RecruitingOsteoarthritis of the Knees
Evaluation of Intra-articular CX-011 to Treat Moderate to Severe Pain From Knee Osteoarthritis
Eligible age
40–75 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
Study is designed to evaluate the safety and effectiveness of a drug called CX-011 to treat pain in patients with osteoarthritis of the knee. Osteoarthritis produces pain in the knee (and other joints) that typically is worsened by activities such as long distance walking and is alleviated by rest.
Sponsor: CarthroniX, Inc.
You may qualify if…
- ✓ 1. Written consent to participate in the study.
- ✓ 2. Males or females 40 years of age or less than 75 years old.
- ✓ 3. Diagnosis OA of the index knee by a combination of clinical and radiographic findings wherein the index knee is self-identified by the subject as the more severe knee (if both knees qualified) and symptoms have persisted for \>3 months.
- ✓ 4. Radiographic evidence of OA in the tibiofemoral compartment of the index knee (Kellgren-Lawrence grades II or III) within 6 months prior to Screening or during the Screening period
- ✓ 5. Index knee pain on most days (\>15 days) over the last month
- ✓ 6. Subjects who have failed to adequately respond for at least 6 months within the previous 12 months to at least three osteoarthritis therapies that include at least two pharmacological treatments such as simple analgesics (e.g., acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDS)), corticosteroid injection, extended-release steroid use within 4 months, Viscosupplement (e.g., hyaluronic acid) injection, platelet-rich plasma injection, bone marrow aspiration concentrate, placental-derived tissue/cells, adipose tissue, or any other autologous or allogeneic product. Conservative, non-pharmacological therapy includes: avoidance of activities that cause joint pain; exercise; weight loss; physical therapy; and removal of excess fluid from the knee.
- ✓ 7. VAS Pain score of 4-8 on a 0 - 10 scale.
- ✓ 8. Overall index knee pain score of 11 or more in the index knee using the 0 - 20 WOMAC Pain scale.
You may not qualify if…
- ✕ 1. Daily use of assistive devices (e.g. cane or walker) or presence of comorbidities that would limit the subject's ability to walk.
- ✕ 2. History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis.
- ✕ 3. Unstable joint (such as a torn anterior cruciate ligament)
- ✕ 4. Inability to undergo Magnetic Resonance Imaging (MRI) due to presence of surgical hardware or other foreign body in the index knee, or because of subject's claustrophobia or other MRI contraindication, including intolerance of or allergic reaction to IV contrast
- ✕ 5. Regular daily use of anticoagulants
- ✕ 6. VAS Pain score of ≥4 on a 0 - 10 scale in the contralateral knee
- ✕ 7. Symptoms of locking, intermittent block to range of motion, or loose body sensation that could indicate meniscal displacement or an IA loose body; knee ligament instability at the index knee.
- ✕ 8. Major dysplasia or congenital abnormalities
Where it's recruiting
California
Los Angeles
Source: ClinicalTrials.gov · NCT07308834 · last updated 2026-08-26