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

NCT07308834 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CX011-2024-001
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Osteoarthritis of the Knees

Keywords

OA; Knee; injectable

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  24 weeks

Secondary Outcomes (2)

• Pain (Visual Analog Scale, VAS)

  24 weeks

• Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  24 weeks

Study Arms (4)

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

Interventions

CX-011 DRUG

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.

CX-011 high dose; CX-011 low dose; CX-011 medium dose; Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• hsCRP greater or equal 2 mg/L
• Body mass index less than 40 kg/m2
• If female, must not be pregnant or nursing and willing to refrain from becoming pregnant.
• Willing to agree not to use illicit drugs during the study, 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, including post-hospitalization, outpatient, and follow-up visits and ability to follow verbal and written instructions.

You may not qualify if:

• Daily use of assistive devices (e.g. cane or walker) or presence of comorbidities that would limit the patient'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 patient's claustrophobia
• Regular use of anticoagulants
• 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.
• Major dysplasias 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 patients with conditions that would likely include treatment with immunosuppressive therapy (including corticosteroids) during the study period.
• HbA1c \> 8% and/or insulin-dependent diabetes

Sponsors & Collaborators

• CarthroniX, Inc.: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a one-center, prospective, randomized, double-blind, placebo-controlled, escalating three dose, Phase 1/2a study

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: December 30, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 30, 2025

Record last verified: 2025-12