Osteoarthritis of the KneesPhase 1/2NCT07308834
Evaluation of Intra-articular CX-011 to Treat Moderate to Severe Pain From Knee Osteoarthritis
A Phase 1/2 study testing CX-011 in people with Osteoarthritis of the Knees, run by CarthroniX, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis of the Knees
- What is being tested?
- CX-011
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2026to 31 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 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 (>15 days) over the last month
- 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.
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- 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.
- Subjects shall agree to refrain from taking NSAIDS, opioids, intra-articular steroids and hyaluronic acid (viscosupplementation), electrotherapy and acupuncture during the study.
- Subjects 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 weeks prior to screening, with no dose adjustments, and are not undergoing dose titration or escalation.
- Subjects shall agree to refrain from using topical pain therapies including capsaicin, lidocaine patches, heat patches, CBD oil and topical NSAIDs.
- Subjects shall agree to refrain from any additional pain medication for 24 h prior to all study visits, excluding screening visit.
- Male or female subjects 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 method of contraception is defined as one that has no higher than a 1% failure rate. In this study, the only acceptable methods of contraception are as follows:
- Hormonal contraception and male condom. ii. Placement of intrauterine system and male condom. iii. Female subject's partner vasectomized for ≥6 months prior to Screening and subject's verbal confirmation that absence of sperm in the ejaculate was confirmed.
- Female subject or male subject's partner with bilateral tubal ligation ≥6 months prior to Screening.
- Sexual abstinence when in relation to the preferred and usual lifestyle of the subject.
- Contraception requirements do not apply for subjects in an exclusively same-sex relationship. Subjects with reproductive potential who are not currently sexually active must agree to use acceptable contraception as specified above if they become sexually active during the study period and for 90 days after the last dose of study drug. Subjects with reproductive potential must agree not to donate sperm or eggs during the study and for 90 days after the last dose of study drug.
- Subjects are considered of non-reproductive potential if any of the following apply:
- Post-menopausal female with ≥12 consecutive months of spontaneous amenorrhea with follicle stimulating hormone (FSH) >30 mIU/mL at Screening.
- Surgically sterile female and at least 6 weeks post-sterilization (i.e., bilateral oophorectomy or hysterectomy).
- Sterilized male ≥6 months post vasectomy and subject's verbal confirmation that absence of sperm in the ejaculate was confirmed.
- Prior to dosing on Day 1, subjects must meet the following criteria:
- 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. Afebrile
Who cannot join
- 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 intolerance of or allergic reaction to IV contrast
- Regular daily use of anticoagulants
- VAS Pain score of ≥4 on a 0 - 10 scale in the contralateral knee
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- 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 or allogeneic product) into the index knee within 3 months prior to screening.
- 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 subjects with conditions that would likely include treatment with immunosuppressive therapy (including corticosteroids) during the study period.
- 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 increase subject risk.
- 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 disorder, fibromyalgia, complex regional pain syndrome, clinical anxiety, clinical depression, any active infection including hepatitis B or C) that would jeopardize subject safety, limit participation, or compromise interpretation of data derived from the subject.
- 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 subjects and >470 msec in female subjects or any clinically significant ECG abnormality as judged by the Investigator.
- 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, limit the subject's ability to complete the study, and/or compromise the objectives of the study.
- Positive drug or alcohol screen.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Southern California
Los Angeles, California, 90033
Pui Yan, 323-442-6984, puiyan@med.usc.edu
Jay Lieberman, MD
About this study
Official title: Phase 1/2a Study to Evaluate the Safety and Tolerability Intra-articular CX-011 to Treat Moderate to Severe Pain From Knee Osteoarthritis
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.
Read the detailed description
The primary objective of the study is to assess the safety and tolerability of three escalating doses of CX-011 (100, 300, and 1000 μg) following a single intra-articular administration. Safety assessments will include the incidence and severity of local and systemic adverse events, procedure- and product-related serious adverse events, physical examinations, index knee evaluations, vital signs, electrocardiograms, and safety laboratory tests. Dose-limiting toxicities and the maximum tolerated dose will be determined based on these assessments.
Secondary objectives focus on evaluating the preliminary efficacy of CX-011 for the treatment of knee osteoarthritis pain and function, as well as further characterization of its safety profile. Efficacy endpoints include changes from baseline in pain intensity measured by the Visual Analog Scale (VAS) at 4, 12, and 24 weeks post-injection, as well as percentage improvements in the pain and function subscales of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at the same time points.
Up to 72 patients will participate in this study (in one study center). The expected length of participation in the study is about 28 weeks including the screening period.
