Study to Compare Exposure of TA Following Administration of FX006 or TAcs in Patients With OA of the Shoulder or Hip

NCT03382262 | Completed Phase 2 Results FDA Drug

• 1 other identifier: FX006-2017-013
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 6

Brief Summary

This is an open-label study to compare systemic exposure to triamcinolone acetonide following a dose of extended-release FX006 or immediate-release TAcs (triamcinolone acetonide suspension) in patients with osteoarthritis of the shoulder (glenohumeral joint) or hip

Conditions

Osteoarthritis of the Shoulder; Osteoarthritis of the Hip

Keywords

Osteoarthritis; Shoulder; Hip; Pain; Intra-articular; Injection; Corticosteroid

Outcome Measures

Primary Outcomes (2)

• Concentration of Triamcinolone Acetonide (TA) in Blood Plasma

  Characterize the Pharmacokinetic Profile of FX006 and TCA IR \[Time Frame: Day 1 (pre-treatment,1, 2, 3, 4, 5, 6, 8,10, and 12 hrs. post-dose) and Days 2, 3, 5, 8, 15, 22, 29, 57,and 85\] 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

  12 Weeks

• Total Number of Treatment Emergent Adverse Events

  Analyses of adverse events (AE) were performed for events considered treatment-emergent (TE). TE was defined as any AE with onset after administration of the 1st dose of study drug or any event present at baseline but worsened in intensity through the study. Severity was graded by the PI using the Common Terminology Criteria for AEs Version 4.0. Grading went from Grade 1 (Mild) to Grade 5 (Death Related to AE).

  12 Weeks

Study Arms (2)

FX006 32 mg

EXPERIMENTAL

Single intra-articular (IA) injection of FX006 32 mg

Drug: FX006 32 mg

TAcs 40 mg

ACTIVE COMPARATOR

Single intra-articular (IA) injection of TAcs 40 mg

Drug: TAcs 40 mg

Interventions

FX006 32 mg DRUG

Extended-release 32 mg FX006 IA injection

Also known as: Zilretta

FX006 32 mg

TAcs 40 mg DRUG

Immediate-release 40mg TAcs IA injection

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
• Body mass index (BMI) less than or equal to 40 kg/m2
• 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 treatments from Screening through End-of-Study visit
• Symptoms consistent with OA of the index joint for ≥ 6 months prior to Screening (patient reported is acceptable)
• Pain in the index joint for greater than15 days over the last month (as reported by the patient)
• For Shoulder OA patients: Radiologic findings of OA of the index shoulder meeting the Samilson-Prieto (S-P) Classification Grades 2 or 3
• For Hip OA patients: ACR Criteria (clinical and radiological) for OA of the index hip

You may not qualify if:

• Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
• History of infection in the index joint
• Clinical findings consistent with active infection or crystal disease in the index joint within 1 month of Screening
• History of fracture in the index limb within 12 months of Screening, or fracture with sequelae at any time
• Planned or anticipated surgery of the index joint during the study period
• Index joint instability or history of acute dislocation within 12 months of Screening
• If shoulder is the index joint, history of full or partial rotator cuff tear or significantly compromised rotator cuff function that, in the opinion for the Investigator, increases the difficulty or risk of IA injection
• Presence of surgical hardware or other foreign body in the index joint
• Surgery or arthroscopy of the index joint within 12 months of Screening
• IA treatment of any joint with any of the following agents within 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 of the index joint 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 (6)

TriWest Research Associates, LLC

El Cajon, California, 92020, United States

Location

Biosolutions Clinical Research Center

La Mesa, California, 91942, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

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 (2)

• Kivitz A, Mehra P, Hanson P, Kwong L, Cinar A, Lufkin J, Kelley S. A Randomized, Open-Label, Single-Dose Study to Assess Safety and Systemic Exposure of Triamcinolone Acetonide Extended-Release in Patients With Hip Osteoarthritis. Rheumatol Ther. 2022 Apr;9(2):679-691. doi: 10.1007/s40744-022-00430-3. Epub 2022 Mar 8.

  PMID: 35258839 DERIVED

• Hanson P, Kivitz A, Mehra P, Kwong L, Cinar A, Lufkin J, Kelley SD. Safety and Systemic Exposure of Triamcinolone Acetonide Following Ultrasound-Guided Intra-Articular Injection of Triamcinolone Extended-Release or Standard Triamcinolone Acetonide in Patients with Shoulder Osteoarthritis: An Open-Label, Randomized Study. Drugs R D. 2021 Sep;21(3):285-293. doi: 10.1007/s40268-021-00348-1. Epub 2021 Aug 4.

  PMID: 34350546 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip; 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

4 patients with hip as index joint, were excluded from the PK population. 3 patients had incomplete FX006 administration. 1 patient enrolled at 2 different study centers; receiving TAcs and FX006 5 days apart in the same hip with no TEAEs reported.

Results Point of Contact

• Title: Scott Kelley MD, 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
• Restriction Type: OTHER
• 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 6, 2017
• First Posted: December 22, 2017
• Study Start: December 18, 2017
• Primary Completion: October 9, 2018
• Study Completion: October 9, 2018
• Last Updated: January 24, 2024
• Results First Posted: December 9, 2019

Record last verified: 2024-01

Locations

US (6)