Phase 3
Completed N=129
Study to Evaluate the Effect of FX006 on Synovial Inflammation in Patients With OA of the Knee
Osteoarthritis, Knee
Source: ClinicalTrials.gov NCT03529942 ↗
Enrolled (actual)
129
Serious AEs
0.9%
Results posted
Dec 2020
Primary outcomePrimary: Mean Standardized Change in Synovial Volume (SV) at 6 Weeks — -0.67; -0.9 Standardized Units
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Standardized Change in Synovial Volume (SV) at 6 Weeks |
-0.67; -0.9 | — |
| SECONDARY Mean Absolute Change in Synovial Volume at 6 Weeks |
-5469.68; -7549.55 | — |
| SECONDARY Mean Standardized Change in Synovial Volume (SV) at 24 Weeks |
0.20; 0.20 | — |
| SECONDARY Mean Absolute Change in Synovial Volume at 24 Weeks |
3239.94; 3476.52 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03529942). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.