- Conditions
- Osteoarthritis of the Knees
- Being tested
- CX-011
- Keywords
- OA, Knee, injectable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CX-011Drug
CX-011 is a hydrophobic small molecule for intra-articular (IA) administration that is being developed for the treatment of subjects with osteoarthritis of the knee.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: CX-011 |
| CX-011 low dose | Experimental | Not described Receives: Drug: CX-011 |
| CX-011 medium dose | Experimental | Not described Receives: Drug: CX-011 |
| CX-011 high dose | Experimental | Not described Receives: Drug: CX-011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine tolerability by monitoring the frequency of treatment-emergent adverse events
Tolerability will be measured by the incidence and severity of dose-limiting toxicity events as well as the incidence and severity of local and systemic adverse events (AEs)
Measured: 24 weeks
Composite safety profile of CX-011 based on change from baseline in clinical laboratory parameters
The incidence and severity of clinically-significant laboratory findings determined by change from baseline in blood chemistry, hematology and urinalysis as indicators of blood, liver and kidney function, respectively.
Measured: 24 weeks
Secondary outcomes (2)
Pain (Visual Analog Scale, VAS)
Determine the change from baseline to 4, 12 and 24 weeks in the Visual Analog Scale (VAS), with scores ranging from 0-100; lower scores represent better outcomes.
Measured: 24 weeks
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Determine the percent improvement in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain and function subscales at 4, 12 and 24 weeks. Scores for the pain subscale range from 0-20, while scores for the function subscale range from 0-68; lower scores reflect better outcomes.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start11 Aug 2026
- Primary completion30 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a one-center, prospective, randomized, double-blind, placebo-controlled, escalating three dose, Phase 1/2a study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CarthroniX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308834
- Sponsor's protocol ID
- CX011-2024-001
- Status last verified
- Aug 2026
- First submitted
- 22 Dec 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD in this study could represent proprietary information; once the study has been completed, the release of IPD will be re-evaluated.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2a Study to Evaluate the Safety and Tolerability Intra-articular CX-011 to Treat Moderate to Severe Pain From Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07308834
- Acronym / sponsor ID
- CX011-2024-001
- Conditions
- Osteoarthritis of the Knees
- Keywords
- OA, Knee, injectable
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- CarthroniX, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2026 (actual)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective of the study is to assess the safety and tolerability of three escalating doses of CX-011 (100, 300, and 1000 μg) following a single intra-articular administration. Safety assessments will include the incidence and severity of local and systemic adverse events, procedure- and product-related serious adverse events, physical examinations, index knee evaluations, vital signs, electrocardiograms, and safety laboratory tests. Dose-limiting toxicities and the maximum tolerated dose will be determined based on these assessments.
Secondary objectives focus on evaluating the preliminary efficacy of CX-011 for the treatment of knee osteoarthritis pain and function, as well as further characterization of its safety profile. Efficacy endpoints include changes from baseline in pain intensity measured by the Visual Analog Scale (VAS) at 4, 12, and 24 weeks post-injection, as well as percentage improvements in the pain and function subscales of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at the same time points.
Up to 72 patients will participate in this study (in one study center). The expected length of participation in the study is about 28 weeks including the screening period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This is a one-center, prospective, randomized, double-blind, placebo-controlled, escalating three dose, Phase 1/2a study
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: CX-011 |
| CX-011 low dose | Experimental | Drug: CX-011 |
| CX-011 medium dose | Experimental | Drug: CX-011 |
| CX-011 high dose | Experimental | Drug: CX-011 |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- 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 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 (>15 days) over the last month
Key exclusion criteria (34 listed)
- 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 intolerance of or allergic reaction to IV contrast
- Regular daily use of anticoagulants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CX-011CX-011 is a hydrophobic small molecule for intra-articular (IA) administration that is being developed for the treatment of subjects with osteoarthritis of the knee. | Drug | CX-011 high dose, CX-011 low dose, CX-011 medium dose, Placebo |
Primary outcome
Determine tolerability by monitoring the frequency of treatment-emergent adverse events
Time frame: 24 weeks
Tolerability will be measured by the incidence and severity of dose-limiting toxicity events as well as the incidence and severity of local and systemic adverse events (AEs)
Composite safety profile of CX-011 based on change from baseline in clinical laboratory parameters
Time frame: 24 weeks
The incidence and severity of clinically-significant laboratory findings determined by change from baseline in blood chemistry, hematology and urinalysis as indicators of blood, liver and kidney function, respectively.
2 secondary outcomes
Pain (Visual Analog Scale, VAS)
Time frame: 24 weeks
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Undecided. IPD in this study could represent proprietary information; once the study has been completed, the release of IPD will be re-evaluated.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CX-011 in people with Osteoarthritis of the Knees, run by CarthroniX, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine tolerability by monitoring the frequency of treatment-emergent adverse events (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.