Overview

Study to Assess the Safety of Repeat Administration of FX006 Administered to Patients With Osteoarthritis of the Knee

Status:
Completed
Trial end date:
2018-07-19
Target enrollment:
0
Participant gender:
All
Summary
This is an Open-label Study to Assess the Safety of Repeat Dose of FX006 Administered to Patients with Osteoarthritis (OA) of the Knee
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Flexion Therapeutics, Inc.
Treatments:
FX006
Criteria
Inclusion Criteria:

- 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

- Male or female ≥ 40 years of age

- Symptoms associated with OA of the index knee for ≥ 6 months prior to Screening

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

- Kellgren-Lawrence (KL) Grade 2, 3 or 4 in the index knee based on X-ray performed
during Screening

- Qualifying score for WOMAC A at Screening and Day 1/Baseline

- 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

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

- IA corticosteroid (investigational or marketed) in index knee within 3 months of
Screening

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

- IV or intramuscular (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 use 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

- Women of child-bearing potential not using effective contraception or who are pregnant
or nursing