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

Primary Purpose

Bilateral Knee Osteoarthritis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

FX006 32 mg

TAcs 40 mg

About this trial

This is an interventional treatment trial for Bilateral Knee Osteoarthritis focused on measuring Osteoarthritis, Knee, Corticosteroid, Bilateral, Pain, Intra-articular, Injection

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

LA Biomed at Harbor-UCLA Medical Center
Rochester Clinical Research
Altoona Center for Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FX006 32 mg

TAcs 40 mg

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT03378076

First Posted

December 8, 2017

Last Updated

November 20, 2019

Sponsor

Flexion Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03378076

Brief Title

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

Official Title

A Randomized, Open-label, Parallel Group Study in Patients With Bilateral Knee Osteoarthritis Comparing the Systemic Exposure of Triamcinolone Acetonide Following Administration Into Both Knees of Either Extended-release FX006 or Immediate-release TAcs (Triamcinolone Acetonide Suspension)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

December 6, 2017 (Actual)

Primary Completion Date

March 14, 2018 (Actual)

Study Completion Date

March 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Flexion Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This is a randomized, open label, parallel group study that will be conducted in male and female patients ≥ 40 years of age with bilateral knee OA. Approximately 24 patients will be randomized to one of two treatment groups (1:1) and treated with IA injections to both knees of either: extended-release FX006 64 mg total dose (approximately 12 patients) or immediate-release TAcs 80 mg total dose (approximately 12 patients) Each patient will be screened to confirm the diagnosis of OA and eligibility based on the inclusion/exclusion requirements and will be randomized to treatment on Day 1. Following screening, pharmacokinetics (PK) and safety will be evaluated at 6 out-patient visits scheduled on Study Days 1 [calendar day of injection], 2, 8, 15, 29, and 43.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bilateral Knee Osteoarthritis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FX006 32 mg

Arm Type

Experimental

Arm Description

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

Arm Title

TAcs 40 mg

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

FX006 32 mg

Other Intervention Name(s)

Zilretta

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

TAcs 40 mg

Other Intervention Name(s)

Kenalog®-40 Injection, Triamcinolone Acetonide Crystalline Suspension (TAcs), TCA-IR 40

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

43 days

Title

Incidence of Treatment Emergent Adverse Events

Description

Time Frame

43 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott Kelley, MD

Organizational Affiliation

Flexion Therapeutics, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

LA Biomed at Harbor-UCLA Medical Center

City

Torrance

State/Province

California

ZIP/Postal Code

90509

Country

United States

Facility Name

Rochester Clinical Research

City

Rochester

State/Province

New York

ZIP/Postal Code

14609

Country

United States

Facility Name

Altoona Center for Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

31662801

Citation

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.

Results Reference

derived

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

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