Study to Evaluate the Effect of FX006 on Synovial Inflammation in Patients With OA of the Knee



Status:Recruiting
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:40 - Any
Updated:4/6/2019
Start Date:April 24, 2018
End Date:June 2020
Contact:Corrinne Lauze
Email:clauze@flexiontherapeutics.com
Phone:781-305-7124

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An Open-Label Study to Evaluate the Effect of the Administration of FX006 on Synovial Inflammation in Patients With Osteoarthritis of the Knee

This is an open-label study assessing the effect of the administration of a single
intra-articular (IA) injection of FX006 32 mg on synovial volume in patients with
osteoarthritis (OA) of the knee.

This is an open-label study assessing the effect of the administration of a single
intra-articular (IA) injection of FX006 32 mg on synovial volume in patients with
osteoarthritis (OA) of the knee. The study will be conducted in male and female patients who
are ≥ 40 years of age.

Eligible patients who provide written consent and meet all entry criteria will undergo
initial ultrasound examination and MRI with contrast of the index knee, and then receive a
single IA injection of FX006 administered to the index knee at Baseline/Day 1. Patients will
return to the clinic at Weeks 6 and 24 for an MRI with contrast of the index knee and other
assessments. Patients must also have a blood sample drawn for Estimated Glomerular Filtration
Rate (eGFR) testing within 30 days prior to the scheduled MRIs. In addition, a patient
questionnaire will be administered and adverse events (AEs) and concomitant medication
updates will be collected via telephone at Weeks 12 and 18.

Inclusion Criteria:

- Written consent to participate in the study

- Male or female ≥ 40 years of age

- Body mass index (BMI) ≤ 40 kg/m^2

- 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

- Symptoms associated with OA of the index knee for ≥ 6 months prior to Screening
(patient self-report is acceptable)

- Currently meets American College of Rheumatology (ACR) Criteria (clinical and
radiological) for OA

- Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee based on X-ray performed during
Screening (centrally read)

Exclusion Criteria:

- Any inflammatory arthritis including reactive arthritis, rheumatoid arthritis,
psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory
bowel disease, gout or secondary OA from gout

- History of infection or crystal disease in the index knee joint

- Unstable index knee joint (such as a torn anterior cruciate ligament) within 12 months
of Screening

- Surgery or arthroscopy of the index knee within 12 months of Screening

- IA corticosteroid (investigational or marketed) in any joint within 3 months of
Screening

- IA treatment of the index knee with hyaluronic acid (investigational or marketed)
within 6 months of Screening

- IV or IM corticosteroids (investigational or marketed) within 3 months of Screening

- Oral corticosteroids (investigational or marketed) within 1 month of Screening

- Any other IA drug/biologic in the index knee within 6 months of Screening or 5
half-lives (whichever is longer) (e.g., platelet rich plasma (PRP) injection, stem
cells, prolotherapy and amniotic fluid injection)

- Prior administration of FX006

- eGFR results <40 mL/minute

- Any contraindication to MRI Scanning (e.g., presence of certain ferromagnetic foreign
bodies or electronic devices including most cardiac pacemakers, claustrophobia)

- Known hypersensitivity to any form of radiographic contrast

- Females who are pregnant or nursing or plan to become pregnant during the study; men
who plan to conceive during the study
We found this trial at
10
sites
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Phone: 312-805-8456
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Clearwater, Florida 33761
Phone: 727-724-3316
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Duncansville, Pennsylvania 16635
Phone: 814-693-0300
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Phone: 919-660-6782
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Egg Harbor Township, New Jersey 08234
Phone: 609-407-6446
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El Cajon, California 92020
Phone: 619-334-4735
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Knoxville, Tennessee 37912
Phone: 865-244-4276
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La Mesa, California 91942
Phone: 619-637-0770
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Pomona, California 91767
Phone: 714-780-0076
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