide into both knees of patients with bilateral knee osteoarthritis. Ther Adv Musculoskelet Dis. 2019 Oct 16;11:1759720X19881309. doi: 10.1177/1759720X19881309. eCollection 2019.

  PMID: 31662801 DERIVED

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

Results Point of Contact

• Title: Scott Kelley, Chief Medical Officer
• Organization: Flexion Therapeutics

skelley@flexiontherapeutics.com

781-305-7142

Study Officials

• Scott Kelley, MD

  Pacira Pharmaceuticals, Inc

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 19, 2017
• Study Start: December 6, 2017
• Primary Completion: March 14, 2018
• Study Completion: March 14, 2018
• Last Updated: January 24, 2024
• Results First Posted: May 1, 2019

Record last verified: 2024-01

Locations

US (3)