Not Yet RecruitingPhase 1/2

Evaluation of Intra-articular CX-011 to Treat Moderate to Severe Pain From Knee Osteoarthritis

72 participantsStarted 2026-02-01

Plain-language summary

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.

Who can participate

Age range40 Years – 75 Years

SexALL

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Inclusion criteria

✓. Written consent to participate in the study.
✓. Males or females 18 years of age or less than 75 years old.
✓. Diagnosis OA of the index knee by a combination of clinical and radiographic findings wherein the index knee is self-identified by the patient as the more severe knee and symptoms have persisted for 3 months.
✓. 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.
✓. Index knee pain on most days (greater than 15) over the last month
✓. Patients who have failed to adequately respond for at least 6 months within the previous 12 months to at least two osteoarthritis therapies that include least 1 pharmacological treatment such as simple analgesics (e.g., acetaminophen); nonsteroidal anti- inflammatory drugs (NSAIDS) conservative, non-pharmacological therapy; avoidance of activities that cause joint pain; exercise; weight loss; physical therapy; and removal of excess fluid from the knee.
✓. VAS Pain score of 40-80 on a 0 - 100 scale to be reconfirmed at time of treatment.
✓. Overall index knee pain score of 11 or more in the index knee using the 0 - 20 WOMAC Pain scale.

Exclusion criteria

✕4. Daily use of assistive devices (e.g. cane or walker) or presence of comorbidities that would limit the patient's ability to walk.
✕5. History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis.
✕6. Unstable joint (such as a torn anterior cruciate ligament)
✕7. Inability to undergo Magnetic Resonance Imaging (MRI) due to presence of surgical hardware or other foreign body in the index knee, or because of patient's claustrophobia
✕8. Regular use of anticoagulants
✕9. 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.
✕0. Major dysplasias or congenital abnormalities
✕1. Corticosteroid injection into the index knee within 3 months prior to screening; extended-release steroid use within 4 months prior to screening.

What they're measuring

Determine tolerability by monitoring the frequency of treatment-emergent adverse events

Timeframe: 24 weeks

Composite safety profile of CX-011 based on change from baseline in clinical laboratory parameters

Timeframe: 24 weeks

Trial details

NCT IDNCT07308834

SponsorCarthroniX, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-10-30

View on ClinicalTrials.gov More Osteoarthritis of the Knees trials