Evaluation of Intra-articular CX-011 to Treat Moderate to Severe Pain From Knee Osteoarthritis (NCT07308834) | Clinical Trial Compass
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 range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine tolerability by monitoring the frequency of treatment-emergent adverse events
Timeframe: 24 weeks
2
Composite safety profile of CX-011 based on change from baseline in clinical laboratory parameters
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.