Clinical trial for Osteoarthritis of the Knees
Official title Evaluation of Intra-articular CX-011 to Treat Moderate to Severe Pain From Knee Osteoarthritis
ClinicalTrials.gov ID: NCT07308834
What this study is testing
What is CX-011?
CX-011 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for osteoarthritis of the knees.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75
You may be able to join if
- Written consent to participate in the study.
- Males or females 40 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 subject as the...
- Radiographic evidence of OA in the tibiofemoral compartment of the index knee (Kellgren-Lawrence grades II or III) within 6 months prior to Screening...
- Index knee pain on most days (\>15 days) over the last month
You likely can't join if
- Daily use of assistive devices (e.g. cane or walker) or presence of comorbidities that would limit the subject's ability to walk.
- History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel...
- Unstable joint (such as a torn anterior cruciate ligament)
- Inability to undergo Magnetic Resonance Imaging (MRI) due to presence of surgical hardware or other foreign body in the index knee, or because of...
- Regular daily use of anticoagulants
- VAS Pain score of ≥4 on a 0 - 10 scale in the contralateral knee
See the full eligibility criteria
Who can join
- Written consent to participate in the study.
- Males or females 40 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 subject as the more severe knee (if both knees qualified) and symptoms have...
- 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 (\>15 days) over the last month
- people 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...
- VAS Pain score of 4-8 on a 0 - 10 scale.
- Overall index knee pain score of 11 or more in the index knee using the 0 - 20 WOMAC Pain scale.
- hsCRP ≥ 2 mg/L
- Body mass index \< 40 kg/m2
- If female, must not be pregnant or nursing and willing to refrain from becoming pregnant during the study.
- Willing to agree not to use illicit drugs during the study, including cannabinoids, and to have illicit drug testing at screening and at later time points if illicit drug use is suspected during the study.
- Able to comply with study requirements and complete the full sequence of protocol-related procedures and evaluations.
- people shall agree to refrain from taking NSAIDS, opioids, intra-articular steroids and hyaluronic acid (viscosupplementation), electrotherapy and acupuncture during the study.
- people receiving glucagon-like peptide-1 receptor agonists (GLP-1RAs), including semaglutide, liraglutide, dulaglutide, or tirzepatide, may be enrolled only if they have been on a stable maintenance dose for at least 12...
- people shall agree to refrain from using topical pain therapies including capsaicin, lidocaine patches, heat patches, CBD oil and topical NSAIDs.
- people shall agree to refrain from any additional pain medication for 24 h prior to all study visits, excluding screening visit.
- Male or female people with reproductive potential agree to comply with a highly effective contraceptive method from the first Screening visit through 90 days after last study drug administration. A highly effective...
- Prior to dosing on Day 1, people must meet the following criteria: i. BP systolic between 90-160 mmHg and diastolic between 60-100 mmHg ii. Pulse between 60-100 bpm iii. Respiratory Rate between 12-20 per minute iv...
What rules you out
- Daily use of assistive devices (e.g. cane or walker) or presence of comorbidities that would limit the subject's ability to walk.
- History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis.
- Unstable joint (such as a torn anterior cruciate ligament)
- 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...
- Regular daily use of anticoagulants
- VAS Pain score of ≥4 on a 0 - 10 scale in the contralateral knee
- 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.
- Major dysplasia or congenital abnormalities
- Corticosteroid injection into the index knee within 3 months prior to screening; extended-release steroid use within 4 months prior to screening.
- Viscosupplement (e.g., hyaluronic acid [HA] injection, platelet-rich plasma injection, bone marrow aspirate or bone marrow aspiration concentrate, placental-derived tissue/cells, adipose tissue, or any other autologous...
- Knee surgery or procedure on the index knee within 12 months prior to screening and/or planned knee surgery during the study including cold or radiofrequency nerve ablation.
- Knee surgery or procedure on the contralateral knee within 6 months prior to screening and/or planned knee surgery during the study including cold or radiofrequency nerve ablation.
- Acute index knee trauma within 3 months prior to screening.
- Knee joint infections, skin diseases or infections in the area of the injection site.
- Current therapy with any immunosuppressive therapy, including corticosteroids (\> 5 mg/day of prednisone) or people with conditions that would likely include treatment with immunosuppressive therapy (including...
- HbA1c ≥ 8% and/or insulin-dependent diabetes
- Initiation of GLP-1RA therapy, dose titration or escalation, switching between GLP-1RA agents or discontinuation of GLP-1RA therapy within 12 weeks prior to screening or planned during the study period.
- Known intention to start any anti-obesity pharmacotherapy (including GLP-1RAs) during the study period.
- Moderate to severe renal impairment
- Moderate to severe hepatic impairment
- Active use of moderate to strong inhibitors or inducers of major P450s
- Systolic BP \> 160 mmHg or diastolic BP \> 100 mmHg or on \> 3 blood pressure medications at screening.
- Clinically significant findings on physical examination or screening tests (e.g. laboratory and radiographic) that are not specific to OA of the knee and may interfere with study conduct or interpretation of data or...
- Clinically significant intercurrent illness, medical condition, non-knee pain, or medical history (including neurological or mental illness, human immunodeficiency virus, autoimmune diseases or connective tissue...
- Participation in another clinical trial within the previous 30 days before screening or planned participation in another clinical trial during the study.
- X-ray showing any exclusionary criteria such as subchondral insufficiency fracture, tumor, osteonecrosis, fragmentation or collapse of part of the joint, infiltration of the bone marrow, stress fracture or reaction.
- History of active malignancy, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ within 5 years.
- Known active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, viral or parasitic infections, or ocular herpes simplex.
- Any infection requiring intravenous antibiotics within 4 weeks of Screening, infection requiring oral antibiotics within 2 weeks of Screening, history of chronic infection, or a history of osteomyelitis.
- Screening 12-lead electrocardiogram (ECG) consistently demonstrating heart rate corrected QT intervals (QTc) \>450 msec in male people and \>470 msec in female people or any clinically significant ECG abnormality as...
- Active psychiatric disorder including psychosis and major depressive disorder.
- History of or active Cushing's syndrome
- Any other clinically significant acute or chronic medical conditions (e.g., uncontrolled diabetes) that, in the judgment of the Investigator, would preclude the use of CX-011 or that could compromise subject safety...
- Positive drug or alcohol screen.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.